2004/376/EC: Commission Decision of 20 April 2004 on the publication of the reference of standard EN 1970:2000 "Adjustable beds for disabled persons — Requirements and test methods" in accordance with Council Directive 93/42/EEC (Text with EEA relevance) (notified under document number C(2004) 1290)
Date: 2004-04-20
Institutions: European Commission
Subjects: European standard, facilities for people with disabilities, harmonisation of standards

L 118/76

EN

Official Journal of the European Union

23.4.2004

COMMISSION DECISION

of 20 April 2004

on the publication of the reference of standard EN 1970:2000 ‘Adjustable beds for disabled
persons — Requirements and test methods’ in accordance with Council Directive 93/42/EEC

(notified under document number C(2004) 1290)

(Text with EEA relevance)

(2004/376/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 93/42/EEC of 14 June 1993
on the approximation of
the Member States
concerning medical devices (1), as amended by Directive 98/79/
EC (2),

the laws of

Having regard to the opinion of the Standing Committee set up
in accordance with Article 5 of Directive 98/34/EC of the Euro-
pean Parliament and of the Council of 22 June 1998 laying
down a procedure for the provision of information in the field
of technical standards and regulations and of rules on Informa-
tion Society Services (3), as amended by Directive 98/48/EC (4),

(5)

(6)

(7)

Whereas:

(1)

(2)

(3)

(4)

Article 2 of Directive 93/42/EEC stipulates that medical
devices may be placed on the market and put
into
service only if, when normally used,
they do not
compromise the safety of persons.

Under Article 5 of Directive 93/42/EEC, medical devices
are presumed to comply with the essential requirements
referred to in Article 3 of that Directive if they conform
to the national standards applicable to them transposing
the harmonised standards the reference numbers of
which have been published in the Official Journal of the
European Union.

Member States are required to publish the reference
numbers of national standards transposing harmonised
standards the reference numbers of which have been
published in the Official Journal of the European Union.

Germany raised a formal objection in respect of harmo-
nised standard EN 1970:2000 ‘Adjustable beds
for
disabled persons — Requirements and test methods’,
adopted by the European Committee for Standardisation
(CEN)
in 2000, the reference number of which was
published in the Official Journal of the European Commu-
nities on 14 November 2001 (5), on the grounds that it
does not fully satisfy the essential requirements of Direc-

(1) OJ L 169, 12.7.1993, p. 1.
(2) OJ L 331, 7.12.1998, p. 1.
(3) OJ L 204, 21.7.1998, p. 37.
(4) OJ L 217, 5.8.1998, p. 18.
(5) OJ C 319, 14.11.2001, p. 10.

tive 93/42/EEC, especially those relating to electrical
safety, and that, in some cases, a dangerous situation can
occur causing death or serious injury.

On the basis of the information received in the frame-
work of a consultation of national authorities, no
specific evidence was indicated to substantiate the risk of
fire in hospital beds in other Member States.

Recently reported information from France indicates a
number of accidents involving hospital beds, but details
of the causes have not been established.

Consequently, it has not been demonstrated that harmo-
nised standard EN 1970:2000 generally fails to meet the
essential requirements of Directive 93/42/EEC. However
it is necessary to draw the attention to the existence of
standard EN60601-2-38 ‘Particular requirements for the
safety of electrically operated hospital beds’ in relation
with EN1970: 2000,

HAS ADOPTED THIS DECISION:

Article 1

The reference of standard EN 1970:2000 ‘Adjustable beds for
disabled persons — Requirements and test methods’, adopted
by the European Committee for Standardisation (CEN) on 21
June 2000 and published for the first time in the Official Journal
of the European Communities of 14 November 2001, shall not be
withdrawn from the list of standards published in the Official
Journal of the European Communities. The standard shall therefore
continue to confer the presumption of conformity to the rele-
the
vant provisions of Directive 93/42/EEC provided that
action in Article 2 is fulfilled.

Article 2

A statement for clarification, as described in the Annex, with
reference to EN1970, will be published in the Official Journal of
the European Union.

23.4.2004

EN

Official Journal of the European Union

L 118/77

This Decision is addressed to the Member States.

Article 3

Done at Brussels, 20 April 2004.

For the Commission

Erkki LIIKANEN

Member of the Commission

Note for the Official Journal concerning Directive 93/42/EEC:

ANNEX

Commission Statement for clarification with reference to EN1970 — ‘Adjustable beds for disabled persons — Require-
ments and test methods’ — as published in OJ C 319, 14 November 2001

It is recognised that in European standard EN1970 ‘Beds for the disabled’, specific matters relating to electrical safety are
covered by a normative reference to EN60601-1 ‘Medical electrical equipment — Part 1 — General Requirements for
Safety’.

It is important, however, to refer also to the associated Part 2 standard EN60601-2-38 ‘Particular requirements for the
safety of electrically operated hospital beds’ and to apply these specific particular electrical safety requirements when
using EN1970 to meet the Essential Requirements of Directive 93/42/EEC on Medical Devices.

It is also recognised, in considering the needs for electrical safety of beds covered by EN1970, that the scope of this
standard covers beds intended for use either within or outside the hospital environment.

CEN/CENELEC is invited to prepare an amendment to EN1970 to include these matters of clarification.