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BSI - BS EN ISO 10993-18

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

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Organization: BSI
Publication Date: 30 June 2020
Status: inactive
Page Count: 83
ICS Code (Biological evaluation of medical devices): 11.100.20

Document History

BS EN ISO 10993-18 + A1
June 30, 2020
Biological evaluation of medical devices Part 18: Chemical characterization of medical device materials within a risk management process
A description is not available for this item.
BS EN ISO 10993-18
June 30, 2020
Biological evaluation of medical devices Part 18: Chemical characterization of medical device materials within a risk management process
A description is not available for this item.
BS EN ISO 10993-18
June 30, 2020
Biological evaluation of medical devices Part 18: Chemical characterization of medical device materials within a risk management process
A description is not available for this item.
BS EN ISO 10993-18
June 30, 2009
Biological evaluation of medical devices Part 18: Chemical characterization of materials
A description is not available for this item.
BS EN ISO 10993-18
November 17, 2005
Biological evaluation of medical devices Part 18: Chemical characterization of materials
A description is not available for this item.

References

This document references:
BS EN ISO 10993-1 - Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
Published by BSI on December 31, 2020
A description is not available for this item.
This document references:
EN 455-3 - Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
Published by CEN on November 1, 2023
This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labelling and the disclosure of information relevant to...
This document references:
ISO TS 10993-19 - Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
Published by ISO on March 1, 2020
This document provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physical, i.e. physico‑chemical, morphological and topographical...
This document references:
ISO TS 21726 - Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
Published by ISO on February 1, 2019
This document describes the basis for, selection of, and general applicability of a threshold of toxicological concern (TTC) value for a constituent present in/on a medical device or released from a...
This document references:
BS EN ISO 10993-15 - Biological evaluation of medical devices Part 15: Identification and quantification of degradation products from metals and alloys
Published by BSI on May 31, 2023
A description is not available for this item.
This document references:
BS EN ISO 10993-1 - Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
Published by BSI on December 31, 2020
A description is not available for this item.
This document is referenced by:
BS EN ISO 10993-12 - Biological evaluation of medical devices Part 12: Sample preparation and reference materials
Published by BSI on October 31, 2012
A description is not available for this item.
This document is referenced by:
BS EN ISO 7405 - Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
Published by BSI on November 30, 2018
A description is not available for this item.
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