AAMI/ISO TIR11137-4:2022(R2023)
Current
The latest, up-to-date edition.
Sterilization of health care products—Radiation—Part 4: Guidance on process control
English
25-01-2023
This technical information report provides additional guidance to that given in ISO 11137-3 on meeting the requirements specified in ISO 11137-1, ISO 11137-2 and ISO/TS 13004 for the establishment and control of a radiation sterilization process using gamma, electron beam, and X-irradiation.
| Committee |
ISO/TC 198
|
| DocumentType |
Standard
|
| ISBN |
978-1-57020-839-3
|
| Pages |
67
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| ISO 14971:2019 | Medical devices — Application of risk management to medical devices |
| ASTM E 2587 : 2016 | Standard Practice for Use of Control Charts in Statistical Process Control |
| AAMI TIR37 : 2013 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - GUIDANCE ON STERILIZATION OF BIOLOGICS AND TISSUE-BASED PRODUCTS |
| ASTM E 2281 : 2015 | Standard Practice for Process Capability and Performance Measurement |
| ISO 11462-2:2010 | Guidelines for implementation of statistical process control (SPC) — Part 2: Catalogue of tools and techniques |
| ISO/ASTM 52303:2015 | Guide for absorbed-dose mapping in radiation processing facilities |
| ISO/ASTM 51261:2013 | Practice for calibration of routine dosimetry systems for radiation processing |
| ISO/ASTM 52701:2013 | Guide for performance characterization of dosimeters and dosimetry systems for use in radiation processing |
| ASTM E 2232 : 2021 | Standard Guide for Selection and Use of Mathematical Methods for Calculating Absorbed Dose in Radiation Processing Applications |
| ISO/ASTM 51707:2015 | Guide for estimation of measurement uncertainty in dosimetry for radiation processing |
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