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)
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and published for the first time in the Official Journal of the European Communities of 14 November 2001, shall not be withdrawn from the list of standards published in the Official Journal of the European Communities.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 relevant provisions of Directive 93/42/EEC provided that the action in Article 2 is fulfilled.
A statement for clarification, as described in the Annex, with reference to EN1970, will be published in the Official Journal of the European Union.
This Decision is addressed to the Member States.
Done at Brussels, 20 April 2004.
For the Commission
Erkki Liikanen
Member of the Commission
(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.
Supplementary provisions
ANNEXSupplementary provisions
Note for the Official Journal concerning Directive 93/42/EEC:
Commission Statement for clarification with reference to EN1970 - "Adjustable beds for disabled persons - Requirements 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.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
