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Medical sodium hyaluronate dressing
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Basic data
| Standard ID | YY/T 1938-2024 (YY/T1938-2024) |
| Description (Translated English) | Medical sodium hyaluronate dressing |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C48 |
| Classification of International Standard | 11.120.20 |
| Word Count Estimation | 14,129 |
| Date of Issue | 2024-09-29 |
| Date of Implementation | 2025-10-15 |
| Issuing agency(ies) | State Drug Administration |
| Summary | This standard specifies the requirements, marking and packaging of medical sodium hyaluronate dressings, and specifies the corresponding test methods. This standard applies to medical sodium hyaluronate dressings. This standard does not apply to medical sodium hyaluronate dressings containing antibacterial and drug ingredients. |
YY/T 1938-2024: Medical sodium hyaluronate dressing
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.120.20
CCSC48
Pharmaceutical Industry Standards of the People's Republic of China
Medical Sodium Hyaluronate Dressing
Released on 2024-09-29
Implementation on October 15, 2025
The State Drug Administration issued
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
Please note that some of the contents of this document may involve patents.
The institution does not bear responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the National Medical Protective Equipment Standardization Working Group (SAC/SWG30).
This document was drafted by. Bloomage Biotech Co., Ltd., Shandong Medical Device and Drug Packaging Inspection Institute, Beijing Medical
Medical Device Inspection Institute (Beijing Medical Biological Protection Equipment Inspection and Research Center), Jinan Pansheng Biotechnology Co., Ltd., Shandong Sili Medical
Technology Co., Ltd., Nanjing Tianzong Yikang Biotechnology Co., Ltd., and Shandong Tongqi Medical Technology Co., Ltd.
The main drafters of this document are. Guo Xueping, Bo Xiaowen, Li Fan, Fu Jie, Wang Lixia, Luan Yuanyuan, Zhang Ping, Zhang Ting, Zheng Xiaofeng, Gai Xiaoxiao, Tian Xin,
Xu Nianqin and Tian Xiaolei.
Medical Sodium Hyaluronate Dressing
1 Scope
This document specifies the requirements, labeling and packaging of medical sodium hyaluronate dressings and describes the corresponding test methods.
This document applies to medical sodium hyaluronate dressings.
This document does not apply to medical sodium hyaluronate dressings containing antibacterial or pharmaceutical ingredients.
Note. This document provides reference for the requirements and test methods of cross-linked sodium hyaluronate dressings for medical use.
2 Normative references
The contents of the following documents constitute essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 6682 Specifications and test methods for water used in analytical laboratories
GB/T 16886.1 Biological evaluation of medical devices Part 1.Evaluation and testing in the risk management process
GB/T 19633.1 Terminally sterilized medical device packaging Part 1.Requirements for materials, sterile barrier systems and packaging systems
YY/T 0466.1 Symbols for medical devices used to provide information for manufacturers Part 1.General requirements
YY/T 1571 Tissue Engineering Medical Devices - Sodium Hyaluronate
Pharmacopoeia of the People's Republic of China 2020 Edition Volume IV
3 Terms and definitions
The terms and definitions defined in YY/T 1571 apply to this document.
4 Product Type
Medical sodium hyaluronate dressings are usually in the form of liquids/sprays, gels, patches, etc.
5 Requirements
5.1 Appearance
There should be no visible foreign matter.
5.2 Size and loading
5.2.1 Dimensions (if applicable)
Should be within the range specified by the manufacturer.
5.2.2 Filling quantity (if applicable)
It should meet the requirements of Table 1.
Note. The amount of medical sodium hyaluronate dressing in the form of an application is measured by weight.
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