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SNV - SN EN ISO 10993-18

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

active, Most Current
Organization: SNV
Publication Date: 1 November 2020
Status: active
Page Count: 85
ICS Code (Biological evaluation of medical devices): 11.100.20
scope:

This document 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 which can include one or more of the following: ? the identification of its materials of construction (medical device configuration); ? the characterization of the materials of construction via the identification and quantification of their chemical constituents (material composition); ? the characterization of the medical device for chemical substances that were introduced during manufacturing (e.g. mould release agents, process contaminants, sterilization residues); ? the estimation (using laboratory extraction conditions) of the potential of the medical device, or its materials of construction, to release chemical substances under clinical use conditions (extractables); ? the measurement of chemical substances released from a medical device under its clinical conditions of use (leachables). This document can also be used for chemical characterization (e.g. the identification and/or quantification) of degradation products. Information on other aspects of degradation assessment are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15. The ISO 10993 series is applicable when the material or medical device has direct or indirect body contact (see ISO 10993-1 for categorization by nature of body contact). This document is intended for suppliers of materials and manufacturers of medical devices, to support a biological evaluation.

Document History

SN EN ISO 10993-18
November 1, 2020
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process
This document 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...
August 1, 2009
Biological evaluation of medical devices - Part 18: Chemical characterization of materials
A description is not available for this item.
September 1, 2005
Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
A description is not available for this item.

References

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