Standard Svensk standard · SS-EN ISO 7197:2009

Neurokirurgiska implantat - Sterila hydrocefalus shuntar och tillbehör för engångsbruk (ISO 7197:2006, inklusive Cor 1:2007)

Status: Gällande

Omfattning
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.

Ämnesområden

Kirurgiska implantat, proteser och ortoser (11.040.40)


Produktinformation

Språk: Engelska

Framtagen av: Implantat, SIS/TK 340/AG 03

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

Artikelnummer: STD-69807

Utgåva: 2

Fastställd: 2009-05-25

Antal sidor: 24

Ersätter: SS-EN ISO 7197:2006/AC:2008 , SS-EN ISO 7197:2006