I.S. EN ISO 10993-7:2008&AC:2009&A1:2022
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The latest, up-to-date edition.
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants
Hardcopy , PDF
English
30-01-2022
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Product release
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
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