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  • CSA Z11140.1 : 2007 : R2012 : FR

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-07-2016

    Language(s):  English

    Published date:  01-01-2012

    Publisher:  Canadian Standards Association

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Classification
    5 General requirements
    6 Performance requirements
    7 Test methods
    8 Additional requirements for process (Class 1) indicators
    9 Additional requirements for single variable (Class 3)
       indicators
    10 Additional requirements for multi-variable (Class 4)
       indicators
    11 Additional requirements for steam integrating (Class 5)
       indicators
    12 Additional requirements for dry heat integrating
       (Class 5) indicators
    13 Additional requirements for ethylene oxide integrating
       (Class 5) indicators
    14 Additional requirements for emulating (Class 6) indicators
    Annex A - (informative) 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 (BIs) 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 components
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes 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 variables required for a sterilization process.

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

    Document Type Standard
    Product Note Reconfirmed F
    Publisher Canadian Standards Association
    Status Superseded
    Superseded By
    Supersedes

    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
    ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
    EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
    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 9001:2015 Quality management systems — Requirements
    ISO 11607:2003 Packaging for terminally sterilized medical devices
    ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
    ISO 11137:1995 Sterilization of health care products Requirements for validation and routine control Radiation sterilization
    EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
    EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
    ISO/IEC Guide 22:1996 General criteria for supplier's declaration of conformity
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