I.S. EN ISO 10993-7:2008
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Hardcopy , PDF
10-07-2020
English
01-01-2008
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
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
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
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
Bibliography
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