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  3. AAMI/ISO 10993-10:2010/(R)2014 PDF

AAMI/ISO 10993-10:2010/(R)2014 PDF

AAMI/ISO 10993-10:2010/(R)2014 PDF

Name:
AAMI/ISO 10993-10:2010/(R)2014 PDF

Published Date:
09/04/2010

Status:
Active

Description:

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

Publisher:
Association for the Advancement of Medical Instrumentation/International Org. for Standardization

Document status:
Active
Format:
Electronic (PDF)
Delivery time:
10 minutes
Delivery time (for Russian version):
200 business days
SKU:
Choose Document Language:
$82.5
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Describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. Includes: a) pretest considerations for irritation, including in silico and in vitro methods for dermal exposure; b) details of in vivo (irritation and sensitization) test procedures, and; c) key factors for the interpretation of the results. Instructions are given in Annex A for the preparation of materials specifically in relation to the above tests. In Annex B several special irritation tests are described for application of medical devices in areas other than skin.
ANSI : ANSI Approved
File Size : 1 file , 510 KB
ISBN(s) : 1570203954
Note : This product is unavailable in Ukraine, Russia, Belarus
Number of Pages : 88
Published : 09/04/2010
Same As : AAMI/ISO 10993-10:2010/(R)2014

History

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