ISO 14708-4:2022
p
ISO 14708-4:2022
73537

Abstract

 Preview

This document specifies particular requirements for active implantable medical devices intended to deliver a medicinal substance to site-specific locations within the human body, to provide basic assurance of safety for both patients and users. It amends and supplements ISO 14708-1:2014. The requirements of this document take priority over those of ISO 14708-1.

This document is applicable to active implantable medical devices intended to deliver medicinal substances to site-specific locations within the human body.

This document is also applicable to some non-implantable parts and accessories of the devices defined in Clause 3.

The tests that are specified in this document are type tests intended to be carried out on a sample of a device to show compliance and are not intended to be used for the routine testing of manufactured products.

NOTE       This document is not intended to apply to non-implantable infusion systems.


General information 

  •  :  Published
     : 2022-02
  •  : 2
     : 58
  •  : ISO/TC 150/SC 6 Active implants
  •  :
    11.040.40 Implants for surgery, prosthetics and orthotics

Buy this standard

en
Format Language
std 1 178 PDF + ePub
std 2 178 Paper
  • CHF178

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

Keep up to date with ISO

Sign up to our newsletter for the latest news, views and product information.