Cart

No products

Shipping $0.00
Total $0.00

Cart Check out

AAMI/ISO 16142-2:2017

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

More details

Download

PDF AVAILABLE FORMATS IMMEDIATE DOWNLOAD
$117.73

$294.32

(price reduced by 60 %)

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).

Contact us