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Normas DIN – AENOR
DIN EN ISO 7197:2009-08

DIN EN ISO 7197:2009-08

Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007); German version EN ISO 7197:2009 / Note: DIN EN ISO 7197 (2006-09) and DIN EN ISO 7197 Berichtigung 1 (2008-06) remain valid alongside this standard until 2010-03-21.

Implants neurochirurgicaux - Systèmes de dérivation et composants stériles, non réutilisables, pour hydrocéphalie (ISO 7197:2006, Cor 1:2007 inclus); Version allemande EN ISO 7197:2009 / Attention: DIN EN ISO 7197 (2006-09) et DIN EN ISO 7197 Berichtigung 1 (2008-06) restent valable avec la présente norme jusqu'à 2010-03-21.

Neurochirurgische Implantate - Sterile Hydrozephalus-Shunts zum Einmalgebrauch und deren Bestandteile (ISO 7197:2006, einschließlich Cor 1:2007); Deutsche Fassung EN ISO 7197:2009 / Achtung: Daneben gelten DIN EN ISO 7197 (2006-09) und DIN EN ISO 7197 Berichtigung 1 (2008-06) noch bis 2010-03-21.

Fecha:
2019-08 /Active
Equivalencias internacionales:

EN ISO 7197 (2009-05)

ISO 7197 Technical Corrigendum 1 (2007-07)

ISO 7197 (2006-06)

Relación con otras normas DIN:
Resumen:
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. It gives no recommendation concerning the superiority of a certain type of valve. The benefit of this International Standard for the surgeon and the patient is to understand the information given by the manufacturer and to get 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.
Keywords:
CE marking, Data of the manufacturer, Definitions, Designations, English language, Enterprises, Equipment for single use, Hoses, Implants (surgical), Instructions for use, Labelling (process), Marking, Medical devices, Medical equipment, Medical instruments, Medical sciences, Medical technology, Neurology, Packages, Quality control, Specification (approval), Specifications, Sterile equipment, Surgery, Surgical implants, User information, Valves
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