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AAMI ANSI/AAMI/ISO 16142-2:2017 [HISTORICAL]

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
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AAMI ANSI/AAMI/ISO 16142-2:2017 [HISTORICAL]

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

PUBLISH DATE 2017
AAMI ANSI/AAMI/ISO 16142-2:2017 [HISTORICAL]
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 standard identifies and describes the six general essential principles of safety and performance that apply to all medical devices, including IVD medical devices (in vitro 14937diagnostic).
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number 16142-2
Publication Date Aug. 1, 2017
Language en - English
Page Count
Revision Level
Supercedes
Committee
Publish Date Document Id Type View
Aug. 1, 2017 Revision