Power Adapter Solution & Manufacturing
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What are the certifications for medical equipment power supplies?
Issue Time:2019-07-01
The safety certification of medical power supply involves personal safety and can not be ignored. Domestic requirements must comply with General Electric standards, and also need to pass 3C certification, IEC/EN 61601-1, EN60950, ISO9000 standards, and some export products must also comply with local countries and regions. The standards, such as the MIL-STD-810E standard, have different requirements for different products.

Certifications vary from country to country.

IEC International Electrotechnical Commission

3C certification CCEE is the meaning of China Electrician Certification, which is certified by the China Electrotechnical Commission.

The difference between CCC power and CCEE power:

1) CCC certification includes CCEE, CCIB (China Import and Export Quality Certification), EMC (Electromagnetic Compatibility Certification), and CCEE does not have EMC (electromagnetic compatibility certification), so the radiation of CCC power supply is smaller than CCEE power supply.

2) Since the CCC power supply contains a PFC circuit, the power factor is higher. In other words, the use of the CCC power supply is more energy efficient.

3) The quality of the CCC power supply is better than the CCEE power supply.

FCC: US ​​Federal Communications Commission

UL (Underwriters Laboratories) is the most authoritative and non-profit civil safety testing institution in the United States.

CSA is the Canadian Standards Association

CE certification in the European Economic Area (European Union, European Free Trade Association member countries, except Switzerland) market sales of goods, the use of CE mark more and more

GS mark GS mark is a German safety certification mark

TUV logo TUV logo is a type certification mark for German parts and components

1. The US Food and Drug Administration (FDA) requires medical products to be manufactured at a facility that is GMP-qualified (ie, has good practices). This is a set of quality certification system that should be required by the manufacturer in addition to the traditional ISO9000 certification to prove that its quality control procedures comply with GMP regulations. Similarly, China also has strict control over medical power, such as must comply with US UL, Canadian CUL/CSA, European TUV/GS, CE, British BS, Australian SAA, Korean KC, Japanese PSE, and ROHS, LVD, CEC, EMC, A series of requirements such as FCC, CB and other medical certifications.

2, the normal operation of medical equipment is critical, especially the power supply of medical equipment, must comply with safety, leakage, EMI-RFI radiation and protection regulations. These standards and related safety regulations constitute a set of strict normative requirements. Power supplies used in such demanding applications must meet stringent specifications for insulation measures to prevent patient and medical personnel from getting an electric shock. For the design of medical power supplies, the first choice must be the quality and reliability of the product.

3. When selecting medical power supply, you can tell the manufacturer whether there are parts quality control procedures, quality data and test documents, understand what procedures are required and require manufacturers to produce documents that can prove the quality and reliability of their products. Reputable manufacturers will be happy to provide them. . For the selection of a good medical power supply, GMP qualification can prove the production and quality control of the product accordingly. In addition, the performance parameters and reliability of the product must be grasped, that is, whether the product has passed some international general specifications.

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