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  • ISO 13408-1:2008

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    Aseptic processing of health care products — Part 1: General requirements

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

    Superseded date:  15-08-2023

    Language(s): 

    Published date:  10-06-2008

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 13408-1:2008 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products.

    ISO 13408-1:2008 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.

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

    Committee ISO/TC 198
    Development Note Supersedes ISO/DIS 13408-1. (06/2008)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Superseded
    Superseded By
    Supersedes

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

    NF EN ISO 13408-5 : 2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: STERILIZATION IN PLACE
    ANSI/AAMI/ISO 13408-4:2005(R2014) ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 4: CLEAN-IN-PLACE TECHNOLOGIES
    DIN EN ISO 13408-4:2011-09 Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
    I.S. EN 13824:2005 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
    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
    ANSI/AAMI/ISO 13408-3:2006(R2015) ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION
    04/300654 DC : DRAFT JAN 2004 BS EN ISO 14630 - NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    14/30295067 DC : 0 BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY
    14/30295064 DC : 0 BS EN ISO 16672 - OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES
    BS EN ISO 16671 : 2015 OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY
    DIN EN ISO 13408-7:2015-11 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS (ISO 13408-7:2012)
    04/30090376 DC : DRAFT DEC 2004 ISO 13408-3 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION
    NF EN ISO 13408-6 : 2011 AMD 1 2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
    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
    AAMI ISO 13408-2 : 2003 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION
    AAMI ISO 13408-5 : 2006 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: STERILIZATION IN PLACE
    AAMI ISO 13408-3:2006 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION
    UNI EN ISO 13408-6 : 2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
    UNE-EN ISO 22442-1:2016 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
    ISO 11040-8:2016 Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes
    ASTM F 2212 : 2011 : REDLINE Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
    DIN EN ISO 22442-1:2016-05 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
    BS EN ISO 22803:2005 Dentistry. Membrane materials for guided tissue regeneration in oral and maxillofacial surgery. Contents of a technical file
    ISO 14644-7:2004 Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
    BS EN ISO 14534:2015 Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements
    UNE-EN ISO 16672:2016 Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)
    BS EN ISO 14630:2012 Non-active surgical implants. General requirements
    BS EN 13824:2004 Sterilization of medical devices. Aseptic processing of liquid medical devices. Requirements
    CEN ISO/TR 14969:2005 Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)
    ISO/TR 20520:2018 Traditional Chinese medicine Infection control for acupuncture treatment
    I.S. EN ISO 15798:2013 OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013)
    UNE-EN ISO 16061:2015 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
    I.S. EN ISO 13408-5:2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: STERILIZATION IN PLACE
    04/30090382 DC : DRAFT NOV 2004 ISO 13408-5 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: CLEANING IN PLACE
    DIN ISO 13022 E : 2014 MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012)
    DIN EN ISO 13408-6:2013-07 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005 + Amd 1:2013) (includes Amendment A1:2013)
    BS EN ISO 13408-7:2015 Aseptic processing of health care products Alternative processes for medical devices and combination products
    I.S. EN ISO 13408-2:2018 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION (ISO 13408-2:2018)
    UNI EN ISO 13408-5 : 2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: STERILIZATION IN PLACE
    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
    ANSI/AAMI/ISO 13022:2012 MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES
    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
    DIN EN ISO 16061:2015-09 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
    ASTM F 2064 : 2017 : REDLINE Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
    ASTM F 2347 : 2015 : REDLINE Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
    UNE-EN ISO 13408-6:2011 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
    BS EN ISO 13408-6 : 2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
    I.S. EN ISO 13408-4:2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 4: CLEAN-IN-PLACE TECHNOLOGIES
    ISO 18362:2016 Manufacture of cell-based health care products Control of microbial risks during processing
    AAMI ISO 13408-2 : 2003 : R2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION
    I.S. EN ISO 13408-6:2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS (ISO 13408-6:2005)
    NF EN ISO 13408-4 : 2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 4: CLEAN-IN-PLACE TECHNOLOGIES
    ASTM F 3089 : 2014 Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
    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 22803:2006-01 Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004)
    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
    ISO 13408-5:2006 Aseptic processing of health care products Part 5: Sterilization in place
    ISO 13408-6:2005 Aseptic processing of health care products Part 6: Isolator systems
    BS EN ISO 14644-4:2001 Cleanrooms and associated controlled environments Design, construction and start-up
    BS EN ISO 22442-1:2015 MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT
    I.S. EN ISO 14534:2015 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS (ISO 14534:2011)
    I.S. EN ISO 22794:2009 DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE
    I.S. EN ISO 22442-1:2015 MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT (ISO 22442-1:2015)
    EN ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
    I.S. EN ISO 14630:2012 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 14630:2012)
    I.S. EN ISO 16672:2015 OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES (ISO 16672:2015)
    13/30285624 DC : 0 BS EN ISO 16061 - INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    I.S. CEN ISO TR 14969:2005 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485: 2003
    DIN EN ISO 13408-7 E : 2015 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS (ISO 13408-7:2012)
    BS PD ISO/TR 14969 : 2004 AMD 15958 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    09/30207531 DC : 0 BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS
    DIN EN ISO 13408-5:2011-09 Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
    UNE-EN ISO 13408-4:2011 Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
    01/121101 DC : DRAFT MAR 2001 BS EN ISO 14644-7 - CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 7: SEPARATIVE ENCLOSURES (CLEAN AIR HOODS, GLOVEBOXES, ISOLATORS, MINI-ENVIRONMENTS)
    AAMI ISO TIR 14969 : 2004 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    BS EN ISO 13408-5:2011 Aseptic processing of health care products Sterilization in place
    UNE-EN ISO 13408-3:2011 Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
    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
    AAMI ISO 13408-6 : 2005 : INC : AMD 1 : 2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
    ANSI/AAMI/ISO 22442-1:2016 MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT
    DIN ISO 13022:2014-06 MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012)
    EN ISO 16671:2015/A1:2017 OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015/AMD 1:2017)
    I.S. EN ISO 13408-7:2015 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS (ISO 13408-7:2012)
    AAMI ISO 13408-5:2006(R2015) ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: STERILIZATION IN PLACE
    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
    ISO 15798:2013 Ophthalmic implants Ophthalmic viscosurgical devices
    UNI EN ISO 13408-3 : 2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION
    ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
    I.S. EN ISO 16671:2015 OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015)
    DIN EN ISO 22794:2009-11 Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15)
    ISO 22794:2007 Dentistry Implantable materials for bone filling and augmentation in oral and maxillofacial surgery Contents of a technical file
    ONORM EN ISO 15798 : 2013 AMD 1 2018 OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013)
    UNI EN ISO 14630 : 2013 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    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 13408-3:2011 Aseptic processing of health care products Lyophilization
    15/30304642 DC : 0 BS ISO 11040-8 - PREFILLED SYRINGES - PART 8: REQUIREMENTS AND TEST METHODS FOR FINISHED PRIFILLED SYRINGES
    BS ISO 18362:2016 Manufacture of cell-based health care products. Control of microbial risks during processing
    UNI EN ISO 13408-4 : 2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 4: CLEAN-IN-PLACE TECHNOLOGIES
    02/560790 DC : DRAFT FEB 2002 BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY
    EN ISO 13408-2:2018 Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)
    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)
    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)
    00/560097 DC : DRAFT JAN 2000 BS EN 13824 - STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ASEPTIC PROCESSES - REQUIREMENTS AND GUIDANCE
    03/314215 DC : DRAFT OCT 2003 ISO TR 14969 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    CSA ISO TR 14969 : 2005 : R2015 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    01/560508 DC : DRAFT FEB 2001 BS ISO 13408-2 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: FILTRATION
    AAMI ISO 13408-6:2005 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
    CSA ISO TR 14969 :2005 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    ANSI/AAMI/ISO 13408-6:2005(R2013)&A1:2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
    NF ISO 13408-7 : 2012 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR ATYPICAL MEDICAL DEVICES AND COMBINATION PRODUCTS
    AAMI ISO 13408-4 : 2005 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 4: CLEAN-IN-PLACE TECHNOLOGIES
    ANSI/AAMI/ISO 13408-7:2012(R2018) ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS
    ASTM F 2103 : 2011-03 GUIDE FOR CHARACTERIZATION AND TESTING OF CHITOSAN SALTS AS STARTING MATERIALS INTENDED FOR USE IN BIOMEDICAL AND TISSUE-ENGINEERED MEDICAL PRODUCT APPLICATIONS
    ISO 13022:2012 Medical products containing viable human cells — Application of risk management and requirements for processing practices
    I.S. EN ISO 16061:2015 INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015)
    DIN EN ISO 14630:2013-03 Non-active surgical implants - General requirements (ISO 14630:2012)
    DIN EN ISO 14534:2015-08 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
    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 16061:2015 Instrumentation for use in association with non-active surgical implants General requirements
    ISO 13408-4:2005 Aseptic processing of health care products — Part 4: Clean-in-place technologies
    ISO 14644-4:2001 Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
    ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
    ISO 16672:2015 Ophthalmic implants Ocular endotamponades
    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
    UNE-EN ISO 14534:2015 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
    ISO 13408-7:2012 Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products
    ISO 13408-3:2006 Aseptic processing of health care products Part 3: Lyophilization
    UNE-EN ISO 14630:2013 Non-active surgical implants - General requirements (ISO 14630:2012)
    BS EN ISO 14644-7:2004 Cleanrooms and associated controlled environments Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
    BS EN ISO 22794:2009 DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE
    EN ISO 13408-5:2011 Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
    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 13408-4:2011 Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
    EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices
    EN ISO 14644-4:2001 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2001)
    EN ISO 22794:2009 Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15)
    EN ISO 14534:2015 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
    EN ISO 14630:2012 Non-active surgical implants - General requirements (ISO 14630:2012)
    EN ISO 13408-7:2015 Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)
    EN ISO 13408-3:2011 Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
    EN 13824 : 2004 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
    BS EN ISO 16061:2015 INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    BS ISO 13408-7 : 2012 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS
    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
    DIN EN ISO 13408-2:2011-09 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: FILTRATION
    BS EN ISO 13408-4:2011 Aseptic processing of health care products Clean-in-place technologies
    PD CEN ISO/TR 14969:2005 Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003
    NF EN ISO 13408-3 : 2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION
    UNE-EN ISO 13408-5:2011 Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
    DIN EN ISO 13408-3:2011-09 Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
    CSA ISO TR 14969 : 2005 : R2010 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    UNE-EN ISO 16671:2016 Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015)
    ISO 16671:2015 Ophthalmic implants — Irrigating solutions for ophthalmic surgery
    EN ISO 15798:2013/A1:2017 OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013/AMD 1:2017)
    UNI EN ISO 22794 : 2009 DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE
    ISO 22803:2004 Dentistry — Membrane materials for guided tissue regeneration in oral and maxillofacial surgery — Contents of a technical file
    BS EN ISO 16672:2015 Ophthalmic implants. Ocular endotamponades
    ISO 14630:2012 Non-active surgical implants General requirements
    EN ISO 16061:2015 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
    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 (ISO 22442-3:2007)
    DIN EN 13824:2005-02 STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS
    DIN EN ISO 14644-7:2005-01 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004); German version EN ISO 14644-7:2004

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

    ISO 13408-4:2005 Aseptic processing of health care products — Part 4: Clean-in-place technologies
    EN ISO 14644-4:2001 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2001)
    ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    EN ISO 14698-1 : 2003 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS
    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)
    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 14698-2:2003 Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data
    EN ISO 13408-3:2011 Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
    EN ISO 13408-4:2011 Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
    IEC 60812:2006 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
    EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices
    EN ISO 13408-5:2011 Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
    ISO 14644-2:2015 Cleanrooms and associated controlled environments Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
    ISO 13408-2:2003 Aseptic processing of health care products Part 2: Filtration
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 14644-5:2004 Cleanrooms and associated controlled environments Part 5: Operations
    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/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
    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)
    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 13408-3:2006 Aseptic processing of health care products Part 3: Lyophilization
    ISO 14698-1:2003 Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods
    EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
    ISO 14644-3:2005 Cleanrooms and associated controlled environments Part 3: Test methods
    EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
    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 11137-3:2017 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
    EN ISO 14698-2:2003/AC:2006 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 2: EVALUATION AND INTERPRETATION OF BIOCONTAMINATION DATA
    ISO 11137-2:2013 Sterilization of health care products Radiation Part 2: Establishing the sterilization dose
    EN ISO 14644-5 : 2004 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 5: OPERATIONS
    ISO 14644-7:2004 Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
    ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
    ISO 9001:2015 Quality management systems — Requirements
    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 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    ISO 9000:2015 Quality management systems Fundamentals and vocabulary
    ISO 14644-4:2001 Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
    EN 1822-1:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking
    EN ISO 13408-6:2011/A1:2013 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS (ISO 13408-6:2005/AMD 1:2013)
    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 (ISO 17665-1:2006)
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    EN ISO 14644-2:2015 Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration (ISO 14644-2:2015)
    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)
    ISO 13408-6:2005 Aseptic processing of health care products Part 6: Isolator systems
    EN ISO 14644-1:2015 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015)
    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)
    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
    ISO 13408-5:2006 Aseptic processing of health care products Part 5: Sterilization in place
    EN ISO 14644-3:2005 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS
    ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
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