DNS/ISO 16142-1: 2016

MEDICAL DEVICES, SYMBOLS RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES — PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS (ISO 16142-1: 2016, IDT)


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

This part of ISO 16142, 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 part of ISO 16142 identifies and describes the six general essential principles of safety  and performance that apply to all medical devices, including IVD medical devices (in vitro diagnostic). 

This part of ISO 16142 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 medical devices other than IVD medical devices. Future ISO 16142-2 is intended to identify  and describe the essential principles of safety and performance, which need to be considered during  the design and manufacturing process of 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 part of ISO 16142 is intended for use as guidance by medical device manufacturers, standards  development organizations, authorities having jurisdiction, and conformity assessment bodies.


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