ISO 13408-1:2008
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Aseptic processing of health care products — Part 1: General requirements
Amended by
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Superseded date
08-15-2023
Superseded by
Published date
06-10-2008
Important note : All end users must be registered with an Account prior to user licenses being assigned.
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.
| Committee |
ISO/TC 198
|
| DevelopmentNote |
Supersedes ISO/DIS 13408-1. (06/2008)
|
| DocumentType |
Standard
|
| Pages |
48
|
| PublisherName |
International Organization for Standardization
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NF EN ISO 13408-1 : 2016 | Identical |
| NBN EN ISO 13408-1 : 2015 | Identical |
| NEN EN ISO 13408-1 : 2015 | Identical |
| NS EN ISO 13408-1 : 2015 | Identical |
| I.S. EN ISO 13408-1:2015 | Identical |
| PN EN ISO 13408-1 : 2015 | Identical |
| SN EN ISO 13408-1 : 2015 | Identical |
| UNI EN ISO 13408-1 : 2013 | Identical |
| SS-EN ISO 13408-1 :2015 | Identical |
| UNI EN ISO 13408-1:2015 | Identical |
| UNE-EN ISO 13408-1:2015 | Identical |
| BS EN ISO 13408-1:2015 | Identical |
| EN ISO 13408-1:2015 | Identical |
| DIN EN ISO 13408-1:2015-12 | Identical |
| ABNT NBR ISO 13408-1:2022 | Identical |
| ONORM EN ISO 13408-1 : 2015 | Identical |
| DS EN ISO 13408-1 : 2015 | Identical |
| NEN ISO 13408-1 : 2008 | Identical |
| GOST R ISO 13408-1 : 2000 | Identical |
| BS EN ISO 13408-1:2011+A1:2013 | Identical |
| AAMI ISO 13408-1 : 2008 : INC : AMD 1 : 2013 : R201100 | Identical |
| UNE-EN ISO 13408-1:2011 | Identical |
| AAMI ISO 13408-1 : 2008 : R2011 | Identical |
| AAMI ISO 13408-1:2008 | Identical |
| 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 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 |
| 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) |
| 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 |
| 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 14644-7:2004 | Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004) |
| 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 |
| 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 |
| 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 (ISO 14698-1:2003) |
| 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 |
| 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 14644-5:2004) |
| 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 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 14644-7:2004 | Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004) |
| 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 14644-3:2005) |
| ISO 15223:2000 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied |
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