Standard

NS-EN ISO 10993-6:2026

Publisert
Forhåndsvisning

Rettelser og tillegg kjøpes separat.

Språk
Tjenester

Omfang

This document specifies requirements for implantation test methods for preclinical assessment of the local effects after implantation of materials intended for use in medical devices. In order to evaluate local tissue responses from medical devices that are intended to be used where skin or mucosal tissue is breached, this document is applicable when required.This document applies to medical device/materials that require implantation evaluation and can be solid or non-solid (such as porous materials, liquids, gels, pastes, powders, and particulates), absorbable/degradable or non- absorbable, or can be tissue-engineered medical products (TEMPs).These implantation tests are not intended to evaluate or determine the performance of the test sample in terms of mechanical loading or functional performance. This document also does not provide guidance on methods and study design to satisfy requirements for systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the study designs can be modified to also assess other biocompatibility effects.

Dokumentinformasjon

  • Standard fra SN
  • Publisert:
  • Utgave: 2026-05
  • Versjon: 1
  • Varetype: NAT
  • ICS 11.100.20
  • National Committee SN/K 115

Produktrelasjon

Produkt livssyklus