ISO 63:2019
ISO 63:2019 Guide to the development and inclusion of aspects of safety in International Standards for medical devices
CDN $263.00
Description
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.
Edition
3
Published Date
2019-08-12
Status
PUBLISHED
Pages
26
Language
English
Format
Secure PDF
Secure – PDF details
- Save your file locally or view it via a web viewer
- Viewing permissions are restricted exclusively to the purchaser
- Device limits - 3
- Printing – Enabled only to print (1) copy
See more about our Environmental Commitment
Abstract
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.
Previous Editions
Can’t find what you are looking for?
Please contact us at:
Related Documents
-
ISO 71:2014 Guide for addressing accessibility in standards
CDN $352.00 Add to cart -
ISO 10241:2012 Terminological entries in standards – Part 2: Adoption of standardized terminological entries
CDN $310.00 Add to cart -
ISO 17:2016 Guide for writing standards taking into account the needs of micro, small and medium-sized enterprises
CDN $131.00 Add to cart -
ISO 30:2019 Competence of standards professionals – Part 1: In companies
CDN $295.00 Add to cart
