This part of YY 0466 identifies requirements for the development and use of symbols that may be used to convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this part of YY 0466.
This part of YY 0466 is limited to symbols applicable to a broad spectrum of devices that may be marketed globally. These symbols may be used on the device itself or its package or in the associated documentation.
2 Normative References
The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of YY 0466. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies.
GB/T 7408 Data elements and interchange formats — Information interchange — Representation of dates and times (ISO 8601, IDT)
GB/T 23371.3 Basic principles for graphical symbols for use on equipment — Part 3: Guidelines for the application of graphical symbols (IEC 80416-3, IDT)
IEC 80416-1:2001 Basic principles for graphical symbols for use on equipment — Part 1: Creation of symbol originals
ISO 80416-2 Basic principles for graphical symbols for use on equipment — Part 2: Form and use of arrows
ISO 80416-4 Basic principles for graphical symbols for use on equipment — Part 4: Guidelines for the adaptation of graphical symbols for use on screens and displays (icons)
3 Terms and Definitions
For the purposes of this document, the following terms and definitions apply.
3.1
Characteristic information
Mental representation of a property or properties of an object or set of objects.
3.2
Description
Normative text attached to the representation of the symbol original, which defines the purpose, the application and the use of the symbol original.
