AAMI ISO 20857 : 2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
08-31-2021
English
01-01-2015
Glossary of equivalent standards
Committee representation
Background of US adoption of ISO 20857:2010
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system elements
5 Sterilizing agent characterization
6 Process and equipment characterization
7 Product definition
8 Process definition
9 Validation
10 Routine monitoring and control
11 Product release from sterilization/depyrogenation
12 Maintaining process effectiveness
Annex A (informative) - Guidance on the application of this
International Standard
Annex B (informative) - Process definition based on inactivation
of the microbial population in its natural state
(bioburden-based approach)
Annex C (informative) - Process definition based on the
inactivation of reference microorganisms and knowledge
of bioburden (combined bioburden/biological indicator
approach)
Annex D (informative) - Conservative process definition
based on inactivation of reference microorganisms
(overkill method)
Annex E (informative) - Process development
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.