Commission communication in the framework of the implementation of Council Directive 93/42/EEC of 14 June 1993 in relation to medical devices (Text with EEA relevance)
Date: 2001-11-14
Institutions: European Commission
Subjects: European standard, harmonisation of standards, medical device

C 319/10

EN

Official Journal of the European Communities

14.11.2001

Commission communication in the framework of the implementation of Council Directive
93/42/EEC of 14 June 1993 in relation to medical devices (1)

(2001/C 319/05)

(Text with EEA relevance)

(Publication of titles and references of European harmonised standards under the Directive)

ESO (1)

Reference

Title of the harmonised standards

Year of ratification

CEN

EN 1970

Adjustable beds for disabled persons (cid:151) Requirements and
test methods

CEN

EN 12442-1

Animal tissues and their derivatives utilised in the manu-
facture of medical devices (cid:151) Part 1: Analysis
and
management of risk

CEN

EN 12442-2

Animal tissues and their derivatives utilised in the manu-
facture of medical devices (cid:151) Part 2: Controls on sourcing,
collection and handling

CEN

EN 12442-3

Animal tissues and their derivatives utilised in the manu-
facture of medical devices (cid:151) Part 3: Validation of the elim-
ination and/or
inactivation of viruses and transmissible
agents

CEN

EN 12470-2

Clinical thermometers (cid:151) Part 2: Phase change type (dot
matrix) thermometers

CEN

EN 12470-4

Clinical thermometers (cid:151) Part 4: Performance of electrical
thermometers for continuons measurement

2000

2000

2000

2000

2000

2000

CEN

EN 13014

for gas
Connections
respiratory equipment

sanpling tubes

to anaesthetic and

2000

CEN

EN 13221

High-pressure flexible connections for use with medical gases

2000

CEN

EN 13503-8

Ophthalmic implants (cid:151) Intraocular lenses (cid:151) Part 8: Funda-
mental requirements (ISO 11979-8:1999, modified)

2000

Cenelec

EN 60118-13

Hearing aids (cid:151) Part 13: Electromagnetic compatibility (EMC)

1997

Cenelec

EN 60522

Determination of
assemblies

the permanent

filtration of X-ray tube

1999

Cenelec

EN 60601-1-1

Medical
requirements
requirements for medical electrical systems

safety (cid:151) Collateral

equipment (cid:151) Part

electrical
for

1-1: General
standard: Safety

2001

Cenelec

EN 60601-1-2

Medical electrical equipment (cid:151) Part 1: General requirements
for safety (cid:151) 2. Collateral standard: Electromagnetic compati-
bility (cid:151) Requirements and tests

1993

(1) OJ L 169, 12.7.1993, p. 1.

14.11.2001

EN

Official Journal of the European Communities

C 319/11

ESO (1)

Reference

Title of the harmonised standards

Year of ratification

Cenelec

EN 60601-1-4

Cenelec

EN 60601-2-1

Cenelec

EN 60601-2-3

Cenelec

EN 60601-2-8

Cenelec

EN 60601-2-20

Cenelec

EN 60601-2-21

electrical

Medical
1-4: General
requirements for safety (cid:151) Collateral standard: Programmable
electrical medical systems

equipment (cid:151) Part

Amendment A1

electrical

Medical
Particular
requirements for the safety of electron accelerators in the
range of 1 MeV to 50 MeV

equipment (cid:151) Part 2-1:

Medical
Particular
requirements for the safety of short-wave therapy equipment

equipment (cid:151) Part

electrical

2:

Amendment A1

electrical

Medical
Particular
requirements for the safety of therapeutic X-ray equipment
operating in the range 10 kV to 1 MV

equipment (cid:151) Part

2:

Amendment A1

1996

1999

1998

1993

1998

1997

1997

Medical
requirements for the safety of transport incubators

equipment (cid:151) Part

electrical

2:

Particular

1996

Medical
requirements for the safety of infant radiant warmers

equipment (cid:151) Part

electrical

2:

Particular

Amendment A1

Cenelec

EN 60601-2-23

electrical

Medical
equipment (cid:151) Part 2-23: Particular
requirements for the safety, including essential performance,
of transcutaneous partial pressure monitoring equipment

Cenelec

EN 60601-2-25

Cenelec

EN 60601-2-29

Cenelec

EN 60601-2-30

Medical
requirements for the safety of electrocardiographs

equipment (cid:151) Part 2-25: Particular

electrical

Amendment A1

Medical
requirements for the safety of radiotherapy simulators

equipment (cid:151) Part 2-29: Particular

electrical

electrical

Medical
equipment (cid:151) Part 2-30: Particular
requirements for the safety, including essential performance,
of automatic cycling non-invasive blood pressure monitoring
equipment

Cenelec

EN 60601-2-31

electrical

Medical
equipment (cid:151) Part 2-31: Particular
requirements for the safety of external cardiac pacemakers
with internal power source

Amendment A1

Cenelec

EN 60601-2-33

electrical
Medical
requirements
safety
for
equipment for medical diagnosis

equipment (cid:151) Part 2-33: Particular
resonance
of magnetic
the

Amendment A11

Cenelec

EN 60601-2-38

electrical

equipment (cid:151) Part 2-38: Particular
Medical
requirements for the safety of electrically operated hospital
beds

Amendment A1

1994

1996

2000

1995

1999

1999

2000

1995

1998

1995

1997

1996

2000

C 319/12

EN

Official Journal of the European Communities

14.11.2001

ESO (1)

Reference

Title of the harmonised standards

Year of ratification

Cenelec

EN 60601-2-39

Medical
equipment (cid:151) Part 2-39: Particular
requirements for the safety of peritoneal dialysis equipment

electrical

Cenelec

EN 60601-2-41

Cenelec

EN 60601-2-44

Cenelec

EN 60601-2-45

Cenelec

EN 60601-2-46

Medical
requirements
luminaires for diagnosis

electrical
for

equipment (cid:151) Part 2-41: Particular
luminaires and
the safety of

surgical

equipment (cid:151) Part 2-44: Particular
Medical
for
the
requirements
computed tomography

electrical
for

safety of X-ray

equipment

Medical
requirements
equipment and mammographic stereotactic devices

equipment (cid:151) Part 2-45: Particular
safety of mammographic X-ray
the

electrical
for

Medical
requirements for the safety of operating tables

equipment (cid:151) Part 2-46: Particular

electrical

Cenelec

EN 61217

Radiotherapy equipment (cid:151) Coordinates, movements and
scales

Amendment A1

Cenelec

EN 61223-3-1

Cenelec

EN 61223-3-4

and

routine

Evaluation
imaging
departments (cid:151) Part 3-1: Acceptance testes (cid:151) Imaging
performance of X-ray equipment for radiographic and radio-
scopic systems

in medical

testing

and

Evaluation
imaging
departments (cid:151) Part 3-4: Acceptance tests (cid:151) Imaging
performance of dental X-ray equipment

in medical

routine

testing

1999

2000

1999

1998

1998

1996

2001

1999

2000

(1) ESO (European standardisation organisation):

(cid:151) CEN: rue de Stassart/Stassartstraat 36, B-1050 Brussels; tel.
(32-2) 550 08 11, fax (32-2) 550 08 19 (http://www.cenorm.be);
(cid:151) Cenelec: rue de Stassart/Stassartstraat 35, B-1050 Brussels; tel. (32-2) 519 68 71, fax (32-2) 519 69 19 (http://www.cenelec.be);
(cid:151) ETSI: F-06561 Sophia Antipolis Cedex, tel. (33-4) 92 94 42 00, fax (33-4) 93 65 47 16 (http://www.etsi.org).

NOTE:

(cid:151) any information concerning the availability of the standards can be obtained either from the European
standardisation organisations or from the national standardisation bodies of which the list is annexed to
the Directive 98/34/EC (1) of the European Parliament and of the Council of 22 June 1998,

(cid:151) publication of the references in the Official Journal of the European Communities does not imply that the

standards are available in all the Community languages,

(cid:151) the Commission ensures the updating of this list (2).

(1) OJ L 204, 21.7.1998, p. 37.
(2) OJ C 181, 26.6.1999, p. 4, OJ C 227, 10.8.1999, p. 15, OJ C 288, 9.10.1999, p. 43, OJ C 293, 14.10.2000, p. 9.