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EN ISO 7197:2006

Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006) EN ISO 7197:2006

Publication date:   Dec 27, 2006

General information

99.60 Withdrawal effective   May 13, 2009

CEN

CEN/TC 285 Non-active surgical implants

European Norm

11.040.40   Implants for surgery, prosthetics and orthotics

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Scope

This International Standard specifies requirements for sterile, single-use hydrocephalus shunts and components. This International Standard is applicable to, but is not limited to: a) complete sterile, single-use hydrocephalus shunts of the one-piece type; or b) complete sterile, single-use hydrocephalus shunts of the multipiece type, supplied either assembled by the manufacturer or in kit form for assembly by the physician; or c) sterile, single-use shunt components which (individually or in combination) compromise shunt assemblies, for example: valves, valved catheters...

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Legislation 93/42/EEC

Life cycle

NOW

WITHDRAWN
EN ISO 7197:2006
99.60 Withdrawal effective
May 13, 2009

CORRIGENDA / AMENDMENTS

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EN ISO 7197:2006/AC:2008

REVISED BY

WITHDRAWN
EN ISO 7197:2009