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Standard

ISO 14160:2011

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Hinweis: Neuste Ausgabe: ISO 14160:2020

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Zusammenfassung

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.

Produktspezifikationen

  • Standard von ISO
  • Ausgabedatum:
  • Rückzugsdatum:
  • Einspruchsfrist bis:
  • Edition: 2
  • Dokumenttyp: IS
  • Seiten
  • Herausgeber: ISO
  • Lieferant: ISO
  • ICS: 11.080.01
  • Internationales Komitee: ISO/TC 198

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