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  • PREN ISO 11140-1 : DRAFT 2012

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO/DIS 11140-1:2012)

    Available format(s): 

    Superseded date:  01-11-2014

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Comite Europeen de Normalisation

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Categorization
    5 General requirements
    6 Performance requirements
    7 Test methods
    8 Additional requirements for process
       (Type 1) indicators
    9 Additional requirements for single
       process variable (Type 3) indicators
    10 Additional requirements for multi
       process variable (Type 4) indicators
    11 Additional requirements for steam
       integrating (Type 5) indicators
    12 Additional requirements for ethylene
       oxide integrating (Type 5) indicators
    13 Additional requirements for emulating
       (Type 6) indicators
    Annex A (normative) - Method for demonstrating
            shelf life of the product
    Annex B (informative) - Examples of testing
            indicators
    Annex C (informative) - Rationale for the requirements
            for integrating indicators and the link to the
            requirements for biological indicators
            specified in ISO 11138 and microbial
            inactivation
    Annex D (informative) - Rationale for the liquid-phase
            test method for steam-formaldehyde
            indicators
    Annex E (informative) - Relationship of indicator
            and indicator system components
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the process parameter(s) specified for a sterilization process.

    General Product Information - (Show below) - (Hide below)

    Comment Closes On
    Committee TC 102
    Document Type Draft
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

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

    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
    EN 45014 : 1998 GENERAL CRITERIA FOR SUPPLIER'S DECLARATION OF CONFORMITY
    ISO 15882:2008 Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
    EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 11140-3:2007 Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
    EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
    ISO 18472:2006 Sterilization of health care products Biological and chemical indicators Test equipment
    ISO 11140-4:2007 Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
    EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    ISO/TS 11139:2006 Sterilization of health care products Vocabulary
    ISO 9001:2015 Quality management systems — Requirements
    ISO 11140-5:2007 Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
    ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
    EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
    ISO/IEC Guide 22:1996 General criteria for supplier's declaration of conformity
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