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  • NF EN ISO 14160 : 2011

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    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

    Available format(s): 

    Superseded date:  15-03-2023

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Association Francaise de Normalisation

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    Table of Contents - (Show below) - (Hide below)

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

    Abstract - (Show below) - (Hide below)

    Defines requirements for developing, validating, process control and monitoring of the sterilization, using liquid chemical sterilants, of single-use medical devices consisting either entirely or partly of materials of animal origin. Not applicable to material of human origin.

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    Development Note Indice de classement: S98-112. PR NF EN ISO 14160 July 2009. (07/2009)
    Document Type Standard
    Publisher Association Francaise de Normalisation
    Status Superseded
    Superseded By

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
    ISO 22442-2:2015 Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
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