SR EN ISO 15001:2004

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

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.

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General information

Status : Withdrawn
Approval date : 11/20/2004
Publish date : 11/21/2004
Withdrawal date : 11/30/2010
Number of pages : 53
ICS : 11.040.10 Anaesthetic, respiratory and reanimation equipment
Technical Committee : 377 - Medical devices

Relations with other standards:

Normative reference SR EN ISO 14971:2003
Replaced by SR EN ISO 15001:2010