DANSK DS/ISO/TR 15499 PDF

DANSK DS/ISO/TR 15499 PDF

Name:
DANSK DS/ISO/TR 15499 PDF

Published Date:
12/20/2016

Status:
[ Withdrawn ]

Description:

Biological evaluation of medical devices – Guidance on the conduct of biological evaluation within a risk management process

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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$19.8
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ISO/TR 15499:2016 is applicable to the conduct of biological evaluation of medical devices according to the requirements of ISO 10993‑1. It does not add to, or otherwise change, the requirements of ISO 10993‑1. This document does not include requirements to be used as the basis of regulatory inspection or certification assessment activities. This guidance is applicable to all biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices.


Edition : 16
File Size : 1 file , 1.2 MB
Number of Pages : 24
Product Code(s) : DS-021, DS-021
Published : 12/20/2016

History

DANSK DS/ISO/TR 15499
Published Date: 12/20/2016
Biological evaluation of medical devices – Guidance on the conduct of biological evaluation within a risk management process
$19.8
DANSK DS/ISO/TR 15499
Published Date: 09/07/2012
Biological evaluation of medical devices – Guidance on the conduct of biological evaluation within a risk management process
$21.3

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