EN ISO 15001:2004

Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2003)

Publication date:   Aug 10, 2006

General information

99.60 Withdrawal effective   Jun 1, 2010

CEN

CEN/TC 215 Respiratory and anaesthetic equipment

European Norm

11.040.10   Anaesthetic, respiratory and reanimation equipment

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Scope

This European Standard specifies minimum requirements for the oxygen compatibility of materials which can come in contact with oxygen at pressures greater than 50 kPa in medical devices. Aspects of compatibility that are addressed include: cleanliness, resistance to ignition and the toxicity of products of combustion and/or decomposition. NOTE: It is expected that particular device standards will make reference to this horizontal standard but may, if appropriate, strengthen these minimum requirements.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Life cycle

NOW

WITHDRAWN
EN ISO 15001:2004
99.60 Withdrawal effective
Jun 1, 2010

REVISED BY

WITHDRAWN
EN ISO 15001:2010

Relations

Adopted from ISO 15001:2003 IDENTICAL