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AAMI ISO 10993-7:2008(R2012)

Current
Current

The latest, up-to-date edition.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-06-2012

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
WG 11
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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