This standard specifies various medical adhesive bandages (also known as adhesive bandages) contacting with body surface or surface of a wound, including general requirements of adhesive dressing.
This Standard excludes:
a) The requirements for protective layer on adhesive surface of medical adhesive bandages including adhesive dressing;
b) The requirements for dressing pad in adhesive dressing;
c) Packaging requirements of medical adhesive bandages.
2 Normative References
The following documents contain provisions which, through reference in this standard, constitute provisions of this standard. For dated reference, subsequent amendments to (excluding corrections to), or revisions of, any of these publications do not apply. However, the parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards. For undated references, the latest edition of the normative document referred to applies.
GB/T 16886.1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing (GB/T 16886.1-2001, idt ISO 10993-1: 1997)
YY 0466 Medical Devices - Symbols to be Used with Medical Device Labels Labelling and Information to be Supplied (YY 0466-2003, ISO 15233: 2000, IDT)
YY/T 0471.3-2004 Test Methods for Primary Wound Dressings - Part 3: Water-proofness
YY/T 0471.4-2004 Test Methods for Primary Wound Dressing - Part 4: Conformability
3 Terms and Definitions
For the purpose of this standard, the terms and definitions specified in YY/T 0471 and the following apply.
3.1
Titanium dioxide elastic adhesive bandage