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EVS-EN ISO 9713:2009

Neurosurgical implants - Self-closing intracranial aneurysm clips

General information

Withdrawn from 15.02.2022
Base Documents
ISO 9713:2002; EN ISO 9713:2009
ICS Groups
11.040.40 Implants for surgery, prosthetics and orthotics
Directives or regulations
93/42/EEC Medical devices (MDD)

Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 93/42/EEC and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union.
 
To view the latest lists of harmonised standards published in the Official Journal of the European Union, visit: http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/

Standard history

Status
Date
Type
Name
15.02.2022
Main
EVS-EN ISO 9713:2022
03.12.2009
Main
EVS-EN ISO 9713:2009
Main
EVS-EN ISO 9713:2004
This International Standard describes characteristics of self-closing aneurysm clips intended for permanentintracranial implantation and specifies requirements for their marking, packaging, sterilization and for labelling andaccompanying documentation. In addition it gives a method for the measurement of closing force.This International Standard is not applicable to malleable clips, or clips intended to be used during the course ofsurgery and removed before wound closure (temporary clips).

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Standard monitoring
English (PDF 177 KB)

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English