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YY 0331-2006 (YY0331-2006)

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YY 0331-2006English155 Add to Cart 0-9 seconds. Auto-delivery. Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze Obsolete


YY 0331-2006: PDF in English

YY 0331-2006
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.120.20
C 48
Replacing YY 0331-2002
Performance requirements and test methods
for absorbent cotton gauze and absorbent
cotton and viscose gauze
(EN 14079:2003, MOD)
ISSUED ON: APRIL 19, 2006
IMPLEMENTED ON: APRIL 01, 2007
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3 
Introduction ... 4 
1 Scope ... 5 
2 Normative references ... 5 
3 Terms and definitions ... 5 
4 Requirements ... 6 
5 Test methods ... 9 
6 Test report ... 16 
Appendix A (Normative) Reagent for determining liquid’s chroma ... 17 
Appendix B (Normative) Preparation of test solution S ... 20 
Appendix NA (Informative) Technical differences between this standard and EN
14079:2003 and their causes ... 21 
Foreword
The yarn counts (4.5), mass per square meter (4.6), minimum fracture
force (4.7) in this standard are recommended.
This standard modifies and adopts EN 14079:2003 “Non-active medical
devices - Performance requirements and test methods for absorbent cotton
gauze and absorbent cotton and viscose gauze”. Meanwhile it has been
amended as necessary according to the 1993 version of the British
Pharmacopoeia. The differences from EN 14079:2003 are indicated by vertical
lines in the margins of the clauses to which they relate. The technical
differences and causes are given in Appendix NA.
This standard replaces YY 0331-2002 “Medical purified gauze”. As compared
with YY 0331-2002, the main technical differences are as follows:
a) CANCEL the requirements for whiteness, traits, sterility, ethylene oxide
residues;
b) ADD the absorbent cotton and viscose ribbon gauze;
c) ADD the requirements for fiber identification, foreign fibers, yarn count,
mass per square meter, extractable colored materials;
d) MODIFY the requirements for pH and sulphated ash;
e) CANCEL the requirements for inspection rules, markings, labels.
Appendix A and Appendix B of this standard are normative appendixes.
Appendix NA is an informative appendix.
This standard was proposed by and shall be under the jurisdiction of the State
Food and Drug Administration Jinan Medical Device Quality Supervision and
Inspection Center.
Main drafting organizations of this standard: Shandong Medical Device Product
Quality Inspection Center.
Participated drafting organizations of this standard: Henan Piaoan Group Co.,
Ltd.
The main drafters of this standard: Liu Bin, Wu Ping, Li Kefang, Wang Jiyong,
Fan Xiangyang.
Performance requirements and test methods
for absorbent cotton gauze and absorbent
cotton and viscose gauze
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
When tested according to 5.8, the minimum fracture force per 50 mm (in
Newtons) shall comply with Tables 1 and 2.
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 Y5, 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.
into the liquid surface. Calculate the average value of the three tests, as the
test result.
Check whether it meets 4.8.
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:
W1 - The mass of the sample before drying, in grams (g);
W2 - 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.
Appendix A
(Normative)
Reagent for determining liquid’s chroma
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
(FeCl3 • 6H2O) 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(Na2S2O3) = 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 • 6H2O) 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(Na2S2O3) = 0.1 mol/L] to titrate the released iodide ion to the end.
When the solution changes red, it reaches the end of titration.
Appendix NA
(Informative)
Technical differences between this standard and EN 14079:2003 and
their causes
Table NA.1 gives a list of the technical differences between this standard and
EN 14079:2003 and their causes.
Table NA.1 -- Technical differences between this standard and EN
14079:2003 and their causes
Clause No. of
this standard Technical differences Causes
Table 1
Add the description column and the
types of commonly-used gauzes in
China (note c).
Whilst recommending the types of European
gauze, it preferably selects the types of four
commonly-used gauzes in China (heavy-duty).
The larger the mass per unit area, the higher the
water-absorption capability of gauze per unit
area. Currently, heavy-duty gauze is commonly-
used in China, which has a higher consumption
of cotton resource and a lower requirement for
the quality of cotton. Considering from
reasonable use of resources and improvement of
gauze quality, it shall advocate producing and
using the light-duty gauze as specified in EN
14079:2003.
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.
......
(Above excerpt was released on 2019-05-03, modified on 2021-06-07, translated/reviewed by: Wayne Zheng et al.)
Source: https://www.chinesestandard.net/PDF.aspx/YY0331-2006