ISO 13408-6:2005
Withdrawn
Withdrawn
View Superseded by
Aseptic processing of health care products — Part 6: Isolator systems
Amended by
Available format(s)
Hardcopy , PDF
Published date
06-20-2005
Withdrawn date
04-09-2025
Superseded by
US$96.00
Excluding Tax where applicable
ISO 13408-6:2005 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products.
ISO 13408-6:2005 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials.
ISO 13408-6:2005 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular to national or regional jurisdictions.
| DevelopmentNote |
Supersedes ISO/DIS 13408-6 (06/2005)
|
| DocumentType |
Standard
|
| Pages |
17
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| GOST R ISO 13408-6 : 2009 | Identical |
| NF EN ISO 13408-6 : 2011 AMD 1 2013 | Identical |
| NBN EN ISO 13408-6 : 2011 AMD 1 2013 | Identical |
| NEN ISO 13408-6 : 2005 | Identical |
| NEN EN ISO 13408-6 : 2011 AMD 1 2013 | Identical |
| NS EN ISO 13408-6 : 2011 AMD 1 2013 | Identical |
| I.S. EN ISO 13408-6:2011 | Identical |
| PN EN ISO 13408-6 : 2011 AMD 1 2013 | Identical |
| BS EN ISO 13408-6 : 2011 | Identical |
| DIN EN ISO 13408-6:2013-07 | Identical |
| ANSI/AAMI/ISO 13408-6:2005(R2013)&A1:2013 | Identical |
| AAMI ISO 13408-6 : 2005 : INC : AMD 1 : 2013 | Identical |
| AAMI ISO 13408-6:2005 | Identical |
| UNE-EN ISO 13408-6:2011 | Identical |
| 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 |
| 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 |
| ISO 13408-2:2018 | Aseptic processing of health care products — Part 2: Sterilizing filtration |
| 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) |
| 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 |
| ISO 13408-1:2008 | Aseptic processing of health care products — Part 1: General requirements |
| 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 13408-1:2015-12 | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
| I.S. EN ISO 13408-2:2018 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION (ISO 13408-2:2018) |
| 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 |
| BS EN ISO 13408-1:2015 | Aseptic processing of health care products General requirements |
| AAMI ISO 13408-2 : 2003 : R2013 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION |
| 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 |
| BS EN 556-2:2015 | Sterilization of medical devices. Requirements for medical devices to be designated \'STERILE\' Requirements for aseptically processed medical devices |
| 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 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) |
| VDI 2083 Blatt 16.1:2010-08 | Cleanroom technology - Barier systems (isolators, mini-environments, separative devices) - Effectiveness and certification |
| 09/30207531 DC : 0 | BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS |
| 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 13408-1 : 2008 : R2011 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
| 07/30090385 DC : 0 | ISO 13408-1 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
| 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) |
| 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 |
| EN ISO 13408-2:2018 | Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018) |
| 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 |
| AAMI ISO 13408-1 : 2008 : INC : AMD 1 : 2013 : R201100 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
| AAMI ISO 13408-1:2008 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
| PD CEN/TS 16244:2018 | Ventilation in hospitals. Coherent hierarchic structure and common terms and definitions for a standard related to ventilation in hospitals |
| S.R. CEN/TS 16244:2018 | VENTILATION IN HOSPITALS - COHERENT HIERARCHIC STRUCTURE AND COMMON TERMS AND DEFINITIONS FOR A STANDARD RELATED TO VENTILATION IN HOSPITALS |
| ISO 13022:2012 | Medical products containing viable human cells — Application of risk management and requirements for processing practices |
| 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 |
| ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management |
| 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 |
| BS EN ISO 14644-7:2004 | Cleanrooms and associated controlled environments Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) |
| EN ISO 13408-1:2015 | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
| EN ISO 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 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 14534:2015 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
| I.S. EN 556-2:2015 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES |
| I.S. EN ISO 13408-1:2015 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013) |
| CEN/TS 16244:2018 | Ventilation in hospitals - Coherent hierarchic structure and common terms and definitions for a standard related to ventilation in hospitals |
| 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 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 |
| I.S. EN ISO 22442-1:2020 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management |
| ANSI/AAMI/ISO 13408-2:2018 | Aseptic processing of health care products—Part 2: Sterilizing filtration |
| 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 |
| UNE-EN ISO 14534:2015 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
| 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 13408-4:2005 | Aseptic processing of health care products — Part 4: Clean-in-place technologies |
| ISO 10648-1:1997 | Containment enclosures — Part 1: Design principles |
| ISO/TS 17665-2:2009 | Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 |
| ISO 14971:2000 | Medical devices — Application of risk management to medical devices |
| ISO 13408-1:2008 | Aseptic processing of health care products — Part 1: General requirements |
| ISO/TS 11139:2006 | Sterilization of health care products — Vocabulary |
| 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 10648-2:1994 | Containment enclosures — Part 2: Classification according to leak tightness and associated checking methods |
| ISO/IEC 90003:2014 | Software engineering — Guidelines for the application of ISO 9001:2008 to computer software |
| ISO 9001:2000 | Quality management systems — Requirements |
| 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 |
Summarise
US$96.00
Excluding Tax where applicable
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