Name: EN ISO 7197:2009
Brand: CEN

Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007)

Published date

13-05-2009

Publisher

Comite Europeen de Normalisation

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
Bibliography
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements
of EU Directive 93/42/EEC

ISO 7197:2006 specifies 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.For manufacturing, ISO 7197:2006 defines the mechanical and technical requirements. This International Standard defines the technical information of the valve, to be given by the manufacturer. In respect to the different principles of the valve types, specific characteristics are defined for each group as declared by the manufacturer.The benefit of ISO 7197:2006 for the surgeon and the patient is to understand the information given by the manufacturer and to obtain standardized information about the performance of a well working product with new design characteristics. The benefit for the manufacturer is to define the important requirements for shunts as a basis for investigations during development as well as for quality control during manufacture.

Committee	CEN/TC 285
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Current

Standards	Relationship
ISO 7197:2006	Identical
NBN EN ISO 7197 : 2009	Identical
NEN EN ISO 7197 : 2009	Identical
NS EN ISO 7197 : 2009	Identical
I.S. EN ISO 7197:2009	Identical
PN EN ISO 7197 : 2009	Identical
SN EN ISO 7197 : 2009	Identical
UNI EN ISO 7197 : 2009	Identical
UNE-EN ISO 7197:2009	Identical
BS EN ISO 7197:2009	Identical
NF EN ISO 7197 : 2009	Identical
DIN EN ISO 7197:2009-08	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