DANSK DSF/FPREN ISO 10993-16 PDF

DANSK DSF/FPREN ISO 10993-16 PDF

Name:
DANSK DSF/FPREN ISO 10993-16 PDF

Published Date:

Status:
[ Draft-Obsolete ]

Description:

Biological evaluation of medical devices – Part 16: Toxicokinetic study design for degradation products and leachables (ISO/FDIS 10993-16:2016)

Publisher:
Dansk Standard

Document status:
Active

Format:
Electronic (PDF)

Delivery time:
10 minutes

Delivery time (for Russian version):
200 business days

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Choose Document Language:
$12
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DRAFT * SAME AS ISO FDIS 10993-16

This part of ISO 10993 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.


Edition : 16
File Size : 1 file , 660 KB
Number of Pages : 28
Product Code(s) : DSF-021, DSF-021

History


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