DNS/ISO 16142-2: 2017

MEDICAL DEVICES — RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES — PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS (ISO 16142-2: 2017, IDT)


Status: Public comments
Start date: 20240718
End date: 20240916

This document, which includes the essential principles of safety and performance, identifies significant  standards and guides that can be used in the assessment of conformity of a medical device to the  recognized essential principles that when met, indicate a medical device is safe and performs as  intended. This document identifies and describes the six general essential principles of safety and  performance (see Table B.1) that apply to all medical devices, including IVD medical devices (in vitro diagnostic). 

This document also identifies and describes the additional essential principles of safety and  performance which need to be considered during the design and manufacturing process, which are  relevant to IVD medical devices. 

NOTE  During the design process, the manufacturer selects which of the listed design and manufacturing  principles apply to the particular medical device and documents the reasons for excluding others. 

This document is intended for use as guidance by medical device manufacturers, standards development  organizations, authorities having jurisdiction, and conformity assessment bodies. 


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