Medical devices - 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)
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.
Published
PDF
11/05/2020
71
NSC R - Medical Devices and Facilities for Healthcare
