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
$377.91
Including GST where applicable
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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