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General requirements for skin disinfectant
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GB 27951-2011: PDF in English GB 27951-2011
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080
C 59
Hygiene requirements for skin disinfectant
ISSUED ON: DECEMBER 30, 2011
IMPLEMENTED ON: MAY 01, 2012
Issued by: Ministry of Health of the People's Republic of China;
Standardization Administration of the People's Republic of
China.
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Technical requirements ... 5
5 Test methods ... 7
6 Use methods ... 8
7 Labels and user manual ... 8
8 Precautions for use ... 8
Annex A (normative) Test methods for microorganism ... 10
Hygiene requirements for skin disinfectant
1 Scope
This Standard specifies technical requirements, test methods, use methods,
labels and user manual as well as precautions for use of skin disinfectant.
This Standard is applicable to disinfectant for intact and damaged skin
disinfection. It is not applicable to hand disinfectant.
2 Normative references
The following referenced documents are indispensable for the application of
this document. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any
amendments) applies.
GB/T 601, Chemical Reagent - Preparations of Standard Volumetric
Solutions
GB/T 6680, General rules for sampling liquid chemical products
GB 15603, Rule for storage of chemical dangers
GB 15982, Hygienic standard for disinfection in hospitals
Pharmacopoeia of People's Republic of China
Disinfection technical specifications, Ministry of Public Health
Hygienic specifications for cosmetics, Ministry of Public Health
Specification for the management of label instructions for disinfection
products, Ministry of Public Health
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 skin disinfection
Kill or remove pathogenic microorganisms on human skin and meet disinfection
requirements.
b When it is estimated that the disinfectant has a sensitizing effect, this test is required.
4.3.5 Stability
The validity of the original packaged product is ≥12 months.
4.3.6 Requirements for disinfectants in use
The sensory traits, effective ingredient content, pH of the disinfectant in use
after opening meet the product quality requirements. The total number of
colonies ≤50CFU/mL (g), mold and yeast ≤10CFU/mL (g). It shall meet the
requirements of GB 15982. Pathogenic bacteria (staphylococcus aureus,
pseudomonas aeruginosa, hemolytic streptococcus) shall not be detected.
Disinfectant for damaged skin in use shall meet the exit-factory requirements.
5 Test methods
5.1 Sensory traits examination
Visually inspect disinfectant color, clarity.
5.2 Determination of physical and chemical indicators
5.2.1 pH determination
Determine according to relevant methods in Disinfection technical
specifications.
5.2.2 Active ingredient content
Determine according to relevant provisions in Disinfection technical
specifications, GB 6680, GB/T 601.
5.2.3 Determination of lead, mercury and arsenic limits
Determine according to relevant methods in Hygienic specifications for
cosmetics.
5.2.4 Stability test
Determine according to relevant methods in Disinfection technical
specifications.
5.3 Microorganism killing test
Determine according to relevant methods in Disinfection technical
specifications.
5.4 Identification of microbial contamination
See Annex A for inspections of total colony, mold and yeast, pathogenic bacteria
and sterility.
5.5 Toxicology test
Determine according to relevant methods in Disinfection technical
specifications.
6 Use methods
6.1 Disinfection of intact skin
Use disinfectant to wipe or rub to disinfect 2~3 times. Act 1min~5min to achieve
disinfection effect.
6.2 Disinfection of damaged skin
Use disinfectant to rub or rinse to disinfect. Act 1min~5min to achieve
disinfection effect.
6.3 Disinfection of skin at injection or puncture site
Use disinfectant to wipe to disinfect 2~3 times. Act ≤1min to achieve disinfection
effect.
7 Labels and user manual
In accordance with relevant provisions of Specification for the management of
label instructions for disinfection products.
8 Precautions for use
8.1 Protect from light. Seal. Keep away from moisture. Store in a cool, dry place.
8.2 Avoid use with antagonist drugs.
8.3 For allergy sufferers, use with caution.
8.4 Disinfectant for external use must not to be taken orally. Keep out of the
reach of children.
8.5 After disinfection with iodine disinfectant, deiodination shall be conducted.
Annex A
(normative)
Test methods for microorganism
A.1 Determination of the total number of colonies
A.1.1 Test equipment
A.1.1.1 Erlenmeyer flask: 250mL.
A.1.1.2 Measuring cylinder: 200mL.
A.1.1.3 Autoclave.
A.1.1.4 Level-100 clean room or level-100 laminar flow ultra-clean workbench.
A.1.1.5 Test tube: 15mm × 150mm.
A.1.1.6 Sterilization plate: 9cm in diameter.
A.1.1.7 Sterilization scale pipette: 10mL, 1mL.
A.1.1.8 Alcohol lamp.
A.1.1.9 Constant temperature incubator: 36°C±1°C.
A.1.1.10 Magnifier.
A.1.1.11 Saline.
A.1.1.12 Common nutrient agar medium.
A.1.1.13 Neutralizer.
A.1.2 Methods
A.1.2.1 Sample processing
Use a sterile pipette to pipette 1.0mL of disinfectant. Add into 9.0mL of sterile
saline that contains corresponding neutralizing agent. Shake 20s or beat 80
times. Take 1:10 dilution for testing.
A.1.2.2 Operating steps
Use a sterile pipette to pipette 2mL of 1:10 dilution testing solution. Respectively
inject into two sterilization plates, 1mL for each plate. Take another 1mL to inject
A.2.1.12 Saline.
A.2.2 Methods
A.2.2.1 Sample processing: see A.1.2.1.
A.2.2.2 Operating steps: Respectively take 1mL of 1:10, 1:100, 1:1000 test
solutions into sterilization plates. Separately use 2 plates for each dilution. Inject
Sapura agar medium that has been melted and cooled to about 45°C±1°C.
Completely shake well. After solidification, turn the plate. Incubate at 28°C± 1°C
for 72h±2h. Count the number of molds and yeasts growing in the plate. If there
is mold spread, to avoid affecting the count of other molds and yeasts, the plate
shall be taken out in time and counted in 48h±2h. Take another sterilized empty
plate without sample. Add about 15mL of Sabaero agar medium. After the agar
solidifies, turn the dish. Incubate at 28°C±1°C for 72h±2h, for blank control.
A.2.2.3 Result report: First count the number of mold and yeast colonies
growing on each plate. Calculate the average number of colonies per dilution.
When determining the result, it shall select the plate count of which the number
of colonies is within the range of 5~50. Multiplied by the dilution factor shall be
the number of mold and yeast contained in the disinfectant per milliliter (or per
gram), in CFU/mL (g). If all dilutions are grown aseptically, the reported number
shall be < 10CFU/mL (g).
A.3 Test methods for pathogenic bacteria
A.3.1 Test methods for staphylococcus aureus
A.3.1.1 Test apparatuses
A.3.1.1.1 Microscope.
A.3.1.1.2 Constant temperature incubator: 36°C±1°C.
A.3.1.1.3 Centrifuge.
A.3.1.1.4 Sterile pipette: 1mL, 10mL.
A.3.1.1.5 Sterilization test tube: 15mm × 150mm.
A.3.1.1.6 Glass slide.
A.3.1.1.7 Alcohol lamp.
A.3.1.1.8 7.5% sodium chloride broth.
A.3.1.1.9 Blood agar medium.
A.3.1.1.10 Mannitol fermentation medium.
A.3.2.2.3 Separate culture: Pick cultures from the culture film. Conduct crossed
inoculation on the cetyltrimethylammonium bromide agar plate. Incubate at
36°C±1°C for 18h~24h. For pseudomonas aeruginosa on this medium, the
colony is flat and amorphous, spreading to the periphery or spreading slightly.
The surface is wet. The colony is grayish white. The water-soluble green
pigment is often diffused in the culture medium around the colony.
A.3.2.2.4 Staining microscopy: Pick suspicious colonies. Smear. Conduct Gram
stain. Those who are Gram-negative under microscope shall be tested for
oxidase.
A.3.2.2.5 Oxidase test: Take a small piece of clean white filter paper and put it
in a sterilization dish. Use a sterile glass rod to pick up the suspicious colonies
of pseudomonas aeruginosa and apply it to the filter paper. Then add a drop of
freshly-prepared 1% dimethyl-p-phenylenediamine test solution. Within
15s~30s, when pink or purple appears, it is positive for oxidase test. If the
culture does not change color, the oxidase test is negative.
A.3.2.2.6 Pyocyanin test: Take 2~3 suspicious colonies. Respectively inoculate
on pseudomonas aeruginosa determination medium. Incubate at 36°C±1°C for
24h±2h. Add 3mL~5mL of chloroform. Shake well to dissolve the pyocyanin in
the chloroform solution. When the chloroform extract is blue, pipette chloroform
into another test tube and add about 1mL of 1mol/L hydrochloric acid. After
oscillation, let stand for a while. If there is pink to purple in the upper
hydrochloric acid, it is positive, which means that pyocyanin exists in the test
object.
A.3.2.2.7 Nitrate reduction gas production test: Pick suspicious pure cultures of
pseudomonas aeruginosa. Inoculate in nitrate peptone water medium. Incubate
at 36°C±1°C for 24h±2h. Observe the results. Where there is gas in the small
inverted tube in nitrate peptone water culture medium, it is positive, which
means that the bacteria can reduce nitrate and decompose nitrite to produce
nitrogen.
A.3.2.2.8 Gelatin liquefaction test: Take pure culture of suspicious colonies of
pseudomonas aeruginosa. Puncture and inoculate in gelatin medium. Incubate
at 36°C±1°C for 24h±2h. Take out and put in the refrigerator for 10min~30min.
If it is still dissolved or the surface is dissolved, the gelatin liquefaction test shall
be positive. If it is coagulation insoluble, it shall be negative.
A.3.2.2.9 42°C growth test: Pick suspicious pure cultures of pseudomonas
aeruginosa. Inoculate on the plain agar slant medium. Place in a 42°C±1°C
incubator and cultivate for 24h~48h. If pseudomonas aeruginosa can grow, it
shall be positive while pseudomonas fluorescens cannot grow.
A.3.2.3 Result report
A.3.3.2.3 Separate culture: Pick cultures from the culture film. Conduct crossed
inoculation on the blood plate. Incubate at 36°C±1°C for 18h~24h. The type of
hemolytic streptococcus on the blood plate is grayish white, translucent or
opaque, with needle-shaped protrusions, smooth surface, neat edges, and β
hemolytic circle around.
A.3.3.2.4 Staining microscopy: Pick suspicious colonies. Smear. Conduct Gram
stain. It is Gram-positive, chain-like cocci under microscope.
A.3.3.2.5 Catalase test: Use the inoculating ring to pick up the central culture
of single colony that has been incubated for 18h~24h and place it on a clean
glass slide. Use a dropper to add 30% H2O2 to the bacteria on the slide (the
operation sequence cannot be reversed, otherwise it is easy to have false
positives). Immediately observe for bubbling. Record the results. When there
are bubbles, it shall be positive. Hemolytic streptococcus B is negative.
A.3.2.2.6 Streptokinase test: Pipette 0.2mL of potassium oxalate plasma (0.02g
of potassium oxalate plus 5mL of human plasma and mix well. After centrifugal
precipitation, absorb supernatant). Add 0.8mL sterile saline and mix well. Then
add 0.5mL of 24h broth culture to be tested and 0.25mLof 0.25% calcium
chloride. Mix well. Put in 36°C±1°C water bath. Observe every 2min (usually
coagulable within 10min). Continue to observe and record the time of
dissolution after plasma coagulation. If it does not melt within 2h, move it to the
incubator and observe the result for 24h. If all melt, it is positive. When it still
does not melt within 24h, it shall be negative.
A.3.2.2.7 Bacitracin sensitivity test: Apply the concentrated bacteria solution of
the tested bacteria to the blood plate. Use sterile forceps to take 0.04 unit of
bacitracin paper and place it on the surface of the plate. At the same time, a
known positive strain is used as a control. Incubate at 36°C±1°C for 18h~24h.
Those with bacteriostatic zone are positive.
A.3.3.3 Result report: After the tested disinfectant is separated and cultured by
enriching bacteria, when cocci is proved as Gram-positive, chain-like; catalase
is negative, streptokinase test is positive, and sensitive to bacitracin, it may
report that streptococcus hemolyticus is detected.
A.3.4 Sterility test
A.3.4.1 Test equipment
A.3.4.1.1 Aerobic-anaerobic medium.
A.3.4.1.2 Fungal medium for sterility test (hereinafter referred to as fungal
medium).
A.3.4.1.3 Neutralizer.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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