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NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2009

Publisher

National Standards Authority of Ireland

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For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for shunts
5 Specific requirements for components
6 Marking and labeling for shunts
7 Packaging
8 Information supplied by the manufacturer
Annex ZA (informative) Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC
Bibliography

Describes safety and performance requirements for sterile, single-use non-active hydrocephalus shunts and components. This includes the components used in shunts, like valves, tubes and reservoirs.

DocumentType	Standard
Pages	20
PublisherName	National Standards Authority of Ireland
Status	Current
Supersedes	I.S. EN ISO 7197:2006

Standards	Relationship
ISO 7197:2006	Identical
EN ISO 7197:2009	Identical

ISO 14155-2:2003	Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
ISO 11135:2014	Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
ASTM F 2503 : 2013 : REDLINE	Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
ISO 14155-1:2003	Clinical investigation of medical devices for human subjects Part 1: General requirements
ISO 14630:2012	Non-active surgical implants General requirements
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 11134:1994	Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 11137:1995	Sterilization of health care products Requirements for validation and routine control Radiation sterilization
ASTM F 640 : 2012 : REDLINE	Standard Test Methods for Determining Radiopacity for Medical Use

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I.S. EN ISO 7197:2009

NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory