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YY/T 1947-2025: Recombinant collagen protein dressing
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1947-2025 | English | 219 |
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Recombinant collagen protein dressing
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YY/T 1947-2025
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Basic data | Standard ID | YY/T 1947-2025 (YY/T1947-2025) | | Description (Translated English) | Recombinant collagen protein dressing | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C48 | | Classification of International Standard | 11.120.20 | | Word Count Estimation | 10,124 | | Date of Issue | 2025-02-26 | | Date of Implementation | 2026-03-01 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the requirements, markings, and packaging of recombinant collagen dressings, and describes the corresponding test methods. This standard applies to recombinant collagen dressings used on non-chronic wounds. This standard does not apply to recombinant collagen dressings containing antibacterial and drug ingredients. | YY/T 1947-2025: Recombinant collagen protein 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
Recombinant collagen dressing
Released on 2025-02-26
2026-03-01 Implementation
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 issuing organization of this document does not assume the 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. Shandong Medical Device and Drug Packaging Inspection Institute, Sichuan Drug Inspection Institute (Sichuan Medical Device
Medical Device Testing Center), Jiangsu Chuangjian Medical Technology Co., Ltd., Zhejiang Zhuji Juyuan Biotechnology Co., Ltd., Shanxi Jinbo Biopharmaceutical Co., Ltd.
Co., Ltd., Shaanxi Juzi Biotechnology Co., Ltd., Shanghai Deepai Biotechnology Co., Ltd., and Huaxi Biotechnology Co., Ltd.
The main drafters of this document are. Liu Xueting, Zhang Bo, Liu Bin, Zhao Dengwei, Ma Heng, Wang Shuai, Meng Xiaoyi, Li Chong, Gai Xiaoxiao, Wang Jian, Fan Daidi,
Liu Xinglan, Jin Jian, and Fu Jie.
Recombinant collagen dressing
1 Scope
This document specifies the requirements, labeling and packaging of recombinant collagen dressings and describes the corresponding test methods.
This document applies to recombinant collagen dressings used on non-chronic wounds.
This document does not apply to recombinant collagen dressings containing antibacterial or pharmaceutical ingredients.
2 Normative references
The contents of the following documents constitute the 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 1849 Recombinant collagen
YY/T 1888 Recombinant humanized collagen
Pharmacopoeia of the People's Republic of China (2020 Edition, Part IV)
3 Terms and definitions
The terms and definitions defined in YY/T 1849 apply to this document.
4 Product Type
Recombinant collagen dressings are usually in the form of gels, liquids, patches, pastes or fibers.
5 Requirements
5.1 Materials
The recombinant collagen added to recombinant collagen dressings should comply with the requirements of YY/T 1849 or YY/T 1888.
5.2 Appearance
There should be no visible foreign matter on the surface.
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