YY/T 0471.5-2017 (YY/T0471.5-2017, YYT 0471.5-2017, YYT0471.5-2017)
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Test methods for primary wound dressings—Part 5: Bacterial barrier properties
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YY/T 0471.5-2017
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Standards related to: YY/T 0471.5-2017
| Standard ID | YY/T 0471.5-2017 (YY/T0471.5-2017) | | Description (Translated English) | Test methods for primary wound dressings--Part 5: Bacterial barrier properties | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C48 | | Classification of International Standard | 11.120.20 | | Word Count Estimation | 10,198 | | Date of Issue | 2017-02-28 | | Date of Implementation | 2018-01-01 | | Older Standard (superseded by this standard) | YY/T 0471.5-2004 | | Drafting Organization | Shandong Province Medical Device Quality Inspection Center, Shandong Saikesaisi Pharmaceutical Technology Co., Ltd., Minnesota Mining Manufacturing Medical Equipment (Shanghai) Co., Ltd., Leisure Insurance (China) Medical Supplies Co., Ltd. | | Administrative Organization | State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | YY/T 0471.5-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.120.20
C 48
Replacing YY/T 0471.5-2004
Test Methods for Primary Wound Dressings -
Part 5. Bacterial Barrier Properties
ISSUED ON. FEBRUARY 28, 2017
IMPLEMENTED ON. JANUARY 1, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Terms and Definitions ... 5
3 Reagents and Materials ... 6
4 Challenge Microbial Preparation ... 6
5 Bacterial Barrier Properties under Low-moisture Condition ... 6
6 Bacterial Barrier Properties under Semi-wet Condition (Dry Outside, Wet
Inside) ... 9
7 Bacterial Barrier Properties under Semi-wet Condition (Wet Outside, Dry
Inside) ... 11
8 Bacterial Barrier Properties under Wet Condition ... 13
Appendix A (informative appendix)... 15
Test Methods for Primary Wound Dressings -
Part 5. Bacterial Barrier Properties
1 Scope
This Part of YY/T 0471 specifies test methods 1 of evaluating bacterial barrier
properties of primary wound dressings that claim to have bacterial barrier properties.
In this Part, test methods involve microbial detection, which shall be conducted by
trained personnel in biosafety laboratories.
2 Terms and Definitions
The following terms and definitions are applicable to this Standard.
2.1 Low-moisture Condition
Under low-moisture condition, 2 sides of dressings are not wet. Under this condition,
dressings shall manifest no or minimal exudate on the wound; the external surface of
dressings shall be under low-moisture condition.
NOTE. dressings that do not claim to be water resistant shall be deemed to have a dry
external surface.
2.2 Semi-wet Condition
Under semi-wet condition, 1 side of dressings is wet. Under this condition, there is
exudate on the wound, but the external surface of dressings shall be under low-
moisture condition, namely, “dry outside, wet inside”; or there is no or minimal exudate
on the wound, and the external surface of dressings is expected to be under wet
condition, namely, “wet outside, dry inside”.
NOTE. dressings that do not claim to be water resistant shall be deemed to have a dry
external surface; dressings that claim to be water resistant shall be deemed to
have a wet external surface.
2.3 Wet Condition
Under wet condition, 2 sides of dressings are wet. Under this condition, there is
exudate on the wound, and the external surface of dressings is expected to be under
wet condition.
1 Antibacterial ingredients in dressings might exert influence on the test result in this Part. Please refer
to Appendix A for an instruction for application of this Part.
Respectively take 3 samples, turn the internal surface of the samples towards the
sampling room. Clamp the samples to the area between the challenge room and the
sampling room. The mode of clamping shall be confirmed; guarantee that there is no
leakage of challenge microorganism. In terms of relatively large sample, cut off the
remaining part or wrap it around the test device; in terms of relatively small sample,
raw materials of large samples can be adopted for testing, or an appropriate mode can
be adopted to fill up the missing part for testing.
5.2.2 Add challenge microorganism
Use sterile swab to wipe-take challenge inoculum; inoculate it on the external surface
of the samples through the mouth of the challenge room; smear as even as possible.
5.2.3 Sample challenge
Take an appropriate mode to seal the mouth of the challenge room and the sampling
room of the test device; guarantee that no external contamination will be generated.
Place the test device into an incubator at 26 °C and maintain for 24 h.
5.2.4 Penetrating microbiological examination
After the stipulated time, pre-moisturize sterile swab in sterile saline solution and
squeeze out surplus water. Try to wipe all the internal surfaces of the samples through
the mouth of the sampling room. Then, inoculate in the mode of wiping the plate
surface of nutrient agar. Use 3 sterile swabs to wipe each sample; respectively
inoculate on the plate of 3 nutrient agars; during this process, swabs shall be rotated
for several times. Place the plate of nutrient agar at 26 °C and start culture for 24 h.
5.2.5 Challenge microbiological vitality examination
After the stipulated time, operate in accordance with 5.2.4. Wipe the external surface
of the samples through the mouth of the challenge room to examine challenge
microbiological vitality.
5.3 Result Judgment
On the plate of nutrient agar medium that is adopted for vitality examination, there shall
be the growth of Serratia marcescens; otherwise, the test shall be deemed as invalid.
If there is no growth of microorganism on the plate of nutrient agar that is adopted for
the sampling analysis of the internal surface of the sample, it shall be deemed that the
sample complies with the requirement of bacterial barrier properties under low-
moisture condition. If there is growth of microorganism on the plate of nutrient agar
that is adopted for the sampling analysis of the internal surface of the sample,
appropriate microbiological methods shall be adopted to examine whether it is Serratia
marcescens. If it is Serratia marcescens, it shall be deemed that the sample does not
comply with the requirement of bacterial barrier properties under low-moisture
condition; if it is not Serratia marcescens, it signifies that there is external
2---Glass elbow;
3---Challenge bacterial solution;
4---Sample to be tested;
5---Glass test device;
6---Sterile swab;
7---Fixing screw;
8---Support.
Figure 3 -- Sketch Map of Test Device - Semi-wet Condition (wet outside, dry
inside)
7.2 Test Method
7.2.1 Sample clamping
Operate in accordance with 5.2.1.
7.2.2 Add challenge microorganism
Fill up the challenge room with challenge bacterial solution.
7.2.3 Sample challenge
Operate in accordance with 5.2.3.
7.2.4 Penetrating microbiological examination
Operate in accordance with 5.2.4.
7.2.5 Challenge microbiological vitality examination
After the stipulated time, use sterile swab to take challenge bacterial solution to wipe
the plate of nutrient agar medium to examine challenge microbiological vitality. Use 3
sterile swabs to take bacterial solution on each sample; respectively smear it on 3
nutrient agar plates for inoculation. Place the plate at 26 °C and start culture for 24 h.
7.3 Result Judgment
On the plate of nutrient agar medium that is adopted for vitality examination, there shall
be the growth of Serratia marcescens; otherwise, the test shall be deemed as invalid.
If there is no growth of microorganism on the plate of nutrient agar that is adopted for
the sampling analysis of the internal surface of the sample, it shall be deemed that the
sample complies with the requirement of bacterial barrier properties under semi-wet
Appendix A
(informative appendix)
Instruction for Standard Application
A.1 Applicable Object
Clinically speaking, infection is an important complication of wound. Primary wound
dressings play a role as a mechanical barrier of wound. The bacterial barrier properties
of primary wound dressings are tremendously important to the control of wound
infection. However, this does not mean all the primary wound dressings are requested
to manifest bacterial barrier properties. Certain types of wound with extremely low risks
of infection might not need primary wound dressings with bacterial barrier properties.
Furthermore, the bacterial barrier properties of some primary wound dressings that
need to be matched with secondary dressings are jointly provided by the two types of
dressing, and merely conducting evaluation on the bacterial barrier properties of
primary wound dressings might also lead to unilateral information. The evaluation of
whether a specific primary wound dressing has the bacterial barrier properties
depends on intensive study of risks of infection of different types of wound.
A.2 Method Selection
The condition of the internal surface of dressings depends on the amount of exudate,
which correspondingly manifests the wet or low-moisture condition. Under the normal
environment, the external surface of dressings would be under low-moisture condition.
If the external surface is under wet condition, it is not a normal condition of dressings.
However, in terms of certain dressings, for example, dressings that claim to be water
resistant, the external surface might be under wet condition. During the evaluation of
the bacterial barrier properties of dressings, test methods shall be selected in
accordance with the different expected conditions of the dressings.
If dressings are expected to be applied to wound with minimal exudate, at least the
test method of low-moisture condition shall be the first option. On this basis, if the
external surface of dressings is expected to be under wet condition, for example,
dressings that claim to be water resistant, the test method of semi-wet condition (wet
outside, dry inside) shall be selected.
If dressings are expected to be applied to wound with a great deal of exudate, at least
the test method of semi-wet condition (dry outside, wet inside) shall be the first option.
On this basis, if the external surface of dressings is expected to be under wet condition,
for example, dressings that claim to be water resistant, the test method of wet condition
shall be selected.
At present, there is no adequate proof that verifies which test method is more rigorous.
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