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SRPS EN ISO 9713:2011

Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)

Sep 30, 2011
95.99   Withdrawal of Standard   Jun 30, 2022

General information

95.99     Jun 30, 2022

ISS

Z076

European Norm

11.040.40  

English  

From plan 2011

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Scope

ISO 9713:2002 describes characteristics of self-closing aneurysm clips intended for permanent intracranial implantation and specifies requirements for marking, packaging, sterilization and for labelling and accompanying documentation. In addition it gives a method for the measurement of closing force.
ISO 9713:2002 is not applicable to malleable clips, or clips intended to be used during the course of surgery and removed before wound closure (temporary clips).

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

93/42/EEC

Medical devices

Harmonized
Directive 93/42/EEC
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

Directive 2007/47/EC

Life cycle

NOW

WITHDRAWN
SRPS EN ISO 9713:2011
95.99 Withdrawal of Standard
Jun 30, 2022

REVISED BY

PUBLISHED
SRPS EN ISO 9713:2022

Related project

Adopted from EN ISO 9713:2009

Adopted from ISO 9713:2002 IDENTICAL