Biological Evaluation Of Medical Devices Part 6

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Biological evaluation of medical devices — Part 6: Tests …

https://www.iso.org/standard/61089.html

Biological evaluation of medical devices — Part 6: Tests for local effects after implantation Abstract ISO 10993-6:2016 specifies test methods for the assessment of the …

ISO - ISO/WD 10993-6 - Biological evaluation of medical …

https://www.iso.org/standard/83976.html

Biological evaluation of medical devices — Part 6: Tests for local effects after implantation General information Status : Under development Edition : 1 Technical …

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 …

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 -- Part 6: Tests for local effects after implantation: 07/06/2020: Biocompatibility: 2-273: ISO: 10993-9 Third edition 2019-11 : …

Recognized Consensus Standards

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/results.cfm?start_search=1&sortcolumn=pdd&productcode=&category=&title=Biological%20evaluation%20of%20medical%20devices&ascapilotyn=off&organization=&referencenumber=®ulationnumber=&recognitionnumber=&effectivedatefrom=&effectivedateto=

Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation: 08/21/2017: Biocompatibility: 2-248: ANSI AAMI ISO: 10993-4: 2017: …

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

Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Guidance for Industry …

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 6: Tests for local effects after implantation: 07/26/2016: Biocompatibility: 2-170: ANSI AAMI ISO: 10993-14:2001/(R) …

Use of International Standard ISO 10993-1, …

https://www.fda.gov/media/85865/download

10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk 1 For the purposes of this document, the term “human body” …