AAMI TIR39:2009(R2017)
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
GUIDANCE ON SELECTING A MICROBIAL CHALLENGE AND INOCULATION SITES FOR STERILIZATION VALIDATION OF MEDICAL DEVICES
Hardcopy , PDF
English
19-10-2017
27-04-2023
Glossary of equivalent standards
Committee representation
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Microbial challenge types and
criteria for selection
5 Selection of product, inoculation
site, and process for inoculation
6 Testing and assessment of
inoculated product
7 Considerations for the use of
liquid inoculum
Bibliography
Gives guidance for selecting the appropriate type of microbial challenge to use in a sterilization validation process, the selection of appropriate inoculation sites, and the methods for inoculation and recovery of inoculated microorganisms from these sites.
| DocumentType |
Technical Report
|
| Pages |
21
|
| ProductNote |
Reconfirmed 2017
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| AAMI ISO TIR 11139 : 2006 | STERILIZATION OF HEALTH CARE PRODUCTS - VOCABULARY |
| ANSI/AAMI ST55:2016 | TABLE-TOP STEAM STERILIZERS |
| AAMI ISO 14161 : 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE, AND INTERPRETATION OF RESULTS |
| ANSI/AAMI/ISO 11138-1:2017 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
| ISO 10012:2003 | Measurement management systems — Requirements for measurement processes and measuring equipment |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| AAMI/ISO 13485:2016 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES |
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