AAMI TIR35 : 2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 - RADIATION STERILIZATION - PRODUCT ADOPTION AND ALTERNATIVE SAMPLING PLANS FOR VERIFICATION DOSE EXPERIMENTS AND STERILIZATION DOSE AUDITS
English
05-06-2016
01-10-2022
Glossary of equivalent standards
Committee representation
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Sample sizes for the verification dose
experiment and dose establishment or
dose audit
5 Evaluation and Methods for Product
Adoption
6 Maintenance of Product Families
Annex A (informative) - Sample sizes for
implementation of sampling plans
and sampling scheme
Annex B (informative) - Radiation product
adoption assessment flowchart
Bibliography
Specifies approaches to the selection and auditing of a sterilization dose that may reduce the number of product items required while maintaining assurance of attaining the desired sterility assurance level (SAL).
| DevelopmentNote |
Supersedes AAMI ST31 and AAMI ST32. (02/2007) Supersedes AAMI ISO TIR 15843. (09/2009)
|
| DocumentType |
Standard
|
| ISBN |
1-57020-618-X
|
| Pages |
36
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| S.R. CEN ISO/TS 16775:2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014) |
| CEN ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014) |
| PD CEN ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| ANSI/AAMI/ISO TIR16775:2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
| ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| AAMI TIR37 : 2013 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - GUIDANCE ON STERILIZATION OF BIOLOGICS AND TISSUE-BASED PRODUCTS |
| AAMI ISO 11137-2 : 2013 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
| AAMI ISO 11737-3 : 2004 | STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 3: GUIDANCE ON EVALUATION AND INTERPRETATION OF BIOBURDEN DATA |
| AAMI/ISO 13485:2016 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES |
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