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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