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YY/T 1293.6-2020: Contacting wound dressing - Part 6: Mussel adhesive protein dressing
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1293.6-2020 | English | 189 |
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Contacting wound dressing - Part 6: Mussel adhesive protein dressing
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YY/T 1293.6-2020
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Basic data | Standard ID | YY/T 1293.6-2020 (YY/T1293.6-2020) | | Description (Translated English) | Contacting wound dressing - Part 6: Mussel adhesive protein dressing | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.120.20 | | Word Count Estimation | 10,138 | | Date of Issue | 2020-09-27 | | Date of Implementation | 2021-09-01 | | Regulation (derived from) | Announcement No. 108 (2020) of the National Medical Products Administration | | Issuing agency(ies) | State Drug Administration | YY/T 1293.6-2020: Contacting wound dressing - Part 6: Mussel adhesive 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.
(Contact wound dressing part 6: mussel mucin dressing)
ICS 11:120:20
C31
People's Republic of China Pharmaceutical Industry Standard
Contact wound dressing
Part 6: mussel mucin dressing
2020-09-27 release
2021-09-01 implementation
Issued by the State Drug Administration
Foreword
YY/T 1293 "Contact Wound Dressings" consists of the following parts:
---Part 1: Vaseline gauze;
---Part 2: Polyurethane foam dressing;
---Part 3: Negative pressure drainage foam dressing;
---Part 4: Hydrocolloid dressing;
---Part 5: Alginate dressing;
---Part 6: mussel mucin dressing;
This part is part 6 of YY/T 1293:
This section was drafted in accordance with the rules given in GB/T 1:1-2009:
Please note that certain contents of this document may involve patents: The issuing agency of this document is not responsible for identifying these patents:
This part was proposed by the State Drug Administration:
This part is under the jurisdiction of Shandong Medical Device Product Quality Inspection Center:
Drafting organizations of this section: Shandong Medical Device Product Quality Inspection Center, China Food and Drug Control Research Institute, Jiangyin Berison Biochemical
Technology Co:, Ltd:
The main drafters of this section: Peng Jian, Xu Hong, Gu Ming, Liu Lili, Liu Bin, Gao Min, Sun Lingxiao, Luan Tongqing:
Introduction
Mussel mucin dressing refers to a dressing with mussel mucin as the main component: The main characteristics and functions of mussel mucin in this dressing
The mechanism is the auto-oxidation and cross-linking of dopa in the mussel mucin structure to form a microscopic biofilm to protect the wound: It has been reported to promote wound healing: Currently
Most of the dressings that contain mucin mucin components seen in the market are liquids, and generally have no solid load, such as bottled liquids or gels:
The instructions provided by the supplier are used: For other dressings containing mussel mucin with multiple functions, the manufacturer can refer to the implementation based on the risk assessment:
Run this standard:
Mussel mucin is mainly derived from lower invertebrate tissues: YY/T 0771 provides information on virus control of animal-derived medical devices:
Claim:
Contact wound dressing
Part 6: mussel mucin dressing
1 Scope
This part of YY/T 1293 specifies the technical requirements, biological evaluation, test methods and markings for dressings containing mussel mucin
And packaging:
This section applies to wound dressings with mussel mucin as the main component:
2 Normative references
The following documents are indispensable for the application of this document: For dated reference documents, only the dated version applies to this article
Pieces: For undated references, the latest version (including all amendments) applies to this document:
GB/T 16886:1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing in the Process of Risk Management
GB/T 19633:1 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems, and packaging systems
YY/T 0466:1 Medical devices are used for medical device labeling, marking and information symbols: Part 1: General requirements
YY/T 0615:1 Requirements for labeling "sterile" medical devices Part 1: Requirements for terminally sterilized medical devices
YY/T 0615:2 Requirements for labeling "sterile" medical devices Part 2: Requirements for aseptically processed medical devices
Pharmacopoeia of the People's Republic of China (2015 edition four)
3 Terms and definitions
The following terms and definitions apply to this document:
3:1
Mussel mucin
For proteins containing dopa groups, the dopa groups can be self-oxidized and cross-linked to form high molecular polymers:
4 Technical requirements
4:1 Appearance
When tested according to 6:1, there should be no visible foreign matter:
4:2 Identification
When tested according to 6:2, mussel mucin and nitrotetrazolium chloride blue (NBT) staining solution developed blue-purple:
4:3 Capacity (if applicable)
When testing according to 6:3, the average filling volume and the filling volume per container should meet the requirements of the Pharmacopoeia of the People’s Republic of China (2015 edition four) 0942
Claim:
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