EN ISO 10993-7 : 2008 COR 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS (ISO 10993-7:2008/COR 1:2009)
21-01-2022
15-11-2009
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
10993 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
Annex ZA (informative) - Relationship between this International
Standard and the Essential Requirements
of EU Directive 93/42/EEC Medical
devices
Annex ZB (informative) - Relationship between this International
Standard and the Essential Requirements
of EU Directive 90/385/EEC on Active
Implantable Medical Devices
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