NS EN ISO 10993-7 : 2008 AC 2009

Introduction
1 Scope
2 Normative references
3 Definitions
4 Requirements
4.1 General
4.2 Categorization of devices
4.3 Allowable limits
4.3.1 Permanent contact devices
4.3.2 Prolonged exposure devices
4.3.3 Limited exposure devices
4.3.4 Special situations
4.4 Determination of EO and ECH residuals
4.4.1 Safety considerations
4.4.2 Determination of residue
4.4.3 Product sampling
4.4.4 Sample/fluid ratios
4.4.5 Extraction time and conditions
4.4.6 Product extraction
4.4.7 Data analysis and interpretation
5 Product release
5.1 Release of products without dissipation curve
        data
5.2 Procedure for product release using residue
        dissipation curves
Annexes
A Evaluation of gas chromatograms
B Gas chromatographic determination for EO and ECH
C Factors influencing product residuals
D Extraction conditions for determination of
        residual EO
E Rationale
F Bibliography
ZA Normative references to international publications
        with their relevant European publications

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