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  • EN ISO 17665-1 : 2006

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    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)

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    Published date:  15-08-2006

    Publisher:  Comite Europeen de Normalisation

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

    Foreword
    Introduction
    1 Scope
       1.1 Inclusions
       1.2 Exclusions
    2 Normative references
    3 Terms and definitions
    4 Quality management system elements
       4.1 Documentation
       4.2 Management responsibility
       4.3 Product realization
       4.4 Measurement, analysis and improvement - Control
            of non-conforming product
    5 Sterilizing agent characterization
       5.1 Sterilizing agent
       5.2 Microbicidal effectiveness
       5.3 Materials effects
       5.4 Environmental consideration
    6 Process and equipment characterization
       6.1 Process
            6.1.1 General
            6.1.2 Saturated steam processes
            6.1.3 Contained product processes
       6.2 Equipment
    7 Product definition
    8 Process definition
    9 Validation
       9.1 General
       9.2 Installation qualification (IQ)
            9.2.1 Equipment
            9.2.2 Installation
            9.2.3 Function
       9.3 Operational qualification (OQ)
       9.4 Performance qualification (PQ)
       9.5 Review and approval of validation
    10 Routine monitoring and control
    11 Product release from sterilization
    12 Maintaining process effectiveness
       12.1 Demonstration of continued effectiveness
       12.2 Recalibration
       12.3 Maintenance of equipment
       12.4 Requalification
       12.5 Assessment of change
    Annex A (informative) Guidance
    Annex B (informative) Process definition based on
             inactivation of the microbial population in
             its natural state (bioburden-based method)
    Annex C (informative) Process definition based on the
             inactivation of a reference microorganism and
             a knowledge of bioburden on product items to
             be sterilized (combined bioburden/biological
             indicator based method)
    Annex D (informative) Conservative process definition
             based on inactivation of reference microorganisms
             (overkill method)
    Annex E (informative) Operating cycles
    Annex ZA (informative) Relationship between this European
             Standard and the Essential Requirements of EU
             Directive 90/385/EEC, 93/42/EEC and 98/79/EEC
    Bibliography

    Abstract - (Show below) - (Hide below)

    ISO 17665-1:2006 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.

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

    Committee TC 204
    Development Note Supersedes EN 554. (09/2006)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current
    Supersedes

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

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    I.S. EN ISO 15798:2013 OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013)
    PREN 556-2 : DRAFT 2014 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES
    BS EN ISO 25539-1:2017 Cardiovascular implants. Endovascular devices Endovascular prostheses
    PREN 17180 : DRAFT 2017 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE VAPORIZED HYDROGEN PEROXIDE STERILIZERS - REQUIREMENTS AND TESTING
    I.S. EN 285:2015 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    DIN EN ISO 7199 E : 2017 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016)
    UNE-EN ISO 7198:2017 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
    12/30262894 DC : 0 BS EN 14180 - STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
    BS EN ISO 7198:2017 Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches
    PREN 45502-1 : DRAFT 2013 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER
    08/30184602 DC : DRAFT SEP 2008 BS EN 1639 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
    15/30317874 DC : 0 BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
    12/30261215 DC : 0 BS EN 13060 - SMALL STEAM STERILIZERS
    BS EN 16372:2014 Aesthetic surgery services
    I.S. EN 556-2:2015 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES
    I.S. EN ISO 13408-1:2015 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)
    VDI 6300-1 : 2016 GENETIC ENGINEERING OPERATIONS IN GENETIC ENGINEERING FACILITIES - GUIDANCE ON SAFE OPERATION OF GENETIC ENGINEERING FACILITIES
    14/30273161 DC : 0 BS EN 556-2 - STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED ''STERILE'' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES
    11/30252448 DC : 0 BS EN 1422 - STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
    VDI 5700-1 : 2015 REPROCESSING HAZARDS - RISK MANAGEMENT IN REPROCESSING OF MEDICAL DEVICES - MEASURES FOR RISK CONTROL
    13/30233325 DC : 0 BS EN 45502-1 - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER
    13/30278952 DC : 0 BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES
    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)
    VDI 2083-8-1 : 2014 Cleanroom technology - Air cleanliness chemical concentration (ACC)
    I.S. EN 16844:2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
    PREN 14180 : DRAFT 2012 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
    BS EN ISO 7199 : 2017 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016)
    BS EN ISO 15798 : 2013 OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES
    13/30278676 DC : 0 BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    UNE-EN 16372:2015 Aesthetic surgery services
    PREN 285 : DRAFT 2013 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    12/30254927 DC : 0 BS EN 16372 - AESTHETIC SURGERY SERVICES
    PREN 13060 : DRAFT 2012 SMALL STEAM STERILIZERS
    I.S. EN 16844:2017+A2:2019 Aesthetic medicine services - Non-surgical medical treatments
    I.S. EN 16372:2014 AESTHETIC SURGERY SERVICES
    BS EN ISO 13408-1:2015 (published 2015-08) Aseptic processing of health care products General requirements
    I.S. EN ISO 7198:2017 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016)
    I.S. EN ISO 25539-1:2017 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
    EN 13060:2014 SMALL STEAM STERILIZERS
    STANAG 2906 : 2015 ESSENTIAL PHYSICAL REQUIREMENTS AND PERFORMANCE CHARACTERISTICS OF FIELD TYPE HIGH PRESSURE STEAM STERILIZERS
    17/30362728 DC : 0 BS EN 17169 - TATTOOING - SAFE AND HYGIENIC PRACTICE
    EN ISO 15798:2013/A1:2017 OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013/AMD 1:2017)
    UNE-EN 13060:2015 Small steam sterilizers
    BS EN 16844 : 2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS
    I.S. EN 60601- 1:2006&A1:2013&AC:2014&A12:2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
    I.S. EN ISO 7199:2017 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016)
    EN 16844 : 2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS
    EN 285:2015 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    DIN EN 13060:2015-03 SMALL STEAM STERILIZERS
    DIN EN 1639:2010-02 Dentistry - Medical devices for dentistry - Instruments
    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 14180:2014-09 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
    DIN EN 13544-1:2009-12 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
    DIN EN 285:2016-05 Sterilization - Steam sterilizers - Large sterilizers
    BS EN 556-2:2015 Sterilization of medical devices. Requirements for medical devices to be designated \'STERILE\' Requirements for aseptically processed medical devices
    UNE-EN 285:2016 Sterilization - Steam sterilizers - Large sterilizers
    BS EN 60601-1 : 2006 MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
    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
    BS EN 45502-1:2015 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
    BS EN 1639 : 2009 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
    UNE-EN ISO 16672:2016 Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)
    ISO 13408-1:2008 Aseptic processing of health care products Part 1: General requirements
    EN ISO 7199:2017 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016)
    BS EN 13544-1 : 2007 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
    BS EN 13060 : 2014 SMALL STEAM STERILIZERS
    BS EN 285 : 2015 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    BS EN 14180:2014 Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing
    I.S. EN 13544-1:2007 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
    I.S. EN 1639:2009 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
    I.S. EN 14180:2014 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
    DIN EN 14180:2003-10 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
    I.S. EN 45502-1:2015 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
    EN 13544-1:2007+A1:2009 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
    EN 45502-1 : 2015 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
    EN 16372:2014 Aesthetic surgery services
    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 7198 : 2017 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016)
    EN 1639:2009 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
    EN 556-2:2015 (edition 2) Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices
    EN 14180:2014 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
    UNI EN 13544-1 : 2009 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
    UNI EN 14180 : 2014 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING

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

    IEC 61010-2-040:2015 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
    EN 12442-3 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS
    ISO 15883-1:2006 Washer-disinfectors Part 1: General requirements, terms and definitions and tests
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    ISO 11138-3:2017 Sterilization of health care products Biological indicators Part 3: Biological indicators for moist heat sterilization processes
    EN 556-1:2001/AC:2006 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED "STERILE" - PART 1: REQUIREMENTS FOR TERMINALLY STERILIZED MEDICAL DEVICES
    ISO 15882:2008 Sterilization of health care products Chemical indicators Guidance for selection, use and interpretation of results
    EN 285:2015 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    ISO 11737-2:2009 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
    ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
    EN 868-5 : 2009 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    EN 868-1 : 1997 PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS
    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 11140-3:2007 Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
    ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
    EN 868-2:2017 (edition 2) Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
    EN 868-3:2017 (edition 2) Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
    ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
    ISO 18472:2006 Sterilization of health care products Biological and chemical indicators Test equipment
    ISO 11140-4:2007 Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
    ISO 9004:2009 Managing for the sustained success of an organization A quality management approach
    ISO/TS 11139:2006 Sterilization of health care products Vocabulary
    ISO 15883-4:2008 Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
    ISO 10993-17:2002 Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances
    ISO 14001:2015 Environmental management systems Requirements with guidance for use
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
    ISO 9001:2015 Quality management systems - Requirements
    ISO 22442-2:2015 Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
    ISO 9000:2015 Quality management systems Fundamentals and vocabulary
    ISO 11140-5:2007 Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
    EN 12442-1 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
    ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
    ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
    ISO 14040:2006 Environmental management Life cycle assessment Principles and framework
    ISO 15883-2:2006 Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
    EN 13060:2014 SMALL STEAM STERILIZERS
    EN 12442-2 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING
    ISO 9000-3:1997 Quality management and quality assurance standards Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software
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