1984L0539 — EN — 01.01.1995 — 001.001 — 1
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►B COUNCIL DIRECTIVE
of 17September 1984
on the approximation of the laws of the Member States relating to electro-medical equipment used
in►M1 ◄veterinary medicine
(84/539/EEC)
(OJ L 300, 19.11.1984, p. 179)
Amended by:
OfficialJournal
No page date
►M1 CouncilDirective 93/42/EEC of 14 June 1993 L 169 1 12.7.1993
Amended by:
►A1 Act of Accession of Spain and PortugalL 302 23 15.11.1985
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COUNCIL DIRECTIVE
of 17September 1984
on the approximation of the laws of the Member States relating to
electro-medical equipment used in ►M1 ◄veterinary
medicine
(84/539/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community, and in particular Article 100 thereof,
Having regard to the proposalfrom the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and SocialCommittee (3),
Whereas, in each Member State, electro-medical equipment used in
human or veterinary medicine must meet a high and clearly-defineddegree of safety both for the users of such equipment and for thosereceiving treatment by means of the equipment;
Whereas severalMember States have sought to ensure that degree of
safety by mandatory specifications relating both to the technical safetyregulations and the inspection procedures; whereas those specificationsdiffer from one Member State to another;
Whereas these obstacles to the establishment and operation of the
common market can be reduced or even eliminated if the same specifi-cations are adopted by all the Member States, either in addition to or inplace of their present legislation;
Whereas it is advisable in the first instance to harmonize at Community
level one section of the equipment in question; whereas the mostadequate form of harmonization is by reference to the standards drawnup by the European Committee for Electrotechnical Standardization(Cenelec);
Whereas, in order to ensure that the equipment complies with the
harmonized standards, the manufacturer acknowledges his responsibilityby a mark or declaration of conformity;
Whereas technicalprogress requires prompt adaptation of the technical
specifications laid down by the Directives with respect to electro-medical equipment; whereas, in order to facilitate the implementation ofthe measures required, provision should be made for a procedure estab-lishing close cooperation between the Member States and the Commis-sion within the Committee on the Adaptation to TechnicalProgress ofthe Directives for Removing TechnicalBarriers to Trade in El ectro-medicalEquipment;
Whereas electro-medical equipment, although conforming to the
requirements of this Directive, might endanger public safety and health;whereas a procedure should therefore be laid down to obviate this risk,
HAS ADOPTED THIS DIRECTIVE:
Article 1
This Directive shall apply to the electro-medical equipment listed in
Annex II (hereinafter called ‘equipment') which is intended, by itsnature, for use in ►
M1 ◄veterinary medicine.
(1) OJ No C 33, 12. 2. 1975, p. 5.
(2) OJ No C 76, 14. 3. 1975, p. 37.
(3) OJ No C 233, 17. 11. 1975, p. 39.
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Article 2
1. Member States may not, on grounds of safety relating to its
manufacture, refuse, prohibit or restrict the sale, free movement or usefor its intended purpose of the equipment referred to in Article 1 of thisDirective where it conforms with the requirements of this Directive.
Annex I contains the technicalrequirements to which the equipment
must conform.
▼
M1
If the appliance is at the same time a medical device within the meaningof Directive 93/42/EEC (
1) and if it satisfies the essentialrequirements
laid down therein for that device, the device shall be deemed to be inconformity with the requirements of this Directive.
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2. The conformity of equipment to the requirements of this Directiveshall be attested by the manufacturer or by the importer, under thelatter’s responsibility, by the affixing of a mark which conforms to thespecimen shown in Annex III or by a declaration which conforms to thespecimen shown in Annex IV.
Article 3
Member States shall ensure that the services provided with the help of
equipment meeting the requirements of this Directive are reimbursed onthe same terms as the services provided with the help of equipmentmeeting the criteria required under the provisions in force within theirterritory as regards the authorized applications and minimum require-ments for the equipment.
Article 4
The following shall be adopted in accordance with the procedure laid
down in Article 6:
— any amendments to Annex I made necessary by the adaptation to
technicalprogress of the harmonized standards by the rel evant stan-dards organization,
— any amendments to Annex I which are desirable because of adapta-
tion to technicalprogress where the rel evant standards organizationhas not made the corresponding amendments to the harmonizedstandard.
In the latter case, the amendments shall be notified to the competent
standards organization.
Article 5
1. A Committee on the Adaptation to TechnicalProgress of the
Directives for Removing TechnicalBarriers to Trade in El ectro-medicalEquipment (hereinafter called ‘the Committee') is hereby set up; it shallconsist of representatives of the Member States and shall be chaired bya Commission representative.
2. The Committee shall draw up its own rules of procedure.
Article 6
1. Where reference is made to the procedure laid down in this
Article, the matter shall be referred to the Committee by its chairman,either on his own initiative or at the request of a representative of aMember State.
2. The Commission representative shall submit to the Committee a
draft of the measures to be taken. The Committee shall give its opinionon that draft within a time limit set by the chairman having regard to theurgency of the matter. Opinions shall be delivered by a majority of►
A1fifty-four ◄votes, the votes of the Member States being
(1) OJ No L 169, 12. 7. 1993, p. 1.
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weighted as provided for in Article 148 (2) of the Treaty. The chairman
shall not vote.
3. (a) Where the proposed measures are in accordance with the opinion
of the Committee the Commission shall adopt them.
(b) Where the proposed measures are not in accordance with the
opinion of the Committee or if no opinion is delivered, theCommission shall without delay submit to the Council aproposalon the measures to be taken. The Councilshal lact by aqualified majority.
(c) If, within three months of the proposalbeing submitted to it, the
Councilhas not acted, the proposed measures shal lbe adoptedby the Commission.
Article 7
1. If a Member State determines, on the basis of a substantiated
justification, that one or more appliances, although complying with therequirements of this Directive, represent a hazard to safety, it mayprovisionally prohibit the sale, free movement or use of the appliance orappliances on its territory or make it subject to special conditions. Itshall immediately inform the other Member States and the Commissionthereof, stating the grounds for its decision.
2. The Commission shall, within six weeks, consult the Member
States concerned, following which it shall deliver its opinion withoutdelay and take the appropriate steps.
3. If the Commission is of the opinion that technicaladaptations to
the Directive are necessary, such adaptations shall be adopted by eitherthe Commission or the Councilin accordance with the procedure l aiddown in Article 6. In that case, the Member State which has adopted thesafeguard measures may maintain them untilthe entry into force of theadaptations.
Article 8
1. Member States shall take all appropriate measures to ensure that
the marks and declaration of conformity referred to in Article 2 areissued by the manufacturer or the importer only under the conditionslaid down in the Directive.
2. Member States shall make all necessary arrangements to ensure
adequate surveillance of the manufacture of the equipment.
Article 9
Member States shall take all appropriate measures to prevent the use on
equipment of marks or markings which might be confused with theEEC mark described in Annex III.
Article 10
1. Member States shall bring into force the measures necessary to
comply with this Directive within 24 months of its notification and shallforthwith inform the Commission thereof (
1).
2. Member States shall communicate to the Commission the texts of
the provisions of national law which they adopt in the field governed bythis Directive.
Article 11
This Directive is addressed to the Member States.
(1) This Directive was notified to the Member States on 26 September 1984.
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ANNEX I
The technical requirements to which the equipment referred to in Article 1
must conform are the following:
Harmonization document of the European Committee for Electrotechnical Stan-
dardization (Cenelec) HD 395-1: General Requirements (1979 edition — docu-ment based on IEC No 601-1 of the InternationalEl ectrotechnicalCommission);this standard being applicable subject to the following amendments:
In the case of the equipment referred to in 2.2.1.1 of Annex II, the requirements
of HD 395-1 are amended as follows:
Sub-clause 14.6 (b): The equipment shall be minimally of type BF;
Sub-clause 19.3: Patient Auxiliary Current:
Normalconditio n—1m A
Single fault conditio n—5m A .
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ANNEX II
LIST OF EQUIPMENT REFERRED TO IN ARTICLE 1
1. DIAGNOSTIC EQUIPMENT
(excluding equipment subject to defibrillator discharge protection)
1.1.Equipment for the procurement of information from a living being
without the influence of an external source.
1.1.1.Equipment for the procurement of biopotentials.
1. Equipment and corresponding accessories for diagnostic or monitoring
purposes to study or monitor electrical activity or electrical characteris-tics of living beings:
— electroencephalographs and electrocorticographs,— electromyographs,— electroretinographs,— electronystagmographs.
2. Equipment and corresponding accessories.
1.1.2.Equipment for the procurement of other parameters.
1. Equipment and corresponding accessories to study the infra-red radia-
tion produced by living organisms for diagnostic purposes:
— thermoscanners,— thermographs,— radiation thermometers.
2. Equipment and corresponding accessories to study acoustic activity or
sensitivity of living beings:
— electronic stethoscopes,— phonocardioscopes and phonocardiographs only where not
intended for cardiovascular interventions,
— audiometers,— audiophones.
3. Equipment and corresponding accessories:
— ballistocardiographs,— electronic thermometers only where intended for cardiovascular
interventions.
1.2.Equipment for the procurement of information from a living being
under the influence of an external source.
1.2.1.Equipment using an electronic source.
Equipment and corresponding accessories which apply directly electrical
currents to living organisms:
— equipment for the measurement of skin resistance,— equipment for pulmonary or vascular impedance rheography.
1.2.2.Equipment using another source.
1. Equipment and corresponding accessories for ophthalmological diag-
nosis:
— equipment for illumination of the eye: slit lamps, eye mirrors,
spectral light sources, ophthalmoscopes,
— equipment for viewing, imaging and measurement of the eye:
ophthalmometers, refractometers, tonometers, photometers, retino-scopes, cornea-microscopes,
— ophthalmological diagnostic units consisting of ophthalmological
equipment as mentioned above combined with necessary auxiliarydevices: stands, columns, chairs.
2. Equipment and corresponding accessories intended to support visibility
by monocular or binocular enlargement for diagnostic purposes and tobe used for viewing surgicalprocedures (excl uding high-frequencysurgicalequipment):
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— surgicalmicroscopes,
— colposcopes,— otoscopes,— dermatoscopes.
3. Equipment and corresponding accessories intended for local illumina-
tion of areas to be examined or treated:
— head-lamps,— illuminated head-mirrors,— fluorescent hand-lamps,— mouth-lamps.
2. THERAPEUTIC EQUIPMENT
2.1.Specific therapeutic equipment.
2.1.1.Equipment using electric energy.
1. Equipment and corresponding accessories which produce electrically
charged or ionized air, vapours or mists; charging or ionization may beachieved by:
— high voltage,— electron emission from hot metal.
2.1.2.Equipment applying other formsof energy.
1. Equipment and corresponding accessories which produce certain
mechanicaleffects in medicine:
— vibrators,— equipment for pressurized water-massage,— equipment for extracorporalcardiac massage.
2. Equipment and corresponding accessories which produce hot air, steam
or vapours for medicaltherapeutic purposes:
— equipment in which solid or liquid material is evaporated by
heating or mechanicalmeans for inhal ation purposes,
— hot-air baths.
This section does not include ultrasonic equipment.
2.2.Electro-surgical equipment.
2.2.1.Equipment using electric energy.
1. Equipment and corresponding accessories using low-frequency electric
energy to produce heat for electrocautery:
— equipment for electrocautery,— parts of combined medical electrical equipment intended for elec-
trocautery.
2.2.2.Equipment using other forms of energy.
1. Equipment and corresponding accessories for ophthalmological thera-
peutic purposes:
— equipment for treatment of the eye,— eye magnets.
2. Equipment and corresponding accessories.3. Equipment and corresponding accessories which produce certain
mechanicaleffects in medicine:
— drilling, sawing and polishing equipment for dentistry or surgery,— water-driven equipment.
2.3.Equipment for the support or replacement of body functions
(excluding implanted cardiac stimulators and other implanted devices).
2.3.1.Equipment for support or replacement by other means.
1. Equipment and corresponding accessories intended to support or
replace certain body functions:
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— artificiall imbs,
— aids for the paralyzed,— artificialspeech equipment.
2. Equipment and corresponding accessories intended to assist human
sensors:
— aids for the blind.
3. OTHER EQUIPMENT
Equipment and accessories for handling and positioning of the patient for
surgicalor dentalpurposes:
— operating tables,— operating chairs,— operating units,— dentalchairs,— dentalunits.
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ANNEX III

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ANNEX IV