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BSI BS EN ISO 10993-6:2026

Biological evaluation of medical devices -- Tests for local effects after implantation
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BSI BS EN ISO 10993-6:2026

Biological evaluation of medical devices -- Tests for local effects after implantation

PUBLISH DATE 2026
PAGES 56
BSI BS EN ISO 10993-6:2026
This document specifies requirements for implantation test methods for preclinical assessment of the local effects after implantation of medical devices or materials intended for use in medical devices. This document is applicable to the evaluation of local tissue responses from medical devices that are intended to be used where skin or mucosal tissue is breached, when required. This document is applicable to medical device or materials that require implantation evaluation and can be solid or non-solid (such as porous materials, liquids, gels, pastes, powders, and particulates), absorbable, degradable, 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 biological effects.
SDO BSI: British Standards Institution
Document Number ISO 10993-6
Publication Date May 20, 2026
Language en - English
Page Count 56
Revision Level
Supercedes
Committee CH/194
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