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DANSK DS/EN ISO 10993-7 PDF

DANSK DS/EN ISO 10993-7 PDF

Name:
DANSK DS/EN ISO 10993-7 PDF

Published Date:
12/15/2008

Status:
[ Active ]

Description:

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

Publisher:
Dansk Standard

Document status:
Active
Format:
Electronic (PDF)
Delivery time:
10 minutes
Delivery time (for Russian version):
200 business days
SKU:
Choose Document Language:
$38.7
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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).


Edition : 08#
File Size : 1 file , 2.9 MB
Number of Pages : 101
Product Code(s) : DS-ZZZ, DS-ZZZ
Published : 12/15/2008

History

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