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>UNE EN ISO 7197:2025 - Neurosurgical implants - Sterile, single-use hydrocephalus shunts (ISO 7197:2024)
sklademVydáno: 2025-07-09
UNE EN ISO 7197:2025 - Neurosurgical implants - Sterile, single-use hydrocephalus shunts (ISO 7197:2024)

UNE EN ISO 7197:2025

Neurosurgical implants - Sterile, single-use hydrocephalus shunts (ISO 7197:2024)

Implantes neuroquirúrgicos. Sistemas de derivación estériles, de un solo uso, para hidrocefalia. (ISO 7197:2024).

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Označení normy:UNE EN ISO 7197:2025
Počet stran:19
Vydáno:2025-07-09
Status:Norma
DESCRIPTION

UNE EN ISO 7197:2025

This document specifies safety and performance requirements for sterile, single use non active hydrocephalus shunts. This includes not only the valve, but also additional components such as tubes and reservoirs. This document gives no recommendation concerning the superiority of a certain type of valve. For manufacturing, it specifies the mechanical and technical requirements. This document specifies the technical information supplied by the manufacturer, including the technical information of the valve. In respect to the principles of the different valve types, this document specifies characteristics for each type. The benefit of this document 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 specify the important requirements for shunts as a basis for investigations during development as well as for quality control during manufacture. This document does not apply to active implants for the treatment of hydrocephalus.

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