ISO 10993-6:2007

Biological evaluation of medical devices — Part 6: Tests for local effects after implantation

Publication date:   Apr 4, 2007

95.99 Withdrawal of Standard   Nov 28, 2016

General information

95.99 Withdrawal of Standard   Nov 28, 2016

ISO

ISO/TC 194 Biological and clinical evaluation of medical devices

International Standard

11.100.20   Biological evaluation of medical devices

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Scope

ISO 10993-6:2007 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices.
ISO 10993-6:2007 applies to materials that are:
solid and non-biodegradable;degradable and/or resorbable;non-solid, such as porous materials, liquids, pastes and particulates.
ISO 10993-6:2007 may also be applied to medical devices that are intended to be used topically in clinical indications where the surface or lining may have been breached, in order to evaluate local tissue responses.
This part of ISO 10993 does not deal with systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the long-term implantation studies intended for evaluation of local biological effects may provide insight into some of these properties. Systemic toxicity studies conducted by implantation may satisfy the requirements of ISO 10993-6:2007.

Life cycle

PREVIOUSLY

Revises
ISO 10993-6:1994

NOW

WITHDRAWN
ISO 10993-6:2007
95.99 Withdrawal of Standard
Nov 28, 2016

REVISED BY

PUBLISHED
ISO 10993-6:2016