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  • DIN EN ISO 20857:2013-08

    Current The latest, up-to-date edition.

    Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)

    Available format(s):  Hardcopy, PDF

    Language(s):  German, English

    Published date:  01-08-2013

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Current

    Standards Referenced By This Book - (Show below) - (Hide below)

    DIN HDBK 263 : 4ED 2014
    DIN EN ISO 16672:2015-12 Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)
    DIN EN ISO 14161:2010-03 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
    DIN EN ISO 11138-4:2015-10 (Draft) STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 4: BIOLOGICAL INDICATORS FOR DRY HEAT STERILIZATION PROCESSES (ISO 11138-4:2017)

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

    DIN EN ISO 11607-1:2014-11 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006 + AMD 1.:2014)
    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
    ISO 15883-1:2006 Washer-disinfectors Part 1: General requirements, terms and definitions and tests
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    VDE 0411-2-040 : 2016 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 (IEC 61010-2-040:2015)
    DIN EN ISO 13485:2016-08 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
    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
    DIN EN ISO 17664:2016-06 (Draft) PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017)
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
    DIN EN ISO 14161:2010-03 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
    ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
    ISO/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
    ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
    ISO 18472:2006 Sterilization of health care products Biological and chemical indicators Test equipment
    VDE 0411-1 : 2011 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS
    ISO/TS 11139:2006 Sterilization of health care products Vocabulary
    DIN EN ISO 11607-2:2014-11 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES (ISO 11607-2:2006 + AMD 1.:2014)
    ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
    DIN EN ISO 11737-2:2010-04 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
    DIN EN ISO 9000:2015-11 QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY (ISO 9000:2015)
    DIN EN ISO 22442-2:2016-05 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015)
    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
    ISO 9001:2015 Quality management systems — Requirements
    ISO 22442-2:2015 Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
    DIN EN ISO 11138-1:2015-10 (Draft) STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017)
    DIN EN ISO 22442-3:2008-03 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
    DIN EN ISO 18472:2006-10 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    DIN EN ISO 9001:2015-11 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015)
    ISO 11140-5:2007 Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
    DIN EN 61010-1 : 2011 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS
    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
    DIN EN ISO 15883-1:2014-10 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006 + AMD 1:2014)
    DIN EN ISO 11737-1:2009-09 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    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
    IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    ISO 11138-4:2017 Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes
    DIN EN ISO 10993-17:2009-08 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
    DIN EN 61010-2-040 : 2016 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 (IEC 61010-2-040:2015)
    DIN EN ISO 11138-4:2015-10 (Draft) STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 4: BIOLOGICAL INDICATORS FOR DRY HEAT STERILIZATION PROCESSES (ISO 11138-4:2017)
    DIN EN ISO 11140-1:2015-03 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
    DIN EN ISO 22442-1:2016-05 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
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