1996L0098 — EN — 28.11.1998 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCIL DIRECTIVE 96/98/EC
of 20 December 1996
on marine equipment
(OJ L 46, 17.2.1997, p. 25)
Amended by:
Official Journal
No page date
►M1Commission Directive 98/85/EC of 11 November 1998 L315 14 25.11.1998
Corrected by:
►C1Corrigendum, OJ L 246, 10.9.1997, p. 7 (96/98)
►C2Corrigendum, OJ L 241, 29.8.1998, p. 27 (96/98)
1996L0098 — EN — 28.11.1998 — 001.001 — 2
▼B
COUNCIL DIRECTIVE 96/98/EC
of 20 December 1996
on marine equipment
THE COUNCIL OF THE EUROPEAN UNION,
HavingregardtotheTreatyestablishingtheEuropeanCommunity,and
in particular Article 84 (2) thereof,
Having regard to the proposal from the Commission(1),
HavingregardtotheopinionoftheEconomicandSocialCommittee(2),
Acting in accordance with the procedure laid down in Article 189c of
the Treaty(3),
(1)Whereas within the framework of the common transport policyfurther measures must be adopted to ensure safety in maritimetransport;
(2)WhereasshippingaccidentsareamatterofseriousconcerntotheCommunity,inparticularthosethatcauselossofhumanlifeandpollution of the Member States’ seas and coastlines;
(3)Whereastheriskofshippingaccidentscanbeeffectivelyreducedby means of common standards that ensure high safety levels inthe performance of the equipment carried on board ships;whereas testing standards and testing methods can have greatinfluence on the future performance of equipment;
(4)Whereas international conventions require flag States to ensurethat the equipment carried on board ships complies with certainsafetyrequirementsandtoissuetherelevantcertificates;whereasto that end testing standards for certain types of marine equip-ment have been developed by the international standardizationbodies and by the International Maritime Organization (IMO);whereas the national testing standards implementing the inter-national standards leave a margin of discretion certificationauthorities, which themselves have different levels of qualifica-tions and experience; whereas that leads to varying levels ofsafetyforproductswhichthecompetentnationalauthoritieshavecertifiedascomplyingwiththerelevantinternationalsafetystan-dards and to great reluctance on the part of Member States toaccept that without further verification ships flying their flagscarry equipment approved by other Member States;
(5)Whereas common rules must be laid down to eliminate differ-ences in the implementation of international standards; whereassuch common rules will result in the elimination of unnecessarycosts and administrative procedures relating to the approval ofequipment, the improvement of operating conditions and of thecompetitivepositionofCommunityshippingandtheeliminationoftechnicalbarrierstotradebymeansofthemarkofconformityaffixed to equipment;
(6)Whereasinitsresolutionof8June1993onacommonpolicyonsafe seas(
4) the Council urged the Commission to submit
proposals for harmonizing the implementation of IMO standardsand the procedures for the approval of marine equipment;
(1) OJ No C 218, 23. 8. 1995, p. 9.
(2) OJ No C 101, 3. 4. 1996, p. 3.
(3) European Parliament opinion of 29 November 1995 (OJ No C 339, 18.
12. 1995, p. 21), Council common position of 18 June 1996 (OJ No C248, 26. 8. 1996, p. 10) and European Parliament Decision of 24 October1996 (OJ No C 347, 18. 11. 1996).
(
4) OJ No C 271, 7. 10. 1993, p. 1.
1996L0098 — EN — 28.11.1998 — 001.001 — 3
▼B
(7)Whereas action at Community level is the only possible way of
achieving such harmonization, since Member States acting inde-pendently or through international organizations cannot establishthe same level of safety performance in equipment;
(8)Whereas a Council Directive is the appropriate legal instrumentasitprovidesaframeworkforuniformandcompulsoryapplica-tion of the international testing standards by Member States;
(9)Whereas it is appropriate in the first place to address equipmentthecarriageofwhichonboardshipandtheapprovalofwhichbynational administrations in accordance with safety standards laiddown in international conventions or resolutions is mandatoryunder the main international conventions;
(10)Whereas there are various Directives that ensure the free move-ment of certain products which could be used inter alia,a s
equipmentonboardshipsbutwhichdonotconcerntheMemberStates’certificationofequipmentinaccordancewiththerelevantinternational conventions; whereas equipment to be placed onboard ships must therefore be regulated exclusively by newcommon rules;
(11)Whereas new testing standards must be laid down, preferably atinternationallevel,forequipmentforwhichsuchstandardsdonotalready exist or are not sufficiently detailed;
(12)Whereas Member States should ensure that the notified bodiesthat assess the compliance of equipment with testing standardsare independent, efficient and professionally competent to carryout their tasks;
(13)Whereascompliancewithinternationaltestingstandardscanbestbe demonstrated by means of conformity-assessment proceduressuch as those laid down in Council Decision 93/465/EEC of 22July 1993 concerning the modules for the various phases of theconformity-assessment procedures and the rules for the affixinganduseoftheCEconformitymarking,whichareintendedtobeused in the technical harmonization Directives(
1);
(14)Whereas nothing in this Directive restricts the right granted to aflagStateadministrationbyinternationalconventionstocarryoutoperational-performance tests on board a ship for which it hasissued a safety certificate, provided such tests do not duplicatethe conformity-assessment procedures;
(15)Whereas equipment covered by this Directive should, as ageneral rule, bear a mark to indicate its compliance with therequirement of this Directive;
(16)Whereas Member States may in certain cases take provisionalmeasures to limit or prohibit the use of equipment bearing themark of conformity;
(17)Whereas the use of equipment not bearing the mark ofconformity may be allowed in exceptional circumstances;
(18)Whereasasimplifiedprocedureinvolvingaregulatorycommitteemust be followed for the amendment of this Directive,
HAS ADOPTED THIS DIRECTIVE:
Article 1
ThepurposeofthisDirectiveshallbetoenhancesafetyatseaandthe
prevention of marine pollution through the uniform application of therelevantinternationalinstrumentsrelatingtoequipmentlistedinAnnexAtobeplacedonboardshipsforwhichsafetycertificatesareissuedby
(1) OJ No C 220, 30. 8. 1993, p. 23.
1996L0098 — EN — 28.11.1998 — 001.001 — 4
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oronbehalfofMemberStatespursuanttointernationalconventionsand
toensurethefreemovementofsuchequipmentwithintheCommunity.
Article 2
For the purposes of this Directive:
(a) ‘conformity-assessment procedures'shall mean the procedures set
out in Article 10 and Annex B;
(b) ‘equipment'shallmeanitemslistedinAnnexesA.1andA.2which
must be placed on board a ship for use in order to comply withinternationalinstrumentsorarevoluntarilyplacedonboardforuse,and for which the approval of the flag State administration isrequired according to international instruments;
▼
M1
(c) ‘radiocommunications equipment'shall mean equipment required
by Chapter IV of the 1974 SOLAS Convention, in the version inforceon1January1999,andsurvivalcrafttwo-wayVHFradiote-lephone apparatus required by Regulation III/6.2.1 of the sameConvention;
▼
B
(d) ‘international conventions'shall mean:
—►C2the 1966 International Convention ◄on Load Lines
(LL66),
— the 1972 Convention on the International Regulations for
Preventing Collisions at Sea (Colreg),
— the1973InternationalConventionforthePreventionofPollu-
tion from Ships (Marpol) and
— the1974InternationalConventionfortheSafetyofLifeatSea
(Solas),
together with their Protocols and the amendments thereto in force
on►M11 January 1999 ◄;
(e) ‘international instruments'shall mean the relevant international
conventions, the relevant resolutions and circulars of the Inter-national Maritime Organization (IMO), and the relevant inter-national testing standards;
(f) ‘mark'shallmeanthesymbolreferredtoinArticle11andsetout
in Annex D;
(g) ‘notified body'shall mean an organization designated by the
competentnationaladministrationofaMemberStateinaccordancewith Article 9;
(h) ‘placed on board'shall mean installed or placed on board a ship;
(i) ‘safety certificates'shall mean the certificates issued by or on
behalf of Member States in accordance with international conven-tions;
(j) ‘ship'shall mean a ship falling within the scope of international
conventions; warships shall not be covered;
(k) ‘Community ship'shall mean a ship for which safety certificates
are issued by or on behalf of Member States under internationalconventions. This definition shall not include a Member Stateadministration’s issuing a certificate for a ship at the request of athird country’s administration;
(l) ‘newship'shallmeanashipthekeelofwhichislaidorwhichis
at a similar stage of construction on or after the date of the entryinto force of this Directive. For the purposes of this definition, ‘asimilar stage of construction'shall mean the stage at which:
(i) construction identifiable with a specific ship begins
and
(ii) assembly of that ship has commenced, comprising at least
50tonnes or 1% of the estimated mass of all structuralmaterial, whichever is less;
1996L0098 — EN — 28.11.1998 — 001.001 — 5
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(m) ‘existing ship'shall mean a ship which is not a new ship;
(n) ‘testing standards'shall mean the standards set by
— the International Maritime Organization (IMO),
— the International Organization for Standardization (ISO),— the International Electrotechnical Commission (IEC),— the European Committee for Standardization (CEN),— the European Committee for Electrotechnical Standardization
(Cenelec)
and
— the European Telecommunication Standards Institute (ETSI)
in force on ►
M11 January 1999 ◄, and established in accord-
ancewiththerelevantinternationalconventionsandwiththerele-vant IMO resolutions and circulars to define testing methods andtest results, but only in the form referred to in Annex A;
(o) ‘type-approval'shall mean the procedures for evaluating equip-
mentproducedinaccordancewiththeappropriatetestingstandardsand the issue of the appropriate certificate.
Article 3
1. This Directive shall apply to equipment for use on board:
(a) a new Community ship whether or not the ship is situated within
the Community at the time of construction;
(b) an existing Community ship
— where such equipment was not previously carried on board
or
— where equipment which was previously carried on board the
ship is replaced, except where international conventions permitotherwise,
whetherornottheshipissituatedwithintheCommunitywhenthe
equipment is placed on board.
2. This Directive shall not apply to equipment which on the date of
theentryintoforceofthisDirectivehasalreadybeenplacedonboardaship.
3. Notwithstanding the fact that the equipment referred to in para-
graph1mayfallwithinthescopeofDirectivesotherthanthisDirectiveforthepurposeoffreemovement,andinparticularCouncilDirectives89/336/EEC of 3 May 1989 on the approximation of the laws of theMember States relating to electromagnetic compatibility(
1) and 89/
686/EECof21December1989ontheapproximationofthelawsoftheMemberStatesrelatingtopersonalprotectiveequipment(
2),thatequip-
ment shall be subject only to this Directive, to the exclusion of allothers for those purposes.
Article 4
Each Member State or the organizations acting on its behalf shall
ensure, when issuing or renewing the relevant safety certificates, thatthe equipment on board Community ships for which it issues safetycertificates complies with the requirements of this Directive.
Article 5
1. Equipment listed in Annex A.1that is placed on board a
Communityshiponorafterthedatereferredtointhesecondsubpara-graph of Article 20 (1) shall meet the applicable requirements of theinternational instruments referred to in that Annex.
(1) OJ No L 139, 23. 5. 1989, p. 19. Directive as last amended by Directive
93/68/EEC (OJ No L 220, 31. 8. 1993, p. 1).
(2) OJ No L 399, 30. 12. 1989, p. 18. Directive as last amended by Directive
93/95/EEC (OJ No L 276, 9. 11. 1993, p. 11).
1996L0098 — EN — 28.11.1998 — 001.001 — 6
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2. Thecomplianceofequipmentwiththeapplicablerequirementsof
the international conventions and of the relevant resolutions and circu-lars of the International Maritime Organization shall be demonstratedsolely in accordance with the relevant testing standards and theconformity-assessment procedures referred to in Annex A.1. For itemslisted in Annex A.1, where both IEC and ETSI testing standards aregiven, those standards shall be alternatives and a manufacturer or hisauthorizedrepresentativeestablishedwithintheCommunitymaydeter-mine which of them is to be used.
3. EquipmentlistedinAnnexA.1andmanufacturedbeforethedate
referred to in paragraph 1may also be placed on the market and onboardaCommunityshipthecertificatesofwhichwereissuedbyoronbehalfofaMemberStateinaccordancewithinternationalconventionsduring the two years following that date if it was manufactured inaccordance with procedures for type-approval already in force withintheterritoryofthatMemberStatebeforethedateoftheadoptionofthisDirective.
Article 6
1. No Member State shall prohibit the placing on the market or the
placingonboardaCommunityshipofequipmentreferredtoinAnnexA.1 which bears the mark or for other reasons complies with thisDirective or refuse to issue or renew the safety certificates relatingthereto.
2. Aradiolicenceshallbeissuedinaccordancewiththeinternational
radio regulations by the competent authority before the relevant safetycertificate is issued.
Article 7
1. After the date of the entry into force of this Directive, the
Community shall submit a request to the IMO or to the Europeanstandardization organizations, as appropriate, for the establishment ofstandards, including detailed testing standards, for the equipment listedin Annex A.2.
2. The request referred to in paragraph 1 shall be made:
— bythePresidencyoftheCouncilandbytheCommission,whenitis
submitted to the IMO,
— by the Commission, in accordance with Council Directive 83/
189/EECof28March1983layingdownaprocedurefortheprovi-sion of information in the field of technical standards and regula-tions(
1),whenitissubmittedtotheEuropeanstandardizationorgan-
izations.ThemandatesissuedbytheCommissionshallaimforthedevelopment of international standards through procedures forcooperation between the European bodies and their counterparts atinternational level.
3. Member States shall do their utmost to ensure that the inter-
national organizations, including the IMO, develop those standardsexpeditiously.
4. The Commission shall monitor the development of the testing
standards on a regular basis.
5. Should the international organizations, including the IMO, fail or
refuse to adopt appropriate testing standards for a specific item ofequipmentwithinareasonabletime,standardsbasedontheworkoftheEuropean standardization organizations may be adopted in accordancewith the procedure laid down in Article 18.
6. When the testing standards referred to in paragraphs 1 or 5 are
adopted or enter into force, as appropriate, for a specific item ofequipment, that equipment may be transferred from Annex A.2to
(1) OJ No L 109, 26. 4. 1983, p. 8. Directive as last amended by the 1994
Act of Accession.
1996L0098 — EN — 28.11.1998 — 001.001 — 7
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Annex A.1 in accordance with the procedure laid down in Article 18and, Article 5 shall apply from the date of that transfer.
Article 8
1. In the case of a new ship which, irrespective of its flag, is not
registeredinaMemberStatebutistobetransferredtotheregisterofaMemberState,suchashipshall,ontransfer,besubjecttoinspectionbythe receiving Member State to verify that the actual condition of itsequipmentcorrespondstoitssafetycertificatesandeithercomplieswiththisDirectiveandbearsthemarkorisequivalent,tothesatisfactionofthat Member State’s administration, to equipment type-approval inaccordance with this Directive.
2. Unlesstheequipmenteitherbearsthemarkorthatadministration
considers it to be equivalent, it shall be replaced.
3. EquipmentwhichisconsideredequivalentpursuanttothisArticle
shallbegivenacertificatebytheMemberStatewhichshallatalltimesbecarriedwiththeequipmentandwhichgivestheflagMemberState’spermission for the equipment to be placed on board the ship andimposesanyrestrictionsorlaysdownanyprovisionsrelatingtotheuseof the equipment.
4. In the case of radiocommunications equipment, the flag State
administrationshallrequirethatsuchequipmentdoesnotundulyaffectthe requirements of the radio-frequency spectrum.
Article 9
1. MemberStatesshallnotifytheCommissionandtheotherMember
Statesofthebodieswhichtheyhavedesignatedtocarryouttheproced-ures for in Article 10together with the specific tasks which thosenotifiedbodieshavebeendesignatedtocarryoutandtheidentificationnumbersassignedtothembeforehandbytheCommission.Eachorgan-ization shall submit to the Member State which intends to designate itcompleteinformationconcerning,andevidenceofcompliancewiththecriteria laid down in Annex C.
2. At least once every two years each Member State shall cause an
auditofthedutiesitsnotifiedbodiesareundertakingonitsbehalftobecarried out by the administration or by an impartial external organ-ization appointed by the administration. That audit shall ensure thateach notified body continues to comply with the criteria laid down inAnnex C.
3. A Member State which has designated a body shall withdraw its
designationifitfindsthatthatbodynolongercomplieswiththecriterialaiddowninAnnexC.ItshallimmediatelyinformtheCommissionandthe other Member States accordingly.
Article 10
1. The conformity-assessment procedure, details of which are listed
in Annex B, shall be:
(i) EC type-examination (module B) and, before equipment is placed
on the market and according to the choice made by the manufac-turer or his authorized representative established within theCommunity from the possibilities indicated in Annex A.1, allequipment shall be subject to:
(a) the EC declaration of conformity to type (module C);
(b) the EC declaration of conformity to type (production-quality
assurance) (module D);
(c) theECdeclarationofconformitytotype(product-qualityassur-
ance) (module E);
(d) the EC declaration of conformity to type (product verification)
(module F); or
1996L0098 — EN — 28.11.1998 — 001.001 — 8
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(ii) EC full-quality assurance (module H).
2. Thedeclarationofconformitytotypeshallbeinwrittenformand
shall give the information specified in Annex B.
3. Where sets of equipment are produced individually or in small
quantities and not in series or in mass, the conformity-assessmentprocedure may be the EC unit verification (module G).
4. The Commission shall keep an up-to-date list of approved equip-
mentandapplicationswithdrawnorrefusedandshallmakeitavailableto interested parties.
Article 11
1. Equipment referred to in Annex A.1 which complies with the
relevant international instruments and is manufactured in accordancewiththeconformity-assessmentproceduresshallhavethemarkaffixedto it by the manufacturer or his authorized representative establishedwithin the Community.
2. The mark shall be followed by the identification number of the
notified body which has performed the conformity-assessment proce-dure, if that body is involved in the production-control phase, and bythe last two digits of the number of the year in which the mark isaffixed.Theidentificationnumberofthenotifiedbodyshallbeaffixedunderitsresponsibilityeitherbythebodyitselforbythemanufactureror his authorized representative established within the Community.
3. The form of the mark to be used shall be as set out in Annex D.4. Themarkshallbeaffixedtotheequipmentortoitsdataplateso
as to be visible, legible and indelible throughout the anticipated usefullife of the equipment. However, where that is not possible or notwarrantedonaccountofthenatureofthepieceofequipment,itshallbeaffixed to the packaging of the product, to a label or to a leaflet.
5. Nomarksorinscriptionswhicharelikelytomisleadthirdparties
with regard to the meaning or the graphics of the mark referred to inthis Directive shall be affixed.
6. The mark shall be affixed at the end of the production phase.
Article 12
1. NotwithstandingArticle6,eachMemberStatemaytakethemeas-
ures necessary to ensure that sample checks are carried out on equip-ment bearing the mark which is on its market and which has not yetbeen placed on board, in order to ensure that it complies with thisDirective.SamplecheckswhicharenotprovidedforinthemodulesforconformityassessmentinAnnexBshallbecarriedoutattheexpenseofthe Member State.
2. Notwithstanding Article 6, after the installation of equipment
whichcomplieswiththisDirectiveonboardaCommunityship,evalu-ationbythatship’sflagStateadministrationofthatequipmentshallbepermittedwhenoperationalon-boardperformancetestsarerequiredbyinternational instruments for safety and/or pollution-preventionpurposes,providedthattheydonotduplicatetheconformity-assessmentprocedures already carried out. The flag State administration mayrequirethemanufactureroftheequipment,hisauthorizedrepresentativeestablished within the Community or the person responsible formarketing the equipment within the Community to provide the inspec-tion/testing reports.
Article 13
1. WhereaMemberStateascertainsbyinspectionorotherwisethat,
notwithstanding the fact that it bears the mark, a piece of equipmentreferredtoinAnnexA.1,whencorrectlyinstalled,maintainedandusedfor its intended purpose, may compromise the health and/or safety ofthe crew, the passengers or, where applicable, other persons, oradversely ►
C1affect the marine environment, it shall take all appro-
priate interim measures to withdraw that piece of equipment from the
1996L0098 — EN — 28.11.1998 — 001.001 — 9
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market◄orprohibitorrestrictitsbeingplacedonthemarketorbeing
used on board a ship for which it issues the safety certificates. TheMember State shall immediately inform the other Member States andtheCommissionofthatmeasureandindicatethereasonsforitsdecisionand,inparticular,whethernon-compliancewiththisDirectiveisdueto:
(a) failure to comply with Article 5 (1) and (2);
(b) incorrectapplicationofthetestingstandardsreferredtoinArticle5
(1) and (2); or
(c) shortcomings in the testing standards themselves.
2. The Commission shall enter into consultation with the parties
concerned as soon as possible. Where, after such consultation, theCommission finds that:
— the measures are justified, it shall immediately so inform the
Member State which took the initiative and the other MemberStates;wherethedecisionreferredtoinparagraph1isattributedtoshortcomings in the testing standards, the Commission shall, afterconsulting the parties concerned, bring the matter before theCommittee referred to in Article 18 within two months if theMember State which has taken the decision intends to maintain itand shall initiate the procedure referred to in Article 18,
— the measures are unjustified, it shall immediately so inform the
MemberStatewhichtooktheinitiativeandthemanufacturerorhisauthorized representative established within the Community.
3. Where a non-complying piece of equipment bears the mark, the
appropriate measures shall be taken by the Member State which hasauthority over whomsoever affixed the mark; that Member State shallinformtheCommissionandtheotherMemberStatesofthemeasuresithas taken.
4. The Commission shall ensure that the Member States are kept
informed of the progress and outcome of this procedure.
Article 14
1. Notwithstanding the provisions of Article 5, in exceptional
circumstancesoftechnicalinnovation,theflagStateadministrationmaypermit equipment which does not comply with the conformity-assess-ment procedures to be placed on board a Community ship if it isestablished by trial or otherwise to the satisfaction of the flag Stateadministrationthatsuchequipmentisatleastaseffectiveasequipmentwhich does comply with the conformity-assessment procedures.
In the case of radiocommunications equipment, the flag State adminis-
tration shall require that such equipment does not unduly affect therequirements of the radio-frequency spectrum.
2. Suchtrialproceduresshallinnowaydiscriminatebetweenequip-
ment produced in the flag Member State and equipment produced inother States.
3. Equipment covered by this Article shall be given a certificate by
the flag Member State which shall at all times be carried with theequipmentandwhichgivestheflagMemberState’spermissionfortheequipment to be placed on board the ship and imposes any restrictionsor lays down any provisions relating to the use of the equipment.
4. Where a Member State allows equipment covered by this Article
to be placed on board a Community ship, that Member State shallforthwith communicate the particulars thereof together with the reportsofallrelevanttrials,assessmentsandconformity-assessmentproceduresto the Commission and the other Member States.
5. Equipmentsuchasisreferredtoinparagraph1shallbeaddedto
Annex A.2 in accordance with the procedure laid down in Article 18.
6. Where a ship with equipment on board which is covered by
paragraph 1 is transferred to another Member State, the receiving flagMember State may undertake the measures necessary, which mayincludetestsandpracticaldemonstrations,toensurethattheequipment
1996L0098 — EN — 28.11.1998 — 001.001 — 10
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is at least as effective as equipment which does comply with theconformity-assessment procedures.
Article 15
1. NotwithstandingArticle5,aflagStateadministrationmaypermit
equipment which does not comply with the conformity-assessmentprocedures or is not covered by Article 14to be placed on board aCommunityshipforreasonsoftestingorevaluation,butonlywhenthefollowing conditions are complied with:
(a) theequipmentmustbegivenacertificatebytheflagMemberState
which must at all times be carried with the equipment and whichgives the flag Member State permission for the equipment to beplaced on board the Community ship and imposes any restrictionsor lays down any provisions relating to the use of the equipment;
(b) the permission must be limited to a short period of time;
(c) the equipment must not be relied on in place of equipment which
meetstherequirementsofthisDirectiveandmustnotreplacesuchequipment, which must remain on board the Community ship inworking and ready for immediate use.
2. In the case of radiocommunications equipment, the flag State
administrationshallrequirethatsuchequipmentdoesnotundulyaffectthe requirements of the radio-frequency spectrum.
Article 16
1. Where equipment needs to be replaced in a port outwith the
Communityandinexceptionalcircumstanceswhichshallbedulyjusti-fiedtotheflagStateadministrationwhereitisnotpracticableintermsofreasonabletime,delayandcosttoplaceonboardequipmentwhichisECtype-approved,otherequipmentmaybeplacedonboardinaccord-ance with the following procedure:
(a) theequipmentshallbeaccompaniedbydocumentationissuedbya
recognized organization equivalent to a notified body, where anagreement has been concluded between the Community and thethird country concerned on the mutual recognition of such organ-izations;
(b) shoulditproveimpossibletocomplywith(a),equipmentaccompa-
niedbydocumentationissuedbyaMemberStateoftheIMOwhichis a party to the relevant conventions, certifying compliance withtherelevantIMOrequirements,maybeplacedonboard,subjecttoparagraphs 2 and 3.
2. The flag State administration shall be informed at once of the
nature and characteristics of such other equipment.
3. The flag State administration shall, at the earliest opportunity,
ensure that the equipment referred to in paragraph 1, along with itstesting documentation, complies with the relevant requirements of theinternational instruments and of this Directive.
4. In the case of radiocommunications equipment, the flag State
administrationshallrequirethatsuchequipmentdoesnotundulyaffectthe requirements of the radio-frequency spectrum.
Article 17
This Directive may be amended in accordance with the procedure laid
down in Article 18, in order:
— toapplysubsequentamendmentsofinternationalinstrumentsforthe
purposes of this Directive,
— to update Annex A, both by introducing new equipment and by
transferring equipment from Annex A.2to Annex A.1 and viceversa,
— to add the possibility of using modules B + C and module H for
equipment listed in Annex A.1,
1996L0098 — EN — 28.11.1998 — 001.001 — 11
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— to include other standardization organizations in the definition of
‘testing standards'in Article 2.
Article 18
1. The Commission shall be assisted by the committee set up by
Article 12 of Council Directive 93/75/EEC of 13 September 1993concerning minimum requirements for vessels bound for or leavingCommunity ports and carrying dangerous or polluting goods(
1)i n
accordance with the procedure laid down in this Article.
2. The Commission representative shall submit to the committee a
draft of the measures to be taken. The committee shall deliver itsopinion on the draft within a time limit which the chairman may laydown according to the urgency of the matter. The opinion shall bedeliveredbythemajoritylaiddowninArticle148(2)oftheTreatyinthe case of decisions which the Council is required to adopt on aproposal from the Commission. The votes of the representatives of theMember States within the committee shall be weighted in the mannerset out in that Article. The chairman shall not vote.
3. (a) TheCommissionshalladoptthemeasuresenvisagediftheyare
in accordance with the opinion of the committee.
(b) Ifthemeasuresenvisagedarenotinaccordancewiththeopinion
ofthecommittee,orifnoopinionisdelivered,theCommissionshall,withoutdelay,submittotheCouncilaproposalrelatingtothe measures to be taken. The Council shall act by a qualifiedmajority.
IftheCouncilhasnotactedwithintwomonthsofthedateofthe
referraltoit,theCommissionshalladoptthemeasuresproposed.
Article 19
TheMemberStatesshalloffereachothermutualassistancewithaview
to the effective implementation and enforcement of this Directive.
Article 20
1. Member States shall adopt and publish the laws, regulations and
administrative provisions necessary to comply with this Directive nolater than 30 June 1998.
They shall apply those measures from 1 January 1999.When Member States adopt the measures referred to in the first
subparagraph,theseshallcontainreferencestothisDirectiveorshallbeaccompanied by such references on their official publication. Themethods of making such references shall be laid down by the MemberStates.
2. The Member States shall immediately communicate to the
Commission the texts of the provisions of national law which theyadopt in the field governed by this Directive. The Commission shallinform the other Member States thereof.
Article 21
ThisDirectiveshallenterintoforceonthedayofitspublicationinthe
Official Journal of the European Communities .
Article 22
This Directive is addressed to the Member States.
(1) OJ No L 247, 5. 10. 1993, p. 19.
1996L0098 — EN — 28.11.1998 — 001.001 — 12▼M1
RegulationSOLAS74,asamended,ApplicableregulationsofSOLAS74, Modulesforconformityassessment
ItemNo Itemdesignationwhere‘type-approval'isrequiredasamended,andtherelevantresolu-
tionsandcircularsoftheIMO(1)Testingstandards(2)
B+CB+DB+EB+FGHANNEXA
Annex A.1: Equipment for which detailed testing standards already exist in international instruments(*)
IN ADDITION TO THE TESTING STANDARDS SPECIFICALLY MENTIONED, A NUMBER OF PROVISIONS, WHICH MUST BE CHECKED DURING TYPE-EXAMINATION (TYPE
APPROVAL) AS REFERRED TO IN THE MODULES FOR CONFORMITY ASSESSMENT IN ANNEX B, ARE TO BE FOUND IN THE APPLICABLE REQUIREMENTS OF THE
INTERNATIONAL CONVENTIONS AND THE RELEVANT RESOLUTIONS AND CIRCULARS OF THE IMO
1.Life-saving appliances
A.1/1.1 Lifebuoys RegulationIII/4 RegulationIII/7.1&III/34,
IMOResolutionMSC48(66)IMOResolutionA.689(17)as
amendedbyIMOResolution
MSC.54(66)×××
A.1/1.2 Position-indicatinglightsfor
life-savingappliancesRegulationIII/4 RegulationIII/7.1.3,III/22.3.1,
III/32.2.2&III/34,
IMOResolutionMSC48(66)IMOResolutionA.689(17)as
amendedbyIMOResolution
MSC.54(66)×××
A.1/1.3 Life-buoysself-activating
smokesignalsRegulationIII/4 RegulationIII/7.1&III/34,
IMOResolutionMSC48(66)IMOResolutionA.689(17)as
amendedbyIMOResolution
MSC.54(66)×××
A.1/1.4 Lifejackets RegulationIII/4 RegulationIII/7.2&III/34,
IMOResolutionMSC48(66)IMOResolutionA.689(17)as
amendedbyIMOResolution
MSC.54(66),
EN394,
EN396+A1,
EN399+A1×××
A.1/1.5 Immersionsuitsandanti-
exposuresuitsRegulationIII/4 RegulationIII/7.3&III/34,
IMOResolutionMSC48(66)IMOResolutionA.689(17)as
amendedbyIMOResolution
MSC.54(66)×××
(*) Where module H appears in column six, module H plus design-examination certifi-
cate is to be understood.
1996L0098 — EN — 28.11.1998 — 001.001 — 13▼M1
RegulationSOLAS74,asamended,ApplicableregulationsofSOLAS74, Modulesforconformityassessment
ItemNo Itemdesignationwhere‘type-approval'isrequiredasamended,andtherelevantresolu-
tionsandcircularsoftheIMO(1)Testingstandards(2)
B+CB+DB+EB+FGH
A.1/1.6 Immersionsuitsandanti-
exposuresuitsclassifiedaslifejacketsRegulationIII/4 RegulationIII/7.3&III/34,
IMOResolutionMSC48(66)IMOResolutionA.689(17)as
amendedbyIMOResolutionMSC.54(66)×××
A.1/1.7 Thermalprotectiveaids RegulationIII/4 RegulationIII/22.4,III/32.3&III/34,
IMOResolutionMSC48(66)IMOResolutionA.689(17)as
amendedbyIMOResolutionMSC.54(66)×××
A.1/1.8 Rocketparachuteflares(pyro-technics) RegulationIII/4 RegulationIII/6.3&III/34,
IMOResolutionMSC48(66)IMOResolutionA.689(17)as
amendedbyIMOResolutionMSC.54(66)× ×
A.1/1.9 Handflares(pyrotechnics) RegulationIII/4 RegulationIII/34,
IMOResolutionMSC48(66)IMOResolutionA.689(17)as
amendedbyIMOResolutionMSC.54(66)× ×
A.1/1.10 Buoyantsmokesignals(pyro-technics) RegulationIII/4 RegulationIII/34,
IMOResolutionMSC48(66)IMOResolutionA.689(17)as
amendedbyIMOResolutionMSC.54(66)× ×
A.1/1.11 Line-throwingappliances(pyrotechnics) RegulationIII/4 RegulationIII/18&III/34,
IMOResolutionMSC48(66)IMOResolutionA.689(17)as
amendedbyIMOResolutionMSC.54(66)× ×
A.1/1.12 Inflatablelife-rafts RegulationIII/4 RegulationIII/21,III/31&III/34,
IMOResolutionMSC48(66)IMOResolutionA.689(17)as
amendedbyIMOResolutionMSC.54(66)×
A.1/1.13 Rigidlife-rafts RegulationIII/4 RegulationIII/21,III/31&III/34,
IMOResolutionMSC48(66)IMOResolutionA.689(17)as
amendedbyIMOResolutionMSC.54(66)×
A.1/1.14 Automaticallyself-rightinglife-rafts RegulationIII/4&III/26.2.4 RegulationIII/26.2&III/34,
IMOResolutionMSC48(66),IMOMSCCircular/809IMOResolutionA.689(17)as
amendedbyIMOResolutionMSC.54(66)andmodifiedbytheAppendixtoMSCCircular/809(
3)×
1996L0098 — EN — 28.11.1998 — 001.001 — 14▼M1
RegulationSOLAS74,asamended,ApplicableregulationsofSOLAS74, Modulesforconformityassessment
ItemNo Itemdesignationwhere‘type-approval'isrequiredasamended,andtherelevantresolu-
tionsandcircularsoftheIMO(1)Testingstandards(2)
B+CB+DB+EB+FGH
A.1/1.15 Canopiedreversiblelife-rafts RegulationIII/4&III/26.2.4 RegulationIII/26.2&III/34,
IMOResolutionMSC48(66),IMOMSCCircular/809IMOResolutionA.689(17)as
amendedbyIMOResolutionMSC.54(66)andmodifiedbytheAppendixtoMSCCircular/809(
3)×
A.1/1.16 Float-freearrangementsforlife-rafts(hydrostaticreleaseunits) RegulationIII/4 RegulationIII/13.4&III/34,
IMOResolutionMSC48(66),IMOMSCCircular/811IMOResolutionA.689(17)as
amendedbyIMOResolutionMSC.54(66)×××
A.1/1.17 Lifeboats RegulationIII/4 RegulationIII/21,III/31&III/34,
IMOResolutionMSC48(66)IMOResolutionA.689(17)as
amendedbyIMOResolutionMSC.54(66)× ×
A.1/1.18 Rigidrescueboats RegulationIII/4 RegulationIII/21,III/31&III/34,
IMOResolutionMSC48(66)IMOResolutionA.689(17)as
amendedbyIMOResolutionMSC.54(66)× ×
A.1/1.19 Inflatedrescueboats RegulationIII/4 RegulationIII/21,III/31&III/34,
IMOResolutionMSC48(66)IMOResolutionA.689(17)as
amendedbyIMOResolutionMSC.54(66)× ×
A.1/1.20 Fastrescueboats RegulationIII/4&III/26.3.1 RegulationIII/26.3&III/34,
IMOResolutionMSC48(66),IMOMSCCircular/809IMOResolutionA.689(17)as
amendedbyIMOResolutionMSC.54(66)andmodifiedbytheAppendixtoMSCCircular/809(
3)× ×
A.1/1.21 Launchingappliancesusingfallandwinch(davits) RegulationIII/4 RegulationIII/23,III/33&III/34,
IMOResolutionMSC48(66)IMOResolutionA.689(17)as
amendedbyIMOResolutionMSC.54(66)××××
A.1/1.22 Float-freelaunchingappliancesforsurvivalcraft RegulationIII/4 RegulationIII/34,
IMOResolutionMSC48(66)IMOResolutionA.689(17)as
amendedbyIMOResolutionMSC.54(66)×××
1996L0098 — EN — 28.11.1998 — 001.001 — 15▼M1
RegulationSOLAS74,asamended,ApplicableregulationsofSOLAS74, Modulesforconformityassessment
ItemNo Itemdesignationwhere‘type-approval'isrequiredasamended,andtherelevantresolu-
tionsandcircularsoftheIMO(1)Testingstandards(2)
B+CB+DB+EB+FGH
A.1/1.23 Launchingappliancesforfree-
falllifeboatsRegulationIII/4 RegulationIII/34,
IMOResolutionMSC48(66)IMOResolutionA.689(17)as
amendedbyIMOResolutionMSC.54(66)×
A.1/1.24 Life-raftlaunchingappliances RegulationIII/4 RegulationIII/34,
IMOResolutionMSC48(66)IMOResolutionA.689(17)as
amendedbyIMOResolutionMSC.54(66)××××
A.1/1.25 Fastrescueboatlaunchingappliances RegulationIII/4&III/26.3.2 RegulationIII/26.3&III/34,
IMOResolutionMSC48(66),IMOMSCCircular/809IMOResolutionA.689(17)as
amendedbyIMOResolutionMSC.54(66)andmodifiedbytheAppendixtoMSCCircular/809(
3)×××
A.1/1.26 Releasemechanismforlife-boats,rescueboatsandlife-raftslaunchedbyafallorfalls RegulationIII/4 RegulationIII/34,
IMOResolutionMSC48(66)IMOResolutionA.689(17)as
amendedbyIMOResolutionMSC.54(66)×××
A.1/1.27 Marineevacuationsystems RegulationIII/4 RegulationIII/34,
IMOResolutionMSC48(66)IMOResolutionA.689(17)as
amendedbyIMOResolutionMSC.54(66)× ×
A.1/1.28 Meansofrescue RegulationIII/4 RegulationIII/26.4&III/34,
IMOResolutionMSC48(66),IMOMSCCircular/810IMOResolutionA.689(17)as
amendedbyIMOResolutionMSC.54(66),
MSCCircular/810(section3)×
A.1/1.29 Embarkationladders RegulationIII/4 RegulationIII/34,IMOResolutionMSC48(66) IMOResolutionA.689(17)as
amendedbyIMOResolutionMSC.54(66)×××
A.1/1.30 Retro-reflectivematerials RegulationIII/4 RegulationIII/34,
IMOResolutionMSC48(66)IMOResolutionA.658(16)Annex2 ×××
A.1/1.31 Survivalcrafttwo-wayVHF
radiotelephoneapparatusRegulationIII/4 RegulationIII/6.2.1,
IMOResolutionA.694(17),IMOResolutionA.809(19),IMOResolutionA.813(19)ETS300162,ETS300225,EN300828,EN60945;IEC61097-12,IEC60945 ××××
1996L0098 — EN — 28.11.1998 — 001.001 — 16▼M1
RegulationSOLAS74,asamended,ApplicableregulationsofSOLAS74, Modulesforconformityassessment
ItemNo Itemdesignationwhere‘type-approval'isrequiredasamended,andtherelevantresolu-
tionsandcircularsoftheIMO(1)Testingstandards(2)
B+CB+DB+EB+FGH
A.1/1.32 9GHzSARtransponder
(SART)RegulationIII/4,IV/14&X/3 RegulationIII/6.2.2,IV/7.1.3,X/3,
IMOResolutionA.530(13),IMOResolutionA.694(17),IMOResolutionA.802(19),IMOResolutionA.813(19),ITU-RM.628-2EN61097-1,EN60945-3;IEC61097-1,IEC60945 ××××
A.1/1.33 Radarreflectorforlifeboats
andrescueboatsRegulationIII/4 RegulationIII/34,
IMOResolutionMSC48(66)IMOResolutionA.384(X),EN8729;ISO8729 ××××
A.1/1.34 Compassforlifeboatsand
rescueboatsRegulationIII/4 RegulationIII/34,
IMOResolutionMSC48(66)ISO613,ISO10316 ××××
A.1/1.35 Portablefire-extinguishing
equipmentforlifeboatsandrescueboatsRegulationIII/4 RegulationIII/34,
IMOResolutionMSC48(66),IMOResolutionA.602(15)EN3-1/A1,3-2,3-3,3-4,3-5,
3-6×××
A.1/1.36 Lifeboatpropulsionengine RegulationIII/4 RegulationIII/34,
IMOResolutionMSC48(66)IMOResolutionA.689(17)as
amendedbyIMOResolutionMSC.54(66)×××
A.1/1.37 Rescueboatpropulsionengine RegulationIII/4 RegulationIII/34,
IMOResolutionMSC48(66)IMOResolutionA.689(17)as
amendedbyIMOResolutionMSC.54(66)×××
(1) ITU Recommendations cited are those referred to in the international conventions and the relevant resolutions and circulars of the IMO.
(2) Where IMO Resolutions are cited, only the testing standards contained in relevant parts of the Annexes to the Resolutions are applicable and exclude the provisions of the Resolutions themselves.
(3) The modification by the Appendix to MSC Circ./809 is only applicable if the equipment is to be fitted on ro-ro passenger ships.
1996L0098 — EN — 28.11.1998 — 001.001 — 17▼M1
RegulationMarpol73/78asamendedApplicableregulationMarpol73/78,as Modulesforconformityassessment
ItemNo Itemdesignationwhere‘type-approval'isrequiredamended,andtherelevantresolutions
andcircularsoftheIMOTestingstandards(1)
B+CB+DB+E2B+FGH2.Marine-pollution prevention
A.1/2.1 Oil-filteringequipment(foran
oilcontentoftheeffluentnot
exceeding15p.p.m.)AnnexI,Regulation16(4),(5)
&(7)AnnexI,Regulation16(1)&
(2)MEPC60(33) ×××
A.1/2.2 Oil/waterinterfacedetectors AnnexI,Regulation15(3)(b) AnnexI,Regulation15(3)(b) MEPC5(XIII) ×××
A.1/2.3 Oil-contentmeters AnnexI,Regulation16(5) AnnexI,Regulation16(2) MEPC60(33) ×××
A.1/2.4 Processunitsintendedfor
attachmenttoexistingoily
waterseparatingequipment(for
anoilcontentoftheeffluent
notexceeding15p.p.m.)AnnexI,Regulation16(5) AnnexI,Regulation16(5) IMOResolutionA.444(XI)
MEPC60(33)×××
A.1/2.5 Oildischargemonitoringand
controlsystemforanoiltankerAnnexI,Regulation15(3) AnnexI,Regulation15(3) IMOResolutionA.586(14) ×××
A.1/2.6 Sewagetreatmentplants AnnexIV,Regulation8(b) AnnexIV,Regulation8(b) MEPC2(VI) ××××
A.1/2.7 Shipboardincinerators AnnexVI,Regulation16(2) AnnexVI,Regulation16(2) MEPC76(40) ××××
(1) Where IMO Resolutions are cited, only the testing standards contained in relevant parts of the Annexes to the Resolutions are applicable and exclude the provisions of the Resolutions themselves.
1996L0098 — EN — 28.11.1998 — 001.001 — 18▼M1
RegulationSOLAS74,asamended,ApplicableregulationsofSOLAS74, Modulesforconformityassessment
ItemNo Itemdesignationwhere‘type-approval'isrequiredasamended,andtherelevantresolu-
tionsandcircularsoftheIMOTestingstandards(1)
B+CB+DB+EB+FGH3.Fire protection
A.1/3.1 Primarydeckcoverings RegulationII-2/34.8,II-2/49.3 RegulationII-2/34.8,II-2/49.3 IMOResolutionA.687(17),
IMOMSC/Circular549,
IMOResolutionMSC61(67)
Annex1,Parts 2&6and
Annex2×
A.1/3.2 Portablefireextinguishers RegulationII-2/6.1 RegulationII-2/6,
IMOResolutionA.602(15)EN3-1/A1,3-2,3-3,3-4,3-5,
3-6×××
A.1/3.3 Fireman’soutfit:protective
clothingRegulationII-2/17.1.1.1 RegulationII-2/17.1.1.1 EN366,EN469orEN531,
EN532,EN20811×
A.1/3.4 Fireman’soutfit:boots RegulationII-2/17.1.1.2 RegulationII-2/17.1.1.2 EN344,EN344-2,EN345,
EN345-2×
A.1/3.5 Fireman’soutfit:gloves RegulationII-2/17.1.1.2 RegulationII-2/17.1.1.2 EN659 ×
A.1/3.6 Fireman’soutfit:helmet RegulationII-2/17.1.1.3 RegulationII-2/17.1.1.3 EN443 ×
A.1/3.7 Self-containedcompressed-air-
operatedbreathingapparatusRegulationII-2/17.1.2 RegulationII-2/17.1.2.2 EN137 ×
A.1/3.8 Air-suppliedbreathingappa-
ratusforusewithasmoke
helmetorsmokemaskRegulationII-2/17.1.2 RegulationII-2/17.1.2.1 EN138,EN139 ×
A.1/3.9 Sprinklersystemsequivalentto
thatreferredtoinSOLAS
RegulationII-2/12RegulationII-2/36.1.2,II-2/
36.2,II-2/41-2.5RegulationII-2/12,II-2/36.1.2,
II-2/36.2,II-2/41-2.5IMOResolutionA.800(19) × ×
A.1/3.10 Nozzlesforfixedpressure
water-sprayingfire-extin-
guishingsystemsformachinery
spacesRegulationII-2/10.1 RegulationII-2/10.1 IMOMSCCircular/668as
amendedbyIMOMSC
Circular/728×××
1996L0098 — EN — 28.11.1998 — 001.001 — 19▼M1
RegulationSOLAS74,asamended,ApplicableregulationsofSOLAS74, Modulesforconformityassessment
ItemNo Itemdesignationwhere‘type-approval'isrequiredasamended,andtherelevantresolu-
tionsandcircularsoftheIMOTestingstandards(1)
B+CB+DB+EB+FGH
A.1/3.11 ‘A'and‘B',Classdivisions,fire
integrityRegulationII-2/3.3.5,II-2/3.4.4 RegulationII-2/3.3.5,II-2/16.11,II-2/3.4.4 IMOResolutionA754(18),
IMOResolutionMSC.61(67)Annex1,Part3andAnnex2×××
A.1/3.12 Devicestopreventthepassage
offlameintothecargotanksinoiltankersRegulationII-2/59.1.5,II-2/59.1.4,II-2/59.2 RegulationII-2/59.1.5,II-2/59.1.4,II-2/59.2 IMOMSC/Circular450/Rev.1
IMOMSC/Circular677×××
A.1/3.13 Non-combustiblematerials
usedin‘A',‘B'and‘C'classdivisionsRegulationII-2/3.1,II-2/3.3.4,II-2/3.4.3,II-2/3.5 RegulationII-2/3.1,II-2/3.3.4,II-2/3.4.3,II-2/3.5 IMOResolutionA799(19),
IMOResolutionMSC.61(67)Annex1,Part1andAnnex2×××
A.1/3.14 Materialsotherthansteelfor
pipespenetrating‘A'or‘B'classdivisionsRegulationII-2/3.3.5,II-2/3.4.4,II-2/18.2.1 RegulationII-2/18.2.1 IMOResolutionA753(18),
IMOResolutionA754(18),IMOResolutionMSC.61(67)Annex1,Part3×××
A.1/3.15 Materialsotherthansteelfor
pipesconveyingoilorfueloilRegulationII-2/3.3.5,II-2/18.2.2 RegulationII-2/18.2.2 IMOResolutionA753(18) ×××
A.1/3.16 Firedoors RegulationII-2/3.3.5,II-2/3.4.4,II-2/30.2,II-2/31.1,II-2/47 RegulationII-2/30.2,II-2/31.1,II-2/47 IMOResolutionA754(18),
IMOResolutionMSC.61(67)Annex1,Part3×××
A.1/3.17 Firedoorcontrolsystems RegulationII-2/30.4.15 RegulationII-2/30.4.15 IMOResolutionA754(18),IMOResolutionMSC.61(67)Annex1,Part4 ×××
A.1/3.18 Surfacematerialsandfloor
coveringswithlowflame-spreadcharacteristicsRegulationII-2/3.8,II-2/34.7,II-2/49.2 RegulationII-2/3.8,II-2/3.23.4,II-2/3.23.5,II-2/16.1.1,II-2/32.1.4.3.1,II-2/34.2,II-2/34.3,II-2/49.1,II-2/50.3.1 IMOResolutionA653(16),
IMOResolutionMSC.61(67)Annex1,Parts 2&5and
Annex2ISO1716(
2)×××
A.1/3.19 Draperies,curtainsandothersuspendedtextilematerialsandfilms RegulationII-2/3.23.3 RegulationII-2/3.23.3 IMOResolutionMSC.61(67)
Annex1,Part7×××
1996L0098 — EN — 28.11.1998 — 001.001 — 20▼M1
RegulationSOLAS74,asamended,ApplicableregulationsofSOLAS74, Modulesforconformityassessment
ItemNo Itemdesignationwhere‘type-approval'isrequiredasamended,andtherelevantresolu-
tionsandcircularsoftheIMOTestingstandards(1)
B+CB+DB+EB+FGH
A.1/3.20 Upholsteredfurniture RegulationII-2/3.23.6 RegulationII-2/3.23.6,II-2/34 IMOResolutionA652(16),
IMOResolutionMSC.61(67)Annex1,Part8×××
A.1/3.21 Beddingcomponents RegulationII-2/3.23.7 RegulationII-2/3.23.7,II-2/34 IMOResolutionA688(17),IMOResolutionMSC.61(67)Annex1,Part9 ×××
A.1/3.22 Firedampers RegulationII-2/3.3.5,II-2/
16.11RegulationII-2/16,II-2/32,II-2/48 IMOResolutionA.754(18),
IMOResolutionMSC.61(67)Annex1,Part3andAnnex2×××
A.1/3.23 Non-combustibleductpenetra-
tionsthrough‘A'classdivi-sionsRegulationII-2/3.3.5,II-2/16.11,II-2/18.1.1 RegulationII-2/16,II-2/32,II-2/48 IMOResolutionA.754(18),
IMOResolutionMSC.61(67)Annex1,Part3andAnnex2×××
A.1/3.24 Electriccabletransitsthrough
‘A'classdivisionsRegulationII-2/3.3.5,II-2/18.1.1,II-2/18.1.2 RegulationII-2/18.1.1,II-2/18.1.2 IMOResolutionA.754(18),
IMOResolutionMSC.61(67)Annex1,Part3andAnnex2×××
A.1/3.25 Windowsandsidescuttles RegulationII-2/3.3.5,II-2/33 RegulationII-2/33 IMOResolutionA.754(18),IMOResolutionMSC.61(67)Annex1,Part3andAnnex2,MSCCircular/727 ×××
(1) Where IMO Resolutions are cited, only the testing standards contained in relevant parts of the Annexes to the Resolutions are applicable and exclude the provisions of the Resolutions themselves.
(2) Where the surface material is required to have a certain maximum calorific value, this shall be measured in accordance with ISO 1716.
1996L0098 — EN — 28.11.1998 — 001.001 — 21▼M1
RegulationSOLAS74asamendedApplicableregulationsofSOLAS74, Modulesforconformityassessment
ItemNo Itemdesignationwhere‘type-approval'isrequiredasamended,andtherelevantresolu-
tionsandcircularsoftheIMO(1)Testingstandards(2)
B+CB+DB+EB+FGH4.Navigation equipment
A.1/4.1 Magneticcompass RegulationV/12(r),
RegulationX/3RegulationV/12(b),
RegulationX/3,
IMOResolutionA.382(X),
IMOResolutionA.694(17)EN61162-1,EN60945,ISO
449,ISO613,ISO694,ISO
1069,ISO2269,ISO10316××××
A.1/4.2 Electromagneticcompass RegulationV/12(r),
RegulationX/3RegulationV/12(b),
RegulationX/3,
IMOResolutionA.694(17),
IMOResolutionA.813(19)EN61162-1,EN60945
ISO11606,IEC60945××××
A.1/4.3 Gyrocompass RegulationV/12(r) RegulationV/12(d),
IMOResolutionA.424(XI),
IMOResolutionA.694(17),
IMOResolutionA.813(19)EN61162-1,EN60945,EN
8728;
IEC61162-1,IEC60945,ISO
8728××××
A.1/4.4 RadarEquipment RegulationV/12(r) RegulationV/12(g),
RegulationV/12(h),
IMOResolutionA.477(XII),
IMOResolutionA.694(17),
IMOResolutionA.813(19),
IMOResolutionMSC64(67)
Annex4EN60936,EN60945,EN
61162-1;
IEC60936,IEC60945,IEC
61162-1××××
A.1/4.5 Automaticradarplottingaid
(ARPA)RegulationV/12(r) RegulationV/12(j),
IMOResolutionA.422(XI),
IMOResolutionA.694(17),
IMOResolutionA.813(19),
IMOResolutionA.823(19)EN60872,EN60945,EN
61162-1;
IEC60872,IEC60945,IEC
61162-1××××
A.1/4.6 Echosoundingequipment RegulationV/12(r),
RegulationX/3RegulationV/12(k),
RegulationX/3,
IMOResolutionA.224(VII),
IMOResolutionA.694(17),
IMOResolutionA.813(19),EN9875,EN61162-1,
EN60945;
ISO9875,IEC61162-1,IEC
60945××××
1996L0098 — EN — 28.11.1998 — 001.001 — 22▼M1
RegulationSOLAS74asamendedApplicableregulationsofSOLAS74, Modulesforconformityassessment
ItemNo Itemdesignationwhere‘type-approval'isrequiredasamended,andtherelevantresolu-
tionsandcircularsoftheIMO(1)Testingstandards(2)
B+CB+DB+EB+FGH
IMOResolutionMSC74(69)
Annex4
A.1/4.7 Devicetoindicatespeedanddistance RegulationV/12(r),
RegulationX/3RegulationV/12(1),RegulationX/3,IMOResolutionA.478(XII),IMOResolutionA.694(17),IMOResolutionA.813(19),IMOResolutionA.824(19) EN61023,EN61162-1,EN
60945;
IEC61023,IEC61162-1,IEC
60945××××
A.1/4.8 Rudderangle,rpm,pitchindi-cator RegulationV/12(r), RegulationV/12(m),
IMOResolutionA.694(17),IMOResolutionA.813(19)EN60945;IEC60945 ××××
A.1/4.9 Rate-of-turnindicator RegulationV/12(r),RegulationX/3 RegulationV/12(n),RegulationX/3,IMOResolutionA.526(13),IMOResolutionA.694(17),IMOResolutionA.813(19) EN61162-1,EN60945;IEC61162-1,IEC60945 ××××
A.1/4.10 Directionfinder RegulationV/12(r),RegulationX/3 RegulationV/12(p),RegulationX/3,IMOResolutionA.529(13),IMOResolutionA.665(16),IMOResolutionA.694(17),IMOResolutionA.813(19) EN60945;IEC60945 ××××
A.1/4.11 Loran-Cequipment RegulationV/12(r),RegulationX/3 RegulationV/12(p),RegulationX/3,IMOResolutionA.529(13),IMOResolutionA.694(17),IMOResolutionA.813(19),IMOResolutionA.818(19) EN61075,EN61162-1,EN
60945;
IEC61075,IEC61162-1,IEC
60945××××
1996L0098 — EN — 28.11.1998 — 001.001 — 23▼M1
RegulationSOLAS74asamendedApplicableregulationsofSOLAS74, Modulesforconformityassessment
ItemNo Itemdesignationwhere‘type-approval'isrequiredasamended,andtherelevantresolu-
tionsandcircularsoftheIMO(1)Testingstandards(2)
B+CB+DB+EB+FGH
A.1/4.12 Chaykaequipment RegulationV/12(r),
RegulationX/3RegulationV/12(p),RegulationX/3,IMOResolutionA.529(13),IMOResolutionA.694(17),IMOResolutionA.813(19),IMOResolutionA.818(19) EN61075,EN61162-1,EN
60945;
IEC61075,IEC61162-1,IEC
60945××××
A.1/4.13 Deccanavigatorequipment RegulationV/12(r),
RegulationX/3RegulationV/12(p),RegulationX/3,IMOResolutionA.529(13),IMOResolutionA.694(17),IMOResolutionA.813(19),IMOResolutionA.816(19) EN61135,EN61162-1,EN
60945;
IEC61135,IEC61162-1,IEC
60945××××
A.1/4.14 GPSequipment RegulationV/12(r),
RegulationX/3RegulationV/12(p),RegulationX/3,IMOResolutionA.529(13),IMOResolutionA.694(17),IMOResolutionA.813(19),IMOResolutionA.819(19) EN61108-1,EN61162-1,EN
60945;
IEC61108-1,IEC61162-1,
IEC60945××××
A.1/4.15 GLONASSequipment RegulationV/12(r),
RegulationX/3RegulationV/12(p),RegulationX/3,IMOResolutionA.529(13),IMOResolutionA.694(17),IMOResolutionA.813(19),IMOResolutionMSC.53(66) EN61108-2,EN61162-1,EN
60945;
IEC61108-2,IEC61162-1,
IEC60945××××
A.1/4.16 Auto-pilot(headingcontrolsystem) RegulationV/19 RegulationV/19,
IMOResolutionA.342(IX),as
amendedbyIMOResolutionMSC64(67)Annex3,
IMOResolutionA.694(17),IMOResolutionA.813(19)ISO/TR11674,EN61162-1,
EN60945;
ISO/TR11674,IEC61162-1,
IEC60945××××
1996L0098 — EN — 28.11.1998 — 001.001 — 24▼M1
RegulationSOLAS74asamendedApplicableregulationsofSOLAS74, Modulesforconformityassessment
ItemNo Itemdesignationwhere‘type-approval'isrequiredasamended,andtherelevantresolu-
tionsandcircularsoftheIMO(1)Testingstandards(2)
B+CB+DB+EB+FGH
A.1/4.17 Mechanicalpilothoist RegulationV/17(b), RegulationV/17(b),
IMOResolutionA.426(XI),IMOMSC/Circular568/Rev.1IMOResolutionA.667(16),
ISO799
(1) ITU Recommendations cited are those referred to in the international conventions and the relevant resolutions and circulars of the IMO.
(2) Where IMO Resolutions are cited, only the testing standards contained in relevant parts of the Annexes to the Resolutions are applicable and exclude the provisions of the Resolutions themselves.
1996L0098 — EN — 28.11.1998 — 001.001 — 25▼M1
RegulationSOLAS74asamendedApplicableregulationsofSOLAS74, Modulesforconformityassessment
ItemNo Itemdesignationwhere‘type-approval'isrequiredasamended,andtherelevantresolu-
tionsandcircularsoftheIMO(1)Testingstandards(2)
B+CB+DB+EB+FGH5.Radio-communication equipment
A.1/5.1 VHFradioinstallationcapable
oftransmittingandreceiving
DSCandradiotelephonyRegulationIV/14,
RegulationX/3RegulationIV/7.1.1,
RegulationX/3,
IMOResolutionA.524(13),
IMOResolutionA.694(17),
IMOResolutionA.803(19),
IMOResolutionA.813(19),
IMOResolutionMSC68(68)
Annex1,
ITU-R493,ITU-R541ETS300162-2,ETS300338,
EN300828,EN60945;
IEC61097-3,IEC61097-7,
IEC60945××××
A.1/5.2 VHFDCSwatchkeeping
receiverRegulationIV/14,
RegulationX/3RegulationIV/7.1.2,
RegulationX/3,
IMOResolutionA.609(15),
IMOResolutionA.694(17),
IMOResolutionA.803(19),
IMOResolutionA.813(19),
IMOResolutionMSC68(68)
Annex1,
ITU-R493,ITU-R541ETS300162-2,ETS300,338,
ETS300828,EN301033,EN
60945;
IEC61097-3,IEC61097-8,
IEC60945××××
A.1/5.3 NAVTEXreceiver RegulationIV/14,
RegulationX/3RegulationIV/7.1.4,
RegulationX/3,
IMOResolutionA.525(13),
IMOResolutionA.694(17),
IMOResolutionA.813(19),
ITU-R540,ITU-R625ETS300065+A1,EN
301011,EN60945;
IEC61097-6,IEC60945××××
A.1/5.4 EGCreceiver RegulationIV/14,
RegulationX/3RegulationIV/7.1.5,
RegulationX/3,
IMOResolutionA.570(14),
IMOResolutionA.664(16),ETS300460+A1,EN
300829,EN60945;
IEC61097-4,IEC60945××××
1996L0098 — EN — 28.11.1998 — 001.001 — 26▼M1
RegulationSOLAS74asamendedApplicableregulationsofSOLAS74, Modulesforconformityassessment
ItemNo Itemdesignationwhere‘type-approval'isrequiredasamended,andtherelevantresolu-
tionsandcircularsoftheIMO(1)Testingstandards(2)
B+CB+DB+EB+FGH
IMOResolutionA.694(17),
IMOResolutionA.813(19)
A.1/5.5 HFmarinesafetyinformation
(MSI)equipment(HFNBDPreceiver)RegulationIV/14,
RegulationX/3RegulationIV/7.1.5,RegulationX/3,IMOResolutionA.694(17),IMOResolutionA.700(17),IMOResolutionA.806(19),IMOResolutionA.813(19),ITU-R491,ITU-R492,ITU-R625,ITU-R688 ETS300067&A1,EN60945;IEC61097-11,IEC60945 ××××
A.1/5.6 406MHzEPIRB(COSPAS-
SARSAT)RegulationIV/14,
RegulationX/3RegulationIV/7.1.6,RegulationX/3,IMOResolutionMSC56(66),IMOResolutionA.662(16),IMOResolutionA.694(17),IMOResolutionA.696(17),IMOResolutionA.763(18),IMOResolutionA.810(19),IMOResolutionA.813(19),ITU-R633 ETS300066-2,EN60945;IEC61097-2,IEC60945 ××××
A.1/5.7 L-bandEPIRB(INMARSAT) RegulationIV/14,RegulationX/3 RegulationIV/7.1.6,RegulationX/3,IMOResolutionA.661(16),IMOResolutionA.662(16),IMOResolutionA.694(17),IMOResolutionA.812(19),IMOResolutionA.813(19),ITU-R632-3 ETS300372,EN60945;IEC61097-5,IEC60945 ××××
1996L0098 — EN — 28.11.1998 — 001.001 — 27▼M1
RegulationSOLAS74asamendedApplicableregulationsofSOLAS74, Modulesforconformityassessment
ItemNo Itemdesignationwhere‘type-approval'isrequiredasamended,andtherelevantresolu-
tionsandcircularsoftheIMO(1)Testingstandards(2)
B+CB+DB+EB+FGH
A.1/5.8 2182kHzwatchreceiver RegulationIV/14,
RegulationX/3RegulationIV/7.2,RegulationX/3,IMOResolutionA.383(X),IMOResolutionA.694(17),IMOResolutionA.813(19),ITU-RM219,ITU-R693 ETS300441,EN301090,EN
60945;
IEC61097-15,IEC60945××××
A.1/5.9 Two-tonealarmsignalgener-
atorRegulationIV/14,
RegulationX/3RegulationIV/7.3,RegulationX/3,IMOResolutionA.421(XI),IMOResolutionA.571(14),IMOResolutionA.694(17),IMOResolutionA.813(19),ITU-RM219 ETS300373+A1,EN60945;IEC61097-9,IEC60945 ××××
A.1/5.10 MFradioinstallationcapable
oftransmittingandreceivingDSCandradiotelephonyRegulationIV/14,
RegulationX/3RegulationIV/9.1.1,RegulationIV/10.1.2,RegulationX/3,IMOResolutionA.334(IX),IMOResolutionA.610(15),IMOResolutionA.694(17),IMOResolutionA.804(19),IMOResolutionA.813(19),IMOResolutionMSC68(68)
Annex2,
ITU-RM219,ITU-RM493,ITU-RM541ETS300338,ETS300373+
A1,EN60945;
IEC61097-3,IEC61097-9,
IEC60945××××
A.1/5.11 MFradiotelephoneDSCwatch-keepingreceiver RegulationIV/14,
RegulationX/3RegulationIV/9.1.2,RegulationIV/10.1.3,RegulationX/3,IMOResolutionA.610(15),IMOResolutionA.694(17),IMOResolutionA.804(19),IMOResolutionA.806(19),IMOResolutionA.813(19), ETS300338,ETS300373,EN
301033,EN60945;
IEC61097-3,IEC61097-8,
IEC60945××××
1996L0098 — EN — 28.11.1998 — 001.001 — 28▼M1
RegulationSOLAS74asamendedApplicableregulationsofSOLAS74, Modulesforconformityassessment
ItemNo Itemdesignationwhere‘type-approval'isrequiredasamended,andtherelevantresolu-
tionsandcircularsoftheIMO(1)Testingstandards(2)
B+CB+DB+EB+FGH
IMOResolutionMSC68(68)
Annex2,
ITU-R493,ITU-R541
A.1/5.12 Inmarsat-BSES RegulationIV/14,RegulationX/3 RegulationIV/10.1.1,RegulationX/3,IMOResolutionA.570(14),IMOResolutionA.694(17),IMOResolutionA.698(17),IMOResolutionA.808(19),IMOResolutionA.813(19) IEC61097-10,IEC60945 ××××
A.1/5.13 Inmarsat-CSES RegulationIV/14,RegulationX/3 RegulationIV/10.1.1,RegulationX/3,IMOResolutionA.570(14),IMOResolutionA.663(16),IMOResolutionA.664(16),IMOResolutionA.694(17),IMOResolutionA.807(19),IMOResolutionA.813(19),IMOResolutionMSC68(68)
Annex4ETS300460+A1,EN300829,EN60945;
IEC61097-4,IEC60945××××
A.1/5.14 MF/HFradioinstallation
capableoftransmittingandreceivingDSC,NBDPandradiotelephonyRegulationIV/14,
RegulationX/3RegulationIV/10.2.1,RegulationX/3,IMOResolutionA.613(15),IMOResolutionA.694(17),IMOResolutionA.806(19),IMOResolutionA.813(19),IMOResolutionMSC68(68)
Annex3,
ITU-R476,ITU-R492,ITU-R493,ITU-R541,ITU-R625ETS300338,ETS300373+
A.1,ETS300067+A1,EN60945;
IEC61097-3,IEC61097-9,
IEC61097-11,IEC60945××××
1996L0098 — EN — 28.11.1998 — 001.001 — 29▼M1
RegulationSOLAS74asamendedApplicableregulationsofSOLAS74, Modulesforconformityassessment
ItemNo Itemdesignationwhere‘type-approval'isrequiredasamended,andtherelevantresolu-
tionsandcircularsoftheIMO(1)Testingstandards(2)
B+CB+DB+EB+FGH
A.1/5.15 RadiotelephoneMF/HFDSC
watchkeepingreceiverRegulationIV/14,
RegulationX/3RegulationIV/10.2.2,RegulationX/3,IMOResolutionA.613(15),IMOResolutionA.694(17),IMOResolutionA.806(19),IMOResolutionA.813(19),IMOResolutionMSC68(68)
Annex3,
ITU-R493ETS300338,ETS300373,
EN301033,EN60945,
IEC61097-3,IEC61097-8,
IEC60945××××
A.1/5.16 AeronauticaltwowayVHFradiotelephoneapparatus RegulationIV/14,
RegulationX/3RegulationIV/7.5,RegulationX/3,IMOResolutionA.694(17),IMOResolutionA.813(19),ICAOConvention,Annex10
RadioRegulationsTS101089,EN60945;IEC60945 ××××
(1) ITU Recommendations cited are those referred to in the international conventions and the relevant resolutions and circulars of the IMO.
(2) Where IMO Resolutions are cited, only the testing standards contained in relevant parts of the Annexes to the Resolutions are applicable and exclude the provisions of the Resolutions themselves.
1996L0098 — EN — 28.11.1998 — 001.001 — 30
ItemNo ItemdesignationRegulationSOLAS74as
amendedwhere‘type-approval'
isrequiredTestingstandards
ItemNo ItemdesignationRegulationSOLAS74as
amendedwhere‘typeapproval'
isrequiredTestingstandards▼M1
Annex A.2: Equipment for which no detailed testing standards exist in international instruments
1.Life-saving appliances
A.2/1.1 Radarreflectorforlife-
raftsRegulationIII/4,III/34,
IMOResolution
MSC.48(66)
A.2/1.2 Searchlightforuseinlife-boatsandrescueboats RegulationIII/4,III/34,
IMOResolution
MSC.48(66)
A.2/1.3 Immersionsuitmaterials RegulationIII/4,III/34,
IMOResolution
MSC.48(66)
2.Marine-pollution prevention
P.M.
3.Fire protection
A.2/3.1 Non-portableandtrans-
portableextinguishersRegulationII-2/6,II-2/7.1.3,II-2/7.2.3,II-2/7.3.1
A.2/3.2 Sprinklersystems(limitedtosprinklerheadsandtothemethodofautomaticsprinklingandsignalling)RegulationII-2/12.3,II-2/36.1.2,II-2/36.2,II-2/41-2.5,II-2/52.2 ISO6182
A.2/3.3 Nozzlesforfixedpressurewater-sprayingfire-extin-guishingsystemsforspecialcategoryspacesRegulationII-2/37.1.3 IMOResolutionA123(V)
A.2/3.4 Cold-weatherstartingofgeneratorsets(startingdevices) RegulationII-1/44.2
A.2/3.5 Firehoses RegulationII-2/4.7.1 EN1924-4(draft)
A.2/3.6 Dualpurposetypenozzles(spray/jettype) RegulationII-2/4.8.4
RegulationII-2/41-2.1.5
A.2/3.7 Fixedfiredetectionand
firealarmsystemsforperiodicallyunattendedmachineryspacesRegulationII-2/14.1 EN54-2
A.2/3.8 Smokedetectors RegulationII-2/13.3.2 EN54-7
A.2/3.9 Heatdetectors RegulationII-2/13.3.3 EN54-5
A.2/3.10 Electricsafetylamp RegulationII-2/17.1.1.4
A.2/3.11 Protectiveclothingresistanttochemicalattack RegulationII-2/54.2.6.1 EN368,EN369
1996L0098 — EN — 28.11.1998 — 001.001 — 31
▼M1
ItemNo ItemdesignationRegulationSOLAS74as
amendedwhere‘typeapproval'
isrequiredTestingstandards
ItemNo ItemdesignationRegulationSOLAS74as
amendedwhere‘typeapproval'
isrequiredTestingstandardsA.2/3.12 Oxygenanalysisandgas
detectionequipmentRegulationVI/3.1
A.2/3.13 Low-locatinglightingsystems RegulationII-2/28.1.10,II-2/28.1.11,II-2/41-2.4.7 IMOResolutionA.752(18),ISO/CD15370
4.Navigation equipment
A.2/4.1 Gyrocompassforhigh
speedcraftRegulationX/3,
IMOResolution
MSC.36(63)IMOResolutionA.694(17)
IMOResolutionA.813(19)IMOResolutionA.821(19)EN60945,EN61162-1;IEC60945,IEC61162-1
A.2/4.2 Radarequipmentforhigh
speedcraftRegulationX/3,
IMOResolution
MSC.36(63)IMOResolutionA.694(17)
IMOResolutionA.813(19)IMOResolutionA.820(19)EN60945,EN61162-1;IEC60945,IEC61162-1,
futureIEC60936-2
A.2/4.3 Auto-pilot(headingcontrolsystem)forhighspeedcraft RegulationX/3,
IMOResolution
MSC.36(63)IMOResolutionA.694(17)
IMOResolutionA.813(19)IMOResolutionA.822(19)EN60945,EN61162-1;IEC60945,IEC61162-1
A.2/4.4 Electromagneticcompass
forhighspeedcraftRegulationV/12(r)
RegulationX/3IMOResolutionA.694(17)IMOResolutionA.813(19)EN60945,EN61162-1;IEC60945,IEC61162-1,
futureISO11606
A.2/4.5 Daylightsignallinglampforhighspeedcraft RegulationX/3,
IMOResolution
MSC.36(63)IMOResolutionA.694(17)
IMOResolutionA.813(19)EN60945;IEC60945
A.2/4.6 Searchlightforhighspeed
craftRegulationX/3,
IMOResolution
MSC.36(63)IMOResolutionA.694(17)
IMOResolutionA.813(19)EN60945,EN61162-1;IEC60945,IEC61162-1
A.2/4.7 Nightvisionequipment
forhighspeedcraftRegulationX/3,
IMOResolution
MSC.36(63)IMOResolutionA.694(17)
IMOResolutionA.813(19)EN60945,EN61162-1;IEC60945,IEC61162-1
A.2/4.8
Trackcontrolsystem draftRegulationV/19.1 IMOResolutionA.694(17),
IMOResolutionA.813(19),IMOResolution
MSC74(69)Annex2,
EN61162-1,futureEN
62065,EN60945
1996L0098 — EN — 28.11.1998 — 001.001 — 32
▼M1
ItemNo ItemdesignationRegulationSOLAS74as
amendedwhere‘typeapproval'
isrequiredTestingstandards
IEC61162-1,futureIEC
62065,IEC60945
A.2/4.9 Automatictrackingaid(ATA) draftRegulationV/19.1 IMOResolutionA.694(17),
IMOResolutionA.813(19),IMOResolutionMSC
64(67)Annexe4,
EN61162-1,futureEN
60872-2,EN60945;
IEC61162-1,futureIEC
60872-2,IEC60945
A.2/4.10 Electronicplottingaid(EPA) draftRegulationV/19.1 IMOResolutionA.694(17),
IMOResolutionA.813(19),IMOResolution
MSC64(67)Annex4,
EN61162-1,futureEN
60872-3,EN60945;
IEC61162-1,futureIEC
60872-3,IEC60945
A.2/4.11 Electronicchartdisplayandinformationsystem(ECDIS) draftRegulationV/19.1 IMOResolutionA.694(17),
IMOResolutionA.813(19),IMOResolutionA.817(19),IMOResolution
MSC64(67)Annex5,
EN61174,EN61162-1,EN
60945;
IEC61174,IEC61162-1,
IEC60945
A.2/4.12 Chartradar—Electronicchartdisplayandinforma-tionsystem(ECDIS)backupdraftRegulationV/19.1 IMOResolutionA.694(17),
IMOResolutionA.813(19),IMOResolution
MSC64(67)Annex5,
EN61162-1,futureEN
60936-4,EN60945;
IEC61162-1,futureIEC
60936-4,IEC60945
A.2/4.13 Rasterchartdisplaysystem(RCDS) draftRegulationV/19.1 IMOResolutionA.694(17)
IMOResolutionA.813(19)EN61162-1,EN60945;IEC61162-1,IEC60945
A.2/4.14 CombinedGPS/
GLONASSequipmentdraftRegulationV/19.1 IMOResolutionA.529(13),
IMOResolutionA.694(17),IMOResolutionA.813(19),IMOResolution
MSC74(69)Annex1,
EN61162-1,futureEN
61108-3,EN60945;
IEC61162-1,futureIEC
61108-3,IEC60945
A.2/4.15
DGPS,DGLONASS-
equipmentdraftRegulationV/19.1 IMOResolutionA.529(13),
IMOResolutionA.694(17),IMOResolutionA.813(19),IMOResolution
MSC64(67)Annex2,
EN61162-1,futureEN
61108-4,EN60945;
1996L0098 — EN — 28.11.1998 — 001.001 — 33
▼M1
ItemNo ItemdesignationRegulationSOLAS74as
amendedwhere‘typeapproval'
isrequiredTestingstandards
ItemNo ItemdesignationRegulationSOLAS74as
amendedwhere‘typeapproval'
isrequiredTestingstandardsIEC61162-1,futureIEC
61108-4,IEC60945
A.2/4.16 UniversalAISequipment draftRegulationV/19.1 IMOResolutionA.694(17),
IMOResolutionA.813(19),IMOResolution
MSC74(69)Annexe3,
EN61162-1,futureEN
61993-2,EN60945;
IEC61162-1,futureIEC
61993-2,IEC60945
A.2/4.17 Voyagedatarecorder draftRegulationV/19.1,V/22 IMOResolutionA.694(17),
IMOResolutionA.813(19),IMOResolutionA.861(20),EN61162-1,futureEN
61996,EN60945;
IEC61162-1,futureIEC
61996,IEC60945
A.2/4.18 Integratednavigationsystem draftRegulationV/19.1 IMOResolutionA.694(17),
IMOResolutionA.813(19),IMOResolutionA...(...)
underpreparationbyNAV,
EN61162-1,EN61924,EN
60945;
IEC61162-1,IEC61924,
IEC60945
A.2/4.19 Integratedbridgesystem draftRegulationV/19.1 IMOResolutionA.694(17),
IMOResolutionA.813(19),IMOResolution
MSC64(67)Annex1
EN61162-,EN61209,EN
60945;
IEC61162-1,IEC61209,
IEC60945
A.2/4.20 Radartargetenhancer draftRegulationV/19.1 IMOResolutionA.615(15),
IMOResolutionA.694(17),IMOResolutionA.813(19),ITU-R1176EN60945;IEC60945
5.Radio-communication equipment
A.2/5.1 VHFEPIRB RegulationIV/14
RegulationX/3IMOResolutionA.612(15),IMOResolutionA.662(16),IMOResolutionA.694(17),IMOResolutionA.805(19),IMOResolutionA.813(19),ITU-R693EN60945;IEC60945
1996L0098 — EN — 28.11.1998 — 001.001 — 34
▼M1
ItemNo ItemdesignationRegulationSOLAS74as
amendedwhere‘typeapproval'
isrequiredTestingstandards
ItemNo ItemdesignationRegulationCOLREG72as
amendedwhere‘type-approval'
isrequiredTestingstandards
ItemNo ItemdesignationRegulationSOLAS74as
amendedwhere‘typeapproval'
isrequiredTestingstandardsA.2/5.2 Radioreservesourceof
energyRegulationIV/14 FutureEN61097-14,EN60945;
FutureIEC61097-14,IEC
60945
6.Equipment required under COLREG 72
A.2/6.1 Navigationlights AnnexI/14 IMOResolutionA.694(17),
IMOResolutionA.813(19),EN60945;IEC60945
A.2/6.2 Soundsignalappliances AnnexIII/3
7.Bulk carrier safety equipment
A.2/7.1 Loadinginstrument RegulationXII/11,
1997SOLASConference
Resolution5IACSRecommendationNo48onloadinginstruments(SOLAS/CONF.4/7)
1996L0098 — EN — 28.11.1998 — 001.001 — 35
▼M1
ItemNo ItemdesignationRegulationSolas74as
amendedwhere‘type-approval'
isrequiredInternationaltestingstandards
ItemNo ItemdesignationRegulationSolas74as
amendedwhere‘type-approval'
isrequiredInternationaltestingstandardsAnnex A.2:
Equipment for which no detailed testing standards exist in international instruments
1.Life-saving appliances
1Evacuation,slide
launchingandembarka-tionRegulationIII/48.5
2Lifecraft-launchingappli-ances RegulationIII/4&III,30 IMOResolutionA689(17)
2.Fire protection
3Materialsotherthansteel
forpipespenetrating‘A'or‘B'classdivisionRegulationII-2/18.2.1 Forplasticpipes:IMOResolutionA753(18)
4Materialsotherthansteelforpipesconveyingoilorfueloil RegulationII-2/18.2.2
5Non-portableandtrans-portableextinguishers RegulationII-2/6.1
RegulationII-2/7.1.3,
7.2.3&7.3.1
6Fireman’sbreathingappa-ratus RegulationII-2/17.1.2
7Sprinklersystems(limitedtosprinklerheadsandtothemethodofautomaticsprinklingandsignalling)RegulationII-2/12.3,36.1.2&36.2
Regulation41-2paragraph
5&52.2ISO6182
8Nozzlesforfixedpressurewater-sprayingfire-extin-guishingsystemsformachineryspacesRegulationII-2/10.1
9Nozzlesforfixedpressurewater-sprayingfires-extin-guishingsystemsforspecialcategoryspacesRegulationII-2/37.1.3 IMOResolutionA123(V)
10Cold-weatherstartingofgeneratorsets(startingdevices) RegulationII-1/44.2
11Firehoses RegulationII-2/4.7.1
12Dual-purposenozzles RegulationII-2/4.8.4
RegulationII-2/41—2
paragraph1.5
1996L0098 — EN — 28.11.1998 — 001.001 — 36
▼M1
ItemNo ItemdesignationRegulationSolas74as
amendedwhere‘type-approval'
isrequiredInternationaltestingstandards
ItemNo ItemdesignationRegulationSolas74as
amendedwhere‘type-approval'
isrequiredInternationaltestingstandards13Electricsafetylamp RegulationII-2/17.1.1.4
14Smokedetectors RegulationII-2/13.3.2
15Heatdetectors RegulationII-2/13.3.3
16Primarydeckcovering,
toxicandexplosivehazardsRegulationII-2/34.8
RegulationII-2/49.3IMOResolutionA687(17)
17‘A'and‘B'classbulk-
headsanddecks,fireintegrityRegulationII-2/3.3.5
RegulationII-2/3.4.4IMOResolutionA754(18)
18Devicestopreventthe
passageofflameintothecargotanksinoiltankersRegulationII-2/59.1.5
RegulationII-2/59.1.9.4&
59.2IMOMSC/Circ.373/Rev.1
IMOMSC/Circ.450/Rev.1
19Non-combustiblemate-
rialsusedin‘A',‘B'and‘C'classdivisionsRegulationII-2/3.1
RegulationII-2/3.3.4RegulationII-2/3.4.3RegulationII-2/3.5IMOResolutionA472
(XII)
3.Radio-communication equipment
20VHFEpirb RegulationIV/14 IMOResolutionA612(15)
IMOResolutionA662IMOResolutionA694(17)IEC945ITU-R693
1996L0098 — EN — 28.11.1998 — 001.001 — 37
▼B
ANNEXB
Modules for conformity assessment
EC TYPE-EXAMINATION (MODULE B)
1. Anotifiedbodymustascertainandattestthataspecimen,representativeof
the production envisaged, complies with the provisions of the internationalinstruments that apply to it.
2. TheapplicationfortheECtype-examinationmustbelodgedbythemanu-
facturer or his authorized representative established within the Communitywith a notified body of his choice.
The application must include:
— the name and address of the manufacturer and, if the application is
lodged by the authorized representative, his name and address as well,
— a written declaration that the same application has not been lodged
simultaneously with any other notified body,
— the technical documentation as described in point 3.
The applicant must place at the disposal of the notified body a specimen,
representativeoftheproductionenvisagedandhereinaftercalled‘type'(
1).
The notified body may request further specimens if needed for the testprogramme.
3. The technical documentation must make it possible to assess the product’s
compliance with the requirements of the relevant international instruments.It must, as far as is relevant for such assessment, cover the design, thebuilding standard, manufacture, installation and functioning of the productin accordance with the description of technical documentation set down inthe Appendix to this Annex.
4. The notified body must:4.1. examine the technical documentation and verify that the type has been
manufactured in accordance with the technical documentation;
4.2. perform the appropriate examinations and necessary tests or have them
performed to check whether the requirements of the relevant internationalinstruments have actually been met;
4.3. agreewiththeapplicantthelocationwheretheexaminationsandnecessary
tests will be carried out.
5. Where the type meets the provisions of the relevant international instru-
ments, the notified body must issue an EC type-examination certificate totheapplicant.Thecertificatemustgivethenameandaddressofthemanu-facturer, details of the equipment, the conclusions of the examination, theconditions of its validity and the necessary data for identification of theapproved type.
Alistoftherelevantpartsofthetechnicaldocumentationmustbeannexed
to the certificate and a copy kept by the notified body.
Ifamanufacturerisrefusedatype-certification,thenotifiedbodymustgive
detailed reasons for that refusal.
Whereamanufacturerreappliesfortype-approvalforequipmentforwhich
atype-certificatehasbeenrefused,hissubmissiontothenotifiedbodymustinclude all relevant documentation, including the original test reports, thedetailed reasons for the previous refusal and details of all modificationsmade to the equipment.
6. The applicant must inform the notified body that holds the technical docu-
mentation concerning the EC type-examination certificate of all modifica-tionstotheapprovedproduct,whichmustreceiveadditionalapprovalwheresuchchangesmayaffectcompliancewiththerequirementsortheprescribedconditionsforuseoftheproduct.Suchadditionalapprovalmustbegiveninthe form of an addition to the original EC type-examination certificate.
(1) A type may cover several versions of the product provided that the differences
between the versions do not affect the level of safety or the other requirementsconcerning the performance of the product.
1996L0098 — EN — 28.11.1998 — 001.001 — 38
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7. Eachnotifiedbodymust,onrequest,provideflagMemberStateadministra-
tionsandtheothernotifiedbodieswiththerelevantinformationconcerningthe EC type-examination certificates and additions issued and withdrawn.
8. The other notified bodies may receive copies of the EC type-examination
certificates and/or their additions. The Annexes to the certificates must bekept at the disposal of the other notified bodies.
9. The manufacturer or his authorized representative established within the
Community must keep with the technical documentation copies of ECtype-examination certificates and their additions for at least 10years afterthe last product has been manufactured.
CONFORMITY TO TYPE (MODULE C)
1. A manufacturer or his authorized representative established within the
Communitymustensureanddeclarethattheproductsconcernedconformtotype as described in the EC type-examination certificate and satisfy therequirementsoftheinternationalinstrumentsthatapplytothem.Themanu-facturer or his authorized representative established within the Communitymust affix the mark to each product and draw up a written declaration ofconformity.
2. The manufacturer must take all measures necessary to ensure that the
manufacturing process ensures that the manufactured products conform totype as described in the EC type-examination certificate and comply withthe requirements of the international instruments that apply to them.
3. The manufacturer or his authorized representative established within the
Community must keep a copy of the declaration of conformity for at least10 years after the last product has been manufactured.
PRODUCTION-QUALITY ASSURANCE (MODULE D)
1. A manufacturer who satisfies the obligations of point 2must ensure and
declarethattheproductsconcernedconformtotypeasdescribedintheECtype-examination certificate. The manufacturer or his authorized repres-entative established within the Community must affix the mark to eachproductanddrawupawrittendeclarationofconformity.Themarkmustbeaccompanied by the identification symbol of the notified body responsiblefor surveillance as specified in point 4.
2. The manufacturer must operate an approved quality system for production,
final-product inspection and testing as specified in point 3 and must besubject to surveillance as specified in point 4.
3.Quality system
3.1. The manufacturer must lodge an application for assessment of his quality
system with a notified body of his choice for the products concerned.
The application must include:
— all relevant information for the product category envisaged,
— the documentation concerning the quality system,— thetechnicaldocumentationoftheapprovedtypeandacopyoftheEC
type-examination certificate.
3.2. The quality system must ensure that the products conform to type as
described in the EC type-examination certificate.
Alltheelements,requirementsandprovisionsadoptedbythemanufacturer
must be documented in a systematic and orderly manner in the form ofwritten policies, procedures and instructions. The quality-system documen-tation must permit a consistent interpretation of the quality programmes,plan, manuals and records.
It must, in particular, include an adequate description of:
— the quality objectives and the organizational structure, responsibilities
and powers of the management with regard to product quality,
— the manufacturing, quality-control and quality-assurance techniques,
processes and systematic actions that will be used,
— the examinations and tests that will be carried out before, during and
after manufacture, and the frequency with which they will be carriedout,
— the quality records, such as inspection reports and test data, calibration
data, qualification reports of the personnel concerned, etc.,
1996L0098 — EN — 28.11.1998 — 001.001 — 39
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— themeansofmonitoringtheachievementoftherequiredproductquality
and the effective operation of the quality system.
3.3. The notified body must assess the quality system to determine whether it
satisfies the requirements laid down in point 3.2. It must presume compli-ance with those requirements in respect of quality systems that implementthe relevant harmonized standard.
The auditing team must have at least one member with experience of
assessmentintheproducttechnologyconcerned.Theassessmentproceduremust include a visit to the manufacturer’s premises.
The manufacturer must be notified of the decision. The notification must
include the conclusions of the examination and the reasoned assessmentdecision.
3.4. Themanufacturermustundertaketofulfiltheobligationsarisingoutofthe
qualitysystemasapprovedandtoupholditsothatitremainsadequateandefficient.
The manufacturer or his authorized representative established within the
Community must keep the notified body that has approved the qualitysystem informed of any intended updating of that quality system.
The notified body must assess the modifications proposed and decide
whether the modified quality system will still satisfy the requirements laiddown in point 3.2 or whether a reassessment is required.
The manufacturer must be notified of its decision. The notification must
include the conclusions of the examination and the reasoned assessmentdecision.
4.Surveillance under the responsibility of the notified body
4.1. The purpose of surveillance is to make sure that the manufacturer duly
fulfils the obligations arising out of the approved quality system.
4.2. The manufacturer must allow the notified body access for inspection
purposestothelocationsofmanufacture,inspectionandtestingandstorageand must provide it with all necessary information, in particular:
— the quality-system documentation,
— the quality records, such as inspection reports and test data, calibration
data, qualification reports of the personnel concerned, etc.
4.3. The notified body must periodically carry out audits to make sure that the
manufacturermaintainsandappliesthequalitysystemandmustprovidethemanufacturer with audit reports.
4.4. Inaddition,thenotifiedbodymaypayunannouncedvisitstothemanufac-
turer.Duringsuchvisitsthenotifiedbodymaycarryouttestsorcauseteststobecarriedouttocheckthatthequalitysystemisfunctioningcorrectly,ifnecessary. The notified body must provide the manufacturer with a visitreport and, if a test has taken place, with a test report.
5. Themanufacturermust,foratleast10yearsafterthelastproducthasbeen
manufactured, keep at the disposal of the national authorities:
— the documentation referred to in the second indent of the second para-
graph of point 3.1,
— the updating referred to in the second paragraph of point 3.4,— the decision and reports from the notified body referred to in the final
paragraph of point 3.4, point 4.3 and point 4.4.
6. Eachnotifiedbodymust,onrequest,provideflagMemberStateadministra-
tionsandtheothernotifiedbodieswiththerelevantinformationconcerningthe quality-system approvals issued and withdrawn.
PRODUCT-QUALITY ASSURANCE (MODULE E)
1. Amanufacturerwhosatisfiestheobligationsofpoint2ensuresanddeclares
that the products concerned conform to type as described in the EC type-examination certificate. The manufacturer or his authorized representativeestablishedwithintheCommunitymustaffixthemarktoeachproductanddraw up a written declaration of conformity. The mark must be accompa-nied by the identification symbol of the notified body responsible forsurveillance as specified in point 4.
2. Themanufacturermustoperateanapprovedqualitysystemforfinalinspec-
tionandtestingasspecifiedinpoint3andmustbesubjecttosurveillanceasspecified in point 4.
1996L0098 — EN — 28.11.1998 — 001.001 — 40
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3.Quality system
3.1. The manufacturer must lodge an application for assessment of his quality
system for the products concerned with a notified body of his choice.
The application must include:
— all relevant information for the product category envisaged,
— documentation concerning the quality system,— thetechnicaldocumentationoftheapprovedtypeandacopyoftheEC
type-examination certificate.
3.2. Under the quality system, each product must be examined and appropriate
testsmustbecarriedoutinordertoensureitscompliancewiththerelevantrequirements of the international instruments. All the elements, require-mentsandprovisionsadoptedbythemanufacturermustbedocumentedinasystematic and orderly manner in the form of written policies, proceduresand instructions. That quality-system documentation must ensure commonunderstanding of the quality programmes, plans, manuals and records.
It must, in particular, include an adequate description of:
— the quality objectives and the organizational structure, responsibilities
and powers of the management with regard to product quality,
— the examinations and tests that will be carried out after manufacture,— the means of monitoring the effective operation of the quality system,— the quality records, such as inspection reports and test data, calibration
data, qualification reports of the personnel concerned, etc.
3.3 The notified body must assess the quality system to determine whether it
satisfies the requirements laid down in point 3.2. It must presume compli-ancewiththerequirementsinrespectofqualitysystemsthatimplementtherelevant harmonized standard.
The auditing team must have at least one member with experience as an
assessor in the product technology concerned. The assessment proceduremust include an assessment visit to the manufacturer’s premises.
The manufacturer must be notified of the decision. The notification must
include the conclusions of the examination and the reasoned assessmentdecision.
3.4. Themanufacturermustundertaketofulfiltheobligationsarisingoutofthe
qualitysystemasapprovedandtomaintainitinanappropriateandefficientmanner.
The manufacturer or his authorized representative established within the
Community must keep the notified body that has approved the qualitysystem informed of any intended updating of that quality system.
The notified body must evaluate the modifications proposed and decide
whether the modified quality system will still satisfy the requirements laiddown in point 3.2 or whether a reassessment is required.
The manufacturer must be notified of its decisions. The notification must
include the conclusions of the examination and the reasoned assessmentdecision.
4.Surveillance under the responsibility of the notified body
4.1. The purpose of surveillance is to make sure that the manufacturer duly
fulfils the obligations arising out of the approved quality system.
4.2. The manufacturer must allow the notified body access for inspection
purposestothelocationsofinspection,testingandstorageandmustprovideit with all necessary information, in particular:
— the quality-system documentation,
— the technical documentation,— the quality records, such as inspection reports and test data, calibration
data, qualification reports of the personnel concerned, etc.
4.3. The notified body must periodically carry out audits to make sure that the
manufacturermaintainsandappliesthequalitysystemandmustprovidethemanufacturer with audit reports.
4.4. Inaddition,thenotifiedbodymaypayunannouncedvisitstothemanufac-
turer.Duringsuchvisitsthenotifiedbodymaycarryouttestsorcauseteststobecarriedouttocheckthatthequalitysystemisfunctioningcorrectly,ifnecessary. The notified body must provide the manufacturer with a visitreport and, if a test has been carried out, with a test report.
1996L0098 — EN — 28.11.1998 — 001.001 — 41
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5. Themanufacturermust,foratleast10yearsafterthelastproducthasbeen
manufactured, keep at the disposal of the national authorities:
— thedocumentationreferredtointhethirdindentofthesecondparagraph
of point 3.1,
— the updating referred to in the second paragraph of point 3.4,— the decision and reports from the notified body referred to in the final
paragraph of point 3.4, point 4.3 and point 4.4.
6. EachnotifiedbodymustonrequestprovideflagMemberStateadministra-
tionsandtheothernotifiedbodieswiththerelevantinformationconcerningthe quality-system approvals issued and withdrawn.
PRODUCT VERIFICATION (MODULE F)
1. A manufacturer or his authorized representative established within the
Community must check and attest that the products subject to point 3conform to the type as described in the EC type-examination certificate.
2. The manufacturer must take all measures necessary to ensure that the
manufacturing process ensures that the products conform to type asdescribedintheECtype-examinationcertificate.Hemustaffixthemarktoeach product and must draw up a declaration of conformity.
3. Thenotifiedbodymustcarryouttheappropriateexaminationsandtestsin
order to check that the product complies with the requirements of theinternationalinstrumentseitherbyexaminationandtestingofeveryproductas specified in point 4 or by examination and testing of products on astatistical basis, as specified in point 5, at the choice of the manufacturer.
3a. The manufacturer or his authorized representative established within the
Community must keep a copy of the declaration of conformity for at least10years after the last product has been manufactured.
4.Verification by examination and testing of every product
4.1. All products must be individually examined and appropriate tests must be
carriedoutinordertoverifytheirconformitytotypeasdescribedintheECtype-examination certificate.
4.2. The notified body must affix its identification symbol or cause it to be
affixed to each approved product and draw up a written certificate ofconformity relating to the tests carried out.
4.3. The manufacturer or his authorized representative established within the
Community must ensure that he is able to supply the notified body’scertificateofconformityonrequesttotheflagMemberStateadministration.
5.Statistical verification
5.1. The manufacturer must present his products in the form of homogeneous
lotsandmusttakeallmeasuresnecessarytoensurethatthemanufacturingprocess ensures the homogeneity of each lot produced.
5.2. Allproductsmustbeavailableforverificationintheformofhomogeneous
lots.Arandomsamplemustbedrawnfromeachlot.Productsinasamplemustbeindividuallyexaminedandappropriatetestsmustbecarriedouttoensure that they comply with the requirements of the international instru-ments which apply to them and to determine whether the lot is to beaccepted or rejected.
5.3. In the case of accepted lots, the notified body must affix its identification
symbolorcauseittobeaffixedtoeachproductandmustdrawupawrittencertificateofconformityrelatingtothetestscarriedout.Allproductsinthelotmaybeputonthemarketexceptthoseproductsfromthesamplewhichare found not to comply.
If a lot is rejected, the notified body or the competent authority must take
appropriate measures to prevent that lot’s being put on the market. In theeventoffrequentrejectionoflotsthenotifiedbodymaysuspendstatisticalverification.
The manufacturer may, under the responsibility of the notified body, affix
the latter’s identification symbol during the manufacturing process.
5.4. The manufacturer or his authorized representative established within the
Community must ensure that he is able to supply the notified body’scertificates of conformity on request to the flag Member State administra-tion.
1996L0098 — EN — 28.11.1998 — 001.001 — 42
▼B
UNIT VERIFICATION (MODULE G)
1. The manufacturer must ensure and declare that the product concerned,
which has been issued with the certificate referred to in point 2, complieswith the requirements of the international instruments that apply to it. Themanufacturer or his authorized representative established within theCommunitymustaffixthemarktotheproductanddrawupadeclarationofconformity.
2. The notified body must examine the individual product and carry out
appropriateteststoensurethatitcomplieswiththerelevantrequirementsofthe international instruments.
The notified body must affix its identification number or cause it to be
affixed to the approved product and must draw up a certificate ofconformity concerning the tests carried out.
3. The aim of the technical documentation is to enable compliance with the
requirementsoftheinternationalinstrumentstobeassessedandthedesign,manufacture and operation of the product to be understood.
FULL-QUALITY ASSURANCE (MODULE H)
1. A manufacturer who satisfies the obligations of paragraph 2 must ensure
anddeclarethattheproductsconcernedcomplywiththerequirementsoftheinternational instruments that apply to them. The manufacturer or hisauthorized representative established within the Community must affix themarktoeachproductanddrawupawrittendeclarationofconformity.Themarkmustbeaccompaniedbytheidentificationsymbolofthenotifiedbodyresponsible for surveillance as specified in point 4.
2. The manufacturer must operate an approved quality system for design,
manufacture,final-productinspectionandtestingasspecifiedinpoint3andmust be subject to surveillance as specified in point 4.
3.Quality system
3.1. The manufacturer must lodge an application for assessment of his quality
system with a notified body.
The application must include:
— all relevant information for the product category envisaged and
— documentation concerning the quality system.
3.2. The quality system must ensure that the products comply with the require-
ments of the international instruments that apply to them.
Alltheelements,requirementsandprovisionsadoptedbythemanufacturer
must be documented in a systematic and orderly manner in the form ofwritten policies, procedures and instructions. The quality-system documen-tation must ensure common understanding of the quality policies andprocedures such as quality programmes, plans, manuals and records.
It must, in particular, include an adequate description of:
— the quality objectives and the organizational structure, responsibilities
and powers of the management with regard to product quality,
— the technical design specifications, including standards, that will be
applied and the assurance that the essential requirements of the inter-national instruments that apply to the products will be met,
— the design-control and design-verification techniques, processes and
systematic actions that will be used in the design of the productspertaining to the product category covered,
— the corresponding manufacturing, quality-control and quality-assurance
techniques, processes and systematic actions that will be used,
— the examinations and tests that will be carried out before, during and
after manufacture, and the frequency with which they will be carriedout,
— the quality records, such as inspection reports and test data, calibration
data, qualification reports of the personnel concerned, etc.,
— the means of monitoring the achievement of the required design and
product quality and the effective operation of the quality system.
3.3. The notified body must assess the quality system to determine whether it
satisfies the requirements laid down in point 3.2. It must presume compli-ancewiththerequirementsinrespectofqualitysystemsthatimplementtherelevant harmonized standard.
1996L0098 — EN — 28.11.1998 — 001.001 — 43
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The auditing team must have at least one member with experience as an
assessor in the product technology concerned. The assessment proceduremust include an assessment visit to the manufacturer’s premises.
The manufacturer must be notified of the decision. The notification must
include the conclusions of the examination and the reasoned assessmentdecision.
3.4. The manufacturer must undertake to fulfil the obligations arising from the
qualitysystemasapprovedandtoupholditsothatitremainsadequateandefficient.
The manufacturer or his authorized representative established within the
Community must keep the notified body that has approved the qualitysystem informed of any intended updating of that quality system.
The notified body must evaluate the modifications proposed and decide
whether the modified quality system will still satisfy the requirements laiddown in point 3.2 or whether a reassessment is required.
The manufacturer must be notified of its decisions. The notification must
include the conclusions of the examination and the reasoned assessmentdecision.
4.EC surveillance under the responsibility of the notified body
4.1. The purpose of surveillance is to make sure that the manufacturer duly
fulfils the obligations arising out of the approved quality system.
4.2. The manufacturer must allow the notified body access for inspection
purposestothelocationsofdesign,manufacture,inspectionandtestingandstorage and must provide it with all necessary information, in particular:
— the quality-system documentation,
— the quality records as provided for in the design part of the quality
system, such as the results of analyses, calculations, tests, etc.,
— the quality records as provided for in the manufacturing part of the
qualitysystem,suchasinspectionreportsandtestdata,calibrationdata,qualification reports of the personnel concerned, etc.
4.3. The notified body must periodically carry out audits to make sure that the
manufacturermaintainsandappliesthequalitysystemandmustprovidethemanufacturer with audit reports.
4.4. In addition the notified body may pay unannounced visits to the manufac-
turer.Duringsuchvisits,thenotifiedbodymaycarryouttestsorcauseteststobecarriedouttocheckthatthequalitysystemisfunctioningcorrectly,ifnecessary. The notified body must provide the manufacturer with a visitreport and, if a test has been carried out, with a test report.
5. Themanufacturermust,foratleast10yearsafterthelastproducthasbeen
manufactured, keep at the disposal of the national authorities:
— the documentation referred to in the second indent of the second para-
graph of point 3.1,
— the updating referred to in the second paragraph of point 3.4,— the decision and reports from the notified body referred to in the final
paragraph of point 3.4, point 4.3 and point 4.4.
6. Eachnotifiedbodymust,onrequest,provideflagMemberStateadministra-
tionsandtheothernotifiedbodieswiththerelevantinformationconcerningthe quality-system approvals issued and withdrawn.
7.Design examination
7.1. The manufacturer must lodge an application for examination of the design
with a single notified body.
7.2 Theapplicationmustmakeitpossibletounderstandthedesign,manufacture
andoperationoftheproductandtoassesscompliancewiththerequirementsof international instruments.
It must include:
— the technical design specifications, including standards, that have been
applied and
— the necessary supporting evidence for their adequacy, in particular
wherethestandardsspecifiedinArticle5havenotbeenappliedinfull.Suchsupportingevidencemustincludetheresultsoftestscarriedoutbyan appropriate laboratory of the manufacturer’s or on his behalf.
1996L0098 — EN — 28.11.1998 — 001.001 — 44
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7.3. The notified body must examine the application and where the design
complieswiththoseprovisionsoftheinternationalinstrumentsthatapplyitmustissueanECdesign-examinationcertificatetotheapplicant.Thecertif-icatemustincludetheconclusionsoftheexamination,theconditionsofitsvalidity,thedatanecessaryforidentificationoftheapproveddesignand,ifrelevant, a description of the product’s functioning.
7.4. The applicant must keep the notified body that has issued the EC design-
examination certificate informed of any modification to the approveddesign. Modifications to the approved design must receive additionalapproval from the notified body that issued the EC design-examinationcertificate where such changes may affect compliance with the relevantrequirements of the international instruments or the prescribed conditionsforuseoftheproduct.Suchadditionalapprovalmustbegivenintheformof an addition to the original EC design-examination certificate.
7.5. Thenotifiedbodiesmust,onrequest,provideflagMemberStateadministra-
tionsandtheothernotifiedbodieswiththerelevantinformationconcerning:
— the EC design-examination certificates and additions issued and
— the EC design-approvals and additional approvals withdrawn.
1996L0098 — EN — 28.11.1998 — 001.001 — 45
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Appendix to Annex B
Technical documentation to be supplied by the manufacturer to the notified
body
The provisions set down in this Appendix apply to all modules of Annex B.The technical documentation referred to in Annex B must comprise all relevant
dataandmeansusedbythemanufacturertoensurethatequipmentcomplieswiththe essential requirements relating to it.
The technical documentation must make it possible to understand the design,
manufacture and operation of the product, and must make it possible to assesscompliance with the requirements of the relevant international instruments.
The documentation must, so far as they are relevant to assessment, include:
— a general description of the type,
— conceptual-design, build standard and manufacturing drawings and schemes
of components, sub-assemblies, circuits, etc.,
— descriptionsandexplanationsnecessaryfortheunderstandingofthosedraw-
ings and schemes, including the operation of the product,
— the results of design calculations made, impartial examinations carried out,
etc.,
— impartial test reports,— manuals for installation, use and maintenance.
Where appropriate, the design documentation must contain the following:
— attestations relating to the equipment incorporated in the appliance,
— attestations and certificates relating to the methods of manufacture and/or
inspection and/or monitoring of the appliance,
— any other document that makes it possible for the notified body to improve
its assessment.
1996L0098 — EN — 28.11.1998 — 001.001 — 46
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ANNEXC
Minimum criteria to be taken into account by Member States for the
designation of bodies
1. NotifiedbodiesmustfulfiltherequirementsoftherelevantEN45000series.2. Anotifiedbodymustbeindependentandmustnotbecontrolledbymanufac-
turers or by suppliers.
3. A notified body must be established within the territory of the Community.4. Where type-approvals are issued by a notified body on behalf of a Member
State,theMemberStatemustensurethatthequalifications,technicalexperi-ence and staffing of the notified body are such as will enable it to issuetype-approvals which comply with the requirements of this Directive and toguarantee a high level of safety.
5. A notified body must be in a position to provide maritime expertise.
A notified body is entitled to perform conformity-assessment procedures for
any economic operator established within or outwith the Community.
A notified body may perform conformity-assessment procedures in any
Member State or State outwith the Community using either its home-basedmeans or the personnel of its branch office abroad.
Ifasubsidiaryofanotifiedbodyperformsconformity-assessmentprocedures,
all documents relating to the conformity-assessment procedures must beissued by and in the name of the notified body and not in the name of thesubsidiary.
AsubsidiaryofanotifiedbodywhichisestablishedinanotherMemberState
may,however,issuedocumentsrelatingtoconformity-assessmentproceduresif it is notified by that Member State.
1996L0098 — EN — 28.11.1998 — 001.001 — 47
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ANNEXD
Mark of conformity
The mark of conformity must take the following form:
Ifthemarkisreducedorenlargedtheproportionsgivenintheabovegraduated
drawing must be respected.
The various components of the mark must have substantially the same vertical
dimension, which may not be less than 5mm.
That minimum dimension may be waived for small devices.