Active medical devices Testing
Active devices such as following：
Multi-parameter monitors, cardiac pacemaker, cardiac defibrillator, ultrasonic diagnostic equipment, infusion pumps and infusion controllers, clinical thermometers, sphygmomanometer, non-invasive blood pressure monitoring equipment, pulse photo oximeter equipment, anesthesia respirator, high frequency electrosurgery equipment, nerve and muscle stimulators, en
Laboratory Equipments and In vitro diagnostic Equipments Testing
Products for example:
Clinical chemistry analysis instrument, immunochemical analysis instrument, automatic blood analysis instrument, microbiological analysis instrument, automatic protein analyzer, biochemical analyzer, blood cell analyzer, chemiluminescence immunoassay analyzer, urine sediment analyzer, blood coagulation instrument, nucleic acid purification instrument, blood tissue culture instrument, high temperature pulse vacuum sterilizer, high temperature steam sterilizer, low temperature plasma sterilizer, high temperature washer-disinfector, biological safety cabinet, etc.
Introduction
1. Safety test:
Input test, label wipe test, working voltage, ground continuity test, temperature and humidity (moisture) test, drop, impact and other mechanical tests, ball pressure test, normal temperature rise test, withstand voltage test, single fault test, component failure test, etc.
Standards
NO. | Product/Product Category | Test standard and number |
GB/YY | EN | IEC/ISO | ANSI/AAMI |
1 | Safety requirements for electrical equipment for measurement, control and laboratory use | GB 4793.1 | EN 61010-1 | IEC 61010-1 | UL 61010-1 |
2 | Laboratory equipment for the heating of materials | GB 4793.6 | EN IEC 61010-2-010 | IEC 61010-2-010 |
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3 | Laboratory centrifuges | GB 4793.7 | EN 61010-2-020 | IEC 61010-2-020 |
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4 | Automatic or semi-automatic laboratory equipment for analysis or other purposes | GB 4793.9 | EN IEC 61010-2-081 | IEC 61010-2-081 |
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5 | Cabinet X-ray systems |
| EN IEC 61010-2-091 | IEC 61010-2-091 |
|
10 | Dental units | YY/T 1043.1 | EN ISO 7494-1 | ISO 7494-1 |
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11 | Dental units - Air, water, suction and wastewater systems | YY/T 1043.2 | EN ISO 7494-2 | ISO 7494-2 |
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12 | laboratory centrifuges | GB 4793.7 | EN 61010-2-020 | IEC 61010-2-020 |
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13 | In vitro diagnostic (IVD) medical equipment | YY 0648 | EN 61010-2-101 | IEC 61010-2-101 |
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| … | … | … | … | … |
2. Testing instruments：
Oscilloscope, multimeter, clamp meter, digital power meter, leakage tester, grounding tester, electronic load, variable resistor, dc power supply, electrical safety analyzer, humidity chamber, oven, temperature data acquisition, ball pressure apparatus, illuminance meter, sound pressure meter, etc.
Sterilizer and Washer- Disinfector Tests
Sterilizer
Equipment designed to achieve sterilization which comprises a series of actions or operations needed to achieve the specified requirements for sterility
WASHER-DISINFECTOR
Equipment intended to clean and disinfect medical devices and other articles used in the context for example of medical, dental, pharmaceutical and veterinary practice
NO. | Product/Product Category | Test standard and number |
|
GB/YY | EN | IEC/ISO | ANSI/AAMI |
1 | Sterilizers and disinfectors | GB 4793.4 | EN IEC 61010-2-040 | IEC 61010-2-040 |
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2 | Steam sterilizers - Large sterilizers |
| EN 285 |
|
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3 | Ethylene oxide sterilizers | YY 0503 | EN 1422 |
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4 | Small steam sterilizer |
| EN 13060 |
| ANSI/AAMI ST55 |
5 | Washer-disinfectors | YY/T 0734.1 | EN ISO 15883-1 | ISO 15883-1 |
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6 | Washer-disinfectors – Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc | YY/T 0734.2 | EN ISO 15883-2 | ISO 15883-2 |
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Testing instruments：
Oscilloscope, multimeter, clamp meter, digital power meter, leakage tester, grounding tester, electronic load, variable resistor, dc power supply, electrical safety analyzer, humidity chamber, oven, temperature data acquisition, ball pressure apparatus, illuminance meter, sound pressure meter, etc.
