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ISO 10993-18:2020

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process

standard by International Organization for Standardization , 01/01/2020

📝 Amendments Available

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Full Description

ISO 10993-18:2018 specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to the chemical characterization.
 

Product Details

Edition:
2nd
Published:
01/01/2020
Number of Pages:
74
File Size:
1 file , 4.2 MB
Same As:
DIN EN ISO 10993-18
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. ISO 10993-18:2020

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    Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process

    • Most Recent

  2. ISO 10993-18:2005


    Biological evaluation of medical devices - Part 18: Chemical characterization of materials

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. ISO 10993-18:2020/Amd1:2022


    - Amendment 1: Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor