To help verify the functionality and safety of medical devices, electrical safety standards have been established in the United States, European countries, and other parts of the world. The standards differ in criteria, measurements, and protocol.
The International Organization for Standardization (ISO) and the International Electro-technical Commission (IEC) organizations based in Europe provide standards worldwide in partnership with the World Trade Organization. These include standards for electro-medical equipment. There are general and specific standards for medical device electrical safety.
IEC60601 AAMI/NFPA 99
The primary standard for medical devices is IEC 60601. General requirements for protection against electric shock hazards are covered in IEC 60601.1, Section 3.
Jinhua Huacheng Medical Appliance Co.,Ltd.
Manufactuer of disposable medical products: Electrosurgical pencil,grounding plate,skin stapler and ECG electrode
