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
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).
Legislation related to this standard
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
WITHDRAWN
EN ISO 9713:2004
WITHDRAWN
EN ISO 9713:2009
99.60
Withdrawal effective
Jan 26, 2022
PUBLISHED
EN ISO 9713:2022