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This standard replaces YY 0148-1993 Adhesive plaster. Compared with YY 0148-1993, the main change in this standard is that the application scope is expanded. For its technical content, the relevant requirements of British pharmacopoeia (Edition 1993) are mainly adopted.
Annexes A, B, C and F are normative. Annexes D and E are informative.
This standard is under the jurisdiction of Jinan Center for Medical Equipment Quality Supervision and Testing, State Food and Drug Administration.
Chief drafting organization of this standard: Shandong Product Quality Inspection Center of Medical Equipment.
Participating drafting organization of this part: Henan Piaoan Group Co., Ltd..
Chief drafting staff of this standard: Luo Hongyu, Liu Bin, Sun Guangyu, Fan Xiangyang and Wan Min.
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Introduction
General requirements specified in Clause 5 are applicable to adhesive bandages; special requirements specified in Clause 6 are only applicable to products with corresponding expression. For some special adhesive bandages, meeting this standard doesn't mean that they meet the clinical requirements. For these products, the requirements beyond this standard may also be essential.
The mass of adhesive materials on medical adhesive bandages, organization structure of fabric and thread count are important parameters for controlling product quality, but, due to the variety of adhesive bandages, it's impossible for this standard to provide uniform requirements for these characteristics. In addition, this standard doesn't involve supply form and packaging requirements of products.
Most of the medical adhesive bandages don't directly contact with the surface of a wound, but some adhesive bandages are expected to do so, so they are also referred to as adhesive dressing for which sterile supply is required clinically.
Medical adhesive bandages - General requirements
1 Scope
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: Waterproofness
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
bandage with elasticity in warp or weft whose fabric of cotton and viscose are uniformly coated with adhesive materials containing titanium dioxide
3.2
vapour-permeable adhesive film dressing
sterile product with base material (such as polyurethane membrane) uniformly coated with synthetic adhesive materials. The dressing is stretchable and water-resistant, vapour is permeable and transparent. Adhesive surface is covered with a protective layer. Removal of the protective layer will not bring adhesive materials down. Sterile supply is carried out for single product. On a side of the dressing, an adhesive-free colored area or other proper devices are available for pick-up by hands
4 General test requirements
Conditioning and test environment of each test sample required in this standard meet the requirements of Annex A.
5 General requirements
5.1 Dimensions
Product dimension shall not be less than 99% of the nominal value.
5.2 Adhesiveness
5.2.1 Persistent adhesiveness
When the test is carried out according to B.2 of Annex B, during the test in drying oven, top down-sliding of adhesive bandages on stainless steel plate shall not exceed 2.5mm.
5.2.2 Peel strength
When the test is carried out according to B.2 of Annex B, mean force required by 1cm width adhesive bandages shall not be less than 1.0N??.
5.3 Biocompatibility
Biological evaluation for adhesive bandages shall be carried out according to the requirements of GB/T 16886.1, the result shall indicate that there are no unacceptable biohazards.
6 Special requirements
6.1 Conformability (extensibility)
If adhesive bandages have "conformability" and the test is carried out according to YY/T 0471.4-2004, the extensibility shall not be greater than 14 N·cm-1. When the test is carried out according to YY/T 0471.4-2004, the permanent deformation shall not be greater than 5%.
6.2 Vapour permeability
If adhesive bandages are clearly vapour-permeable (such as vapour-permeable adhesive film dressing), and the test is carried out according to Annex C, vapour penetration per 24h shall not be less than 500 g·m-2.
6.3 Water-resistance
If adhesive bandages are clearly water-resistant, their water-resistance shall meet the test requirements of YY/T 0471.3-2004.
6.4 Specific substances
If adhesive bandages clearly express that adhesive materials contain specific substances with the function of antibiosis, convergence or moistening (such as zinc oxide and titanium dioxide), and suitable method is adopted for inspection, the content of this kind of specific substances shall not be less than 10.0% of the adhesive materials.
Note: Annexes D and E provide the test methods of zinc oxide and titanium dioxide content respectively.
6.5 Elasticity
If adhesive bandages clearly have "elastic force" or "elasticity", and the test is carried out according to Annex F, the recovery length shall not be greater than 80% of the total extended length.
Foreword I
Introduction II
1 Scope
2 Normative References
3 Terms and Definitions
4 General Test Requirements
5 General Requirements
6 Special Requirements
7 Label
Appendix A (Normative) Conditioning and Test Environment
Appendix B (Normative) Test Method for Adhesiveness
Appendix C (Normative) Test Method for Vapor Permeability
Appendix D (Informative) Test Method for Zinc Oxide Content in Adhesive Materials
Appendix E (Informative) Test Method for Titanium Dioxide Content in Adhesive Materials
Appendix F (Normative) Test Method for Elasticity
Bibliography
