AAMI 16142-2:2017 PDF Download
Standard EN Sample
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
Also Known As: ANSI/AAMI/ISO 16142-2:2017
SKU118291331
Published by
Association for the Advancement of Medical Instrumentation
AAMI
Publication Date2017-07-31
Pages CountPages56
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).
Details
| Language(s) | English |
| ISBN | 9781570206719 |
| File Size | 1.2 MB |
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