YY/T 1571-2017 PDF English
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YY/T 1571-2017: Tissue engineering medical device products - Sodium hyaluronate---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1571-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.40
C 45
Replacing YY/T 0606.9-2007
Tissue engineering medical device products - Sodium
hyaluronate
Issued on. MAY 02, 2017
Implemented on. APRIL 01, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword... 3
1 Scope... 6
2 Normative references... 6
3 Terms and definitions... 7
4 Classification... 7
5 Requirements... 8
6 Test methods... 10
7 Marking... 14
8 Packaging, transportation and storage... 15
Appendix A (Normative) Determination of sodium hyaluronate content... 16
Appendix B (Normative) Determination of protein content... 19
Appendix C (Normative) Determination of residual ethanol (headspace gas
chromatography)... 21
Appendix D (Informative) Determination of residual quaternary ammonium salt
(cetylpyridinium chloride)... 23
Appendix E (Normative) Determination of weight-average molecular weight and
molecular weight distribution coefficient... 26
References... 28
Foreword
This Standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This Standard replaces YY/T 0606.9-2007, Tissue engineered medical products - Part
9.Sodium hyaluronate. Compared with YY/T 0606.9-2007, the major technical
changes are as follows.
-- Change the standard name to Tissue engineering medical device products - Sodium
hyaluronate;
-- Delete the normative references of YY/T16886 series (only reserve YY/T 16886.1)
(see Chapter 2; Chapter 2 of the 2007 edition);
-- Add the normative references YY/T 0771.1 ~ 0771.3, Medical devices utilizing
animal tissues and their derivatives (see Chapter 2);
-- Revise the edition year number of “Pharmacopeia of the People’s Republic of
China” in the normative references (see Chapter 2; Chapter 2 of the 2007 edition);
-- Modify the molecular formula (structural unit) of sodium hyaluronate (see 3.2; 3.2
of the 2007 edition);
-- Modify the requirements and test methods for sodium hyaluronate content (see
5.3, 6.3 and Appendix A; 5.3, 6.3 and Appendix A of the 2007 edition);
-- Modify the requirements for intrinsic viscosity and the molecular weight symbol
M in the formula of the test method (see 5.5, 6.5; 5.5, 6.5 of the 2007 edition);
-- Delete the requirements and test methods for dynamic viscosity (see 5.6 and 6.6
of the 2007 edition);
-- Modify the test method for protein content (see 6.6 and Appendix B; 6.7 and
Appendix B of the 2007 edition);
-- Add the requirements and test methods for nucleic acids (see 5.7 and 6.7);
-- Modify the test method for heavy metal content (see 6.8; 6.8 of the 2007 edition);
-- Modify the requirements and test methods for residual ethanol (see 5.9, 6.9 and
Appendix C; 5.9, 6.9 and Appendix C of the 2007 edition);
-- Delete the requirements and test methods for ash content (see 5.11 and 6.11 of the
2007 edition);
-- Delete the requirements and test methods for ultraviolet absorption (see 5.12 and
6.12 of the 2007 edition);
-- Modify the requirements and test methods for dry matter content (see 5.10, 6.10;
5.10, 6.10 of the 2007 edition);
-- Add the requirements and test methods for quaternary ammonium salt residues
(see 5.11, 6.11 and Appendix D);
-- Add the requirements and test methods for sulfated mucopolysaccharides (see 5.12
and 6.12);
-- Add the requirements and test methods for iron content (see 5.13 and 6.13);
-- Add the requirements and test methods for chlorides (see 5.14 and 6.14);
-- Add the requirements and test methods for weight-average molecular weight and
molecular weight distribution coefficient (see 5.15, 6.15 and Appendix E);
-- Add the requirements and test methods for the clarity and color of solution (see
5.16 and 6.16);
-- Add the requirements and test methods for microbial limit (see 5.18, 6.18);
-- Modify the requirements and test methods for bacterial endotoxin limit (see 5.19,
6.19; 5.14, 6.14 of the 2007 edition);
-- Modify the requirements and test methods for raw material safety (see 5.20, 6.20,
6.21; 5.15, 6.15 of the 2007 edition);
-- Delete the specific requirements and test methods for biological evaluation, only
retaining the general principles (see 5.21; 5.16 and 6.16 of the 2007 edition);
-- Delete Chapter 7 Inspection rules (see Chapter 7 of the 2007 edition);
-- Delete the background information of Appendix D (see Appendix D of the 2007
edition);
-- Add the references “Guiding Principles for Registration and Declaration of
Medical Device Products Utilizing Animal Tissues and Their Derivatives” and
European Pharmacopoeia (see References);
-- Modify the version number of the reference ASTM F2347-03 (see References;
References of the 2007 edition).
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 Standard was proposed by State Food and Drug Administration.
This Standard shall be under the jurisdiction of Subcommittee on Tissue Engineering
Medical Device Products of National Technical Committee 110 on Implants for Surgery
and Orthopedic Devices of Standardization Administration of China.
Drafting organizations of this Standard. Bloomage Biotechnology Corporation Limited,
National Institute for Food and Drug Control, Shanghai Qisheng Biological Preparation
Co., Ltd.
Main drafters of this Standard. Guo Xueping, Mu Shu’e, Jiang Lixia, Xu Liming, Wei
Changzheng, Wang Xiujuan, Shao Anliang.
The previous version replaced by this Standard is.
-- YY/T 0606.9-2007.
Tissue engineering medical device products - Sodium
hyaluronate
1 Scope
This Standard specifies the requirements and test methods for sodium hyaluronate used
in surgical implants and tissue engineering medical device products.
This Standard applies to the preparation of sodium hyaluronate for tissue engineering
medical device products and their scaffold materials.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies to this document. For
undated references, the latest edition (including any amendment) applies to this
document.
GB/T 191, Packaging - Pictorial marking for handling of goods
GB/T 14518, Determination of the pH of adhesives
GB/T 16886.1, Biological evaluation of medical devices - Part 1.Evaluation and
testing within a risk management process (GB/T 16886.1-2011, ISO 10993-1.2009,
IDT)
GB 18278 (all parts), Sterilization of health care products - Moist heat
GB 18279 (all parts), Sterilization of health care products - Ethylene oxide
GB 18280 (all parts), Sterilization of health care products - Radiation
YY/T 0313, Medical polymer products - Requirement for package and information
supplied by manufacturer
YY/T 0606.25, Tissue engineered medical product - Part 25.Quantification of
remnant DNA in biological materials utilizing animal tissues and their derivatives.
Fluorescence method
YY/T 0771.1, Medical devices utilizing animal tissues and their derivatives - Part 1.
Application of risk management (YY/T 0771.1-2009, ISO 22442-1.2007, IDT)
YY/T 0771.2, Medical devices utilizing animal tissues and their derivatives - Part 2.
Controls on sourcing, collection and handling (YY/T 0771.2-2009, ISO 22442-
2.2007, IDT)
3 Terms and definitions
The following terms and definitions are applicable to this document.
3.1 Hyaluronic acid
A linear polysaccharide that is composed of disaccharide repeating structural units of
D-glucuronic acid and N-acetyl-D-glucosamine linked by β-(1-3) glycosidic bonds.
Each disaccharide unit is linked to the other by a β-(1-4) glycosidic bond.
4 Classification
The preparation process of sodium hyaluronate can be divided into tissue extraction
method and bacterial fermentation method according to different raw material sources
and preparation methods.
5 Requirements
5.1 Appearance
White or off-white powder or granular or fibrous solid, without any visible foreign
matter.
5.3 Sodium hyaluronate content
Based on the dry product, the content of sodium hyaluronate shall be 95.0% ~ 105.0%
(mass fraction).
5.4 pH
The pH of the 0.5% concentration solution shall be 5.0 ~ 8.5.
5.5 Intrinsic viscosity
It shall be 90% ~ 120% of its marked value.
5.6 Protein content
It shall not exceed 0.1% (mass fraction).
5.7 Nucleic acid content
5.8 Heavy metal content
It shall not exceed 10 μg/g (mass fraction).
5.9 Residual amount of ethanol
It shall not exceed 4 000 μg/g (mass fraction).
5.13 Iron content
It shall not exceed 80 μg/g.
5.14 Chlorine content
It shall not exceed 0.5%.
5.15 Weight-average molecular weight and molecular weight distribution
coefficient
The weight-average molecular weight of sodium hyaluronate shall be within the range
indicated by the manufacturer, and the distribution coefficient 𝑀ௐതതതതത/𝑀തതതത shall be 1.0 ~
3.0.
5.18 Microbiological examination
The number of bacterial colonies per 1 g of the test product shall not exceed 102 CFU;
the number of mold and yeast colonies shall not exceed 20 CFU. Staphylococcus aureus,
Pseudomonas aeruginosa and Escherichia coli shall not be detected.
5.19 Bacterial endotoxins
The amount of endotoxin contained per 1 mg of sodium hyaluronate shall be less than
0.05 EU.
5.20 Raw material safety
6 Test methods
6.1 Appearance
Perform direct observation with the naked eye, which shall comply with the provisions
of 5.1.
6.3 Determination of sodium hyaluronate content
Measure according to the method specified in Appendix A, which shall comply with
the provisions of 5.3.
6.4 pH determination
Use distilled water to prepare sodium hyaluronate (based on the dry product) to a
solution of concentration 5 mg/mL; measure according to the method specified in GB/T
14518, which shall meet the requirements of 5.4.
6.6 Determination of protein content
Measure according to the method specified in Appendix B, which shall comply with
the provisions of 5.6.
6.7 Determination of nucleic acid
Take this product (equivalent to 0.10 g of dry product); add 30 mL of 0.9% sodium
chloride solution; oscillate to mix and dissolve it as the test solution.
6.8 Determination of heavy metal content
Take 1.0 g of this product; measure it according to method II stipulated in the general
rule 0821 of Pharmacopoeia of the People’s Republic of China (2015 Edition, Volume
IV), which shall meet the requirements of 5.8.
6.11 Determination of quaternary ammonium residues
Measure by referring to the method specified in Appendix D, which shall comply with
the provisions of 5.11.
6.12 Determination of sulfated mucopolysaccharides
Test solution. Take about 50.0 mg of this product (based on the dry product); add 1.0
mL of perchloric acid to a stoppered test tube (length is 5 cm; inner diameter is 1.6 cm);
dissolve it; use it as the test solution.
6.13 Determination of iron content
Take 0.25 g of this product (based on the dry product); add 1.0 mL of nitric acid; heat
it in a water bath to dissolve; prepare 5 portions in parallel; after cooling, add water to
one part to dilute to 10 mL as the test solution, and add 0.5 mL, 1.0 mL, 1.5 mL and 2.0
mL of iron standard solution (each 1.0 mL is equivalent to 10 μg/mL iron) to the other
4 portions, respectively;
6.16 Determination of clarity and color of solution
Take 0.10 g of this product (based on the dry product); add 30 mL of 0.9% sodium
chloride solution; shake to mix and dissolve, which shall meet the requirements of 5.16.
6.17 Sterility test
Measure according to the method specified in the general rule 1101 of Pharmacopoeia
of the People’s Republic of China (2015 Edition, Volume IV), which shall meet the
requirements of 5.17.
6.18 Microbial limits
Take 5.0 g of this product; add 100 mL of sterile phosphate buffered saline (pH 7.2)
containing 45 000 units of hyaluronidase; shake and dissolve in a water bath at 42 °C
for 1 h, to obtain a 1.20 test solution. Measure according to the method specified in the
general rules 1105 and 1106 of Pharmacopoeia of the People’s Republic of China (2015
Edition, Volume IV), which shall meet the requirements of 5.18.
7 Marking
7.1 The outer package shall have the following markings.
7.2 The small package shall have the following markings.
7.3 The storage marking shall comply with the provisions given in GB/T 191.
Note. Refer to the graphic symbols given in YY 0466.1, which shall meet the above
requirements.
8 Packaging, transportation and storage
8.1 Packaging shall be appropriate, to ensure the safety and effectiveness of sodium
hyaluronate products.
...... Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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