6.2 抗弯折性能测试项目及弯折次数按表4规定。7.耐清洗消毒性能正常

6.2 抗弯折性能
测试项目及弯折次数按表4规定。
7.耐清洗消毒性能
正常使用时与患者接触的部件，应能承受在正常使用时可能遇到的或由制造厂在使用说明书中规定的清洗，消毒和灭菌，而又不损坏或影响其安全防护性能和使用性能。

8.生物学评价
探头与人体皮肤接触的部件,应符合以下要求:
a) 细胞毒性试验,应不大于1级；
b) 迟发型超敏反应试验,应无致敏反应；
c) 皮肤刺激试验,应不大于极轻微刺激反应。

9.耐灭菌性(可重复使用产品适用)
经环氧乙烷反复灭菌10次后,应符合4.2、4.3的要求。

結果 (英文) 1:

6.2 bending resistance performanceTable 4 requirements the number of test items and bending.7. resistance to cleaning and disinfection performanceParts in contact with the patient when used properly, you may encounter should be able to withstand normal use or by the manufacturer in the instruction manual provided for the cleaning, disinfection and sterilization, without damage or affect its performance and safety performance.8. biological evaluationSensor parts in contact with human skin, shall conform to the following requirements: A) cytotoxicity test should not be greater than 1;B) delayed-type hypersensitivity test should be no allergic reaction;C) skin irritation test shall not be more than minor irritation.9. sterilization (reusable products)After repeated sterilization by ethylene oxide 10, should meet the requirements of 4.2 and 4.3.

結果 (英文) 2:

6.2 kink performance
test items and number of bending according to Table 4.
7. resistance to cleaning and disinfection performance
of normal use in contact with patients member should be able to withstand in normal use may encounter or cleaning, disinfection and sterilization by the manufacturer in the instructions for use specified, without damaging or affecting its safety properties and performance.

8. Biological Evaluation
probe member in contact with human skin, shall meet the following requirements:
A) cytotoxicity test, should be no greater than grade 1;
B) delayed-type hypersensitivity test, should be no sensitization;
C) skin irritation test It should be no more than very minor irritation.

9. sterilization resistance (reusable products applicable)
by ethylene oxide sterilization repeatedly 10 times, 4.2, 4.3 should meet the requirements of.

結果 (英文) 3:

6.2 bending resistanceTest items and the number of times of bending according to table 4.7 cleaning and disinfection performanceNormal use and patient contact parts, should be able to withstand that may be encountered during normal use or prescribed by the manufacturer in the instructions for use in cleaning, disinfection and sterilization, and do not damage or affect its safety performance and service performance.8 biological evaluationProbes and parts of human skin contact, should meet the following requirements:A) cell toxicity test, should not be more than 1;B) delayed type hypersensitivity test, there should be no allergic reaction;C) skin irritation test, should not be greater than the very slight stimulation reaction.9 sterilization resistance (reusable product application)After repeated sterilization by ethylene oxide 10 times, should meet the requirements of 4.3, 4.2.