YY/T 0962-2021Cross-linked sodium hyaluronate gel for plastic surgery (English PDF)
整形手术用交联透明质酸钠凝胶
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
September 6, 2021
Implementation date
September 1, 2022
Scope
YY/T 0962-2021 is the English-translated version of 整形手术用交联透明质酸钠凝胶.
YY/T 0962-2021 is the Chinese pharmaceutical industry standard for cross-linked sodium hyaluronate gel used in plastic surgery, the injectable gel used to fill skin and subcutaneous tissue.
It sets the requirements for the materials it is made from and for the finished gel, the inspection methods, the packaging and the information the manufacturer must provide.
Two normative appendices give the determination of the pushing force needed to inject the gel through its needle and the determination of the degree of swelling, properties that govern how the product handles and how it behaves once implanted.
It replaces YY/T 0962-2014, was issued on 6 September 2021 and has applied since 1 September 2022.
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Document preview — YY/T 0962-2021
National Standard of the People's Republic of China
- Replacing
- YY/T 0962-2014
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope5
- 2 Normative References5
- 3 Terms and Definitions5
- 4 Requirements for Materials6
- 5 Requirements6
- 6 Inspection Methods8
- 7 Packaging10
- 8 Markings10
- Appendix A (Normative) Determination of Pushing Force13
- Appendix B (Normative) Determination of Swelling Degree14
- Appendix C (Normative) Determination of Sodium Hyaluronate Content15
- Appendix D (Normative) Determination of Protein Content18
- Appendix E (Normative) Determination of Residual Amount of Crosslinking Agent 1,4-Butanediol Diglycidyl Ether (BDDE)20
- Appendix F (Normative) Determination of Free Sodium Hyaluronate Content24
Foreword
This Standard was drafted as per the rules specified in GB/T 1.1-2009.
This Standard replaced YY/T 0962-2014 Cross-Linked Sodium Hyaluronate Gel for Plastic Surgery. Compared with YY/T 0962-2014, the major technical changes of this Standard are as follows besides the editorial modifications.
--- Modify the Scope (see Clause 1 of this Edition; Clause 1 of 2014 Edition);
--- Modify the Normative References and the edition year number of Pharmacopoeia of the People's Republic of China (see Clause 2 of this Edition; Clause 2 of 2014 Edition);
--- Modify the test method for appearance (see 6.1 of this Edition; 6.1 of 2014 Edition);
--- Modify the requirements and test methods for particle size distribution (see 5.3, 6.3 of this Edition; 5.3, 6.3 of 2014 Edition);
--- Modify the requirements and test methods for pushing force (see 5.4, 6.4 and Appendix A of this Edition; 5.4, 6.4 and Appendix B of 2014 Edition);
--- Modify the requirements and test methods for infrared identification (see 5.5, 6.5 of this Edition; 5.5, 6.5 and Appendix C of 2014 Edition);
--- Modify the requirements for osmotic pressure (see 5.7 of this Edition; 5.7 of 2014 Edition);
--- Modify the requirements for pH value (see 5.8 of this Edition; 5.8 of 2014 Edition);
--- Modify the requirements and test methods of content (see 5.9, 6.9 of this Edition; 5.9, 6.9 of 2014 Edition);
--- Modify requirements and test methods of protein (see 5.10, 6.10 and Appendix D of this Edition; 5.10 and 6.10 of 2014 Edition);
--- Modify the test method for swelling degree (see 6.6 and Appendix B of this Edition; 6.6 and Appendix D of 2014 Edition);
--- Modify the test method for the total amount of heavy metals (see 6.11 of this Edition;
6.11 of 2014 Edition);
--- Modify the test method for residual cross-linking agent (see 6.12 and Appendix E of this Edition; 6.12 and Appendix F of 2014 Edition);
--- Modify the requirements and test methods for free sodium hyaluronate content (see 5.13, 6.13 and Appendix F of this Edition; 5.13, 6.13 and Appendix G of 2014 Edition);
--- Modify the requirements and test methods for other additives (see 5.14 and 6.14 of this Edition; 5.13 and 6.13 of 2014 Edition);
--- Delete the inspection rules (see Clause 7 of 2014 Edition).
Please note some contents of this Document may involve patents. The issuing agency of this Document shall not assume the responsibility to identify these patents.
1 Scope
This Standard specifies the requirements, inspection methods, packaging and information provided by the manufacturer of cross-linked sodium hyaluronate gel for plastic surgery (hereinafter referred to as cross-linked sodium hyaluronate gel). This Standard applies to cross-linked sodium hyaluronate gel.
NOTE. Cross-linked sodium hyaluronate gel is suitable for filling of skin and subcutaneous tissue.
2 Normative References
The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) is applicable to this document.
GB/T 16886.1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process
YY/T 1571 Tissue Engineering Medical Device Products - Sodium Hyaluronate Pharmacopoeia of the People's Republic of China (IV Volumes) 2020 Edition
3 Terms and Definitions
For the purposes of this Document, the following terms and definitions apply.
3.1 Hyaluronic acid
A linear polysaccharide that is composed of disaccharide repeating structural units formed by connecting D-glucuronic acid and N-acetyl-D-glucosamine through beta-(1-3) glycosidic bond.
Each disaccharide unit is linked to another disaccharide unit by a beta-(1-4) glycosidic bond.
Hyaluronic acid generally exists in the form of sodium salt, namely sodium hyaluronate.
3.2 Cross-linking agent
Substance that is used for cross-linking of sodium hyaluronate.
3.3 Cross-linked sodium hyaluronate gel
The gel that is formed by the chemical reaction between sodium hyaluronate and the cross- linking agent.
4 Requirements for Materials
The used materials shall meet the requirements of YY/T 1571.
5 Requirements
5.1 Appearance
It shall be colorless, transparent, without any foreign matter visible to the naked eye.
5.2 Effective usage amount
The measured value shall be between 90% and 120% of the indicated loading.
5.3 Particle size distribution (if applicable)
The particle size distribution D50, D90 shall be within the nominal value range.
NOTE. D50.The particle size corresponding to the cumulative particle size distribution percentage of a sample reaching 50%. Its physical meaning is that the particles with a particle size larger than it account for 50%, and the particles smaller than it also account for 50%. D50 is also called the median particle diameter or median particle size. D50 is often used to represent the average particle size of the powder.
D90.The particle size corresponding to the cumulative particle size distribution percentage of a sample reaches 90%. Its physical meaning is that particles with a particle size smaller than it account for 90%.
D90 is often used to represent the particle size of the butt end of the powder.
5.4 Pushing force
The maximum pushing force, the minimum pushing force and the average pushing force shall be within the nominal value range.
5.5 Infrared identification
The characteristic peaks in the infrared spectrum specified by the manufacturer shall be met.
5.6 Swelling degree
It shall be within the nominal value range. If not applicable, use other suitable methods to characterize the degree of crosslinking.
5.7 Osmotic pressure
The molar concentration of osmotic pressure shall be 200mOsmol/kg ~ 400mOsmol/kg.
5.8 pH value
It shall be in the range of 6.0~7.6.
5.9 Sodium hyaluronate content
It shall be between 90% and 120% of the indicated value.
5.10 Protein
The protein content of the cross-linked sodium hyaluronate gel shall be no greater than 20µg/g.
5.11 Total amount of heavy metals
The total amount of heavy metals (calculated by Pb2+) shall be no greater than 5µg/g.
5.12 Residual amount of cross-linking agent
The residual amount of cross-linking agent shall be the one including the sodium hyaluronate particles. The residual amount of cross-linking agent 1,4-butanediol diglycidyl ether [referred to as (BDDE)] shall be no greater than 2.0µg/g. If other cross-linking agents are used, limit requirements and inspection methods shall be provided.
5.13 Free sodium hyaluronate content
It shall be within the nominal value range.
5.14 Other additives
If other additives are added in the production process, their limit requirements and inspection methods shall be provided.
5.15 Sterile
It shall be sterile.
5.16 Bacterial endotoxin
It shall be less than 0.5EU/mL.
5.17 Hemolytic streptolysin
There shall be no hemolytic ring.
6 Inspection Methods
6.1 Appearance
The cross-linked sodium hyaluronate gel is placed under the illumination of 1000lx~1500lx for random rotation observation, which shall comply with the provisions of 5.1.
6.2 Effective usage amount
Take out the cross-linked sodium hyaluronate gel in each single package as much as possible according to the normal use method; weigh it and then divide it by the density of the cross- linked sodium hyaluronate gel (rho=1.01g/mL), which shall comply with the provisions of 5.2.
6.3 Particle size distribution
It shall be determined according to Determination Method of 0982 Particle Size and Particle Size Distribution - The Third Method (Light Scattering Method) - Wet Method in Pharmacopoeia of the People's Republic of China (VI Volumes) (2020 Edition), and shall comply with the provisions of 5.3.
6.4 Pushing force
Determined according to the method in Appendix A, it shall comply with the provisions of 5.4.
6.5 Infrared identification
Dry an appropriate amount of cross-linked sodium hyaluronate gel by freeze-drying method, ethanol precipitation and drying method or direct drying method (80°C and below); and then use potassium bromide to press into tablets; and then it shall be determined according to the 0402 Infrared Spectrophotometry in Pharmacopoeia of the People's Republic of China (IV Volumes) (2020 Edition), and shall comply with the provisions of 5.5.
6.6 Swelling degree
Determined according to the method in Appendix B, it shall comply with the provisions of 5.6.
6.7 Osmotic pressure
Direct sampling, it shall be determined according to the Determination Method of 0632 Molar Concentration of Osmotic Pressure in Pharmacopoeia of the People's Republic of China (VI Volumes) (2020 Edition), and shall comply with the provisions of 5.7.
6.8 pH value
The cross-linked sodium hyaluronate gel is diluted with purified water in an equal mass ratio; and it is determined according to the Determination Method of 0631 pH Value in Pharmacopoeia of the People's Republic of China (VI Volumes) (2020 Edition), and shall comply with the provisions of 5.8.
6.9 Sodium hyaluronate content
Determined according to the method in Appendix C, it shall comply with the provisions of 5.9.
6.10 Protein
Determined according to the method in Appendix D, it shall comply with the provisions of 5.10.
6.11 Total amount of heavy metals
It shall be determined according to the Second Method of 0821 Heavy Metal Inspection Method in Pharmacopoeia of the People's Republic of China (VI Volumes) (2020 Edition), and shall comply with the provisions of 5.11.
6.12 Residual amount of cross-linking agent
Determined according to the method in Appendix E, it shall comply with the provisions of 5.12.
If other cross-linking agents are used, limit requirements and inspection methods shall be provided.
The test methods for the residual amount of all cross-linking agents shall be able to detect the residual amount of cross-linking agent in the cross-linked sodium hyaluronate particles together.
6.13 Free sodium hyaluronate content
Determined according to the method in Appendix F, it shall comply with the provisions of 5.13.
6.14 Other additives
If other additives are added in the production process, their limit requirements and inspection methods shall be provided.
6.15 Sterile
It shall be inspected according to the 1101 Sterility Inspection Method in Pharmacopoeia of the People's Republic of China (VI Volumes) (2020 Edition), and shall comply with the provisions of 5.15.
7 Packaging
The single package of cross-linked sodium hyaluronate gel shall be packaged in one-time dosage; and the convenient package design is preferred. Appropriate packaging, such as putting into glass syringes, protective caps on the cones of the syringes, and then packaged in a single- pack container (bag or plastic blister). The plunger in the syringe is preferably made of butyl rubber.
8 Markings
8.1 The following marks shall be on the single package.
a) product name or trademark;
b) name and address of the manufacturer;
c) product registration number;
d) specifications;
e) production batch number or date;
f) expiry date;
g) words or diagrams such as "sterile", "single-use" and "prohibited to use if the package is damaged"; h) storage conditions.
8.2 The outer (large, medium) packaging shall have the following markings.
a) The name and address of the manufacturer;
b) product names and trademarks;
c) product registration number;
d) production batch number or date;
e) specifications;
f) expiry date;
g) storage conditions;
h) volume and weight;
i) words or marks such as "temperature limit" and "humidity limit".
8.3 At least two additional labels shall be included on the surgical record and contact card. Additional labels shall list.
a) product name and trade name;
b) manufacturer's name and address;
c) product serial number and/or batch number;
d) injection site and injection volume;
e) patient name and contact details.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.
Referenced standards
Similar standards
Editions of YY/T 0962
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY/T 0962-2021 | Cross-linked sodium hyaluronate gel for plastic surgery | current edition | Current |
| YY/T 0962-2014 | Cross-linked sodium hyaluronate gel for plastic surgery | previous edition | Superseded |
This page sells the current edition, YY/T 0962-2021. Earlier editions are listed for reference only.
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Related Standards
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
YY/T 1571-2017 — Tissue engineering medical device products—Sodium hyaluronate
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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