Biological Evaluation Of Medical Devices Part 10

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Biological evaluation of medical devices — Part 10: Tests …

https://www.iso.org/standard/75279.html

Biological evaluation of medical devices — Part 10: Tests for skin sensitization This document specifies the procedure for the assessment of medical devices and their …

ISO - ISO 10993-10:2010 - Biological evaluation of …

https://www.iso.org/standard/40884.html

ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation …

ISO 10993-10:2021 - Biological evaluation of medical devices — …

https://standards.iteh.ai/catalog/standards/iso/c982269a-3558-43e0-b2ac-b5bcc1f412a3/iso-10993-10-2021

This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological …

ISO - ISO 10993-1:2018 - Biological evaluation of …

https://www.iso.org/standard/68936.html

This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of …

ISO - ISO 10993-12:2021 - Biological evaluation of …

https://www.iso.org/standard/75769.html

Specifically, this document addresses the following: — test sample selection; — selection of representative portions from a medical device; — test sample preparation; — …

ISO - 10993-10 - Biological evaluation of medical devices …

https://standards.globalspec.com/std/14480908/10993-10

August 1, 2010 Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization This part of ISO 10993 describes the procedure for the …

ISO - ISO 10993-10:2002 - Biological evaluation of …

https://www.iso.org/standard/33364.html

Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity Abstract This part of ISO 10993 describes the procedure for the …

Use of ISO 10993-1, Biological evaluation of medical …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and

The purpose of this guidance is to provide further clarification and updated information on the use of International Standard ISO 10993-1, "Biological evaluation of medical …

Recognized Consensus Standards - Food and Drug …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/results.cfm?start_search=1&productcode=&category=Biocomp&type=&title=&organization=&referencenumber=®ulationnumber=&effectivedatefrom=&effectivedateto=&sortcolumn=rn

Biological evaluation of medical devices - Part 10: Tests for skin sensitization: 07/06/2020: Biocompatibility: 2-276: ISO: 10993-18 Second edition 2020-01: Biological …

Recognized Consensus Standards - Food and Drug …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/results.cfm?start_search=26&sortcolumn=std&productcode=&category=Biocomp&type=&title=&organization=&referencenumber=®ulationnumber=&effectivedatefrom=&effectivedateto=

Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents: 12/19/2022: …

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Biological Evaluation Of Medical Devices Part 10