| No. | รหัสมาตรฐาน  | ชื่อมาตรฐาน | |
|
1.
|
ISO/TR 80002-2:2017
|
Medical device software -- Part 2: Validation of software for medical device quality systems
|
|
|
2.
|
ISO/TC 84
|
Devices for administration of medicinal products and catheters
|
|
|
3.
|
ISO 16142-2:2017
|
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
|
|
|
4.
|
ISO 16142-1:2016
|
Recognized essential principles of safety and performance of medical devices
|
|
|
5.
|
ISO 16142-1:2016
|
Recognized essential principles of safety and performance of medical devices -- Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
|
|
|
6.
|
ISO 15378:2017
|
Primary packaging materials for medicinal products -- Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
|
|
|
7.
|
ISO 15223-2:2010
|
Symbols to be used with medical device labels, labelling, and information to be supplied -- Part 2: Symbol development, selection and validation
|
|
|
8.
|
ISO 15223-1:2016
|
Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
|
|
|
9.
|
ISO 14971:2007
|
Application of risk management to medical devices
|
|
|
10.
|
IEC/TR 80002-3:2014
|
Medical device software -- Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
|
|