ISO 10993:2021
ISO 10993:2021 Biological evaluation of medical devices – Part 10: Tests for skin sensitization
CDN $312.00
Description
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.
This document includes:
-    details of in vivo skin sensitization test procedures;
-    key factors for the interpretation of the results.
NOTE      Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.
Edition
4
Published Date
2021-11-16
Status
PUBLISHED
Pages
48
Language
English
Format
Secure PDF
Secure – PDF details
- Save your file locally or view it via a web viewer
- Viewing permissions are restricted exclusively to the purchaser
- Device limits - 3
- Printing – Enabled only to print (1) copy
See more about our Environmental Commitment
Abstract
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.
This document includes:
-    details of in vivo skin sensitization test procedures;
-    key factors for the interpretation of the results.
NOTE      Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.
Previous Editions
Can’t find what you are looking for?
Please contact us at:
Related Documents
-
ISO 10993:2020 Biological evaluation of medical devices – Part 19: Physico-chemical, morphological and topographical characterization of materials
CDN $173.00 Add to cart -
ISO 22442:2020 Medical devices utilizing animal tissues and their derivatives – Part 2: Controls on sourcing, collection and handling
CDN $173.00 Add to cart -
ISO 10993:2023 Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents
CDN $351.00 Add to cart -
ISO 17593:2022 Clinical laboratory testing and in vitro medical devices – Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
CDN $351.00 Add to cart
