YY Translated English of Chinese Standard: YY PHARMACEUTICAL INDUSTRY STANDARD

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1 Translated English of Chinese Standard: YY Buy True-PDF Auto-delivery. PHARMACEUTICAL INDUSTRY STANDARD YY OF THE PEOPLE S REPUBLIC OF CHINA ICS C 31 YY Contacting wound dressing - Part 5: Alginate dressing 接触性创面敷料第 5 部分 : 藻酸盐敷料 Issued on: May 2, 2017 Implemented on: April 3, 2018 Issued by: China Food and Drug Administration Buy True-PDF Auto-delivery. Page 1 of 13

2 Table of Contents Foreword... 3 Introduction Scope Normative references Classification Requirements Biocompatibility Test methods Marks Packaging Annex A (informative) Infrared identification map of alginate Buy True-PDF Auto-delivery. Page 2 of 13

3 Foreword All technical content of this Standard is mandatory. YY 1293 "Contacting wound dressing" consists of the following parts: - Part 1: Vaseline gauze; - Part 2: polyurethane foam dressing; - Part 4: hydrocolloid dressing; - Part 5: alginate dressing; This Part is Part 5 of YY This Part was drafted in accordance with the rules given in GB/T Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing authority shall not be held responsible for identifying any or all such patent rights. This Part was proposed by China Food and Drug Administration. This Part shall be under the jurisdiction of China Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center. The drafting organizations of this Part: Shandong Medical Device Quality Inspection Center, Winner Industry (Shenzhen) Co., Ltd., Shandong Shengna Medical Products Co., Ltd. Main drafters of this Part: Zhang Limei, Wu Changyan, Bai Bing, Zheng Duozi, Wang Lexin. Buy True-PDF Auto-delivery. Page 3 of 13

4 Contacting wound dressing - Part 5: Alginate dressing 1 Scope This Part of YY 1293 specifies the performance requirements and test methods for alginate dressing. This Part is applicable to aseptically supplied alginate dressing that consists only of alginate fibres. This Part does not include requirements for alginate dressing containing silver and other bacteriostatic agents. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 6682, Water for analytical laboratory use - Specification and test methods GB/T , Biological evaluation of medical devices - Part 1: Guidance on selection of tests YY/T , Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements YY/T , Test methods for primary wound dressing - Part 1: Aspects of absorbency YY/T0615.1, Requirements for medical devices to be designated STERILE - Part 1: Requirements for terminally sterilized medical devices Pharmacopoeia of People's Republic of China (Edition 2010) ISO :2006, Packaging for terminally sterilized medical devices - Part 1: Materials, sterile barrier systems and packaging systems 1 1 The standard corresponding to ISO is GB The latest version has been submitted for approval. Please pay attention to the publication. Buy True-PDF Auto-delivery. Page 5 of 13

5 6.2 Identification test Extract fiber from alginate dressing for infrared identification based on the reference to Annex A. The result shall be substantially the same as or in between the two spectra of the alginate G infrared absorption spectrum or the alginate M infrared absorption spectrum Weigh 5.0 mg of alginate dressing. Add 5mL of water, 1mL of freshly prepared 1% of 1,3 dihydroxynaphthalene ethanol solution, 5mL of hydrochloric acid, boil 3min and cool. Add 5mL of water. Extract with 15 ml of diisopropyl ether. The dark purple in the upper layer shall be deeper than the blank made in the same method Weigh 0.1g of alginate dressing. Add 5mL of water, boil, the sample shall not dissolve. Add 2mL of 10% sodium carbonate solution to generate white precipitate. Perform centrifugation and acidification to generate gelatinous precipitate. 6.3 Loss on drying Take 0.5g of alginate dressing. Conduct the test according to Annex VIII L in Part II of Pharmacopoeia of People's Republic of China (Edition 2010). 6.4 ph test Cut 1.0g of sample into about 1cm 2 pieces. Put into a suitable container. Add 50mL of water. Seal at 37 C ± 1 C to soak 24h. Pour the liquid gently, mix, and obtain the test solution. Determine the ph of the test solution and blank solution with a ph meter. The difference of these two shall be inspection results. 6.5 Ignition residue test Take 1.0g of alginate dressing. Conduct the test according to Annex VIII N Ignition residue inspection method (500 C~600 C) in Part II of Pharmacopoeia of People's Republic of China (Edition 2010). 6.6 Heavy metal test Take residue left under 6.5. Perform according to Annex VIII H Heavy metal inspection method in Part II of Pharmacopoeia of People's Republic of China (Edition 2010). NOTE Add 2mL of acetate buffer (ph3.5). After slight heat dissolution, if there is precipitation, filtrate it and then move to Nessler colorimetric tube. 6.7 Iron content test Take 1.0g of alginate dressing. Slow bake at 500 C~600 C till complete Buy True-PDF Auto-delivery. Page 8 of 13

6 V - EDTA volume consumed in the titration, in milliliters (ml); M - sample mass, in grams (g). 7 Marks 7.1 General The symbols specified in YY/T can be used to meet the requirements of 7.2 and Single packaging The single packaging shall have the following information: a) name, specifications, model of content; b) sterility and sterilization methods; c) "disposable", "broken packaging, prohibition of use", etc.; d) year and month of failure; e) manufacturer's name and address; f) production lot number or date. 7.3 Shelf packaging There shall be at least the following information in the shelf package: a) name, specifications of content ; b) sterility and sterilization methods; c) "disposable", "broken packaging, prohibition of use", etc.; d) year and month of failure; e) manufacturer's name and address; f) production lot number or date; g) storage instructions. 8 Packaging 8.1 The manufacturer shall be able to provide proof that the packaging after Buy True-PDF Auto-delivery. Page 10 of 13