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YY/T 0471 Test methods for primary wound dressings is divided into six parts:
——Part 1: Aspects of absorbency
——Part 2: Moisture vapour transmission rate of permeable film dressings
——Part 3: Waterproofness
——Part 4: Comfortability
——Part 5: Bacterial barrier properties
——Part 6: Odour control
This part is Part 5 of YY/T 0471.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
This part replaces YY/T 0471.5-2004 Test methods for primary wound dressings -Part 5: Bacterial barrier properties. The following technical changes have been made with respect to the YY/T 0471.5-2004:
——the test method for bacterial barrier properties - “dry outside and wet inside” is added;
——every test method is modified;
——informative annex is added;
——other editorial changes are made.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be responsible for identifying any or all such patent rights.
This part was proposed by China Food and Drug Administration.
This part is under the jurisdiction of China Food and Drug Administration Jinan Medical Apparatus Supervision and Inspection Center.
Drafting organizations of this part: Shandong Quality Inspection Center for Medical Devices, Shandong Saikesaisi Pharmaceutical Technology Co., Ltd., 3M Medical Devices (Shanghai) Co., Ltd., Coloplast (China) Medical Product Co., Ltd.
Drafters of this part: Wang Wenqing, Hao Dali, Zheng Yang, Hao Jianxin, Lu Jinrong, Li Yu.
The previous edition of this part of YY/T 0471 is as follows:
YY/T 0471.5-2004 was issued on March 23, 2004 for the first time.
Test methods for primary wound dressings -
Part 5: Bacterial barrier properties
1 Scope
This part of YY/T 0471 specifies the test methods for evaluation on bacterial barrier properties of primary wound dressings that are claimed to be with bacterial barrier properties. 1
As this test method involves microorganism testing operation, this test should be conducted by trained personnel in microorganism safety laboratory.
2 Terms and definitions
For this purpose of this document, the following terms and definitions apply.
2.1
low moisture condition
The condition with two sides of dressings not wet. As for the dressings in this condition, the wound gives no exudate or extremely little exudate, and the outer surface of the dressings is in dry state.
Note: as for the dressings not claimed waterproof, their outside surface is deemed as in dry condition.
2.2
semi wet condition
The condition with one side of dressings wet. As for the dressings in this state, the wound gives exudate and the outside surface of the dressings is dry, namely, “dry outside, wet inside”; or the wound gives no exudate or extremely little exudate while the outside surface of the dressings is in wet status, namely “wet outside, dry inside”.
Note: as for the dressings not claimed as waterproof, the outside surface is deemed as in dry status; otherwise, it is deemed as in wet status.
2.3
wet condition
The condition with two sides of the dressings wet. As for the dressings in this condition, the wound gives exudate, while the outside surface of the dressings is in wet status.
Note: as for the dressings claimed as waterproof, the outside surface is deemed as in wet status.
3 Reagent and materials
3.1 Serratia marcescens2;
3.2 .Nutrient broth medium;
3.3 Nutrient agar medium;
3.4 Sterilized saline water;
3.5 Sterile swab.
4 Preparation of challenge microorganism
4.1 Preparation of challenge inoculant
Pick up viscid serratia marcescens colony from the slant of work bacteria strains of serratia marcescens, conduct streak inoculation on the slab of nutrient agar medium. Challenge inoculant is prepared after cultivation at 26℃ overnight for the test on bacterial barrier properties in low moisture condition and semi wet condition (dry outside, wet inside). The prepared challenge inoculant slab should be used in the current day.
4.2 Preparation of challenge bacteria solution
Pick up viscid serratia marcescens colony from the challenge inoculant slab prepared in Subclause 4.1 and conduct inoculation in nutrient broth medium; after cultivation at 26℃ overnight, obtain challenge bacteria solution with the concentration of about 109 CFU/mL for test on bacterial barrier properties in semi wet condition (wet outside, dry inside) and wet condition. The prepared challenge bacteria solution should be used in the current day.
5 Bacterial barrier properties in low moisture condition
5.1 Test device
Figure 1 indicates the test device for bacterial barrier properties in low moisture condition. The challenge chamber is used to contain the challenge inoculant while the sampling chamber is used to wipe the sample. Before the test, prepare the test device via sterilization with the confirmed sterilization procedure.
Foreword i
1 Scope
2 Terms and definitions
3 Reagent and materials
4 Preparation of challenge microorganism
5 Bacterial barrier properties in low moisture condition
6 Bacterial barrier properties in semi wet condition (dry outside, wet inside)
7 Bacterial barrier properties in semi wet condition (wet outside, dry inside)
8 Bacterial barrier properties in wet condition
Annex A (Informative) Application description of standard
