07/30090385 DC : 0
Withdrawn
Withdrawn
ISO 13408-1 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
Available format(s)
Hardcopy , PDF
Language(s)
English
Publisher
Withdrawn date
04-26-2007
Excluding Tax where applicable
| Committee |
CH/198
|
| DocumentType |
Draft
|
| Pages |
56
|
| PublisherName |
British Standards Institution
|
| Status |
Withdrawn
|
| ISO 13408-4:2005 | Aseptic processing of health care products — Part 4: Clean-in-place technologies |
| EN 13624:2013 | Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1) |
| 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 |
| 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 |
| 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 |
| 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 |
| EN 14348:2005 | Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1) |
| 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/TR 14969:2004 | Medical devices — Quality management systems — Guidance on the application of ISO 13485: 2003 |
| ISO 13408-3:2006 | Aseptic processing of health care products — Part 3: Lyophilization |
| EN 13727:2012+A2:2015 | Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1) |
| ISO 14698-1:2003 | Cleanrooms and associated controlled environments — Biocontamination control — Part 1: General principles and methods |
| ISO 14644-3:2005 | Cleanrooms and associated controlled environments — Part 3: Test methods |
| 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 14644-7:2004 | Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) |
| EN 1275:2005 | Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic fungicidal or basic yeasticidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1) |
| 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 |
| 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 1040:2005 | Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1) |
| ISO 13408-6:2005 | Aseptic processing of health care products — Part 6: Isolator systems |
| EN 14347:2005 | Chemical disinfectants and antiseptics - Basic sporicidal activity - Test method and requirements (phase 1) |
| 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 |
| ISO 15223:2000 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied |
Summarise