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  • BS EN 15424:2007

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-08-2011

    Language(s):  English

    Published date:  30-04-2007

    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 System Elements
       4.1 Documentation
       4.2 Management responsibility
       4.3 Product realization
       4.4 Control of non-conforming product
    5 Sterilizing agent characterization
       5.1 General
       5.2 Sterilizing agent
       5.3 Microbicidal effectiveness
       5.4 Material effects
       5.5 Environmental considerations
    6 Process and equipment characterization
       6.1 General
       6.2 Process
       6.3 Equipment
    7 Product definition
    8 Process definition
    9 Validation
       9.1 General
       9.2 Installation qualification
            9.2.1 General
            9.2.2 Installation
            9.2.3 Equipment
       9.3 Operational qualification
       9.4 Performance qualification
            9.4.1 General
            9.4.2 Performance qualification - physical
            9.4.3 Performance qualification - microbiological
            9.4.4 Performance qualification - desorption and drying
       9.5 Review and approval of validation
    10 Routine monitoring and control
       10.1 General
       10.2 Biological indicators
       10.3 Chemical indicators
       10.4 Records
    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 (normative) Process definition based on inactivation of
            reference microorganisms and knowledge of bioburden on
            product items to be sterilized
          A.1 General
          A.2 Procedure
    Annex B (normative) Process definition based on inactivation of
            reference microorganisms
          B.1 General
          B.1.1 Overkill approach
          B.1.2 Penetration characteristics into medical devices
          B.2 Test procedure
          B.2.1 General
          B.2.2 Biological indicators
          B.2.3 Test systems
          B.2.4 Load configuration
          B.2.5 Testing
    Annex C (informative) Guidance on application of this European
            Standard
          C.1 Scope
          C.2 Normative references
          C.3 Terms and definitions
          C.4 Quality management system elements
          C.5 Sterilizing agent characterization
              C.5.1 Neutralization
              C.5.2 Studies of microbial inactivation
          C.6 Process and equipment characterization
          C.7 Product definition
              C.7.1 General
              C.7.2 Design considerations for medical devices intended
                    for sterilization
              C.7.3 Packaging
          C.8 Process definition
              C.8.1 General
              C.8.2 Influence on product and packaging
              C.8.3 Determination of process effectiveness
          C.9 Validation
              C.9.1 General
              C.9.2 Installation qualification (IQ)
              C.9.3 Operational qualification (OQ)
              C.9.4 Performance qualification (PQ)
              C.9.5 Documentation and approval of validation
          C.10 Routine monitoring and control
          C.11 Product release from sterilization
               C.11.1 General
               C.11.2 Product release using biological indicators
               C.11.3 Parametric release
          C.12 Maintaining process effectiveness
               C.12.1 Change control
               C.12.2 Requalification
    Annex D (informative) Environmental aspects regarding development,
            validation and control of Low Temperature Steam and
            Formaldehyde processes
          D.1 General
          D.2 Formaldehyde (brief description)
          D.3 Environmental impact of formaldehyde
          D.4 Other environmental burdens
    Annex ZA (informative) Relationship between this European Standard
             and the Essential Requirements of EU Directive 93/42/EEC
             Medical devices
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines requirements for the development, validation and routine control of a Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices.

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

    Committee CH/198
    Development Note Supersedes 05/30066638 DC. (04/2007)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    EN 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 11737-2:2009)
    IEC 61010-2-040:2015 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
    EN 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 14937:2009)
    EN 61010-2-040:2015 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040 Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
    EN ISO 11140-3:2009 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007)
    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
    EN ISO 10993-17:2009 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
    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
    EN ISO 14161:2009 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009)
    EN 867-5:2001 Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S
    EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
    EN ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017)
    EN ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
    ISO/TS 11139:2006 Sterilization of health care products Vocabulary
    AAMI RD47 : 2008 REPROCESSING OF HEMODIALYZERS
    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
    EN 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 (ISO 11140-4:2007)
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
    CEN Guide 4:2008 GUIDE FOR ADDRESSING ENVIRONMENTAL ISSUES IN PRODUCT STANDARDS
    EN ISO 10012:2003 Measurement management systems - Requirements for measurement processes and measuring equipment (ISO 10012:2003)
    ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
    ISO 11138-5:2017 Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
    EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
    EN ISO 11138-5:2017 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017)
    EN ISO 9000:2015 Quality management systems - Fundamentals and vocabulary (ISO 9000:2015)
    1997/23/EC : 1997 DIRECTIVE 97/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 29 MAY 1997 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES CONCERNING PRESSURE EQUIPMENT
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