Specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices and procedures for the measurement of EO and ECH. Does not apply for EO-sterilized devices that have no patient contact such as in vitro diagnostic devices.
Status: WithdrawnPublication date: 1995-10
Edition: 1Number of pages: 40
Technical Committee: ISO/TC 194 Biological and clinical evaluation of medical devices
- ICS :
- 11.100.20 Biological evaluation of medical devices
ISO 10993-7:1995Stage: 95.99
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