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: 2000-10-14
Institutions: European Commission
Subjects: European standard, harmonisation of standards, medical device, public health

14.10.2000

EN

Official Journal of the European Communities

C 293/9

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

(2000/C 293/06)

(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 455-3

Medical gloves for single use (cid:151) Part 3: requirements and
testing for biological evaluation

CEN

EN 737-2/A1

Medical gas pipeline systems (cid:151) Part 2: anaesthetic gas
scavenging disposal systems (cid:151) basic requirements

CEN

EN 737-3/A1

Medical gas pipeline systems (cid:151) Part 3: pipelines
compressed medical gases and vacuum

for

CEN

EN 738-2

Pressure regulators for use with medical gases (cid:151) Part 2:
manifold and line pressure regulators

CEN

EN 738-3

Pressure regulators for use with medical gases (cid:151) Part 3:
pressure regulators integrated with cylinder valves

CEN

EN 738-4

Pressure regulators for use with medical gases (cid:151) Part 4:
low-pressure regulators
incorporation into
medical equipment

intended for

CEN

EN 1089-3/A1

Transportable gas cylinders (cid:151) gas cylinder identification (cid:151)
Part 3: colour coding

CEN

EN 1865

CEN

EN ISO 10079-1

Specifications
equipment used in road ambulances

for

stretchers and other patient-handling

Medical suction equipment (cid:151) Part 1: electrically powered
suction
requirements
(cid:151)
(ISO 10079-1:1999)

equipment

safety

CEN

EN ISO 10079-2

Medical suction equipment (cid:151) Part 2: manually powered
suction equipment (ISO 10079-2:1999)

CEN

EN ISO 10079-3

Medical suction equipment (cid:151) Part 3: suction equipment
powered
source
(ISO 10079-3:1999)

vacuum or

from a

pressure

CEN

EN ISO 10535

Hoists for the transfer of disabled persons (cid:151) requirements
and test methods (ISO 10535:1998)

CEN

EN ISO 10555-1/A1 Sterile, single-use intra-vascular catheters (cid:151) Part 1: general

requirements (ISO 10555-1:1996/Amd 1:1999)

CEN

EN ISO 11990

Optics and optical
instruments (cid:151) lasers and laser-related
equipment (cid:151) determination of laser resistance of tracheal
tube shafts (ISO 11990:1999)

CEN

EN 12006-1

Non-active surgical implants (cid:151) particular requirements for
cardiac and vascular
implants (cid:151) Part 1: heart valve
substitutes

CEN

EN 12182

Technical aids for disabled persons (cid:151) general requirements
and test methods

CEN

CEN

EN 12218

Rail systems for supporting medical equipment

EN 12470-1

Clinical thermometers (cid:151) Part 1: metallic liquid-in-glass ther-
mometers with maximum device

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

1999

1998
1999

1998
1999

1998

1998

1998

1997
1999

1999

1999

1999

1999

1998

1996
1999

1999

1999

1999

1998

2000

C 293/10

EN

Official Journal of the European Communities

14.10.2000

ESO (1)

Reference

Title of the harmonised standards

Year of ratification

CEN

EN 12470-3

Clinical thermometers (cid:151) Part 3: performance of compact
electrical thermometers (non-predictive and predictive) with
maximum device

CEN

EN 13220

Flow-metering devices for connection to terminal units of
medical gas pipeline systems

2000

1998

(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 (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 (www.cenelec.be);
(cid:151) ETSI: BP 152, F-06561 Valbonne Cedex, tel. (33-4) 92 94 42 12, fax (33-4) 93 65 47 16 (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.

Commission Communication in the framework of the implementation of Council Directive
90/385/EEC of 20 June 1990 in relation to active implantable medical devices (1) and Council
Directive 93/42/EEC of 14 June 1993 in relation to medical devices (2)

(2000/C 293/07)

(Text with EEA relevance)

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

ESO (1)

Reference

Title of the harmonised standards

Year of ratification

CEN

EN 980/A1

Graphical symbols for use in the labelling of medical devices

CEN

EN 30993-7

Biological evaluation of medical devices (cid:151) Part 7: ethylene
oxide sterilisation residuals (ISO 10993-7:1995)

CEN
Cenelec

EN 46003

Quality
requirements for the application of EN ISO 9003

systems (cid:151) medical

devices (cid:151) particular

1996
1999

1995

1999

(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 (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 (www.cenelec.be);
(cid:151) ETSI: BP 152, F-06561 Valbonne Cedex, tel. (33-4) 92 94 42 12, fax (33-4) 93 65 47 16 (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 (3) 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 (4).

(1) OJ L 189, 20.7.1990, p. 17.
(2) OJ L 169, 12.7.1993, p. 1.
(3) OJ L 204, 21.7.1998, p. 37.
(4) OJ C 181, 26.6.1999, p. 2, OJ C 227, 10.8.1999, p. 15, OJ C 288, 9.10.1999, p. 42.