60.55 Ratification completed (DOR) Jul 28, 2024
CEN
CEN/TC 285 Non-active surgical implants
European Norm
11.040.40 Implants for surgery, prosthetics and orthotics
Draft
This document specifies the 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 does not provide any recommendations on which type of valve is most suitable for any specific context of use.
This document specifies the mechanical and technical requirements to manufacture shunts and the technical information of the valve to be supplied by the manufacturer.
This document does not apply to active implants for the treatment of hydrocephalus.
Legislation related to this standard
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
PUBLISHED
EN ISO 7197:2009
IN_DEVELOPMENT
EN ISO 7197:2024
60.55
Ratification completed (DOR)
Jul 28, 2024
