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

SS-EN-ISO-7197 - 2009 EDITION - CURRENT
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This International Standard 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. This International Standard gives no recommendation concerning the superiority of a certain type of valve. For manufacturing, it 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 this International Standard 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. This International Standard does not apply to active implants for the treatment of hydrocephalus.

To find similar documents by classification:

11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)


Medical devices

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Designation Name

SS-EN ISO 7197:2009

Revision Level

2009 EDITION

Status

Current

Publication Date

May 25, 2009

Language(s)

English

Page Count

24

International Equivalent

EN ISO 7197:2009(IDT); ISO 7197:2006, including Cor 1:2007(IDT)