YY/T 1293.6-2020Contacting wound dressing - Part 6: Mussel adhesive protein dressing (English PDF)

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.

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 document. 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.

4 Technical requirements