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  • 04/30048118 DC : DRAFT MAY 2004

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BS EN ISO 11135 - STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES

    Available format(s): 

    Superseded date:  29-06-2007

    Language(s): 

    Published date:  23-11-2012

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
       1.1 Inclusions
       1.2 Exclusions
    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 Material effects
       5.4 Environmental considerations
    6 Process and equipment characterization
       6.1 Process
       6.2 Equipment
    7 Product definition
       7.1 General
       7.2 Product safety and performance
       7.3 Microbiological quality
    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 Data to be monitored
    11 Product release from sterilization
       11.1 General
       11.2 Product release using biological indicators
       11.3 Parametric release
    12 Maintaining process effectiveness
       12.1 General
       12.2 Maintenance of equipment
       12.3 Requalification
       12.4 Assessment of change
    Annex A (normative) Bioburden Method
          A.1 General- Bioburden-Approach Method
          A.2 Bioburden evaluations
          A.3 Sampling
          A.4 Procedure
    Annex B (normative) Biological Indicator/Bioburden Method
          B.1 General
          B.2 Procedure
          B.3 Enumeration
    Annex C (normative) Overkill
          C.1 Conservative process definitions based on the
               inactivation of reference microorganisms
          C.2 Procedure
    Annex D (informative) - General guidance
          D.1 Scope
          D.2 Normative references
          D.3 Terms and definitions
          D.4 Quality management systems
          D.5 Sterilizing agent characterization
          D.6 Process and equipment characterization
          D.7 Product definition
          D.8 Process definition
          D.9 Validation
          D.10 Routine monitoring and control
          D.11 Product release from sterilization
          D.12 Maintaining process effectiveness
    Annex E (informative) Microbiological performance
            qualification - method for calculating D
            values using the BI/Biodurden approach
    Bibliography
    Annex ZA (normative) Normative references to international
             publications with their relevant European publications
    Annex ZB (informative) Relationship between this European Standard
             and the Essential Requirements of EU Directives 90/385/EEC
             of 20 June 1990 concerning active implantable medical
             devices, 93/42/EEC of 14 June 1993 concerning medical
             devices and 98/78/EC of 7 December 1988 concerning in vitro
             diagnostic medical devices

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

    Comment Closes On
    Committee CH/198
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    EN 12442-3 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    ISO 11737-2:2009 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
    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
    ISO 11138-2:2017 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
    ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
    ISO/TS 11139:2006 Sterilization of health care products Vocabulary
    ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
    ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
    ISO 14001:2015 Environmental management systems — Requirements with guidance for use
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 9001:2015 Quality management systems — Requirements
    EN 12442-1 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
    ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
    IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    ISO 14040:2006 Environmental management Life cycle assessment Principles and framework
    ISO 10012-1:1992 Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
    IEC 61010-2-042:1997 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-042: Particular requirements for autoclaves and sterilizers using toxic gas for the treatment of medical materials, and for laboratory processes
    EN 12442-2 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING
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