世聯翻譯公司完成醫學類英文翻譯

3 Sterility test
3.1  Purpose
  This test will vaccinate medical aplliance and its extract into substratum to examine whether  the test product has bacterium and fungoid.
3.2  Reagent
   9 g/L asepsis NaO solution, the required diluent and fluid wash which comply with China Business Criterion.
3.3  Capital Equipment
   Bechtop, Light Miroscope, Constant temperature incubator, Constant temperature water bath box, Pressure steam sterilizer, Electric drying oven.
3.4 Pretest
3.4.1  Sterilization of instruments
 All the instrument will be sterilizated safely that used on extract then put in the 121 Pressure Steam sterilizer 30min or in 160 Constant temperature water bath box 2 hour.
 
3.4.2 Requiement of Desinfection chamber
3.4.2.1  The desinfection chamber or Bechtop should comply with the requirment of 100 - level one - way flow air region.After sterilizing the desinfection chamber then follow up checking the air colony count and the method is as follows: Take a diameter of 90mm pertri dish and pour into  Nutrient agar melt 20ml,after cultivating 48 hour under temperature between 30~35 and make sure that are certified sterile, opening up 3 pertri dish on the average location of the desinfection chamber or Bechtop and exposing 30min then be covered and put under temparature of 30~45 to cultivate and check up. Nuber of colony count should not exceed 1 on 3 pertri dish.
 
3.7 Testing Method
3.7.1 Number of testing product
The same lot number 3~11 unit testing product
Note:Another style of Medical appliance can adopt according to specific situation.
3.7.2 The extraction medium
9 g/L asepsis NaO solution, the required diluent and fluid wash which comply with China Business Criterion.
3.7.3 Test preparation
Pouring the test product prior into the pertri dish to cultivate directly. If the test product is improper to pour directly, should make the extraction medium wash the surface of test product fully as the following method to prepare test solution. Preparation of test solution should conduct by aseptic manipulation and will be use after 2hour preparation.
 Choosing the following method according to test product’s specific charicterics.
a)       Tube apparatus: according to tube inside superficial area 10cm2 flow into pipe cavity 1 ml extraction medium, rate of flow is about 10ml/min.
b)       Container such equipment: If possible can extract the container’s liquid as test solution,empty container will add extraction medium 1ml each 10cm and shake many times.
c)       Entity such equipment:The entity equipment will add 1ml extraction medium of each 10 cm superficial area and shake many times.
3.7.4 Vaccination, Cultivation and Observation
According to the specific characteristics and choose the “Sterility test method” appropriate vaccination method from appendix of the “Chine Business Criterion(secondary)” and conduct with aseptic way.
Cultivation and Observation of test product should be ruled by :sterility test method which from the appendix of China Business Criterion
3.7.5 Judgement of the result
Ruled by :sterility test method which from the appendix of China Business Criterion
3.7.6 Test Report
The following information should be show on the test report:
a)       Name of test product
b)       Lot number or Steriliazation number
c)       Preparation of test solution method
d)       Inoculation Methods
e)       Obserbation report of each day
f)        Judgement of result
 
5 Pyrogen test
5.1 Purpose
This test will insert the extract of medical devices to rabbit’s vein,Observing the rabbit’s temperature situation within some period to judge whether the test product has the potential material heating effect.
5.2 Reagent
9g/l Nacl solution with free sterilization and free pylogen .
5.3 Capital Equipment
Bechtop, Electric drying oven , Constant temperature incubator ,Pressure steam sterilizer, Pyrogen test instrument.
5.4 Pretest
5.4.1 Remove instrument pyrogen
All the glassware should be dry at least 2 hour in Electric drying oven 180 which tough with the test solution or in 250 with 30min, as well another method be available to remove pyrogen.
5.4.2 Test the instrument temperature
The test of rabbit temperature should conducted by the Pyrogen and Anal thermometer of accuracy +_0.1.
5.4.3 The Lab environment
Before 1d-2d of the test, test rabbit should be put under the same temperature,the difference between experiment lab and feeding roon will not exceed 5,experiment lad temperature is about17~28.
During the whole process,the viaration of experiment lab will be controlled within 3 and avoid nosie disturbution.
5.4.4 Test Rabbit
According to the “Pyrogen test”that from China Business Criterion (Secondary) to choose the test rabbit, each rabbit’s usage should be controlled within 10 times.
5.5 Test method
5.5.1 Test solution Preparation
Choose the appropriate extraction condition according to GB/T 16886.12
 
5.5.2 Test Phrase
Conducting according to the rule spring from the China Business Criterion(Secondary), rabbit injection is 10ml/kg
5.5.3 Result Judgement
When the test product comply with the rule from China Business Criterion after the preliminary test and reexamine,as we can judge that there are no material heating effect.
5.6 Test report
The following information should be show on the test report
a)       Name of test product
b)       Lot number
c)       Test solution preparation
d)       Injection dose
e)       Note of Rabbit temperature
f)        Result Judgement
世聯翻譯公司完成醫學類英文翻譯

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