Abstract Preview

This document provides requirements and recommendations to writers of medical device standards on the inclusion of aspects related to safety in International Standards, based on well-established risk management concepts and methodology.

This document is applicable to any aspect related to the safety of people, property, the environment, or a combination of these.

In this document, the term "product" includes a medical device or a system consisting of one or more medical devices, possibly combined with non-medical devices.


General information

  • Status :  Published
    Publication date : 2019-08
  • Edition : 3
    Number of pages : 26
  • :
    ISO/TMBG
    Technical Management Board - groups
  • 11.040.01
    Medical equipment in general
    01.120
    Standardization. General rules

Buy this standard

Format Language
PDF + ePub
Paper
  • CHF118

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