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AAMI/ISO 16142-2:2017

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

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization , 07/31/2017

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Full Description

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 diagnostic).
 

Product Details

Published:
07/31/2017
ISBN(s):
9781570206719
ANSI:
ANSI Approved
Number of Pages:
56
File Size:
1 file , 520 KB
Note:
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