ANSI/AAMI/ISO 11138-1:2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
Hardcopy , PDF
04-20-2024
English
08-01-2017
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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Superseded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 |
| AAMI TIR16 : 2017 | MICROBIOLOGICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION |
| ANSI/AAMI ST58:2013(R2018) | CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION IN HEALTH CARE FACILITIES |
| AAMI TIR39:2009 | GUIDANCE ON SELECTING A MICROBIAL CHALLENGE AND INOCULATION SITES FOR STERILIZATION VALIDATION OF MEDICAL DEVICES |
| AAMI TIR39:2009(R2017) | GUIDANCE ON SELECTING A MICROBIAL CHALLENGE AND INOCULATION SITES FOR STERILIZATION VALIDATION OF MEDICAL DEVICES |
| AAMI ST41 : 2008 | ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS |
| AAMI ST77 : 2013 | CONTAINMENT DEVICES FOR REUSABLE MEDICAL DEVICE STERILIZATION |
| AAMI ST91 : 2015 | FLEXIBLE AND SEMI-RIGID ENDOSCOPE PROCESSING IN HEALTH CARE FACILITIES |
| AAMI TIR14 : 2016 | CONTRACT STERILIZATION USING ETHYLENE OXIDE |
| AAMI TIR16:2023 | Microbiological aspects of ethylene oxide sterilization |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 11737-1:2006 | Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 14937:2009 | 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 |
| ISO 11140-1:2014 | Sterilization of health care products Chemical indicators Part 1: General requirements |
| ISO 18472:2006 | Sterilization of health care products Biological and chemical indicators Test equipment |
| ISO 8601:2004 | Data elements and interchange formats Information interchange Representation of dates and times |
| ISO/TS 11139:2006 | Sterilization of health care products Vocabulary |
| ISO 14161:2009 | Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
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