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      CN EN

      Product Testing

      Applicable Products

      Medical device testing products:

      1. About active products


      Multi-parameter monitors, ultrasonic diagnostic equipment, infusion pumps and infusion controllers, clinical thermometers, non-invasive blood pressure monitoring equipment, pulse photo oximeter equipment, high frequency electrosurgery equipment, nerve and muscle stimulators, endoscopes, EEG machines, surgery Surgery, cosmetics, diagnosis and treatment laser equipment, electrocardiogram diagnosis equipment, etc., clinical chemistry analysis equipment, immunochemical analysis equipment, automatic blood analysis equipment, microbiological analysis equipment, automatic protein analyzer, biochemical analyzer, blood cell analyzer, blood gas analyzer, chemistry Luminescence immunoassay analyzer, urine sediment analyzer, blood coagulation analyzer, automatic blood rheometer, automatic internal bacterial culture analyzer, microorganism identification and bacterial sensitivity analyzer, nucleic acid purification instrument, blood tissue culture instrument, cryostat , Biological tissue dehydration or, tissue embedding machine, centrifuge, mixer, dyeing machine, high temperature pulse vacuum sterilizer, high temperature steam sterilizer, infrared electric sterilizer, high temperature disinfection washing machine, biological safety cabinet, etc.


      2. About Non-active?Products


      1. Surface contact equipment

      Electrodes, external prostheses, fixation bands, compression bandages and various types of monitors, etc.

      Contact lenses, urinary catheters, intravaginal or digestive tract equipment (gastric tube, colonoscope, gastroscope), tracheal intubation, bronchoscope, etc.

      It is used for dressings or nursing equipment for ulcers, burns, granulation tissue and sealing dressings.


      2. External access device

      Blood transfusion, infusion set, extender, transfer device, etc.

      Laparoscopy, arthroscopy, drainage system, dental filling materials, skin nails, etc.

      Intravascular catheters, temporary pacing electrodes, dialyzers, dialysis tubing and accessories, vascular adsorbents, immunoadsorbents, etc.


      3. Implantation device

      Orthopedic nails, artificial joints, prostheses, bone cement and intraosseous devices, pacemakers, implantable drug delivery devices, neuromuscular sensors and stimulators, artificial tendons, breast implants, artificial larynx, subperiosteal implants, Lashing clips, etc.

      Pacemaker electrodes, artificial arteriovenous fistulas, heart valves, artificial blood vessels, internal drug delivery catheters and ventricular assist devices, etc.

      Introduction

      Medical devices are related to human health and safety, and related issues have become the focus of common concern for manufacturers and consumers. Shenzhen Huatongwei is one of the first third-party laboratories engaged in active medical device testing in China. It provides long-term medical product testing services for domestic and foreign medical device manufacturers.

      1. Test items
      Routine safety testing:
      Temperature rise, withstand voltage, leakage current, defibrillation protection test, mechanical test, single failure test, etc.

      Electromagnetic compatibility test:

      Power terminal interference voltage, radiation interference, harmonic current, voltage fluctuation and flicker, electrostatic discharge immunity, radio frequency radiation immunity, power frequency magnetic field immunity, electrical fast transient pulse group immunity, radio frequency conduction immunity Disturbance, surge immunity, voltage sag, short-term interruption and resistance to voltage changes.

      Product-specific standard tests:

      For example: blood pressure accuracy, blood oxygen accuracy, accuracy testing of infusion pumps and infusion controllers, and performance testing of a series of products, such as monitoring, nerve and muscle stimulators.


      In vitro cytotoxicity test

      Subacute systemic toxicity test

      Salmonella typhimurium revertant

      Platelet adhesion test

      Sensitization test

      Complement activation test

      Gene mutation test

      Subchronic systemic toxicity test

      Thrombosis test

      Chronic systemic toxicity test

      Skin irritation test

      Muscle implantation test

      Intradermal stimulation test

      Hemolysis test

      Coagulation test

      Heat source test

      Acute systemic toxicity test

      Chromosome aberration test

      Material characteristic analysis

      Bone implant test

      Subcutaneous implantation test

      Bone marrow micronucleus test


      Endotoxin
      Physical and chemical performance test
      Packaging verification Validation of cleaning and disinfection
      Biosafety assessment
      Preclinical functional evaluation

      Standards

      1. With power supply | EMC, safety regulations, performance, environment:

      NO.

      Product/Product Category

      Test standard and number

      1

      Electromagnetic compatibility requirements for medical electrical equipment

      IEC/EN 60601-1-2;YY0505

      2

      Safety requirements for medical electrical equipment

      IEC/EN 60601-1;GB 9706.1

      ES 60601-1;CSA-C22.2No.601-1

      3

      Medical electrical equipment or systems used in home healthcare environments

      IEC/EN 60601-1-11

      4

      High frequency electrosurgical equipment and its accessories

      IEC/EN 60601-2-2;GB9706.4

      5

      Nerve and muscle stimulators

      IEC/EN 60601-2-10;YY0607

      6

      Injection pump and controller

      IEC/EN 60601-2-24;GB9706.27

      7

      Electrocardiograph

      IEC/EN 60601-2-25;GB10793

      8

      ECG monitoring equipment

      IEC/EN 60601-2-27;EC13;GB9706.25;YY1079

      9

      Automatic circulation indirect blood pressure monitoring equipment

      EN1060-1;EN1060-3;ISO 81060-1

      IEC/EN 80601-2-30;?YY0667;YY 0670

      10

      Invasive blood pressure monitoring equipment

      IEC 60601-2-34;YY0783

      11

      Heating equipment and medical heating equipment used in blankets, cushions and mattresses

      IEC/EN80601-2-35;YY 0834

      12

      Ultrasound medical diagnosis and monitoring equipment

      IEC/EN 60601-2-37;GB9706.9

      13

      Electronic myograph and evoked response equipment

      IEC/EN60601-2-40

      14

      Operating table

      IEC/EN 60601-2-46;YY0570

      15

      Mobile ECG system

      IEC/EN 60601-2-47; YY 0885

      16

      Multifunctional patient monitoring equipment

      IEC 80601-2-49;IEC/EN 60601-2-49;YY0668

      17

      Medical bed

      IEC/EN 60601-2-52;YY0571

      18

      Dental equipment

      IEC/EN 60601-2-60

      19

      Medical pulse photoelectric oximeter equipment

      ISO80601-2-61;YY 0784

      20

      Hearing aids and hearing systems

      IEC/EN 60601-2-66

      21

      Special requirements for human body temperature monitoring equipment

      EN12470-3;EN12470-4;EN12470-5

      ISO80601-2-56;IEC/EN80601-2-59

      ASTM E1112;ASTM E1965;GB/T 21416;GB/T 21417.1

      22

      Medical supply unit (suspension bridge, suspension tower)

      ISO11197

      23

      Environmental requirements and test methods for medical electrical equipment

      GB/T14710

      24

      Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use

      IEC/EN 61326-1;IEC/EN 61326-2-6

      GB/T18268.1;GB/T18268.26

      25

      Safety requirements for electrical equipment for measurement, control and laboratory use

      IEC/EN 61010-1;GB4793.1

      26

      Laboratory diagnostics (IVD) medical equipment

      IEC/EN 61010-2-101;YY 0648

      27

      Experimental equipment for material heating

      IEC/EN 61010-2-010;GB 4793.6

      28

      Automatic or semi-automatic laboratory equipment for analysis or other purposes

      IEC/EN 61010-2-081;GB 4793.9



      2、Biocompatibility test


      NO.

      Project

      Standard

      1

      In vitro cytotoxicity test

      ISO10993-5,GB16886.5

      2

      Sensitization test

      ISO10993-10,GB16886.10

      3

      Skin, intradermal, oral mucosa irritation test

      ISO10993-10,GB16886.10

      4

      Stimulus test

      ISO10993-23

      5

      Acute systemic toxicity test

      ISO10993-11,GB16886.11

      6

      Subacute systemic toxicity test

      ISO10993-11,GB16886.11

      7

      Subchronic systemic toxicity test

      ISO10993-11,GB16886.11

      8

      Chronic systemic toxicity test

      ISO10993-11,GB16886.11

      9

      Heat source test

      ISO10993-11,GB16886.11

      10

      Chromosome aberration test

      ISO10993-3,GB16886.3

      11

      Micronucleus test

      ISO10993-3,GB16886.3

      12

      Gene mutation test

      ISO10993-3,GB16886.3

      13

      Ames?test

      ISO10993-3,GB16886.3

      14

      Thrombosis test

      ISO10993-4,GB16886.4

      15

      Coagulation test

      ISO10993-4,GB16886.4

      16

      Platelet adhesion test

      ISO10993-4,GB16886.4

      17

      Complement activation test

      ISO10993-4,GB16886.4

      18

      Hemolysis test

      ISO10993-4,GB16886.4

      19

      Muscle implant test

      ISO10993-6,GB16886.6

      20

      Subcutaneous implantation test

      ISO10993-6,GB16886.6

      21

      Bone implantation test

      ISO10993-6,GB16886.6

      22

      Material characteristics analysis

      ISO10993-18


      Our company can apply for medical clients:

      Medical equipment CFDA registration, SRRC, e-commerce quality inspection, CCC certification, CQC certification, Taiwan TFDA, US FDA registration, FCC, wireless coexistence, UL, EU CE certification, RED certification, RoHS, WEEE, REACH, Brazil INMETRO certification, ANVISA Registration, ANATEL certification, TGA certification in Australia, RCM certification, CSA certification in Canada, MIC certification in Japan, KFDA certification in South Korea, KC certification, CE certification in machinery and equipment, etc.

      Others

      1. Service advantage

      Professional medical equipment testing equipment
      Relatively stable testing team
      Experienced medical equipment testing and certification engineer
      Maintain good communication with agencies and consulting companies

      2. Huatongwei solution
      Our product inspection reports are widely used in CE registration in the European Union, FDA registration in the United States and ANVISA registration in Brazil.
      The rectification plan for electromagnetic compatibility testing.
      Bottom-up testing of general standards and special product standards for domestic medical device registration and certification.


      3. Q&A
      Q: How long is the testing cycle of medical device products?
      A: The different power supply types of the product and whether it involves special standards determine the test cycle of the product. The regular test cycle ranges from 4 to 8 weeks.

      Other supplements for medical device testing and certification:

      1. Thank you for reviewing. If you don’t understand anything, please click on the "Online Consultation" on the right to find out whether the relevant products can be tested and the test project process, cycle, price, etc. ?


      Email:peifeng.chen@szhtw.com.cn


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