UNLIMITED FREE ACCESS TO THE WORLD'S BEST IDEAS

close
Already an Engineering360 user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your Engineering360 Experience

close
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

BSI - BS ISO 16142-1 - TC

Tracked Changes (Redline) - 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

active, Most Current
Buy Now
Organization: BSI
Publication Date: 24 February 2020
Status: active
Page Count: 133
ICS Code (Medical equipment in general): 11.040.01
scope:

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.

Document History

BS ISO 16142-1 - TC
February 24, 2020
Tracked Changes (Redline) - 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
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...

References

Advertisement