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  • 09/30157765 DC : 0

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    BS EN ISO 14160 REV - STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-07-2011

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Definitions
    4 Quality management system elements
       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 General
       5.2 Sterilizing agent
       5.3 Microbicidal effectiveness
       5.4 Effects on materials
       5.5 Safety and the environment
    6 Process and equipment characterization
       6.1 General
       6.2 Process characterization
       6.3 Equipment characterization
    7 Product definition
    8 Process definition
    9 Validation
       9.1 General
       9.2 Installation qualification
            9.2.1 Equipment
            9.2.2 Installation
       9.3 Operational qualification
       9.4 Performance qualification
            9.4.1 General
            9.4.2 Microbiological performance qualification
            9.4.3 Physical performance qualification
            9.4.4 Aseptic processing qualification
       9.5 Review and approval of validation
    10 Routine monitoring and control
    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 the application of this
            International Standard
       A.1 Scope
       A.2 Normative references
       A.3 Definitions
       A.4 Quality management system elements
            A.4.1 Documentation
            A.4.2 Management responsibility
            A.4.3 Product realization
            A.4.4 Measurement, analysis and improvement - Control
                  of non-conforming product
       A.5 Sterilizing agent characterization
       A.6 Process and equipment characterization
       A.7 Product definition
       A.8 Process definition
       A.9 Validation
       A.10 Routine monitoring and control
       A.11 Product release from sterilization
       A.12 Maintaining process effectiveness
    Annex B (normative) - Determination of lethal rate of
            the sterilization process (Combined Reference
            Organism/bioburden approach)
       B.1 General
       B.2 Procedure
       B.3 Process lethality determination
            B.3.1 Direct enumeration (Survivor Curve)
            B.3.2 Fraction-negative method using Holcomb-Spearman
                  Karber procedure (HSKP)
            B.3.3 Fraction-negative method using Stumbo Murphy
                  Cochran procedure (SMCP)
    Annex C (normative) - Conservative determination of lethal
            rate of the sterilization process (Halfcycle approach)
       C.1 General
       C.2 Procedure
    Annex D (informative) - Flowahart for process definition
            (Clause 8) and Microbiological Performance Qualification
            (9.4.2)
    Annex ZA (informative) - Clauses of this International
             Standard addressing essential requirements
             or other provisions of EU Directives
    Bibliography

    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)

    ISO 13408-4:2005 Aseptic processing of health care products — Part 4: Clean-in-place technologies
    ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 13408-2:2003 Aseptic processing of health care products Part 2: Filtration
    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 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
    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
    ISO 13408-3:2006 Aseptic processing of health care products Part 3: Lyophilization
    ISO 9004:2009 Managing for the sustained success of an organization A quality management approach
    ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
    ISO/TS 11139:2006 Sterilization of health care products Vocabulary
    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 22442-2:2015 Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
    ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
    ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
    ISO/IEC 90003:2014 Software engineering Guidelines for the application of ISO 9001:2008 to computer software
    ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
    ISO 13408-6:2005 Aseptic processing of health care products Part 6: Isolator systems
    ISO 10012-1:1992 Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment
    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 13408-5:2006 Aseptic processing of health care products Part 5: Sterilization in place
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