ISO 10993-18:2020 ✓ Most Recent

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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

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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. See more

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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

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  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

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Product Details

Edition:

2nd

Published:

01/01/2020

Number of Pages:

74

File Size:

1 file

Same As:

DIN EN ISO 10993-18

Note:

This product is restricted and cannot be purchased in the following countries Ukraine, Russia, Belarus