UNI EN ISO 10993-7 : 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

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.