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YY/T 1293.5-2017

Chinese Standard: 'YY/T 1293.5-2017'
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BASIC DATA
Standard ID YY/T 1293.5-2017 (YY/T1293.5-2017)
Description (Translated English) Contacting wound dressing. Part 5: Alginate dressing
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C31
Classification of International Standard 11.120.20
Word Count Estimation 10,156
Date of Issue 2017-05-02
Date of Implementation 2018-04-01
Quoted Standard GB/T 6682; GB/T 16886.1; YY/T 0466.1; YY/T 0471.1-2004; YY/T 0615.1; ISO 11607-1-2006
Drafting Organization Shandong Medical Device Quality Inspection Center
Administrative Organization State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center
Regulation (derived from) Notice of the State Food and Drug Administration of the People's Republic of China No. 49 of 2017; Announcement of the Industry Standards Proclamation No. 1 of 2018 (Total No. 217)
Summary This standard specifies the performance requirements and test methods for alginate dressings. This standard applies to aseptically supplied alginate dressings consisting only of alginate fibers. This standard does not include the requirements for alginate dressings containing antibacterial agents such as silver.

YY/T 1293.5-2017
Contacting wound dressing-Part 5. Alginate dressing
ICS 11.120.20
C31
People's Republic of China Pharmaceutical Industry Standard
YY 1293.5-2017
Contact wound dressing
Part 5. Alginate dressings
Published by.2017-05-02
2018-04-01 implementation
State Food and Drug Administration issued
Foreword
The full technical content of this standard is mandatory.
YY 1293 "Contact Wound Dressing" consists of the following parts.
--- Part 1. Vaseline gauze;
---Part 2. Polyurethane foam dressings;
---Part 4. Hydrocolloid dressings;
---Part 5. Alginate dressings;
This part is the fifth part of YY 1293.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This part is proposed by the State Food and Drug Administration.
This part is under the jurisdiction of the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center.
This section drafted by. Shandong Province Medical Device Product Quality Inspection Center, Steady Industry (Shenzhen) Co., Ltd., Shandong Shengna Medical System
Product Co., Ltd.
The main drafters of this section. Zhang Limei, Wu Changyan, Bai Bing, Zheng Duozi, Wang Lexin.
YY 1293.5-2017
introduction
The alginate dressing is a dressing containing an inorganic salt of alginic acid, which is made from alginate fibers by a nonwoven process. Its main feature is high absorption, gelatinization
Sex, suitable for medium to large amount of exudate wounds. After the alginate fiber absorbs a large amount of wound exudate, the alginate dressing contains calcium ions.
Ion exchange with sodium ions in the wound exudate to form a hydrophilic gel on the wound surface to maintain a certain humidity in the wound.
Alginate dressings are currently used for radiation sterilization.
YY 1293.5-2017
Contact wound dressing
Part 5. Alginate dressings
1 Scope
This section of YY 1293 specifies the performance requirements and test methods for alginate dressings.
This section applies to a sterile supply of alginate dressings consisting only of alginate fibers.
This section does not include the requirements for alginate dressings containing bacteriostatic agents such as silver.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 6682 Analytical laboratory water specifications and test methods
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management
YY/T 0466.1 Medical devices for the labeling, marking and information of medical devices - Part 1. General requirements
YY/T 0471.1-2004 Test methods for contact wounds - Part 1 . Fluid absorption
YY/T 0615.1 Requirements for "sterile" medical devices - Part 1. Requirements for terminally sterilized medical devices
Pharmacopoeia of the People's Republic of China (2010 Edition)
ISO 11607-1.2006 Packaging of terminally sterilized medical devices Part 1 Materials, sterile barrier systems, packaging systems
1) (Packagingforterminalysterilizedmedicaldevices-Part 1.Materials,sterilebarriersystemsand
Packagingsystems)
1) The standard corresponding to ISO 11607-1 is GB 19633. The latest version has been submitted for approval. Please pay attention to the standard release.
3 classification
According to the clinical use of alginate dressings, there are two main categories.
a) Surface wounds are made with an alginate dressing, made from a nonwoven process and cut into sheets.
b) Filling the sinus wound with alginate dressing, made from a non-woven fabric process and cut into strips, or processed after combing
In the form of strips, formed by cutting.
4 requirements
4.1 traits
The alginate dressing consists of off-white or yellowish fibers; odorless or almost odorless.
4.2 Identification
When testing according to 6.2, it should meet the requirements.
YY 1293.5-2017
4.3 Loss on drying
When testing according to 6.3, the weight loss shall not exceed 25%.
4.4 Liquid absorption
When tested in accordance with 3.2 of YY/T 0471.1-2004, it shall be not less than 10 times its initial weight.
4.5 Gelling properties
When tested according to 3.5 in YY/T 0471.1-2004, the sample should be gelled.
4.6 Dispersibility
Appropriate methods for removing the alginate dressing from the wound surface should be indicated in the accompanying document, YY/T 0471.1-
In.2004, 3.6 was evaluated for its dispersion.
4.7 pH
When testing according to 6.4, the difference between the pH of the test solution and the blank solution should be no more than 1.5.
4.8 Burning residue
When testing according to 6.5, the residue should be 15%~37% according to the dry product.
4.9 Heavy metals
When tested in accordance with 6.6, the heavy metal content should not exceed 20 μg/g.
4.10 iron
When tested in accordance with 6.7, the iron content should be no more than 150 μg/g.
4.11 Arsenic
When tested in accordance with 6.8, the arsenic content should not exceed 2 μg/g.
4.12 Cadmium
When tested in accordance with 6.9, the cadmium content should not exceed 2 μg/g.
4.13 Calcium
When tested in accordance with 6.10, the calcium content should be in accordance with the manufacturer's nominal value.
4.14 Sterility
Alginate dressings should be supplied sterile and meet the requirements of YY 0615.1.
5 Biocompatibility
The alginate dressing should be evaluated biologically in accordance with GB/T 16886.1 and the results should indicate no unacceptable biological hazard.
YY 1293.5-2017
6 Test methods
6.1 General
All tests should be performed in the final form of the material.
Unless otherwise specified, the reagents used shall be analytically pure reagents, and the test water shall comply with the secondary test water specified in GB/T 6682.
Claim.
6.2 Identification test
6.2.1 Extract the fibers on the alginate dressing, refer to Appendix A for infrared identification, and the results should be related to the alginate G infrared absorption spectrum or alginate.
The M infrared absorption spectrum is substantially identical or between the two spectra.
6.2.2 Weigh 5.0mg alginate dressing, add 5mL water, 1mL freshly prepared 1% mass fraction of 1,3 dihydroxynaphthalene ethanol solution,
5 mL hydrochloric acid, boiled for 3 min, cooled. Add 5 mL of water and extract with 15 mL of diisopropyl ether. The dark purple of the upper layer should be empty than that of the same method.
The white control is deep.
6.2.3 Weigh 0.1g alginate dressing, add 5mL water, boil, the sample should not dissolve. Add 2mL of 10% sodium carbonate solution, which will produce white
Color precipitation. Centrifugation and acidification yields a gelatinous precipitate.
6.3 Loss on drying
Take alginate dressing 0.5g and test according to the Chinese Pharmacopoeia.2010 edition two appendix VIIIL.
6.4 pH test
Cut 1.0g sample into pieces of about 1cm2, place in a suitable container, add 50mL of water, and soak at 37°C±1°C.
24h, gently pour out the liquid, mix, and get the test solution. The pH of the test solution and the chalk solution was measured with a pH meter, and the difference between the two was used as a test result.
6.5 ignition residue test
Take alginate dressing 1.0g, according to the "Pharmacopoeia of the People's Republic of China" (2010 edition) two appendix VIII N ignition residue inspection method
Tests are carried out under the regulations of (500 ° C ~ 600 ° C).
6.6 Heavy metal test
Take the residue left under 6.5, according to the Second Edition of Appendix VIII H Heavy Metal Inspection Act of the Pharmacopoeia of the People's Republic of China (2010 Edition)
The regulations are carried out.
Note. Add 2mL of acetate buffer (pH3.5), add it to the Nessler colorimetric tube if it is precipitated, filtered, and then filtered.
6.7 Iron content test
Take alginate dressing 1.0g, slowly evaporate at 500 ° C ~ 600 ° C until completely carbonized, let cool, add 4 mL of hydrochloric acid to dissolve, then move in
In a 50mL volumetric flask, add water to the mark, shake well, and accurately measure 5mL. According to the Pharmacopoeia of the People's Republic of China (2010 Edition), Appendix II VIII G
The provisions of the iron salt inspection method are carried out.
6.8 Arsenic content test
Take alginate dressing 1.0g, add 1.0g of calcium hydroxide, mix, and add water to moisten. First heat it with a small heat to complete the reaction, then
500 ° C ~ 600 ° C slowly roasting to complete carbonization, let cool, add 5mL of hydrochloric acid and 23mL of water to dissolve, according to the "People's Republic of China medicine
Code (2010 edition) The second part of the Appendix VIIIJ arsenic salt inspection method "first law" is carried out.
YY 1293.5-2017
6.9 Cadmium content test
Take alginate dressing 1.0g, slowly evaporate at 500 ° C ~ 600 ° C until completely carbonized, let cool, add 5mL of hydrochloric acid and 23mL of water to make it
Dissolution, according to the "Phase I of the People's Republic of China Pharmacopoeia (2010 edition) Appendix IV D atomic absorption spectrophotometry "first law" provisions, in
The measurement was carried out at 228.8 nm.
6.10 Calcium content test
Take the sample under the measurement of dry weight loss, place it in the crucible, slowly burn for about 20min, let cool, add a little hydrogen peroxide (0.5mL~
1.0 mL), continue to burn until no chunks are present, completely ashed at 700 ° C ~ 800 ° C, completely converted from dark red to white. Let it cool,
Add 10 mL of hydrochloric acid (1 3), dilute a few drops of concentrated nitric acid, carefully boil, transfer to a 100 mL volumetric flask, dilute to the mark with distilled water, shake well, as
Test solution.
Accurately remove 5mL of the above test solution into a 250mL Erlenmeyer flask, add 50mL distilled water, 5mL sodium hydroxide test solution, 10% three B
1 mL of alcohol amine solution, 0.1 g of calcium-purine indicator, titrated from wine red to bright blue with EDTA standard solution (c=0.01 mol/L)
Color is the end point. Calculate the calcium content according to formula (1).
Calcium content =
cV×0.04008
m×(5/100)×
100% (1)
In the formula.
c --- EDTA titrant concentration in mol per liter (mol/L);
V---the volume of EDTA consumed by titration, in milliliters (mL);
m---sample mass in grams (g).
7 signs
7.1 General
The symbols specified in YY/T 0466.1 can be used to meet the requirements of 7.2 and 7.3.
7.2 single package
The following information should be available on a single package.
a) the name, specification and model of the contents;
b) sterility and sterilization methods;
c) “One-time use”, “package damage, no use” and other information;
d) the year of failure;
e) manufacturer's name and address;
f) Production lot number or date.
7.3 Shelf packaging
At least the following information should be included in the shelf packaging.
a) the name and specification of the contents;
b) sterility and sterilization methods;
c) “One-time use”, “package damage, no use”;
d) the year of failure;
e) manufacturer's name and address;
f) production lot number or date;
YY 1293.5-2017
g) Storage instructions.
8 packaging
8.1 The manufacturer shall be able to provide proof that the packaging after loading the alginate dressing meets the requirements of ISO 11607-1.2006.
8.2 The design of the single package should be convenient for the contents to be taken aseptically, and the opened trace should be left after the package is opened.
YY 1293.5-2017
Appendix A
(informative appendix)
Alginate infrared identification map
The British Pharmacopoeia (1995 Supplement) gives an infrared map of alginate G (guluronic acid), alginate M (mannuronic acid), using bromine
Potassium or potassium chloride tablets.
Figure A.1 Infrared map of alginate G (guluronic acid) given in the British Pharmacopoeia (1995 Supplement)
Figure A.2 Infrared map of alginate M (mannuronic acid) given in the British Pharmacopoeia (1995 Supplement)
YY 1293.5-2017
Related standard:   YY 1293.5-2017  YY/T 1293.1-2016
Related PDF sample:   YY 1293.5-2017  YY 1282-2016
   
 
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