AAMI TIR52:2014(R2022)
Superseded
View Superseded by
Environmental monitoring for terminally sterilized healthcare products
English
10-31-2022
07-28-2026
This Technical Information Report (TIR) assists in establishing an environmental monitoring program that is meaningful, manageable and defendable, and provides guidance to avoid adverse environmental conditions during the manufacture of terminally sterilized healthcare products.
| DocumentType |
Guide
|
| ISBN |
978-1-57020-515-6
|
| Pages |
23
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| ISO 14971:2019 | Medical devices — Application of risk management to medical devices |
| ISO 14644-6:2007 | Cleanrooms and associated controlled environments — Part 6: Vocabulary |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| ISO 8573-1:2010 | Compressed air — Part 1: Contaminants and purity classes |
| ISO/TS 11139:2006 | Sterilization of health care products — Vocabulary |
| ISO 14644-7:2004 | Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) |
| ISO 14644-3:2019 | Cleanrooms and associated controlled environments — Part 3: Test methods |
| ISO 14644-4:2022 | Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up |
| ISO 11737-1:2018 | Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products |
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