YY 0331-2006Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze (English PDF)
脱脂棉纱布、脱脂棉粘胶混纺纱布的性能要求和试验方法
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
April 19, 2006
Implementation date
April 1, 2007
Scope
YY 0331-2006 is the English-translated version of 脱脂棉纱布、脱脂棉粘胶混纺纱布的性能要求和试验方法.
YY 0331-2006 is the Chinese standard "Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze". Its scope clause reads: This standard specifies the requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose ribbon gauze.
This standard does not relate to the drug-containing gauze. Its clauses include terms and definitions.
Found what you need?
Document preview — YY 0331-2006
National Standard of the People's Republic of China
- Replacing
- YY 0331-2002
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- Introduction4
- 1 Scope5
- 2 Normative references5
- 3 Terms and definitions5
- 4 Requirements6
- 5 Test methods9
- 6 Test report16
- Appendix A (Normative) Reagent for determining liquid's chroma17
- Appendix B (Normative) Preparation of test solution S20
- 14079:2003 and their causes21
1 Scope
This standard specifies the requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose ribbon gauze. This standard does not relate to the drug-containing gauze.
2 Normative references
The provisions in following documents become the provisions of this standard through reference in this standard. For the dated references, the subsequent amendments (excluding corrections) or revisions do not apply to this standard;
however, parties who reach an agreement based on this standard are encouraged to study if the latest versions of these documents are applicable.
For undated references, the latest edition of the referenced document applies.
Pharmacopoeia of PRC
3 Terms and definitions
The following terms and definitions apply to this standard.
3.1 Absorbent cotton gauze
A non-woven plain-woven cotton fabric that has been degreased, bleached or dyed, purified, which has no obvious cotton leaves, cotton seed or other impurities.
3.2 Absorbent cotton ribbon gauze
A non-woven plain-woven cotton fabric that has been formed by degreasing, bleaching or dyeing, purifying the continuous woven cloth of various widths which are woven by cotton thread and have selvage. It has no obvious cotton […]
4.8 Sinking time
When tested according to 5.9, the sinking time shall not exceed 10 s.
4.9 Soluble-in-ether
When tested according to 5.10, the total amount of soluble-in-ether shall be not more than 0.50%.
4.10 Surfactant
When tested according to 5.11, the height of the surfactant foam after 300 s shall not exceed 2 mm.
4.11 Soluble-in-water
When tested according to 5.12, the total amount of soluble-in-water shall be not more than 0.50%.
4.12 Starch and dextrin
When tested according to 5.13, the solution shall not appear blue, purple, reddish or light brown.
4.13 Extractable coloring matter
When tested according to 5.14, the color of the liquid obtained shall not be deeper than the control solution Y 5 , GY6 as specified in Appendix A or the control solution as prepared as follows: add 7.0 mL of hydrochloric acid solution (hydrochloric acid which has a mass concentration of 10 g/L) to 3.0 mL of primary blue solution; use hydrochloric acid solution (hydrochloric acid which has a mass concentration of 10 g/L) to dilute 0.5 mL of the above solution to
10.0 mL.
4.14 Loss-on-drying
When tested according to 5.15, the mass loss of the absorbent cotton gauze shall not exceed 8.0%; the mass loss of the absorbent cotton and viscose ribbon gauze shall not exceed 11.0%.
4.15 Sulphate ash
When tested according to 5.16, the total amount of sulphated ash shall meet the requirements of Table 3.
5.10 Test method of soluble-in-ether
In a continuous leaching device, use diethyl ether to leach 5.00 g of gauze for
4 h, at least 4 times per hour. Evaporate the ether-extract. Dry the residue at
100 °C ~ 105 °C to a constant amount.
Check whether it meets 4.9.
5.11 Test methods of surfactant
Take a measuring cylinder which has an outer diameter of 20 mm ± 2 mm and a frosted glass stopper. Use sulfuric acid to rinse it. Then use water to rinse it.
Add 10 mL of the prepared test solution S. Within 10 s, shake it vigorously for
30 times. Then place it for 1 min. Repeat shaking. Let it be standing for 5 min.
Determine the height of the foam at the liquid surface foam.
Check whether it meets 4.10.
5.12 Test method for soluble-in-water
Take 7.00 g ± 0.1 g of gauze. Place it in 700 mL ± 10 mL of water to boil it for
30 min. Stir it continuously and replenish the loss of water due to evaporation.
Gently pour out the liquid. Use glass rod to squeeze the remaining liquid in the sample. Mix it into the poured liquid. Leave 200 mL of liquid for the test of starch and dextrin (see 4.12). Filter the remaining liquid when it is still hot. Evaporate
400 mL of aqueous immersion liquid (corresponding to the mass of the 4/7 sample). At 100 °C ~ 105 °C, dry it to a constant amount. Calculate the percentage of the mass of the residues to the mass of the actual sample.
Check whether it meets 4.11.
5.13 Test methods of starch and dextrin
5.13.1 Reagents
5 mol/L acetic acid solution: Take 285 mL (300 g) of glacial acetic acid. Use water to dilute it to 1000 mL.
0.05 mol/L iodine solution: Use a small amount of water to dissolve 20 g of potassium iodide. Add 13 g of iodine. Dissolve it. Add water to 1000 mL.
5.13.2 Procedure
Cool 200 mL of the unfiltered leaching solution as left from the test of soluble- in-water (5.12). Add 5 mL of 5 mol/L acetic acid solution and 0.15 mL of 0.05 mol/L iodine solution.
Check whether it meets 4.12.
5.14 Test method for extractable coloring substance
It shall use same colorless and transparent neutral glass flat-bottomed test tubes which have an inner diameter of 15 mm ~ 25 mm, to determine the chroma of the liquid within brown-yellow-red range. Compare the test solution
S with water, solvent or control solution, the liquid level is 40 mm ± 2 mm. In diffuse sunlight, make it be perpendicular to a white background to compare the color of solution.
Note: The control solution as used to determine the chroma of the liquid is as shown in Appendix A.
5.15 Test method of loss on drying
Weigh approximately 5 g of sample, accurate to two decimal places. Place the sample in an oven which is preheated at 100 °C ~ 105 °C. After 30 min, use an appropriate method to take the sample out from the oven. Place it for 30 min.
Weigh the sample, accurate to two decimal places. Use the formula below to calculate the percentage of mass loss:
Where:
W 1 - The mass of the sample before drying, in grams (g);
W 2 - The mass of the sample after drying, in grams (g).
Check whether it meets 4.14.
5.16 Test method of sulphated ash
Place 5.00 g of gauze in a crucible which has reached constant weight. On open fire, carefully heat it. Then at 600 °C, carefully heat it to dark red. Let it cool. Add a few drops of dilute sulfuric acid. Heat and burn it until all the black particles disappear completely. Let it cool. Add a few drops of ammonium carbonate solution which has a mass concentration of 158 g/L. Evaporate and burn it. Let it cool. Weigh it again. Then burn for 5 min to constant weight.
Check whether it meets 4.15.
A.1 Primary solution
A.1.1 Primary yellow solution
Dissolve 46.0 g of ferric chloride in 900 mL ± 10 mL of hydrochloric acid solution (mixed from 25 mL ± 0.5 mL of concentrated hydrochloric acid solution and 975 mL of water). Add this hydrochloric acid solution to 1000.0 mL. Titrate it and add this mixed acid solution, to adjust the content of ferric chloride hexahydrate (FeCl 3 · 6H2 O) in the solution to 45.0 mg/mL. This solution shall be stored in dark.
Titration: Add 10.0 mL ± 0.2 mL of the above solution, 15 mL ± 0.2 mL of water,
5 mL ± 0.2 mL of hydrochloric acid, 4 g of potassium iodide to a 250 mL conical flask with a frosted glass stopper. Cap it. Place it in the dark for 5 min. Add 100 mL ± 5 mL of water. Use 0.5 mL ± 0.05 mL of starch solution as an indicator.
Use sodium thiosulfate standard titration solution [c(Na2 S 2 O 3 ) = 0.1 mol/L] to titrate the released iodide ion. Titrate until the blue color disappears. Take this as the end of titration.
1 mL of sodium thiosulfate standard titration solution is equivalent to 27.03 mg of ferric chloride hexahydrate.
A.1.2 Primary red solution
Dissolve 60 g ± 1 g of cobalt chloride in 900 mL ± 10 mL of hydrochloric acid solution (mixed from 25 mL ± 0.5 mL of concentrated hydrochloric acid solution and 975 mL of water). Add this hydrochloric acid solution to 1000.0 mL. Titrate it and add this mixed acid solution, to adjust the content of cobalt chloride hexahydrate (CoCl2 · 6H 2 O) in the solution to 59.5 mg/mL.
Titration: Add 5.0 mL ± 0.2 mL of the above solution, 5 mL ± 0.02 mL of 3% (volume fraction) dilute hydrogen peroxide solution, 10 mL ± 0.5 mL of sodium hydroxide solution which has a mass concentration of 300 g/L into a 250 mL conical flask which has a frosted glass stopper. Gently boil it for 10 min. Let it cool. Add 60 mL ±1 mL of 1 mol/L dilute sulfuric acid and 2 g ± 0.1 g of potassium iodide. Cap it. Gently shake it to dissolve the precipitate. Use 0.5 mL ± 0.05 mL of starch solution as an indicator. Use sodium thiosulfate standard titration solution [c(Na2 S 2 O 3 ) = 0.1 mol/L] to titrate the released iodide ion to the end.
When the solution changes red, it reaches the end of titration.
4.14
For the 8.0% mass loss indicators, it is determined based on materials as follows: 8.0% for absorbent cotton gauze; 11.0% for absorbent cotton and viscose ribbon gauze
According to the official moisture regain, based on the relevant requirements of the 1993 version of British Pharmacopoeia.
5.2.1.2
In the identification test C, it adds the descriptions of test results that “the fiber shall not be soluble”.
According to the 1993 version of British
Pharmacopoeia, provide the descriptions on test results.
5.13
Add 5.13.1 the requirements for reagents.
According to the 1993 version of British
Pharmacopoeia, correct the errors in the standard EN 14079:2003.
5.15
Change “place it for 5 min” into “place it for 30 min”.
The 5 min placement time is not enough to let it cool down, which does not comply with the operating procedures of balance.
5.16
Define the mass concentration of ammonium carbonate solution.
According to the 1993 version of British
Pharmacopoeia, correct the errors in the standard EN 14079:2003.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Cited by
- YY/T 1467-2016Medical dressings—First aid bandage
- YY/T 1477.1-2016Standard test models for primary wound dressing performance evaluation - Part 1: In vitro wound model for antimicrobial activity evaluation
- YY 0854.1-2011Performance requirements for pure cotton nonwoven surgical compresses - Part 1: Nonwovens used in the manufacture of surgical compresses
- GB/T 26331-2010Optical coatings environmental durability test methods
- YY 0594-2006General requirements for surgical gauze dressings
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Editions of YY 0331
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY 0331-2006 | Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze | current edition | Current |
| YY 0331-2002 | Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze | previous edition | Superseded |
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