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
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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
Describes methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10[-6].
| 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 |
| 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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