ANSI/AAMI ST67:2019
Current
The latest, up-to-date edition.
Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”
English
29-07-2019
This standard specifies requirements and provides guidance on selecting approaches to establish assurance of sterility for a health care product labelled as “sterile.”
| DocumentType |
Standard
|
| ISBN |
978-1-57020-727-3
|
| Pages |
41
|
| ProductNote |
THIS STANDARD ALSO REFERS TO Code of Federal Regulations, Title 21, Part 211.167,Code of Federal Regulations, Title 21, Part 210/211,Code of Federal Regulations, Title 21, Part 820,Code of Federal Regulations, Title 21, Part 1271
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| AAMI CR513:2024 | Guidance on radiation sterilization validation and routine control of single-use systems used for pharmaceutical and biopharmaceutical manufacturing |
| AAMI TIR16:2023 | Microbiological aspects of ethylene oxide sterilization |
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