DS/EN ISO 7197:2009

Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 56.89
Legislation:

Legislation

Harmonized under:
  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Harmonized standards:
Links

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.


Number of pages: 24

Published: 2009-07-20

Date of approval: 2009-07-03

International relationships : EN ISO 7197:2009 IDT ISO 7197:2006 IDT

ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics

Item number: M235341


Committees

Committee

  • CEN/TC 285
  • ISO/TC 150/SC 3

Danish committee

DS/S-160