• 凯发K8国际

    CN EN

    Applicable 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


    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.


    Biocompatibility test:

    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

    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

    …

    …

    …



    Others


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