0

EN ISO 9713:2022

Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2022) EN ISO 9713:2022

Publication date:   May 16, 2022

General information

60.60 Standard published   Jan 26, 2022

CEN

CEN/TC 285 Non-active surgical implants

European Norm

11.040.40   Implants for surgery, prosthetics and orthotics

Buying

Published

Language in which you want to receive the document.

Scope

This document establishes the characteristics of self-closing aneurysm clips intended for permanent intracranial implantation and specifies requirements for their marking, packaging, sterilization and for labelling and accompanying documentation. In addition, it gives a method for the measurement of closing force.
This document is not applicable to malleable clips, or clips intended to be used during the course of surgery and removed before wound closure (temporary clips).
NOTE       In this document when not otherwise established, the term “implant” refers to the self-closing intracranial aneurysm clips.

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 9713:2009

NOW

PUBLISHED
EN ISO 9713:2022
60.60 Standard published
Jan 26, 2022