AAMI CR513:2024
Current
The latest, up-to-date edition.
Guidance on radiation sterilization validation and routine control of single-use systems used for pharmaceutical and biopharmaceutical manufacturing
English
14-06-2024
This consensus report provides guidance on simplified approaches for validation and routine control of single-use systems used for pharmaceutical and biopharmaceutical manufacturing sterilized by radiation.
| DocumentType |
Standard
|
| ISBN |
978-1-57020-897-3
|
| Pages |
14
|
| ProductNote |
This standard also refers to ISO/FDIS 11137-1:2024
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| ANSI/AAMI/ISO 11737-2:2019 | <br>Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| ISO 13408-7:2012 | Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products |
| ISO/ASTM 52303:2015 | Guide for absorbed-dose mapping in radiation processing facilities |
| ISO 13408-1:2023 | Aseptic processing of health care products — Part 1: General requirements |
| 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 |
| ANSI/AAMI/ ISO 11137-2:2013(R2019) | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
| ISO 13004:2022 | Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD |
| ISO/ASTM 52628:2020 | Standard practice for dosimetry in radiation processing |
| ANSI/AAMI/ISO 11737-1:2018 | Sterilization of health care products—Microbiological methods—Part 1: Determination of a population of microorganisms on products |
| ANSI/AAMI ST67:2019 | Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile” |
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