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SSH EN ISO 10993-6:2009

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

Nov 24, 2009
95.99 Withdrawal of Standard   Oct 23, 2017

General information

95.99     Oct 23, 2017

DPS

DPS/KT 206

European Norm

11.100.20  

English  

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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 directives

Directives related to this standards.

93/42/EEC

Medical devices

Harmonized
90/385/EEC

Active implantable medical devices

Harmonized
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

NOW

WITHDRAWN
SSH EN ISO 10993-6:2009
95.99 Withdrawal of Standard
Oct 23, 2017

REVISED BY

WITHDRAWN
SSH EN 30993-6:2000

PUBLISHED
SSH EN ISO 10993-6:2016

Related project

Adopted from EN ISO 10993-6:2009