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SSH EN ISO 10993-1:2009

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

Sep 26, 2012
95.99 Withdrawal of Standard   Sep 16, 2021

General information

95.99     Sep 16, 2021

DPS

DPS/KT 316

European Norm

11.100.20  

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SSH EN ISO 10993-1:2009 :: EN

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Scope

ISO 10993-1:2009 describes:
the general principles governing the biological evaluation of medical devices within a risk management process;
the general categorization of devices based on the nature and duration of their contact with the body;
the evaluation of existing relevant data from all sources;
the identification of gaps in the available data set on the basis of a risk analysis;
the identification of additional data sets necessary to analyse the biological safety of the medical device;
the assessment of the biological safety of the medical device.

Related directives

Directives related to this standards.

90/385/EEC

Active implantable medical devices

Harmonized
93/42/EEC

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WITHDRAWN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 10993-1:2009
95.99 Withdrawal of Standard
Sep 16, 2021

REVISED BY

WITHDRAWN
SSH EN ISO 10993-1:2003

PUBLISHED
SSH EN ISO 10993-1:2020

Related project

Adopted from EN ISO 10993-1:2009