Standard Swedish standard · SS-EN ISO 7197:2009

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

Status: Valid

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Standard Swedish standard · SS-EN ISO 7197:2009

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

Subjects

Implants for surgery, prosthetics and orthotics (11.040.40)


Buy this standard

Standard Swedish standard · SS-EN ISO 7197:2009

Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007)
Subscribe on standards - Read more Dölj
Price: 875 SEK
standard ikon pdf

PDF

Price: 875 SEK
standard ikon

Paper

Price: 1 400 SEK
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PDF + paper

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Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-69807

Edition: 2

Approved: 5/25/2009

No of pages: 24

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