NS-EN ISO 13408-1:2024
Current
Current
The latest, up-to-date edition.
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)
Available format(s)
Hardcopy
Language(s)
English
Published date
06-05-2024
€124.82
Excluding VAT
This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products.
| Committee |
CEN/TC 204
|
| DocumentType |
Standard
|
| Pages |
0
|
| PublisherName |
Norwegian Standards (Norges Standardiseringsforbund)
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 13408-1:2023 | Identical |
| EN ISO 13408-1:2024 | Identical |
| ISO 13408-4:2005 | Aseptic processing of health care products — Part 4: Clean-in-place technologies |
| ISO 5667-13:2011 | Water quality — Sampling — Part 13: Guidance on sampling of sludges |
| ISO 14698-2:2003 | Cleanrooms and associated controlled environments — Biocontamination control — Part 2: Evaluation and interpretation of biocontamination data |
| 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 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 29463-2:2011 | High-efficiency filters and filter media for removing particles in air — Part 2: Aerosol production, measuring equipment and particle-counting statistics |
| ISO 13408-3:2006 | Aseptic processing of health care products — Part 3: Lyophilization |
| ISO 11737-3:2023 | Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing |
| ISO/TS 19930:2017 | Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6 |
| ISO 29463-1:2017 | High efficiency filters and filter media for removing particles from air — Part 1: Classification, performance, testing and marking |
| IEC 61882:2016 | Hazard and operability studies (HAZOP studies) - Application guide |
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