ISO/IEC Guide 63:2012
International Standard
Historical
·
Approved on
10 January 2012
Guide to the development and inclusion of safety aspects in International Standards for medical devices
ISO/IEC Guide 63:2012 Files
English
21 Pages
Historical
61.73 BHD
ISO/IEC Guide 63:2012 Scope
ISO/IEC Guide 63:2012 provides guidance to standards writers on how to include safety aspects in the development of medical device safety standards intended to be used within the risk management framework established in ISO 14971. It expands on the concepts developed in ISO/IEC Guide 51 to include safety-related performance and usability.
ISO/IEC Guide 63:2012 is intended to be read in conjunction with ISO/IEC Guide 51 and ISO 14971.
Best Sellers
GSO 150-2:2013
Gulf Standard
Expiration dates for food products - Part 2 :
Voluntary expiration dates
BH GSO 150-2:2015
GSO 150-2:2013
Bahraini Standard
Expiration dates for food products - Part 2 :
Voluntary expiration dates
BH GSO 2055-1:2016
GSO 2055-1:2015
Bahraini Technical Regulation
HALAL FOOD - Part 1 : General Requirements
GSO 2055-1:2015
Gulf Technical Regulation
HALAL FOOD - Part 1 : General Requirements
Recently Published
ISO 22552:2025
International Standard
Space systems — Manufacturing readiness review
ISO/IEC TR 16088:2025
International Standard
Information technology — Computer graphics, image processing and environmental representation — Constructs for visual positioning systems in mixed and augmented reality (MAR)
ISO 18618:2025
International Standard
Dentistry — Interoperability of CAD/CAM systems
ISO 10286:2025
International Standard
Gas cylinders — Vocabulary