AAMI TIR52:2014(R2022)
Current
Current
The latest, up-to-date edition.
Environmental monitoring for terminally sterilized healthcare products
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
31-10-2022
Important note : Users cannot be edited or removed once added to your Multi user PDF.This technical report addresses routine monitoring for viable (i.e. microorganisms) and non-viable particulates in controlled environments used to produce healthcare products that are intended to be terminally sterilized.
| DocumentType |
Standard
|
| ISBN |
978-1-57020-515-6
|
| Pages |
23
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| 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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