NEUROSURGICAL IMPLANTS - SELF-CLOSING INTRACRANIAL ANEURYSM CLIPS

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2009

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

1 Scope
2 Normative references
3 Terms and definitions
4 Description of aneurysm clips
5 Indication of dimensions
6 Materials
7 Determination of magnetic properties
8 Closing force
9 Marking of clips
10 Sterilization
11 Packaging
12 Labelling and accompanying documentation
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC
National Annex NA (informative) - Bibliography

Explains 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.

DocumentType	Standard
Pages	17
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Current

Standards	Relationship
NEN EN ISO 9713 : 2010	Identical
I.S. EN ISO 9713:2009	Identical
UNI EN ISO 9713 : 2009	Identical
NBN EN ISO 9713 : 2009	Identical
NF EN ISO 9713 : 2009	Identical
NS EN ISO 9713 : 2009	Identical
ISO 9713:2002	Identical
SN EN ISO 9713 : 2009	Identical
EN ISO 9713:2009	Identical
BS EN ISO 9713:2009	Identical
UNE-EN ISO 9713:2009	Identical

ISO 5832-6:1997	Implants for surgery Metallic materials Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy
ISO 5832-5:2005	Implants for surgery Metallic materials Part 5: Wrought cobalt-chromium-tungsten-nickel alloy
ISO 5832-3:2016	Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
ISO 5832-8:1997	Implants for surgery Metallic materials Part 8: Wrought cobalt-nickel-chromium-molybdenum- tungsten-iron alloy
ISO 14630:2012	Non-active surgical implants General requirements
ISO 16061:2015	Instrumentation for use in association with non-active surgical implants General requirements
ISO 5832-2:1999	Implants for surgery Metallic materials Part 2: Unalloyed titanium
ISO 5832-7:2016	Implants for surgery — Metallic materials — Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
ISO 15223:2000	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied

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DIN EN ISO 9713 E : 2009

NEUROSURGICAL IMPLANTS - SELF-CLOSING INTRACRANIAL ANEURYSM CLIPS

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory