EN ISO 10993-6:2009

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

Publication date:   Aug 20, 2010

General information

99.60 Withdrawal effective   Dec 14, 2016

CEN

CEN/TC 206 Biological and clinical evaluation of medical devices

European Norm

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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting
90/385/EEC

Active implantable medical devices

Harmonized/Supporting
2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 10993-6:2007

NOW

WITHDRAWN
EN ISO 10993-6:2009
99.60 Withdrawal effective
Dec 14, 2016

REVISED BY

PUBLISHED
EN ISO 10993-6:2016

Relations

Adopted from ISO 10993-6:2007 IDENTICAL