ANSI/AAMI/ ISO 11137-2:2013(R2019)
Current
The latest, up-to-date edition.
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
Hardcopy , PDF
English
01-05-2019
Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 11137-2:2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
4 Definition and maintenance of product families
for dose setting, dose substantiation and
sterilization dose auditing
5 Selection and testing of product for establishing
the sterilization dose
6 Methods of dose establishment
7 Method 1: dose setting using bioburden information
8 Method 2: Dose setting using fraction positive
information from incremental dosing to determine
an extrapolation factor
9 Method VD[max] - Substantiation of 25 kGy or 15 kGy
as the sterilization dose
10 Sterilization dose audit
11 Worked examples
Bibliography
This document describes methods that can be used to determine the minimum dose necessary to achieve the specified requirement for sterility, including methods to substantiate 25 kGy as the sterilization dose.
| Committee |
WG 02
|
| DevelopmentNote |
Supersedes AAMI ISO 11137, AAMI TIR27 and AAMI ISO TIR 13409 (03/2006)
|
| DocumentType |
Standard
|
| ISBN |
1-57020-502-7
|
| Pages |
92
|
| ProductNote |
THIS STANDARD ALSO REFERS TO :- NHB 5340.1A
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 11137-2:2013 | Identical |
| AAMI CR513:2024 | Guidance on radiation sterilization validation and routine control of single-use systems used for pharmaceutical and biopharmaceutical manufacturing |
| ISO 11137-1:2006 | Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 11737-2:2009 | Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| 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 |
| AAMI TIR27 : 1ED 2001 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - SUBSTANTIATION OF 25 KGY AS A STERILIZATION DOSE - METHOD VD MAX |
| AAMI ST32 : 1991 | GUIDELINE FOR GAMMA RADIATION STERILIZATION |
| ISO/TS 11139:2006 | Sterilization of health care products — Vocabulary |
| ISO 11137-3:2017 | Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO 11137:1995 | Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization |
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