ANSI/AAMI ST67:2019
Current
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”
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
07-29-2019
Important note : All end users must be registered with an Account prior to user licenses being assigned.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 TIR16:2023 | Microbiological aspects of ethylene oxide sterilization |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.