EN ISO 9713:2009

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

Publication date:   Aug 20, 2010

General information

99.60 Withdrawal effective   Jan 26, 2022

CEN

CEN/TC 285 Non-active surgical implants

European Norm

11.040.40   Implants for surgery, prosthetics and orthotics

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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 legislation

Legislation related to this standard

93/42/EEC

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WITHDRAWN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 9713:2004

NOW

WITHDRAWN
EN ISO 9713:2009
99.60 Withdrawal effective
Jan 26, 2022

REVISED BY

PUBLISHED
EN ISO 9713:2022

Relations

Adopted from ISO 9713:2002 IDENTICAL