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  • BSI
    BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices - General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    Edition: 2016
    $564.17
    / user per year

Description of BS ISO 16142-1:2016 2016

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.



Standard NumberBS ISO 16142-1:2016
TitleMedical devices. Recognized essential principles of safety and performance of medical devices - General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
StatusWithdrawn
Publication Date2016-03-31
Withdrawn Date2024-07-03
ReplacesPD ISO/TR 16142:2006
Identical National Standard OfISO 16142-1:2016
DescriptorsSafety measures, Standards, Acceptance (approval), Medical technology, Selection, Electrical medical equipment, Performance, Equipment safety, Medical equipment
ICS11.040.01 Medical equipment in general
CommitteeCH/210
ISBN978 0 580 84345 7
PublisherBSI
Pages60



The following editions for this book are also available...

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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