AAMI ISO 14937:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
Hardcopy , PDF
08-31-2021
English
01-01-2013
Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 14937:2009
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 def
9 Validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
Annex A (normative) - Factors to be considered in selection
of microorganisms for demonstrating
microbicidal effectiveness
Annex B (normative) - Approach 1 - Process definition based
on inactivation of the microbial
population in its natural state
Annex C (normative) - Approach 2 - Process definition based
on inactivation of reference
microorganisms and knowledge of bioburden
Annex D (normative) - Approach 3 - Conservative process
definition based on inactivation of
reference microorganisms
Annex E (informative) - Guidance on application of this
International Standard
Bibliography
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