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Medical Device

Home > Product Testing> Testing Products> Medical Device

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
NO.	Product/Product Category	Test standard and number
1	Electromagnetic compatibility requirements for medical electrical equipment	IEC/EN 60601-1-2；YY0505
1		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
…	…	…

Others

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Medical Device

Medical Device

Applicable Products

1. About active products

Introduction

Standards

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