NF EN ISO 14160

NF EN ISO 14160

June 1998
Standard Cancelled

Validation and routine control of sterilization by liquid chemical sterilants. Sterilization of single-use medical devices incorporating materials of animal origin.

Le présent document spécifie les exigences relatives à la mise au point, à la validation, au contrôle et à la surveillance du procédé de stérilisation par agents stérilisants chimiques liquides, de dispositifs médicaux non réutilisables comprenant en partie ou en totalité des matières d'origine animale.

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Main informations

Collections

National standards and national normative documents

Publication date

June 1998

Number of pages

32 p.

Reference

NF EN ISO 14160

ICS Codes

11.080.01   Sterilization and disinfection in general

Classification index

S98-112

Print number

1 - 07/10/2005

International kinship

ISO 14160:1998

European kinship

EN ISO 14160:1998
Sumary
Validation and routine control of sterilization by liquid chemical sterilants. Sterilization of single-use medical devices incorporating materials of animal origin.

Le présent document spécifie les exigences relatives à la mise au point, à la validation, au contrôle et à la surveillance du procédé de stérilisation par agents stérilisants chimiques liquides, de dispositifs médicaux non réutilisables comprenant en partie ou en totalité des matières d'origine animale.
Standard replaced by (1)
NF EN ISO 14160
August 2011
Standard Cancelled
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices

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.

Table of contents
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Définitions
    2
  • 4 Généralités
    4
  • 5 Validation
    5
  • 6 Maîtrise et surveillance du procédé
    8
  • 7 Libération du produit après stérilisation
    9
  • Annexe A (informative) Guide d'application
    11
  • Annexe B (informative) Références aux Normes européennes avec leurs équivalents respectifs
    21
  • Annexe C (informative) Bibliographie
    22
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