UNI EN ISO 10993-7 : 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
05-04-2022
01-01-2009
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
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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