AAMI TIR104:2022
Current
The latest, up-to-date edition.
Guidance on transferring health care products between radiation sterilization sources
English
25-01-2022
The focus of this document is to provide guidance in managing the process for transferring a health care product either from one radiation sterilization modality to another or from one irradiator to another using the same radiation modality.
| DocumentType |
Standard
|
| ISBN |
978-1-57020-831-7
|
| Pages |
31
|
| ProductNote |
This standard also refers to ANSI/AAMI//ISO 11137-1:2006/(R)2015 and A1:2013 and A2:2019,ASTM ISO/ASTM52701-13(2020).
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| ANSI/AAMI/ISO TIR13004:2013(R2016) | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - SUBSTANTIATION OF A SELECTED STERILIZATION DOSE: METHOD VD[MAX][SD] |
| AAMI TIR17 : 2017 | COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION |
| ISO 11137-3:2017 | Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control |
| ISO/ASTM 51707:2015 | Guide for estimation of measurement uncertainty in dosimetry for radiation processing |
| ISO/TS 11137-4:2020 | Sterilization of health care products — Radiation — Part 4: Guidance on process control |
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