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

Publisher:
Association for the Advancement of Medical Instrumentation/International Org. for Standardization

Document status:

Active

Format:

Electronic (PDF)

Delivery time:

10 minutes

Delivery time (for Russian version):

200 business days

SKU:

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).

ANSI :	ANSI Approved
File Size :	2 files , 2.2 MB
ISBN(s) :	9781570206719
Note :	This product is unavailable in Ukraine, Russia, Belarus
Number of Pages :	56
Published :	07/31/2017

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

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

History

Related products

Best-Selling Products