ANSI/AAMI ISO 17665-1:2006(R2013)
Current
The latest, up-to-date edition.
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
English
02-12-2013
Glossary of equivalent standards
Committee representation
Background of AAMI Adoption of ISO 17665-1:2006
Foreword
Introduction
1 Scope
1.1 Inclusions
1.2 Exclusions
2 Normative references
3 Terms and definitions
4 Quality management system elements
4.1 Documentation
4.2 Management responsibility
4.3 Product realization
4.4 Measurement, analysis and improvement - Control
of non-conforming product
5 Sterilizing agent characterization
5.1 Sterilizing agent
5.2 Microbicidal effectiveness
5.3 Materials effects
5.4 Environmental consideration
6 Process and equipment characterization
6.1 Process
6.1.1 General
6.1.2 Saturated steam process
6.1.3 Contained product processes
6.2 Equipment
7 Product definition
8 Process definition
9 Validation
9.1 General
9.2 Installation qualification (IQ)
9.2.1 Equipment
9.2.2 Installation
9.2.3 Function
9.3 Operational qualification (OQ)
9.4 Performance qualification (PQ)
9.5 Review and approval of validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
12.1 Demonstration of continued effectiveness
12.2 Recalibration
12.3 Maintenance of equipment
12.4 Requalification
Annex A (informative) - Guidance
Annex B (informative) - Process definition based on
inactivation of the microbial
population in its natural state
(bioburden-based method)
Annex C (informative) - Process definition based on the
inactivation of a reference
microorganism and a knowledge of
bioburden on product items to be
sterilized (combined bioburden/biological
indicator based method
Annex D (informative) - Conservative process definition
based on inactivation of reference
microorganisms (overkill method)
Annex E (informative) - Operating cycles
Bibliography
Describes requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.
| Committee |
WG 03
|
| DevelopmentNote |
Supersedes AAMI ISO 11134 (05/2006)
|
| DocumentType |
Standard
|
| ISBN |
1570202737
|
| Pages |
57
|
| ProductNote |
Reconfirmed 2013
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 17665-1:2006 | Identical |
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