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  • DD CEN ISO/TS 11135-2:2008

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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. Ethylene oxide Guidance on the application of ISO 11135-1

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-07-2014

    Language(s):  English

    Published date:  30-09-2011

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Quality management systems
       4.1 Documentation
       4.2 Management responsibility
       4.3 Product realization
       4.4 Measurement, analysis and improvement - Control
            of non-conforming product
    5 Sterilizing agent characterization
       5.1 Sterilizing agent
       5.2 Microbicidal effectiveness
       5.3 Materials effects
       5.4 Environmental considerations
    6 Process and equipment characterization
       6.1 Process characterization
       6.2 Equipment characterization
    7 Product definition
       7.1 General
       7.2 Product safety and performance
       7.3 Microbiological quality
       7.4 Documentation
    8 Process definition
    9 Validation
       9.1 Installation qualification
       9.2 Operational qualification
       9.3 Performance qualification
       9.4 Varying load configurations
       9.5 Review and approval of validation
    10 Routine monitoring and control
       10.1 General
       10.2 Parametric release
    11 Product release from sterilization
    12 Maintaining process effectiveness
       12.1 General
       12.2 Maintenance of equipment
       12.3 Requalification
       12.4 Assessment of change
    Annex A (informative) - Guidance on ISO 11135-1:2007 Annex
                            A Determination of process lethality
                            - Biological indicator/bombardon approach
    Annex B (informative) - Guidance on ISO 11135-1:2007 Annex B
                            Conservative determination of lethal rate
                            of the sterilization process - Overkill
                            approach
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives guidance for the requirements in ISO 11135-1:2007.

    Scope - (Show below) - (Hide below)

    This Technical Specification provides guidance for the requirements in ISO 11135-1:2007. It does not repeat the requirements and is not intended to be used in isolation.

    The exclusions in ISO 11135-1 apply also to this Technical Specification.

    For ease of reference, the clause numbering in this Technical Specification corresponds to that in ISO 11135-1:2007. Further guidance for the requirements given in ISO 11135-1 is also included in Annex C of ISO 11135-1:2007 and should be used in conjunction with this Technical Specification.

    This guidance document is intended for people who have a basic knowledge of the principles of EO sterilization but may need help in determining how to best meet the requirements contained in ISO 11135-1. This document is not intended for people lacking a basic knowledge of the principles of EO sterilization.

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

    Committee CH/198
    Document Type Standard
    Publisher British Standards Institution
    Revision Of
    Status Superseded
    Superseded By

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

    ISO 15883-1:2006 Washer-disinfectors Part 1: General requirements, terms and definitions and tests
    AS/NZS 4187:2014 Reprocessing of reusable medical devices in health service organisations
    AAMI ST41 : 2008 ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS
    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 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    AAMI TIR28 : 2016 PRODUCT ADOPTION AND PROCESS EQUIVALENCE FOR ETHYLENE OXIDE STERILIZATION
    ISO 11138-2:2017 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
    ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    AAMI TIR15 : 2016 PHYSICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION
    ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
    ISO/TS 15883-5:2005 Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy
    ISO 15883-4:2008 Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
    ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
    ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
    ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
    ISO 15883-2:2006 Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
    EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
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