Standard

NS-EN ISO 15001:2004

Tilbaketrukket

Merknad: Denne standarden har en ny utgave: NS-EN ISO 15001:2011

Rettelser og tillegg kjøpes separat.

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Omfang

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.

Dokumentinformasjon

  • Standard fra SN
  • Publisert:
  • Tilbaketrukket:
  • Utgave: 2004-05
  • Versjon: 1
  • Varetype: NAT
  • ICS 11.040.10
  • National Committee SN/K 122

Referanser i lov

EU lov: 93/42/EEC

Produktrelasjon

Produkt livssyklus