Regulatory Standards Flashcards
(9 cards)
1
Q
ISO 17025
A
International Standard for Testing and Calibration Laboratories
2
Q
ISO 13485
A
Requirements for a Quality Management System for Medical Devices
3
Q
IEC 60601-1
A
Safety and Essential Performance for Medical Electrical Equipment
4
Q
ISO 11607–1
A
Packaging for Terminally Sterilized Medical Devices
5
Q
ISO 80369
A
Small Bore Connectors in IV lines, enteral feeding systems, and breathing systems
6
Q
ISO 10993-1
A
Biological Evaluation of Medical Devices
7
Q
ISO 80369-5
A
Specifications for small-bore connectors used in limb-cuff inflation applications (blood pressure cuffs)
8
Q
ISO 11607-2
A
Development and Validation of Processes
9
Q
A
