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
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
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