YY/T 1511-2017 PDF in English
YY/T 1511-2017 (YY/T1511-2017, YYT 1511-2017, YYT1511-2017)
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Collagen sponge
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YY/T 1511-2017: PDF in English (YYT 1511-2017) YY/T 1511-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.120.20
C 48
Collagen Sponge
ISSUED ON. MAY 2, 2017
IMPLEMENTED ON. APRIL 1, 2018
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 Biocompatibility ... 7
6 Test Methods ... 7
7 Marking ... 9
8 Packaging ... 9
Appendix A (normative appendix) ... 11
Appendix B (normative appendix) ... 15
References ... 17
Collagen Sponge
1 Scope
This Standard specifies performance requirements and test methods of collagen
sponge.
This Standard is applicable to sterile collagen sponge.
This Standard is not applicable to sponge prepared with genetically engineered
collagen and collagen sponge that contains other materials.
2 Normative References
The following documents are indispensable to the application of this Standard. In terms
of references with a specified date, only versions with a specified date are applicable
to this Standard. The latest version (including all the modifications) of references
without a specified date is also applicable to this Standard.
GB/T 6682 Water for Analytical Laboratory Use - Specification and Test Methods
GB/T 16886.1 Biological Evaluation of Medical Devices - Part 1. Evaluation and
Testing Within a Risk Management Process
YY/T 0466.1 Medical Devices - Symbols to be Used with Medical Device Labels,
Labeling and Information to be Supplied - Part 1. General Requirements
YY/T 0615.1 Requirements for Medical Devices to be Designated STERILE - Part
1. Requirements for Terminally Sterilized Medical Devices
Pharmacopoeia of the People’s Republic of China (Version 2010), Volume I,
Volume II
ISO 11607-1.2006 Packaging for Terminally Sterilized Medical Devices - Part 1.
Materials, Sterile Barrier Systems and Packaging Systems1
3 Terms and Definitions
The following terms and definitions are applicable to this document.
3.1 Collagen Sponge
1 ISO 11607-1 is equivalent to Chinese Standard GB 19633. Its latest version has been submitted for approval.
Please follow the issue of this standard.
substances; hydroxyproline content in collagen sponge shall be more than 9% of total
protein content.
4.9 Tensile Strength
In the test that is conducted in accordance with 6.7, 1 cm width collagen strip can
undertake 0.5 N of tensile force and maintain unruptured in 1 min.
4.10 Crosslinker Residue
If manufacturers adopt chemical reagents for crosslinking, limitation requirements and
test methods of crosslinker residue shall be established.
4.11 Digestibility
Manufacturers can conduct the test in accordance with 6.8; average digestion time can
be adopted to evaluate product’s in-vitro degradation.
4.12 Sterilization
Collagen sponge shall be in sterile supply; collagen sponge shall comply with
requirements in YY/T 0615.1.
5 Biocompatibility
Conduct biological evaluation of collagen sponge in accordance with stipulations in
GB/T 16886.1. The result shall suggest that there is no unacceptable biological hazard.
6 Test Methods
6.1 General Rules
All tests shall be conducted under the ultimate form of materials.
Unless it is otherwise stipulated, all reagents shall be analytical pure; test water shall
comply with the requirements of Grade-2 water stipulated in GB/T 6682.
6.2 Test of Loss on Drying
Take around 0.5 g of sample; conduct the test in accordance with drying mass loss
determination method in Appendix VIII L in Volume II of Pharmacopoeia of the People’s
Republic of China (Version 2010).
6.3 Test of Liquid Absorption
Take around 20 mg of sample; weigh it accurately; record as m1. Soak it in a beaker
that contains 20 °C ± 1 °C water. Use fingers to slightly rub it, till it is completely soaked,
Avoid causing any damage to the sample. Take it out, then, use filter paper to remove
surplus water. Place the moist sample into a 150 mL triangle bottle that has a plug.
The bottle already contains 100 mL of hydrochloric acid solution [c(HCl) = 0.1 mol/L]
that is pre-heated to 37 °C ± 1 °C, mass fraction. 1% pepsin (activity. around 3,000
U/mg). At 37 °C ± 1 °C, slightly shake it at around 150 r/min, till it is completely digested.
Repeat the operation for 2 times. Report the average time of 3 complete digestions.
7 Marking
7.1 General Rules
Symbols that satisfy the requirements in 7.2 and 7.3, and stipulations in YY/T 0466.1
can be adopted.
7.2 Individual Packaging
a) Name and specification of contents;
b) Sterile and sterilization mode;
c) Information like one-time use only and prohibited use after package damage;
d) Expiration date;
e) Name and address of manufacturer;
f) Batch number or date of production.
7.3 Shelf Packaging
Shelf packaging shall at least include the following information.
a) Name and specification of contents;
b) Sterile and sterilization mode;
c) Information like one-time use only and prohibited use after package damage;
d) Expiration date;
e) Name and address of manufacturer;
f) Batch number or date of production.
8 Packaging
8.1 Manufacturers shall be able to provide a certificate, proving the package that holds
Appendix A
(normative appendix)
The Determination of Protein Content with Kjeldahl Method
A.1 Principle
Through the determination of total nitrogen content in the test sample and non-protein
content in the sample filtrate, in which, protein is removed through the method of
tungstic acid precipitation, calculate the protein content.
A.2 Instruments and Equipment
Analytical balance, azotometer, Kjeldahl tube, digestion furnace, fume cupboard or
equivalent equipment.
A.3 Chemical Reagents
a) Concentrated sulfuric acid. analytical purity, relative density. 1.84.
b) Digestive agent. weigh-take 10 g of copper sulfate (CuSO45H2O) and 100 g of
potassium sulfate; place it in a mortar; porphyrize them together, then, mix them
up.
c) 50% sodium hydroxide solution. take 500 g of sodium hydroxide, place it in a
volumetric flask; add distilled water to 1,000 mL; evenly shake it.
d) Mixed indicator. mix 5 PCS of 0.2% bromocresol green ethanol solution and 2
PCS of 0.1% methyl red ethanol solution.
e) 2% boric acid absorption liquid. weigh-take 20 g of boric acid, place it in a
volumetric flask; add distilled water to dissolve it into 1,000 mL. Add 10 mL of
d) mixed indicator; mix it up.
f) Sulfuric acid titration solution [c(H2SO4) = 0.05 mol/L]. take 3 mL of sulfuric acid,
slightly inject it into an appropriate amount of water; cool down to room
temperature; add water to dilute to 1,000 mL, then, shake it up. Take around 0.15
g of benchmark anhydrous sodium carbonate that is dried to constant weight at
270 °C ~ 300 °C, weigh it accurately. Add 50 mL of water to dissolve it; add 10
drops of methyl red-bromocresol chlorine mixed indicator. Use sulfuric acid
titration solution to titrate it, till the solution turns from green to purple red. Boil
for 2 min; cool down to room temperature. Continue to titrate, till the solution
turns from green to dark purple. Every 1 mL of sulfuric acid titration solution is
equivalent to 5.30 mg of anhydrous sodium carbonate. In accordance with the
consumption of sulfuric acid titration solution and the dosage of anhydrous
brown bottle for storage.
g) Sodium hydroxide solution [c(NaOH) = 6 mol/L]. weigh-take 24.0 g of sodium
hydroxide; use water to dissolve and dilute to 100 mL.
h) Hydrochloric acid solution [c(HCl) = 6 mol/L]. take 54 mL of hydrochloric acid;
add water to dilute to 100 mL.
i) Methyl red indicator. take 0.1 g of methyl red, then, add 7.4 mL of 0.05 mol/L
sodium hydroxide solution to dissolve it. Add water to dilute to 200 mL. The
range of discoloration shall be. pH 4.2 ~ 6.3 (redyellow).
j) Hydrochloric acid solution [c(HCl) = 0.001 mol/L]. take 9 mL of hydrochloric acid;
add water to dilute to 100 mL. Thus, obtain 1 mol/L hydrochloric acid solution.
Take another 1 mL of 1 mol/L hydrochloric acid solution; add water to dilute to
1,000 mL.
B.4 Test Methods
B.4.1 Sample processing
Take around 25 mg of collagen sponge sample, weigh it accurately; place it in a test
tube (or an ampoule) with a plug. Add 4 mL of 6 mol/L hydrochloric acid solution; seal
it up; place it in a drying oven at 110 °C, then, start hydrolysis for 24 h. Take it out, cool
it down, then, open the sealing. Add 1 drop of methyl red indicator to make it red. Use
6 mol/L sodium hydroxide solution to neutralize it, till the solution turns yellowish. Add
water to dilute to 250 mL, then, filter it. It shall work as sample test solution.
B.4.2 Determination
Take 0.5 mL of sample test solution, place it in a colorimetric tube with a plug, then,
add 0.5 mL of water. It shall work as sample solution. Add 2 mL of isopropanol and 1
mL of oxidant solution; shake it up; place it at room temperature for 4 min, so that it
can be oxidized. Add 2 mL of Ehrilich reagent, put on the plug, then, shake it up. Place
it in water bath at 60 °C; heat it up. 20 min after color development, place it at room
temperature for 1 h. Use a 1 cm colorimetric cuvette; determine absorbance at 560 nm.
Use reagent for blank correction.
B.5 Standard Curve
Respectively take 0 mL, 0.2 mL, 0.4 mL, 0.6 mL, 0.8 mL, 1.0 mL of standard solution;
add them to 6 colorimetric tubes (hydroxyproline content shall respectively be. 0 μg, 2
μg, 4 μg, 6 μg, 8 μg, 10 μg). Respectively add 1.0 mL, 0.8 mL, 0.6 mL, 0.2 mL, 0.0 mL
of distilled water. In accordance with the steps described in B.4.2, follow the operation,
starting from “add 2 mL of isopropanol”; determine the absorbance; draw a standard
curve.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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