DS/EN ISO 10993-7:2008

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 123.71
Legislation:

Legislation

Harmonized under:
  • Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices

  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Harmonized standards:
Links

Scope

This part of ISO 10993 specifies 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. Additional background, including guidance and a flowchart showing how this document is applied, are also included in the informative annexes.
EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by this part of ISO 10993.
NOTE – This part of ISO 10993 does not specify limits for ethylene glycol (EG).


Number of pages: 102

Published: 2009-02-12

Date of approval: 2008-12-15

International relationships : EN ISO 10993-7:2008 IDT ISO 10993-7:2008 IDT

ICS: 11.100.20 - Biological evaluation of medical devices

Item number: 56689


Committees

Committee

  • CEN/TC 206
  • ISO/TC 194/WG 11

Danish committee

DS/S-258