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Standard

NS-EN ISO 10993-18:2020

Publisert
Forhåndsvisning

Rettelser og tillegg kjøpes separat.

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Omfang

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.

Dokumentinformasjon

  • Standard fra SN
  • Publisert:
  • Utgave: 2020-05
  • Versjon: 1
  • Varetype: NAT
  • Products.Specs.pages
  • ICS 11.100.20
  • National Committee SN/K 115

Referanser i lov

EU lov:
Lov referanseRestriksjoner
93/42/EEC
90/385/EEC
2017/745
2007/47/EC

Produktrelasjon

Produkt livssyklus