• ISO/TS 11139:2006

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    Sterilization of health care products Vocabulary

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Withdrawn date:  13-09-2018

    Language(s):  English, English - French

    Published date:  13-01-2006

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO/TS 11139:2006 gives definitions of terms in the field of sterilization technology.

    ISO/TS 11139:2006 does not provide requirements for the validation and routine control of a sterilization process, but is intended to contribute fundamentally towards mutual understanding amongst those preparing and using International Standards in the field of sterilization technology.

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

    Development Note DRAFT ISO/DIS 11139 is also available for this standard. (06/2017)
    Document Type Technical Specification
    Publisher International Organization for Standardization
    Status Withdrawn
    Superseded By
    Supersedes

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

    ANSI/AAMI/ ISO 11137-2:2013(R2019) STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
    DIN EN ISO 11135-1:2007-08 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    EN ISO 15378:2017 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
    17/30363625 DC : DRAFT SEP 2017 BS EN ISO 11138-7 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 7: GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
    02/124462 DC : DRAFT DEC 2002 BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    I.S. EN 15424:2007 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    08/30149503 DC : DRAFT JAN 2008 BS EN ISO 14161 - STERILIZATION OF HEALTH CAR PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
    12/30261215 DC : 0 BS EN 13060 - SMALL STEAM STERILIZERS
    BS EN ISO 5840-2:2015 Cardiovascular implants. Cardiac valve prostheses Surgically implanted heart valve substitutes
    I.S. EN ISO 11137-1:2015 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013)
    I.S. EN 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
    PREN ISO 11140-1 : DRAFT 2012 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO/DIS 11140-1:2012)
    ANSI/AAMI/ISO 13408-3:2006(R2015) ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION
    AAMI ISO 11137-1 : 2006 : R2010 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    14/30287226 DC : 0 BS EN ISO 15378 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP)
    PREN 14180 : DRAFT 2012 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
    BS EN ISO 4833-2:2013 Microbiology of the food chain. Horizontal method for the enumeration of microorganisms Colony count at 30 degrees C by the surface plating technique
    16/30302485 DC : 0 BS EN ISO 11737-1 - STERILIZATION OF HEALTH CARE PRODUCTS - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCT
    ANSI/AAMI/ISO 11138-1:2017 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
    ANSI/AAMI/ISO 20857:2010(R2015) STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    DIN EN ISO 11135:2014-10 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014)
    PREN 285 : DRAFT 2013 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    I.S. EN ISO 20857:2013 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)
    05/30138310 DC : DRAFT AUG 2005 ISO 15882 ED 2 - STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
    07/30157769 DC : DRAFT DEC 2007 BS EN ISO 11737-2 - STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE VALIDATION OF A STERILIZATION PROCESS
    CSA Z1416: 2011 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
    UNE-EN ISO 4833-1:2014 Microbiology of the food chain - Horizontal method for the enumeration of microorganisms - Part 1: Colony count at 30 degrees C by the pour plate technique (ISO 4833-1:2013)
    CSA Z11135-1 :2009 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    CSA Z11135 : 2015 STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    UNI EN ISO 4833-1 : 2013 MICROBIOLOGY OF THE FOOD CHAIN - HORIZONTAL METHOD FOR THE ENUMERATION OF MICROORGANISMS - PART 1: COLONY COUNT AT 30 DEGREES C BY THE POUR PLATE TECHNIQUE
    AAMI 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
    CSA ISO 14937 : 2011 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 ISO 13408-1 : 2008 : R2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
    PREN 13060 : DRAFT 2012 SMALL STEAM STERILIZERS
    CSA Z11135-1 : 2009 : FR STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    ANSI/AAMI/ISO 14937:2009(R2013) 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 ISO TIR 17665-3:2014 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION
    DIN EN ISO 5840-3:2013-06 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)
    AAMI ISO 11607-1 : 2006 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS
    ANSI/AAMI/ISO 5840-3:2013 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    AAMI/ISO TIR17665-3:2014(R2016) STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION
    PREN ISO 11137-2 : DRAFT 2009 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
    I.S. EN ISO 18369-1:2017 OPHTHALMIC OPTICS - CONTACT LENSES - PART 1: VOCABULARY, CLASSIFICATION SYSTEM AND RECOMMENDATIONS FOR LABELLING SPECIFICATIONS (ISO 18369-1:2017, CORRECTED VERSION 2017-10-01)
    I.S. EN ISO 11135:2014 STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014)
    AAMI ISO 5840-1 : 2016 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS
    S.R. CEN ISO/TS 16775:2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014)
    CAN/CSA-ISO/TS 16775:17 Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO technical specification 16775:2014, first edition, 2014-05-15)
    BS EN ISO 17664:2017 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices
    AAMI ISO 13408-5 : 2006 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: STERILIZATION IN PLACE
    I.S. EN ISO 5840-1:2015 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 5840-1:2015)
    AAMI ISO 13408-3:2006 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION
    ANSI/AAMI/ISO 11135:2014 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    I.S. EN ISO 4833-1:2013 MICROBIOLOGY OF THE FOOD CHAIN - HORIZONTAL METHOD FOR THE ENUMERATION OF MICROORGANISMS - PART 1: COLONY COUNT AT 30 DEGREES C BY THE POUR PLATE TECHNIQUE (ISO 4833-1:2013)
    UNI EN ISO 13408-6 : 2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
    CSA Z17665-1 : 2009 : FR STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    UNE-EN ISO 11607-1:2017 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006, including Amd 1:2014)
    AAMI ISO 11137-1:2006 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
    DIN EN ISO 11140-1:2015-03 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
    DIN EN 1422:2014-08 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
    BS EN ISO 11140-1:2014 Sterilization of health care products. Chemical indicators General requirements
    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
    UNE-EN ISO 14161:2010 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009)
    BS EN ISO 14534:2015 Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements
    BS EN ISO 14160:2011 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
    BS EN 15424:2007 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
    BS EN ISO 14161:2009 Sterilization of health care products. Biological indicators. Guidance for the selection, use and interpretation of results
    ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
    ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
    DIN EN 1422:1997-11 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
    EN ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
    DIN EN 15424:2007-08 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    UNI EN ISO 14160 : 2011 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
    CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014)
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    BS EN ISO 15378:2017 Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
    PREN 1422 : DRAFT 2011 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
    DIN EN ISO 20857 E : 2013 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)
    ISO/TR 20520:2018 Traditional Chinese medicine Infection control for acupuncture treatment
    AAMI ISO 20857 : 2010 STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    BS EN ISO 20857:2013 Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
    I.S. EN 285:2015 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    I.S. EN ISO 13408-5:2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: STERILIZATION IN PLACE
    12/30262894 DC : 0 BS EN 14180 - STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
    I.S. EN 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
    CSA Z17665-2:09 (R2019) Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (Adopted ISO/TS 17665-2:2009, first edition, 2009-01-15)
    PD CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
    AAMI TIR52 : 2014(R2017) ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS
    11/30252448 DC : 0 BS EN 1422 - STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
    DIN EN ISO 4833-1 E : 2013 MICROBIOLOGY OF THE FOOD CHAIN - HORIZONTAL METHOD FOR THE ENUMERATION OF MICROORGANISMS - PART 1: COLONY-COUNT AT 30 DEGREES C BY THE POUR PLATE TECHNIQUE (ISO 4833-1:2013)
    15/30321502 DC : 0 BS EN ISO 11138-1 - STERILIZATION OF HEALTH PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
    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)
    I.S. EN ISO 5840-3:2013 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013)
    14/30281560 DC : 0 BS EN ISO 5840-2 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES
    DIN EN ISO 13408-1:2015-12 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)
    12/30252545 DC : 0 BS ISO 15883-1:2006/AMD - WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
    12/30238553 DC : 0 BS EN ISO 11140-1 - STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
    UNI EN ISO 13408-5 : 2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: STERILIZATION IN PLACE
    13/30278676 DC : 0 BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    CSA Z14161 : 2011 : R2015 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
    04/30066665 DC : DRAFT MARCH 2004 BS ISO 13408-6 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6 - ISOLATOR SYSTEMS
    04/30090379 DC : DRAFT MAR 2004 BS ISO 13408-4 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 4: CLEAN-IN-PLACE TECHNOLOGIES
    14/30266295 DC : 0 BS ISO 18362 - PROCESSING OF CELL-BASED HEALTH CARE PRODUCTS
    CSA Z11137-2 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
    AAMI 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
    CSA Z11138-1 : 2007 : R2012 : FR STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
    CAN/CSA-ISO 11138-1:17 Sterilization of health care products — Biological indicators — Part 1: General requirements (Adopted ISO 11138-1:2017, third edition, 2017-03)
    AAMI ISO 22442-3 : 2007 : R2011 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
    BS EN ISO 11607-2 : 2006 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES
    UNI CEN ISO/TS 17665-2 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
    ISO 19979:2018 Ophthalmic optics — Contact lenses — Hygienic management of multipatient use trial contact lenses
    UNE-EN ISO 15378:2016 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015)
    ANSI/AAMI/ISO 14160:2011(R2016) 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
    UNI EN ISO 5840-3 : 2013 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES
    PD CEN/TS 16244:2018 Ventilation in hospitals. Coherent hierarchic structure and common terms and definitions for a standard related to ventilation in hospitals
    UNE-EN ISO 13408-6:2011 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
    UNE-EN ISO 4833-2:2014 Microbiology of the food chain - Horizontal method for the enumeration of microorganisms - Part 2: Colony count at 30 degrees C by the surface plating technique (ISO 4833-2:2013)
    ISO 15378:2017 Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
    AAMI ISO 11137-2 : 2013 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
    BS EN ISO 13408-1:2015 Aseptic processing of health care products General requirements
    ISO 18369-1:2017 Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labelling specifications
    I.S. EN ISO 25424:2011 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    AAMI ISO 11737-2 : 2009 : R2014 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
    I.S. EN 13060:2014 SMALL STEAM STERILIZERS
    AAMI 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
    BS EN ISO 13408-6 : 2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
    AAMI ISO 11607-2:2006 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING, AND ASSEMBLY PROCESSES
    AAMI ISO 11737-1 : 2006 : R2011 STERILIZATION OF MEDICAL DEVICES - MEDICAL DEVICES - PART 1: DETERMINATION OF THE POPULATION OF MICROORGANISMS ON PRODUCT
    I.S. EN ISO 13408-6:2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS (ISO 13408-6:2005)
    AAMI ST15883-1 : 2009 : INC : AMD 1 : 2014 : R201400 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
    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)
    DIN EN 556-2:2015-11 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES
    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 17665-1:2006-11 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 17665-1:2006)
    DIN EN ISO 5840-2 E : 2016 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015)
    BS EN 556-2:2015 Sterilization of medical devices. Requirements for medical devices to be designated \'STERILE\' Requirements for aseptically processed medical devices
    BS EN ISO 11737-2:2009 Sterilization of medical devices. Microbiological methods Tests of sterility performed in the definition, validation and maintenance of a sterilization process
    ISO 13408-6:2005 Aseptic processing of health care products Part 6: Isolator systems
    ISO 13408-5:2006 Aseptic processing of health care products Part 5: Sterilization in place
    BS EN ISO 11138-1:2017 Sterilization of health care products. Biological indicators General requirements
    ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
    ISO 25424:2009 Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices
    I.S. EN ISO 14534:2015 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS (ISO 14534:2011)
    EN ISO 5840-2:2015 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
    I.S. EN ISO 11140-1:2014 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11140-1:2014)
    I.S. 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
    I.S. EN ISO 11137-2:2015 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE (ISO 11137-2:2013)
    I.S. EN ISO 14160:2011 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
    EN ISO 5840-1:2015 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015)
    I.S. EN ISO 11138-1:2017 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017)
    I.S. EN 14180:2014 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
    DIN EN ISO 11137-2:2015-11 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
    I.S. EN 1422:2014 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
    DIN EN 14180:2003-10 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
    EN ISO 5840-3:2013 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)
    UNI EN ISO 11737-2 : 2010 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
    I.S. EN ISO 15882:2008 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
    UNE-EN ISO 5840-2:2016 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
    04/30048118 DC : DRAFT MAY 2004 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
    14/30270462 DC : 0 BS EN ISO 5840-1 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS
    ISO 5910:2018 Cardiovascular implants and extracorporeal systems Cardiac valve repair devices
    13/30254718 DC : 0 BS ISO 11040-7 - PREFILLED SYRINGES - PART 7: PACKAGING SYSTEMS FOR STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING
    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)
    I.S. EN ISO 4833-2:2013 MICROBIOLOGY OF THE FOOD CHAIN - HORIZONTAL METHOD FOR THE ENUMERATION OF MICROORGANISMS - PART 2: COLONY COUNT AT 30 DEGREES C BY THE SURFACE PLATING TECHNIQUE (ISO 4833-2:2013)
    UNI EN ISO 25424 : 2011 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    09/30207531 DC : 0 BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS
    BS EN ISO 4833-1:2013 Microbiology of the food chain. Horizontal method for the enumeration of microorganisms Colony count at 30 degrees C by the pour plate technique
    DIN EN ISO 13408-5:2011-09 Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
    17/30338806 DC : 0 BS EN ISO 25424 - STERILIZATION OF HEALTH CARE PRODUCTS - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    BS EN ISO 13408-5:2011 Aseptic processing of health care products Sterilization in place
    AAMI ISO 15882 : 2008 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
    BS EN ISO 5840-1:2015 Cardiovascular implants. Cardiac valve prostheses General requirements
    CSA Z11138-1 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
    DIN EN ISO 13408-2:2011-09 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: FILTRATION
    UNE-EN ISO 13408-3:2011 Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
    BS EN ISO 5840-3:2013 Cardiovascular implants. Cardiac valve prostheses Heart valve substitutes implanted by transcatheter techniques
    07/30090385 DC : 0 ISO 13408-1 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
    UNE-EN ISO 5840-1:2016 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015)
    CSA Z11135-1 : 2009 : R2014 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    CSA Z15882:09 (R2019) Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (Adopted ISO 15882:2008, second edition, 2008-09-01)
    CSA ISO 14937 : 2011 : R2016 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 ISO 13408-6 : 2005 : INC : AMD 1 : 2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
    CSA Z11137-2 : 2007 : R2012 : FR STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
    DIN EN ISO 5840-2:2016-05 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
    DIN EN ISO 5840-1:2015-12 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015)
    AAMI TIR52 : 2014 ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS
    CSA Z17665-1:09 (R2019) Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (Adopted ISO 17665-1:2006, first edition, 2006-08-15, with Canadian deviations)
    CSA Z17665-2:09 (R2019) Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009, IDT)
    AAMI ISO 11607-2 : 2006 : R2010 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING, AND ASSEMBLY PROCESSES
    ISO 18362:2016 Manufacture of cell-based health care products Control of microbial risks during processing
    I.S. EN ISO 5840-2:2015 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015)
    EN 13060:2014 Small steam sterilizers
    ANSI/AAMI ISO 17665-1:2006(R2013) STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    AAMI 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
    ANSI/AAMI/ISO 17664:2017 PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES
    AAMI ISO 13408-5:2006(R2015) ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: STERILIZATION IN PLACE
    CSA Z17665-1 : 2009 : R2014 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    AAMI ISO 11135-1 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    I.S. EN ISO 13408-3:2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION
    UNI EN ISO 13408-2 : 2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: FILTRATION
    NF EN ISO 13408-2 : 2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: FILTRATION
    AAMI ST15883-1 : 2009 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
    ANSI/AAMI ST15883-1:2009(R2014) &A1:2014&A2:2012 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
    ASTM E 3083 : 2017 Standard Terminology Relating to Radiation Processing: Dosimetry and Applications
    UNI EN ISO 13408-3 : 2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION
    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
    BS EN ISO 11607-1:2017 Packaging for terminally sterilized medical devices Requirements for materials, sterile barrier systems and packaging systems
    BS EN ISO 11137-1:2015 Sterilization of health care products. Radiation Requirements for development, validation and routine control of a sterilization process for medical devices
    I.S. EN ISO 17664:2017 PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017)
    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 13060:2015-03 SMALL STEAM STERILIZERS
    DIN EN 285:2016-05 Sterilization - Steam sterilizers - Large sterilizers
    UNE-EN ISO 11140-1:2015 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
    ISO 15883-1:2006 Washer-disinfectors Part 1: General requirements, terms and definitions and tests
    UNE-EN ISO 14160:2012 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 (ISO 14160:2011)
    I.S. EN ISO 14161:2009 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
    I.S. 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
    EN ISO 14161:2009 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009)
    I.S. EN ISO 15883-1:2009 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006)
    UNI EN ISO 15883-1 : 2014 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
    UNI EN ISO 15882 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
    UNI 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
    UNI EN ISO 14161 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
    UNI EN 14180 : 2014 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
    UNI EN 1422 : 2014 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
    CSA ISO 11607-1 : 2016 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
    DIN EN ISO 25424:2011-09 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    AAMI ISO 11607-1 : 2006 : R2010 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS
    PREN ISO 14160 : DRAFT 2009 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
    BS EN ISO 25424:2011 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
    BS EN ISO 13408-3:2011 Aseptic processing of health care products Lyophilization
    BS ISO 11040-7:2015 Prefilled syringes Packaging systems for sterilized subassembled syringes ready for filling
    AAMI ISO 11137-1 : 2006 : INC : AMD 1 : 2013 : R201000 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    AAMI ISO 11737-1 : 2006 STERILIZATION OF MEDICAL DEVICES - MEDICAL DEVICES - PART 1: DETERMINATION OF THE POPULATION OF MICROORGANISMS ON PRODUCT
    BS ISO 18362:2016 Manufacture of cell-based health care products. Control of microbial risks during processing
    AAMI ISO TIR 17665-2 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1
    04/30090382 DC : DRAFT NOV 2004 ISO 13408-5 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: CLEANING IN PLACE
    I.S. EN 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
    UNE-EN ISO 20857:2013 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)
    PD ISO/TS 17665-3:2013 Sterilization of health care products. Moist heat Guidance on the designation of a medical device to a product family and processing category for steam sterilization
    17/30302489 DC : DRAFT MAR 2017 BS EN ISO 13408-2 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION
    EN ISO 13408-6:2011/A1:2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS (ISO 13408-6:2005/AMD 1:2013)
    DIN EN ISO 4833-1:2013-12 Microbiology of the food chain - Horizontal method for the enumeration of microorganisms - Part 1: Colony-count at 30 degrees C by the pour plate technique (ISO 4833-1:2013)
    DIN EN ISO 4833-2:2014-05 Microbiology of the food chain - Horizontal method for the enumeration of microorganisms - Part 2: Colony count at 30 degrees C by the surface plating technique (ISO 4833-2:2013 + Cor. 1:2014) (includes Corrigendum :2014)
    09/30157765 DC : 0 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
    UNE-EN ISO 13408-2:2011 Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)
    11/30219211 DC : 0 BS EN ISO 5840-3 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY MINIMALLY INVASIVE TECHNIQUES
    07/30164697 DC : 0 ISO 20857 - STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN INDUSTRIAL STERILIZATION PROCESS FOR MEDICAL DEVICES
    BS EN ISO 18369-1:2017 Ophthalmic optics. Contact lenses Vocabulary, classification system and recommendations for labelling specifications
    NFX 50 796 : 2008 AVAILABILITY OF MEDICAL DEVICES AT HOME - SERVICE COMMITMENTS
    UNI EN ISO 4833-2 : 2013 MICROBIOLOGY OF THE FOOD CHAIN - HORIZONTAL METHOD FOR THE ENUMERATION OF MICROORGANISMS - PART 2: COLONY COUNT AT 30 DEGREES C BY THE SURFACE PLATING TECHNIQUE
    AAMI ISO 13408-1 : 2008 : INC : AMD 1 : 2013 : R201100 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
    09/30197784 DC : 0 BS EN ISO 11137-2 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
    AAMI ISO 13408-6:2005 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
    EN ISO 14160:2011 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 (ISO 14160:2011)
    UNI EN ISO 20857 : 2013 STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    AAMI ISO 13408-1:2008 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
    ANSI/AAMI/ISO 13408-6:2005(R2013)&A1:2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
    UNE-EN ISO 11135:2015 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
    DIN EN ISO 20857:2013-08 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)
    CSA ISO 11137-2 : 2016 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
    AAMI ISO 14161 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE, AND INTERPRETATION OF RESULTS
    CSA ISO 11607-2 : 2016 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES
    ANSI/AAMI/ISO TIR16775:2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
    AAMI/ISO TIR17665-2:2009(R2016) STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1
    UNI EN ISO 11737-1 : 2006 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS
    I.S. EN ISO 11607-1:2017 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006, INCLUDING AMD 1:2014)
    ISO 13485 - PRACTICAL GUIDE : 2016 ISO 13485:2016 - MEDICAL DEVICES - A PRACTICAL GUIDE
    S.R. CEN/TS 16244:2018 VENTILATION IN HOSPITALS - COHERENT HIERARCHIC STRUCTURE AND COMMON TERMS AND DEFINITIONS FOR A STANDARD RELATED TO VENTILATION IN HOSPITALS
    UNE-EN ISO 11607-2:2017 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006, including Amd 1:2014)
    UNI EN ISO 11607-1 : 2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
    UNE-EN ISO 15883-1:2009 Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)
    BS EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices Requirements for materials, sterile barrier systems and packaging systems
    DIN EN 14180:2014-09 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
    DIN EN ISO 14160:2011-10 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 (ISO 14160:2011)
    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 14534:2015-08 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
    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
    BS EN ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
    UNE-EN 556-2:2016 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices
    ISO 20857:2010 Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices
    ISO/TS 16775:2014 Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2
    ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
    ANSI/AAMI/ISO 15882:2008(R2013) STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
    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)
    BS EN ISO 17665-1:2006 Sterilization of health care products. Moist heat Requirements for the development, validation and routine control of a sterilization process for medical devices
    BS 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
    UNE-EN ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017)
    ISO 5840-3:2013 Cardiovascular implants Cardiac valve prostheses Part 3: Heart valve substitutes implanted by transcatheter techniques
    ISO 4833-1:2013 Microbiology of the food chain — Horizontal method for the enumeration of microorganisms — Part 1: Colony count at 30 °C by the pour plate technique
    UNE-EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
    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
    BS EN 13060 : 2014 SMALL STEAM STERILIZERS
    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 14534:2011 Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements
    BS EN 285:2015 Sterilization. Steam sterilizers. Large sterilizers
    UNE-EN ISO 14534:2015 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
    ISO 4833-2:2013 Microbiology of the food chain — Horizontal method for the enumeration of microorganisms — Part 2: Colony count at 30 °C by the surface plating technique
    ISO 5840-2:2015 Cardiovascular implants Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutes
    ISO 13408-3:2006 Aseptic processing of health care products Part 3: Lyophilization
    UNE-EN ISO 14937:2010 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)
    BS EN 14180:2014 Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing
    ISO 14160:2011 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
    BS EN ISO 15883-1 : 2009 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006)
    BS EN ISO 15882:2008 Sterilization of health care products. Chemical indicators. Guidance for selection, use and interpretation of results
    EN ISO 13408-5:2011 Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
    EN 15424:2007 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
    EN 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 11135-1:2007)
    EN ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017)
    EN ISO 13408-1:2015 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
    EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
    UNI CEN ISO/TS 16775 : 2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
    EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
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