AAMI ST67 : 2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Hardcopy , PDF
11-12-2017
English
01-01-2017
Glossary of equivalent standards
Committee representation
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Determination of an appropriate SAL for a health care
product to be labeled 'STERILE'
Annexes
Annex A (informative) - Background and historical application
of sterility assurance
Annex B (informative) - Examples of terminally sterilized
products and sterility assurance levels that have
historically been selected
Annex C (informative) - Guidance on Performing a Risk Analysis
for Selecting an SAL for a product that cannot be
sterilized to a 10[-6] SAL
Annex D (informative) - Bibliography
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.