AAMI ISO 10993-7:2008(R2012)
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
Hardcopy , PDF
English
06-01-2012
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Glossary of equivalent standards
Committee Representation
Background of ANSI/AAMI adoption of ISO 10993-7:2008
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 General
4.2 Categorization of devices
4.3 Allowable limits
4.4 Determination of EO and ECH residuals
5 Product release
5.1 General
5.2 Release of products without dissipation curve data
5.3 Procedure for product release using residue dissipation
curves
Annex A (normative) Evaluation of gas chromatograms
Annex B (informative) Gas chromatographic determination
for EO and ECH
Annex C (informative) Flowchart and guidance for the application
of this part of ISO series of standards to the
determination of EO and ECH residuals in medical devices
Annex D (informative) Factors influencing product residual
Annex E (informative) Extraction conditions for
determination of residual EO
Annex F (informative) Rationale for the provisions of this
part of ISO 10993
Annex G (informative) Establishment of allowable limits for
EO
Annex H (informative) Establishment of allowable limits for
ECH
Annex I (informative) Establishment of allowable limits for
EG
Annex J (informative) Preparation of EO and ECH standards
Annex K (informative) Ethylene oxide residue measuring
methods
Bibliography
Provides allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released.
| Committee |
ISO/TC 194
|
| DevelopmentNote |
Supersedes AAMI ST29 and AAMI ST30 (07/2002) Supersedes AAMI TIR 19. (01/2009)
|
| DocumentType |
Standard
|
| ISBN |
1570203326
|
| Pages |
114
|
| ProductNote |
Reconfirmed 2012
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 10993-7:2008 | Identical |
| ISO 10993-3:2014 | Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| AAMI ST30 : 1989 | DETERMINING RESIDUAL ETHYLENE CHLOROHYDRIN AND ETHYLENE GLYCOL IN MEDICAL DEVICES |
| AAMI ST29 : 1988 | DETERMINING RESIDUAL ETHYLENE OXIDE IN MEDICAL DEVICES |
| ISO 11135-1:2007 | Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 10993-10:2010 | Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization |
| ISO 10993-12:2012 | Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
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