ISO 13408-1:2008
Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by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
Withdrawn date
09-04-2025
Superseded by
Published date
10-06-2008
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 |
Withdrawn
|
| 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 |
| ONORM EN ISO 14630 : 2013 | NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 14630:2012) |
| 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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