Standard

NS-EN ISO 14160:2011

Tilbaketrukket

Merknad: Denne standarden har en ny utgave: NS-EN ISO 14160:2021

Forhåndsvisning

Rettelser og tillegg kjøpes separat.

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Omfang

ISO 14160:2011 specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin. ISO 14160:2011 covers the control of risks arising from contamination with bacteria and fungi by application of a liquid chemical sterilization process. Risks associated with other microorganisms need to be assessed. ISO 14160:2011 is not applicable to material of human origin. ISO 14160:2011 does not describe methods for the validation of the inactivation of viruses and transmissible spongiform encephalopath (TSE) agents. ISO 14160:2011 does not describe methods for validation of the inactivation, elimination, or elimination and inactivation of protozoa and parasites. The requirements for validation and routine control described in ISO 14160:2011 are only applicable to the defined sterilization process of a medical device, which is performed after the manufacturing process, and do not take account of the lethal effects of other bioburden reduction steps. ISO 14160:2011 does not specify tests to establish the effects of any chosen sterilization method upon the fitness for use of the medical device. ISO 14160:2011 does not cover the level of residual sterilizing agent within medical devices. ISO 14160:2011 does not describe a quality management system for the control of all stages of manufacture.

Dokumentinformasjon

  • Standard fra SN
  • Publisert:
  • Tilbaketrukket:
  • Utgave: 2011-07
  • Versjon: 1
  • Varetype: NAT
  • ICS 11.080.01
  • National Committee CEN/TC 204

Referanser i lov

EU lov: 93/42/EEC

Produktrelasjon

Produkt livssyklus