ANSI/AAMI/ISO 13408-1:2023
Current
Aseptic processing of health care products—Part 1: General requirements
English
01-23-2024
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 |
ISO/TC 198
|
| DocumentType |
Guide
|
| ISBN |
978-1-57020-898-0
|
| Pages |
89
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 13408-1:2023 | 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 13408-7:2012 | Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes |
| ISO 13408-3:2006 | Aseptic processing of health care products — Part 3: Lyophilization |
| ISO 10993-17:2023 | Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents |
| ISO 11137-3:2017 | Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control |
| ISO 11737-3:2023 | Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing |
| ISO 11139:2018 | Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 13408-5:2006 | Aseptic processing of health care products — Part 5: Sterilization in place |
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