ANSI/AAMI/ISO 20857:2010(R2015)
Current
The latest, up-to-date edition.
STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
Hardcopy , PDF
English
12-11-2015
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
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