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  • ISO 11137:1995

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    Sterilization of health care products Requirements for validation and routine control Radiation sterilization

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

    Withdrawn date:  12-04-2019

    Language(s): 

    Published date:  09-03-1995

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    Specifies requirements for validation, process control and routine monitoring in the radiation sterilization of health care products. Applies to continuous and batch type gamma irradiators using the radionuclides 60 Co and 137 Cs, and to irradiators using a beam from an electron or x-ray generator. Does not cover facility design, licensing, operator training, factors related to radiation safety, the assessment of the suitability of the product for its intended use.

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

    Document Type Standard
    Publisher International Organization for Standardization
    Status Withdrawn
    Superseded By

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

    03/104519 DC : DRAFT FEB 2003 BS ISO 11737-3 - STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 3: GUIDANCE ON EVALUATION AND INTERPRETATION OF BIOBURDEN DATA
    03/108542 DC : DRAFT MAY 2003 BS EN ISO 11140-1 - STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
    I.S. EN ISO 5840:2009 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES
    16/30310656 DC : 0 BS EN ISO 18369-1 - OPHTHALMIC OPTICS - CONTACT LENSES - PART 1: VOCABULARY, CLASSIFICATION SYSTEM AND RECOMMENDATIONS FOR LABELLING SPECIFICATIONS
    08/30184486 DC : DRAFT JUNE 2008 BS EN ISO 1135-4 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE
    ASTM F 2407 : 2006 : R2013 : EDT 1 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
    13/30276989 DC : 0 BS EN ISO 11070 - STERILE, SINGLE-USE INTRAVASCULAR CATHETER INTRODUCERS
    I.S. EN 13503-8:2000 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
    02/564514 DC : DRAFT OCT 2002 BS EN ISO 8536-4 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED
    DIN EN ISO 7197:2009-08 NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS
    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
    08/30170025 DC : DRAFT AUG 2008 BS ISO 28620 - MEDICAL DEVICES - NON-ELECTRICALLY DRIVEN PORTABLE INFUSION DEVICES
    13/30284721 DC : 0 BS EN ISO 8536-8 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION EQUIPMENT FOR USE WITH PRESSURE INFUSION APPARATUS
    05/30106198 DC : 0 EN ISO 22442-3 - 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
    04/30118691 DC : DRAFT AUG 2004 BS ISO ASTM 51649 - PRACTICE FOR DOSIMETRY IN AN ELECTRON BEAM FACILITY FOR RADIATION PROCESSING AT ENERGIES BETWEEN 300 KEV AND 25 MEV
    CSA Z10651-5 : 2008 : R2013 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS
    02/565247 DC : DRAFT DEC 2002 ISO 8637 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
    BS ISO 14972:1998 Sterile obturators for single use with over-needle peripheral intravascular catheters
    CSA Z10651-5 : 2008 : INC : UPD 1 : 2011 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS
    CSA Z11140.1 : 2007 : R2012 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
    PREN ISO 11137-2 : DRAFT 2009 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
    CSA ISO 7199 : 0 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS)
    CSA ISO 13488 : 1998 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9002
    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
    ASTM F 2761 : 2009 : R2013 Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
    BS EN ISO 11140-1:2014 Sterilization of health care products. Chemical indicators General requirements
    BS EN ISO 22803:2005 Dentistry. Membrane materials for guided tissue regeneration in oral and maxillofacial surgery. Contents of a technical file
    UNE-EN ISO 16672:2016 Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)
    EN 13503-8 : 2000 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
    CEN ISO/TR 14969:2005 Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)
    EN ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
    DIN EN ISO 21649:2010-01 Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)
    ASME BPE : 2016 BIOPROCESSING EQUIPMENT
    ANSI/AAMI/ ISO 11137-2:2013(R2019) STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
    04/30078095 DC : DRAFT JUL 2004 ISO 11138-1 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
    08/30179586 DC : DRAFT MAR 2008 BS ISO 7199 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS)
    BS ISO 10651-5:2006 Lung ventilators for medical use. Particular requirements for basic safety and essential performance Gas-powered emergency resuscitators
    04/30101211 DC : DRAFT APR 2004 ISO 11607-1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
    14/30281560 DC : 0 BS EN ISO 5840-2 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES
    08/30179589 DC : DRAFT MAR 2008 BS ISO 15674 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS
    13/30284770 DC : 0 BS EN ISO 8536-9 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR USE WITH PRESSURE INFUSION EQUIPMENT
    03/103026 DC : DRAFT JAN 2003 BS EN ISO 5840 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES
    BS EN 60544-1:2013 Electrical insulating materials. Determination of the effects of ionizing radiation Radiation interaction and dosimetry
    AAMI ISO 5840 : 2005 : R2010 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES
    CSA Z11137-2 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
    08/30179592 DC : DRAFT MAR 2008 BS ISO 15675 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS
    AAMI ISO 5840 :2005 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES
    CSA Z10651-5 : 2008 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS
    AAMI ISO 11137-2 : 2013 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
    ISO/TS 15539:2000 Cardiovascular implants Endovascular prostheses
    ASTM F 2407 : 2006 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
    ASTM E 1608 : 2015 Standard Practice for Dosimetry in an X-Ray (Bremsstrahlung) Facility for Radiation Processing at Energies between 50 keV and 7.5 MeV
    ASTM E 1538 : 2009 PRACTICE FOR USE OF THE ETHANOL-CHLOROBENZENE DOSIMETRY SYSTEM
    DIN EN ISO 22803:2006-01 Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004)
    IEC 60544-1:2013 Electrical insulating materials - Determination of the effects of ionizing radiation - Part 1: Radiation interaction and dosimetry
    I.S. EN ISO 21649:2009 NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS
    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 11137-2:2015 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE (ISO 11137-2:2013)
    DIN EN ISO 11137-2:2015-11 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
    BS ISO 15572:1998 Guide for estimating uncertainties in dosimetry for radiation processing
    ISO 11737-3:2004 Sterilization of medical devices Microbiological methods Part 3: Guidance on evaluation and interpretation of bioburden data
    BS EN ISO 7197:2009 Neurosurgical implants. Sterile, single-use hydrocephalus shunts and components
    AAMI ISO 10651-5 : 2006 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS
    13/30284773 DC : 0 BS EN ISO 8536-10 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR USE WITH PRESSURE INFUSION EQUIPMENT
    CEI EN 60544-1 : 2014 ELECTRICAL INSULATING MATERIALS - DETERMINATION OF THE EFFECTS OF IONIZING RADIATION - PART 1: RADIATION INTERACTION AND DOSIMETRY
    13/30284776 DC : 0 BS EN ISO 8536-11 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT
    BS EN 60601-2-12:2006 Medical electrical equipment Particular requirements for the safety of lung ventilators. Critical care ventilators
    04/300654 DC : DRAFT JAN 2004 BS EN ISO 14630 - NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    BS ISO 18385:2016 Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes. Requirements
    AAMI ISO TIR 14969 : 2004 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    02/564517 DC : DRAFT OCT 2002 BS EN ISO 8536-10 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR USE WITH PRESSURE INFUSION EQUIPMENT
    CSA ISO TR 14969 : 2005 : R2010 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    03/103294 DC : DRAFT JAN 2003 BS EN ISO 10651-6 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME CARE VENTILATORY SUPPORT DEVICES
    BS ISO 25539-1 : 2003 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES
    14/30257644 DC : 0 BS EN ISO 13485 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
    08/30178723 DC : DRAFT AUG 2008 BS ISO 15798 - OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES
    03/101659 DC : DRAFT JAN 2003 ISO 22803 - DENTISTRY - MEMBRANE MATERIALS FOR GUIDED TISSUE REGENERATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE
    04/30088722 DC : DRAFT APR 2004 ISO 18369-1 - OPHTHALMIC OPTICS - CONTACT LENSES - PART 1: TERMINOLOGY
    CSA Z11137-2 : 2007 : R2012 : FR STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
    CEI EN 60601-2-12 : 2007 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
    ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
    I.S. EN ISO 7197:2009 NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS
    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
    UNE-EN ISO 11140-1:2015 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
    ISO 7197:2006 Neurosurgical implants Sterile, single-use hydrocephalus shunts and components
    BS EN ISO 21649:2009 Needle-free injectors for medical use. Requirements and test methods
    ISO 5840:2005 Cardiovascular implants Cardiac valve prostheses
    ISO 22794:2007 Dentistry Implantable materials for bone filling and augmentation in oral and maxillofacial surgery Contents of a technical file
    ISO 21649:2006 Needle-free injectors for medical use — Requirements and test methods
    04/30106146 DC : DRAFT MARCH 2004 BS EN 60601-1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
    UNE-EN 60601-1:2008 Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
    UNI EN ISO 5840 : 2009 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES
    02/560598 DC : DRAFT FEB 2002 ISO/DIS 13485 - QUALITY SYSTEMS - MEDICAL DEVICES - SYSTEM REQUIREMENTS FOR REGULATORY PURPOSES
    BS EN ISO 25539-1:2017 Cardiovascular implants. Endovascular devices Endovascular prostheses
    UNI EN ISO 21649 : 2009 NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS
    04/30109483 DC : DRAFT AUG 2004 BS ISO ASTM 51608 - PRACTICE FOR DOSIMETRY IN AN X-RAY (BREMSSTRAHLUNG) FACILITY FOR RADIATION PROCESSING
    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
    01/563350 DC : DRAFT AUG 2001 BS ISO 25539-1 - CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES
    02/564513 DC : DRAFT OCT 2002 BS EN ISO 1135-4 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE
    04/30081258 DC : DRAFT MARCH 2004 BS EN ISO 11737-1 - STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1 - DETERMINATION OF A POPULATION OF MICRO ORGANISMS ON PRODUCTS
    11/30219211 DC : 0 BS EN ISO 5840-3 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY MINIMALLY INVASIVE TECHNIQUES
    BS PD ISO/TR 14969 : 2004 AMD 15958 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    03/314215 DC : DRAFT OCT 2003 ISO TR 14969 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    BS EN ISO 13488:2001 Quality systems. Medical devices. Particular requirements for the application of EN ISO 9002
    BS 7208-19(2001) : 2001 CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - VOCABULARY - PART 2: CONTACT LENS CARE PRODUCTS
    UNI EN ISO 7197 : 2009 NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS
    02/564516 DC : DRAFT OCT 2002 BS EN ISO 8536-9 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR USE WITH PRESSURE INFUSION EQUIPMENT
    03/103293 DC : DRAFT JAN 2003 BS EN ISO 10651-2 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
    07/30145258 DC : 0 BS ISO 20072 - AEROSOL DRUG DELIVERY DEVICES DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS
    02/565260 DC : DRAFT DEC 2002 ISO 8638 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
    CSA ISO TR 14969 : 2005 : R2015 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    02/564518 DC : DRAFT OCT 2002 BS EN ISO 8536-11 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR USE WITH PRESSURE INFUSION EQUIPMENT
    09/30197784 DC : 0 BS EN ISO 11137-2 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
    CSA Z11140.1 : 2007 : R2012 : FR STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
    CSA Z11140.1 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
    CSA ISO TR 14969 :2005 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    CSA ISO 11137-2 : 2016 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
    I.S. EN 60544-1:2013 ELECTRICAL INSULATING MATERIALS - DETERMINATION OF THE EFFECTS OF IONIZING RADIATION - PART 1: RADIATION INTERACTION AND DOSIMETRY (IEC 60544-1:2013 (EQV))
    I.S. EN 60601-2-12:2006 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
    ISO 10651-5:2006 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 5: Gas-powered emergency resuscitators
    DIN EN ISO 21649 E : 2010 NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS
    ISO 13488:1996 Quality systems — Medical devices — Particular requirements for the application of ISO 9002
    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)
    00/565497 DC : DRAFT DEC 2000 BS IEC 60601-1 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY AND ESSENTIAL PERFORMANCE
    BS EN 13503-8:2000 Ophthalmic implants. Intraocular lenses Fundamental requirements
    BS EN ISO 5840:2009 Cardiovascular implants. Cardiac valve prostheses
    BS EN ISO 22794:2009 Dentistry. Implantable materials for bone filling and augmentation in oral and maxillofacial surgery. Contents of a technical file
    BS EN 30-1-2:2012 Domestic cooking appliances burning gas. Safety Appliances having forced-convection ovens and/or grills
    EN 30-1-2:2012 Domestic cooking appliances burning gas - Safety - Part 1-2: Appliances having forced-convection ovens and/or grills
    EN ISO 21649:2009 Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)
    EN ISO 13488 : 2000 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
    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)
    EN ISO 22803:2005 Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004)
    EN ISO 7197:2009 Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007)
    EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
    01/561789 DC : DRAFT APR 2001 BS ISO 13960 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - PLASMAFILTERS
    ISO/TR 15844:1998 Sterilization of health care products Radiation sterilization Selection of sterilization dose for a single production batch
    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)
    ISO/TS 15843:2000 Sterilization of health care products Radiation sterilization Product families and sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits
    04/30108670 DC : DRAFT FEB 2004 ISO 51702 - PRACTICE FOR DOSIMETRY IN GAMMA IRRADIATION FACILITIES FOR RADIATION PROCESSING
    I.S. CEN ISO TR 14969:2005 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485: 2003
    PD CEN ISO/TR 14969:2005 Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003
    CSA ISO 5840 : 0 CARDIOVASCULAR IMPLANTS - CARIDAC VALVE PROSTHESES
    04/19975667 DC : 0 BS ISO 15676 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - SINGLE - USE TUBING PACKS FOR CARDIOPULMONARY BYPASS AND EXTRACORPOREAL MEMBRANCE OXYGENATION
    12/30259937 DC : 0 BS EN 50544-1 - ELECTRICAL INSULATING MATERIALS - DETERMINATION OF THE EFFECTS OF IONIZING RADIATION - PART 1: RADIATION INTERACTION AND DOSIMETRY
    BS ISO 7197:1997 Neurosurgical implants. Sterile, single-use hydrocephalus shunts and components
    11/30227618 DC : 0 BS ISO 11658 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - BLOOD/TISSUE CONTACT SURFACE MODIFICATIONS FOR EXTRACORPOREAL PERFUSION SYSTEMS
    CSA Z11137-2 : 2007 : R2012 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
    05/30060678 DC : DRAFT SEP 2005 BS EN ISO 22794 - DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE
    ASTM F 2560 : 2006 Standard Specification for Supralaryngeal Airways and Connectors
    03/113382 DC : DRAFT SEP 2003 BS EN ISO 21649 - NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS
    ASTM F 2726 : 2008 Standard specification for fixation devices for tracheal tubes and other airway devices
    CSA Z10651-5 : 2008 : R2018 Lung Ventilators for Medical Use - Particular Requirements for Basic Safety and Essential Performance - Part 5: Gas-Powered Emergency Resuscitators
    ISO 18385:2016 Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes — Requirements
    ISO/TS 13409:2002 Sterilization of health care products Radiation sterilization Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
    DIN EN ISO 11137-1:2015-11 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)
    UNE-EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
    BS EN ISO 11137-2:2015 Sterilization of health care products. Radiation Establishing the sterilization dose
    ISO 22803:2004 Dentistry — Membrane materials for guided tissue regeneration in oral and maxillofacial surgery — Contents of a technical file
    BS EN ISO 8320-2:2001 Contact lenses and contact lens care products. Vocabulary Contact lens care products
    DIN EN ISO 5840:2009-08 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES
    EN 60544-1:2013 Electrical insulating materials - Determination of the effects of ionizing radiation - Part 1: Radiation interaction and dosimetry
    EN ISO 5840:2009 Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)
    EN 60601-2-12:2006 Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators

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

    ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
    ISO 9002:1994 Quality systems — Model for quality assurance in production, installation and servicing
    ISO 9001:2015 Quality management systems — Requirements
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