1984L0539 — EN — 05.06.2003 — 002.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILDIRECTIVE
of17September1984
ontheapproximationofthelawsoftheMemberStatesrelatingtoelectro-medicalequipmentused
in►M1 ◄veterinary medicine
(84/539/EEC)
(OJ L 300, 19.11.1984, p. 179)
Amended by:
Official Journal
No page date
►M1Council Directive 93/42/EEC of 14 June 1993 L 169 1 12.7.1993
►M2Council Regulation (EC) No 807/2003 of 14 April 2003 L 122 36 16.5.2003
Amended by:
►A1Act of Accessionof Spainan d Portugal L 302 23 15.11.1985
▼B
COUNCILDIRECTIVE
of17September1984
on the approximationof the lawsofthe Member States relating to
electro-medicalequipmentusedin ►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 proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social
Committee (3),
Whereas, ineach Member State, electro-medical equipmen t used in
human or veterinary medicine must meet a high and clearly-defined
degree of safety both for the users of such equipment and for thosereceiving treatment by means of the equipment;
Whereas several Member 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
commonmarket canbe reduced or evenelimin ated 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 most
adequate form of harmonization is by reference to the standards drawn
up 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 responsi-bility by a mark or declarationof con formity;
Whereas technical progress requires prompt adaptation of the technical
specifications laid down by the Directives with respect to electro-medical equipment; whereas, in order to facilitate the implementationof the measures required, provisionshould be made for a procedureestablishing close cooperation between the Member States and the
Commissionwithinthe Committee onthe Adaptationto Techn ical
Progress of the Directives for Removing Technical Barriers to TradeinElectro-medical Equipmen t;
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 downto 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.1984L0539 — EN — 05.06.2003 — 002.001 — 2
(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.
▼B
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 technical requirements to which the equipment
must conform.
If the appliance is at the same time a medical device within the
meaning of Directive 93/42/EEC (
1) and if it satisfies the essential
requirements laid down therein for that device, the device shall bedeemed to be in conformity with the requirements of this Directive.
2. The conformity of equipment to the requirements of this Directive
shall 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 tothe specimen 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 reimbursedonthe same terms as the services provided with the help of equipmen t
meeting the criteria required under the provisions in force within their
territory 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
downinArticle 6:
— any amendments to Annex I made necessary by the adaptation to
technical progress of the harmonized standards by the relevant stan-dards organization,
— any amendments to Annex I which are desirable because of adapta-
tion to technical progress where the relevant standards organization
has 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 onthe Adaptationto Techn ical Progress of the
Directives for Removing Technical Barriers to Trade in Electro-
medical Equipment (hereinafter called ‘the Committee’) is hereby setup; it shall consist of representatives of the Member States and shallbe chaired by a Commissionrepresen tative.
Article 6
1. The Commissionshall be assisted by the Committee onthe Adap-
tation to Technical Progress of the Directives for Removing Technical
Barriers to Trade inElectro-medical Equipmen t.
2. Where reference is made to this Article, Articles 5 and 7 of Deci-
sion1999/468/EC (2) shall apply.
The period laid downinArticle 5(6) of Decision1999/468/EC shall be
set at three months.1984L0539 — EN — 05.06.2003 — 002.001 — 3
(1) OJ No L 169, 12. 7. 1993, p. 1.
(2) OJ L 184, 17.7.1999, p. 23.▼M1
▼B
▼M2
▼M2
3. The committee shall adopt its rules of procedure.
Article 7
1. If a Member State determines, on the basis of a substantiated
justification, that one or more appliances, although complying with
the requirements of this Directive, represent a hazard to safety, it may
provisionally prohibit the sale, free movement or use of the applianceor appliances 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 Commissionshall, withinsix weeks, con sult the Member
States concerned, following which it shall deliver its opinion without
delay and take the appropriate steps.
3. If the Commission is of the opinion that technical adaptations to
the Directive are necessary, such adaptations shall be adopted by eitherthe Commission or the Council in accordance with the procedure laiddowninArticle 6. Inthat case, the Member State which has adoptedthe safeguard measures may maintain them until the entry into force
of the adaptations.
Article 8
1. Member States shall take all appropriate measures to ensure that
the marks and declaration of conformity referred to in Article 2 are
issued by the manufacturer or the importer only under the conditionslaid downinthe 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
shall forthwith 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 governedby this Directive.
Article 11
This Directive is addressed to the Member States.1984L0539 — EN — 05.06.2003 — 002.001 — 4
(1) This Directive was notified to the Member States on 26 September 1984.▼B
▼B
ANNEX I
Thetechnicalrequirementstowhichtheequipmentreferred toinArticle1
mustconformarethefollowing:
Harmonization document of the European Committee for Electrotechnical Stan-
dardization (Cenelec) HD 395-1: General Requirements (1979 edition —
document based on IEC No 601-1 of the International Electrotechnical Commis-
sion); 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:
Normal condition — 1 mASingle fault condition — 5 mA.1984L0539 — EN — 05.06.2003 — 002.001 — 5
▼B
ANNEX II
LISTOFEQUIPMENTREFERREDTOINARTICLE1
1. DIAGNOSTIC EQUIPMENT
(excluding equipment subject to defibrillator discharge protection)
1.1.Equipment for the procurement of information from a living being
withouttheinfluenceofanexternalsource.
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 character-
istics 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,
— radiationthermometers.
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
undertheinfluenceofanexternalsource.
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 auxiliary
devices: stands, columns, chairs.
2. Equipment and corresponding accessories intended to support visibility
by monocular or binocular enlargement for diagnostic purposes and to
be used for viewing surgical procedures (excluding high-frequency
surgical equipment):
— surgical microscopes,
— colposcopes,1984L0539 — EN — 05.06.2003 — 002.001 — 6
▼B
— otoscopes,
— dermatoscopes.
3. Equipment and corresponding accessories intended for local illumina-
tionof areas to be examin ed or treated:
— head-lamps,
— illuminated head-mirrors,
— fluorescent hand-lamps,— mouth-lamps.
2. THERAPEUTIC EQUIPMENT
2.1.Specifictherapeuticequipment.
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
be achieved by:
— high voltage,
— electronemissionfrom hot metal.
2.1.2.Equipment applying other forms of energy.
1. Equipment and corresponding accessories which produce certain
mechanical effects in medicine:
— vibrators,
— equipment for pressurized water-massage,— equipment for extracorporal cardiac massage.
2. Equipment and corresponding accessories which produce hot air,
steam or vapours for medical therapeutic purposes:
— equipment in which solid or liquid material is evaporated by
heating or mechanical means for inhalation 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
mechanical effects in medicine:
— drilling, sawing and polishing equipment for dentistry or surgery,
— water-drivenequipmen t.
2.3.Equipmentforthesupportorreplacementofbodyfunctions
(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:
— artificial limbs,
— aids for the paralyzed,— artificial speech equipment.1984L0539 — EN — 05.06.2003 — 002.001 — 7
▼B
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
surgical or dental purposes:
— operating tables,
— operating chairs,— operating units,
— dental chairs,
— dental units.1984L0539 — EN — 05.06.2003 — 002.001 — 8
▼B
ANNEX III
1984L0539 — EN — 05.06.2003 — 002.001 — 9
▼B
ANNEX IV
1984L0539 — EN — 05.06.2003 — 002.001 — 10