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  • ISO 11137-1:2006

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    Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

    Available format(s):  Hardcopy, PDF 1 User, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s): 

    Published date:  19-04-2006

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.

    ISO 11137-1:2006 covers radiation processes employing irradiators using the radionuclide 60Co or 137Cs, a beam from an electron generator or a beam from an X-ray generator.

    ISO 11137-1:2006 does not:

    • specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease;
    • detail specified requirements for designating a medical device as sterile;
    • specify a quality management system for the control of all stages of production of medical devices;
    • specify requirements for occupational safety associated with the design and operation of irradiation facilities;
    • specify requirements for the sterilization of used or reprocessed devices.

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

    Development Note Supersedes ISO/DIS 11137-1. Together with ISO 11137-2 and ISO 11137-3, Supersedes ISO 11137. (05/2006)
    Document Type Standard
    Product Note NEW CHILD AMD 2 2018 IS NOW ADDED. NEW CHILD AMD 1 2013 IS NOW ADDED.
    Publisher International Organization for Standardization
    Status Current
    Supersedes

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

    UNE-EN ISO 25539-2:2013 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
    ISO 14708-1:2014 Implants for surgery Active implantable medical devices Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
    AAMI RD17 : 2007 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS
    CSA ISO 5361 : 2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
    BS EN ISO 13504:2012 Dentistry. General requirements for instruments and related accessories used in dental implant placement and treatment
    14/30270462 DC : 0 BS EN ISO 5840-1 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS
    16/30331650 DC : 0 BS EN ISO 8637-1 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 1: HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
    DIN EN ISO 24998:2009-03 PLASTICS LABORATORY WARE - SINGLE-USE PETRI DISHES FOR MICROBIOLOGICAL PROCEDURES
    UNE-EN ISO 25539-3:2012 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011)
    14/30295064 DC : 0 BS EN ISO 16672 - OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES
    17/30336573 DC : 0 BS EN ISO 20696 - STERILE URETHAL CATHETERS FOR SINGLE USE
    ASTM F 2903 : 2011 Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair (Withdrawn 2020)
    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)
    BS EN ISO 24998:2008 Plastics laboratory ware. Single-use Petri dishes for microbiological procedures
    DIN EN ISO 8638:2014-03 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS (ISO 8638:2010)
    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
    BS EN ISO 8638:2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
    17/30351717 DC : 0 BS EN ISO 11607-1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
    ANSI/AAMI/ISO 25539-2:2012 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS
    DIN EN ISO 8638 E : 2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS (ISO 8638:2010)
    BS EN ISO 6710:2017 Single-use containers for human venous blood specimen collection
    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 ISO 11712 : 2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - SUPRALARYNGEAL AIRWAYS AND CONNECTORS
    IEC TR 62354:2014 General testing procedures for medical electrical equipment
    I.S. EN ISO 10555-1:2013 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS (ISO 10555-1:2013/AMD 1:2017)
    S.R. CEN ISO/TS 13004:2014 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - SUBSTANTIATION OF SELECTED STERILIZATION DOSE: METHOD VD[MAX][SD] (ISO/TS 13004:2013)
    AAMI ISO 11737-1 : 2006 STERILIZATION OF MEDICAL DEVICES - MEDICAL DEVICES - PART 1: DETERMINATION OF THE POPULATION OF MICROORGANISMS ON PRODUCT
    CSA ISO 8637 : 2012 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
    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
    CSA ISO 8637 : 2012 : R2017 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
    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
    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
    CSA Z11137-3 : 2007 : R2012 : FR STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS
    AAMI ISO 11607-1 : 2006 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS
    ONORM EN ISO 5840-3 : 2013 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013)
    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)
    DIN EN ISO 7199:2015-06 (Draft) CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016)
    ISO 24998:2008 Plastics laboratory ware — Single-use Petri dishes for microbiological procedures
    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 13408-2 : 2003 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION
    PREN ISO 11137-2 : DRAFT 2009 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
    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)
    ANSI/AAMI/ISO 15674:2016 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS
    ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems Vascular device-drug combination products
    ISO 14470:2011 Food irradiation Requirements for the development, validation and routine control of the process of irradiation using ionizing radiation for the treatment of food
    ISO 11658:2012 Cardiovascular implants and extracorporeal systems — Blood/tissue contact surface modifications for extracorporeal perfusion systems
    UNI CEN ISO/TS 13004 : 2014 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - SUBSTANTIATION OF SELECTED STERILIZATION DOSE: METHOD VD[MAX][SD]
    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 ES60601-1 : 2005 : INC : AMD 1 : 2012 : R201200 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
    AAMI ES60601-1 : 2005 : INC : AMD 2 : 2012 : R201200 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
    AAMI ES60601-1 : 2005 : R2012 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
    DIN EN ISO 11140-1:2015-03 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
    DIN EN 1642:2012-06 Dentistry - Medical devices for dentistry - Dental implants
    DIN EN ISO 11137-3:2015-08 (Draft) STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL (ISO 11137-3:2017)
    BS EN ISO 8536-9:2015 INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT
    ISO 8637:2010 Cardiovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
    BS EN ISO 11140-1:2014 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
    ISO 8638:2010 Cardiovascular implants and extracorporeal systems Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
    BS EN ISO 14534:2015 Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements
    ISO 25539-3:2011 Cardiovascular implants Endovascular devices Part 3: Vena cava filters
    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 ISO 14630:2012 Non-active surgical implants. General requirements
    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
    I.S. EN ISO 8536-9:2015 INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-9:2015)
    EN ISO 25539-3:2011 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011)
    EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
    DIN EN ISO 15882:2008-12 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
    EN ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
    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
    EN 13544-1:2007+A1:2009 Respiratory therapy equipment - Part 1: Nebulizing systems and their components
    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)
    BS ISO 19611:2017 Traditional Chinese medicine. Air extraction cupping device
    ANSI/AAMI/ ISO 11137-2:2013(R2019) STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
    ISO 13960:2010 Cardiovascular implants and extracorporeal systems Plasmafilters
    04/30081279 DC : DRAFT MAY 2004 BS EN ISO 11137-3 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS
    15/30275224 DC : 0 BS ISO 18242 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CENTRIFUGAL BLOOD PUMPS
    17/30359001 DC : 0 BS ISO/IEC GUIDE 63 - GUIDE TO THE DEVELOPMENT AND INCLUSION OF ASPECTS OF SAFETY IN INTERNATIONAL STANDARDS FOR MEDICAL DEVICES
    PD IEC/TR 60601-4-1:2017 Medical electrical equipment Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy
    12/30251292 DC : 0 BS ISO/ASTM 51261 - PRACTICE FOR CALIBRATION OF ROUTINE DOSIMETRY SYSTEMS FOR RADIATION PROCESSING
    UNE-EN ISO 16061:2015 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
    BS EN ISO 8836:2014 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014)
    14/30303365 DC : 0 BS ISO/ASTM 51649 - PRACTICE FOR DOSIMETRY IN AN ELECTRON BEAM FACILITY FOR RADIATION PROCESSING AT ENERGIES BETWEEN 300 KEV AND 25 MEV
    UNE-EN ISO 13504:2013 Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO 13504:2012)
    I.S. EN ISO 6710:2017 SINGLE-USE CONTAINERS FOR HUMAN VENOUS BLOOD SPECIMEN COLLECTION (ISO 6710:2017)
    15/30282559 DC : 0 BS EN ISO 11137-3 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL
    CSA Z8638 : 2008 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
    PD CEN ISO/TS 16775:2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
    ANSI/AAMI/ISO 15675:2016 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS
    AAMI ISO 5361 : 2012 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
    15/30321502 DC : 0 BS EN ISO 11138-1 - STERILIZATION OF HEALTH PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
    BS ISO 15378 : 2006 AMD 17315 PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2000, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP)
    15/30321715 DC : 0 BS ISO 15675 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS
    DIN EN ISO 8836 E : 2015 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014)
    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)
    BS ISO 11658:2012 Cardiovascular implants and extracorporeal systems. Blood/tissue contact surface modifications for extracorporeal perfusion systems
    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)
    BS EN ISO 7199:2017 Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)
    11/30193150 DC : 0 BS EN 60601-1:2006 AMD.1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
    15/30321712 DC : 0 BS ISO 15674 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS
    11/30212235 DC : 0 BS EN ISO 13504 - DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT
    15/30321957 DC : 0 BS EN ISO 7199 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS BLOOD-GAS EXCHANGERS (OXYGENATORS)
    BS ISO 14470:2011 FOOD IRRADIATION - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF THE PROCESS OF IRRADIATION USING IONIZING RADIATION FOR THE TREATMENT OF FOOD
    DIN EN ISO 25539-3:2012-03 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011)
    15/30280904 DC : 0 BS ISO 18190 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - GENERAL REQUIREMENTS FOR AIRWAYS AND RELATED EQUIPMENT
    CSA Z11137-3 : 2007 : R2012 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS
    BS ISO 18241:2016 Cardiovascular implants and extracorporeal systems. Cardiopulmonary bypass systems. Venous bubble traps
    BS PD ISO/TS 13004 : 2013 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - SUBSTANTIATION OF SELECTED STERILIZATION DOSE: METHOD VD[MAX][SD]
    BS ISO 15674:2009 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS
    CSA Z11137-2 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
    04/30048584 DC : DRAFT MAY 2004 BS EN ISO 11137-2 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
    16/30302520 DC : 0 BS ISO 19611 - TRADITIONAL CHINESE MEDICINE - AIR EXHAUST CUPPING APPARATUS FOR MEDICAL USE
    CSA Z11138-1 : 2007 : R2012 : FR STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
    CSA Z8836 :2011 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
    CSA Z8836 : 2011 : R2015 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
    ISO 18242:2016 Cardiovascular implants and extracorporeal systems — Centrifugal blood pumps
    CSA ISO 8638 : 2012 : R2017 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
    ISO 8637-1:2017 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
    BS EN ISO 10555-1 : 2013 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS
    I.S. EN ISO 5361:2016 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS (ISO/DIS 5361:2014)
    UNI EN ISO 5840-3 : 2013 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES
    ISO/TS 19930:2017 Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6
    ISO 11712:2009 Anaesthetic and respiratory equipment Supralaryngeal airways and connectors
    BS EN ISO 13408-1:2015 Aseptic processing of health care products General requirements
    BS EN ISO 11607-1:2017 Packaging for terminally sterilized medical devices Requirements for materials, sterile barrier systems and packaging systems
    AAMI ISO 11137-2 : 2013 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
    ANSI/AAMI/ISO 15676:2016 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - REQUIREMENTS FOR SINGLE-USE TUBING PACKS FOR CARDIOPULMONARY BYPASS AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO)
    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
    AAMI ISO 8638 : 2010 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS
    ISO/ASTM 51818:2013 Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV
    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
    AAMI ISO 8836 : 2015 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
    AAMI ISO 8638 : 2010 : R2015 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS
    CSA ISO 11712:14 (R2019) Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors (Adopted ISO 11712:2009, first edition, 2009-05-15)
    AAMI ISO 13408-2 : 2003 : R2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION
    EN ISO 6710:2017 Single-use containers for human venous blood specimen collection (ISO 6710:2017)
    ANSI/AAMI/IEC TIR62354:2015 GENERAL TESTING PROCEDURES FOR MEDICAL ELECTRICAL EQUIPMENT
    ISO 8836:2014 Suction catheters for use in the respiratory tract
    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)
    AAMI ES60601-1 : 2005 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
    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 12182:2012-07 Assistive products for persons with disability - General requirements and test methods
    DIN EN ISO 16672:2015-12 Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)
    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 - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
    BS EN 45502-1:2015 Implants for surgery. Active implantable medical devices General requirements for safety, marking and for information to be provided by the manufacturer
    BS EN 1639:2009 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
    ISO 11137-2:2013 Sterilization of health care products Radiation Part 2: Establishing the sterilization dose
    ISO 7199:2016 Cardiovascular implants and artificial organs Blood-gas exchangers (oxygenators)
    BS EN ISO 8536-8:2015 INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS
    EN ISO 25539-2:2012 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
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