YY/T 0962-2021 PDF English
US$395.00 · In stock · Download in 9 secondsYY/T 0962-2021: Cross-linked sodium hyaluronate gel for plastic surgery Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid YY/T 0962: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY/T 0962-2021 | English | 395 |
Add to Cart
|
0-9 seconds. Auto-delivery
|
Cross-linked sodium hyaluronate gel for plastic surgery
| Valid |
| YY/T 0962-2014 | English | 150 |
Add to Cart
|
0-9 seconds. Auto-delivery
|
Cross-linked sodium hyaluronate gel for plastic surgery
| Obsolete |
Excerpted PDFs (Download full copy in 9 seconds upon purchase)PDF Preview: YY/T 0962-2021
YY/T 0962-2021: Cross-linked sodium hyaluronate gel for plastic surgery---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/YYT0962-2021
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.40
C 45
Replacing YY/T 0962-2014
Cross-Linked Sodium Hyaluronate Gel for Plastic Surgery
Issued on: SEPTEMBER 06, 2021
Implemented on: SEPTEMBER 01, 2022
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
1 Scope... 5
2 Normative References... 5
3 Terms and Definitions... 5
4 Requirements for Materials... 6
5 Requirements... 6
6 Inspection Methods... 8
7 Packaging... 10
8 Markings... 10
Appendix A (Normative) Determination of Pushing Force... 13
Appendix B (Normative) Determination of Swelling Degree... 14
Appendix C (Normative) Determination of Sodium Hyaluronate Content... 15
Appendix D (Normative) Determination of Protein Content... 18
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 Content... 24
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.
This Standard was proposed by National Medical Products Administration.
This Standard shall be under the jurisdiction of National Technical Committee on Implants for
Surgery and Orthopedic Devices of Standardization Administration of China (SAC/TC 110).
Drafting organizations of this Standard. China Research Institute of Food and Drug Verification;
Beijing Montblanc Biotechnology Co., Ltd.; Bloomage Biotechnology Corporation Limited;
Hangzhou Singclean Medical Products Co., Ltd.; Beijing Institute of Medical Device Testing;
Shanghai Qisheng Biological Preparation Co., Ltd.; Imeik Technology Development Co., Ltd.;
and Zhejiang Jingjia Medical Technology Co., Ltd.
Chief drafting staffs of this Standard. Wang Zhaoxu, Fu Bufang, Meng Yichun, Guo Xueping,
Wang Jin, Sun Weiqing, Liu Xi, Guo Panpan, Chen Xiongwe, Yu Hao, Hua Fei, and Gu Qisheng.
The historical edition replaced by this Standard is as follows.
--- YY/T 0962-2014.
Cross-Linked Sodium Hyaluronate Gel for Plastic Surgery
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 β-(1-3) glycosidic bond.
Each disaccharide unit is linked to another disaccharide unit by a β-(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 (ρ=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.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
Tips & Frequently Asked QuestionsQuestion 1: How long will the true-PDF of English version of YY/T 0962-2021 be delivered?Answer: The full copy PDF of English version of YY/T 0962-2021 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice. Question 2: Can I share the purchased PDF of YY/T 0962-2021_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0962-2021_English will be deemed to be sold to your employer/organization who actually paid for it, including your colleagues and your employer's intranet. Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. www.ChineseStandard.us -- YY/T 0962-2021 -- Click this link and select your country/currency to pay, the exact amount in your currency will be printed on the invoice. Full PDF will also be downloaded/emailed in 9 seconds. Question 5: Should I purchase the latest version YY/T 0962-2021?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0962-2021 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically. How to buy and download a true PDF of English version of YY/T 0962-2021?A step-by-step guide to download PDF of YY/T 0962-2021_EnglishStep 1: Visit website https://www.ChineseStandard.net (Pay in USD), or https://www.ChineseStandard.us (Pay in any currencies such as Euro, KRW, JPY, AUD).
Step 2: Search keyword "YY/T 0962-2021".
Step 3: Click "Add to Cart". If multiple PDFs are required, repeat steps 2 and 3 to add up to 12 PDFs to cart.
Step 4: Select payment option (Via payment agents Stripe or PayPal).
Step 5: Customize Tax Invoice -- Fill up your email etc.
Step 6: Click "Checkout".
Step 7: Make payment by credit card, PayPal, Google Pay etc. After the payment is completed and in 9 seconds, you will receive 2 emails attached with the purchased PDFs and PDF-invoice, respectively.
Step 8: Optional -- Go to download PDF.
Step 9: Optional -- Click Open/Download PDF to download PDFs and invoice.
See screenshots for above steps: Steps 1~3 Steps 4~6 Step 7 Step 8 Step 9
|