ANSI/AAMI/ISO 11138-1:2017
Superseded
View Superseded by
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
English
08-01-2017
04-20-2024
Glossary of equivalent standards
Committee representation
Background of AAMI adoption of
ISO 11138-1:2017
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General manufacturing requirements
5 Specific manufacturing requirements
6 Determination of population and resistance
7 Culture conditions
Annex A (normative) - Determination of viable
count
Annex B (normative) - Determination of growth
inhibition by carriers and primary
packaging materials exposed to
sterilization processes
Annex C (normative) - D value determination
by survivor curve method
Annex D (normative) - D value determination
by fraction negative method
Annex E (normative) - Survival-kill response
characteristics
Annex F (informative) - Relationship between
components of biological indicators
Bibliography
Describes general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.
| DevelopmentNote |
Supersedes AAMI ST59. (05/2006)
|
| DocumentType |
Standard
|
| ISBN |
978-1-57020-678-8
|
| Pages |
53
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 11138-1:2017 | Identical |
A newer version of this standard is available.
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