Circular 22/2015/tt-Byt: Assay Procedure Instructions Occasion Massage Cream Mosquitoes

Original Language Title: Thông tư 22/2015/TT-BYT: Hướng dẫn quy trình khảo nghiệm kem xoa xua muỗi

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MINISTRY OF HEALTH
Number: 22 /2015/TT-BYT
THE SOCIALIST REPUBLIC OF VIETNAM.
Independence-Freedom-Happiness
Hanoi, July 27, 2015

IT ' S SMART

Guide to the process of using an ice cream test i

__________________

The Code of Chemical Law 06 /2007/QH12 November 21, 2007;

Product Quality Law, digital goods. 05 /2007/QH12 November 21, 2007;

Base of Protocol 63 /2012/NĐ-CP August 31, 2012 of the Government stipulated the function, mandate, jurisdiction and organizational structure of the Ministry of Health;

At the request of the Bureau of Health Environmental Management.

The Minister of Health issued the Information Guide for the process of the mosquito-ice cream test.

Chapter I

GENERAL REGULATION

What? 1. The adjustment range

This information regulates the effective assessment method, the safety of ice cream rubbing ice cream for registration in Vietnam.

What? 2. Explain the word

In this Information, the words and the abbreviation sign are understood as follows:

1. CAS number is an abbreviation of the English phrase "Chemical Abstract Service Registry number" which is a chemical abstraction register of the number of chemical elements, chemical compounds.

2. WHO code is the abbreviation of the English phrase "World Health Organisation code" as the prescribed chemical code of the World Health Organization.

Chapter II

TEST METHOD

What? 3. The Test Method

Using the biological testing method in the cage cage with the volunteer to evaluate the effect, safety and the undesired effect of the ice cream massage directly on the volunteers. Each experiment included 3 trials and all trials were required to comply with the requirements, how to proceed and evaluate the regulation at this message.

What? 4. Request for Test

1. Request for the instrument, device:

a) the mosquito cage is 40cmx40cmx40cm by a 32-36/cm hole size. 2 The number of 4 c./1 test trials (2 for the numbered object 01, 2 marked blue, two for testing 3, 04 marked red). The door of the cage is with the sleeves to prevent the mosquitoes from coming out.

b) The 1 m cord has a precision of 1 mm to measure the area of the cream of the mosquito on the skin of the volunteer.

c) Personal defense outfits: clothing, helmets, glass, gloves, gloves, boots, support;

d) The results of the specified test results at Appendix 1 issued by this message;

The question of the unintended effect of the Exhibit 2 appendix to this message.

2. The number of volunteers engaged in the trial: 04 people (02 men, 02 women). Volunteers involved in the survey must be selected by regulations at Annex 3 issued by this message and are not used in the use of perfume, chemical or lubricant chemicals on the skin before the 12-hour trial.

3. Mosques used to test whether the female World Health Organization (WHO/CDS/CPC/MAL/98.2) guidelines, raised in the Class II biosecurity room, are sensitive to chemicals, not sucking blood, aged 05-07 days, smoking and smoking. Glucose 10%.

4. Laboratory at ISO/IEC 17025:2005 with temperature and humidity under normal conditions.

What? 5. Test Steps

1. Prepare:

a) The number of mosquito-driving ice cream that is prepared for testing is the 5 smallest packaging units according to the manufacturer's regulation, of which: 04 sample testing, 01 samples for sample storage. These sample units must be with the same batch of production, and shelf life, in a state of integrity;

b) A volunteer practice of shaking hands only for the mosquito to touch without the mosquito to draw blood;

c) You have to clean the arm with no odor soap, wash it in the water, then you can wash it with 70% ethanol and dry before the test is done;

d) The length of the length measured on the forearm (L), measured round in the wrist (C) and circled the gap of the elbow (K), then calculate the arm of the arm where it is exposed to the mosquito to lure the mosquitoes of the four equivalent people from 300cm 2 -600cm 2 according to the formula Lx (K + C: 2) cm 2 Use the rubber gloves to seal the hand and use the thick cloth on the left elbow to avoid the mosquito bites into the undesired place.

Split into two pairs, each pair (1 male and 1 female) is covered with the manufacturer's guide to the manufacturer's instructions on the label before the start of the 30-minute trial, the other pair does not apply the ice cream.

e) Preparing 4000 mosquitoes to the standard standard at paragraph 3 Article 4 this process for one test;

g) The site of the survey: testing and treatment are arranged at the same time in two different chambers but must be similar in terms of temperature and humidity conditions.

2. Testing:

a) Drop in every cage for 200 mosquitoes;

b) The two do not massage the mosquito creams for the left hand in the cage with a blue sign (1 cage for male, 1 for females). Just one hour put your hand in the 30-second cage to count the number of mosquitos touching the open, if the number of mosquito hits on 10 is required. In 30 seconds, if < 10 are infected, the test results need to be discarded. The test is followed by hours: 01, 02, 04, 06, 08 (according to the time of the effect of the mosquito dispenization on the label). After each hour of tracking changes in 200 new mosquitoes;

c) The two men with the cream massage with the left hand rubbed the ice cream on two cages with a red mark (1 cage for male, 1 for females). Each hour for the left hand at 30 seconds to count the number of mosquitoes touching the left hand skin. Follow up: 01, 02, 04, 06, 08 according to the time of the writing effect on the label. After each hour of tracking changes in 200 new mosquitoes;

d) The test was repeated 3 times in similar conditions, participants of the trial and subject exchanged on the 2nd and 3rd days;

b) The results are written in the specified table at Annex 1 issued by this message.

What? 6. Performance Review

The effect is calculated according to the formula, as follows:

Ratio = 90 %-100%: required.

What? 7. Safe Evaluation

Based on the questioner table to evaluate the undesirable effect of the mosquito-massage diet that tests with the test participants. If the number of people is asked to have one of the signs: skin allergies, headache, dizziness > 2/5 is not required.

What? 8. Pay the results and save the

1. Pay the results: the organization performs an answer to the results of the prescribed results in Annex 4 issued by this message.

2. Save the sample: after the survey, the prototype and the used samples must be saved for at least 2 years. The sample needs to be written in the book of information: the product name (manufacturer, production batch, production date, term of use), operations (CAS number, WHO code), test dose, trial date, request agency.

Chapter III

EXECUTION CLAUSE

What? 9. Effect of execution

1. This message has been in effect since 1 January 2016.

2. The process of evaluating the force of dispenseing, the safety of the chemical chemicals on the mosquito anti-mosquito room issued by Decision No. 120 /2000/QĐ-BYT 24 January 2000 of the Minister of Health expires since this date is effective.

What? 10. The organization performs

Department of Public Health Management, Chief of Staff, Chief Inspector, Chief, Chief Secretary, Director General of the Department, Bureau, Directorate of Health, Department of Health, is responsible for this information.

In the course of execution, if there is an entangrium, the agencies, organizations and individuals reflect on the Ministry of Health (Health Environment Management) to study the ./.

KT. MINISTER.
Chief.

(signed)

Nguyen Thanh Long