I.S. EN 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 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

Describes allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released.