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EN ISO 10993-18:2020 Standard

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  Keywords:

#chemical #identification #material #document #biological

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)

  Purpose

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.

  Publication

Wednesday 14th of April 2021

  Related Standards

EN ISO 10993-5:2009

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

EN ISO 13408-2:2018

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Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)

EN ISO 15747:2011

Medical devices Directive (93/42/EEC)

Plastic containers for intravenous injections (ISO 15747:2010)

EN ISO 15223-1:2016

Medical devices Directive (93/42/EEC)

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requir...

EN ISO 15001:2011

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)

EN ISO 14630:2009

Medical devices Directive (93/42/EEC)

Non-active surgical implants - General requirements (ISO 14630:2008)

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