1. About active products
Electromagnetic compatibility test:
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 |
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.
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