EN ISO 10993-7 : 2008 COR 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
Bibliography
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

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.