Acceptance Mark
Briefly difference IEC 60601 series standards(Adapter)
There are many medical devices for electronic products, and medical electronic equipment in addition to pay attention to basic biocompatibility, chemical, human error, labeling and other risks beyond doubt, the most important thing is to touch leakage, excessive energy output, not external electromagnetic interference, such as electrical energy safety, electromagnetic compatibility must also be fully integrated into risk management. The current global medical electronic equipment generally accepted basic safety requirements for the IEC 60601 series of standards. IEC 60601-1 which covers all general regulations, including environmental, mechanical, excessive radiation ... and other hazards described and included in risk tolerance assessment. IEC 60601-1-X series is part of a parallel standard IEC 60601-1, especially for GM to illustrate the nature of electromagnetic compatibility, usability (usability), radiation protection, etc., but must be used simultaneously with the IEC 60601-1. The IEC 60601-2-XX series is for a specific medical equipment, in addition to applicable IEC 60601-1, but also applies to IEC 60601-1-X standard, the relationship between series as shown below:

For example, the production of high-frequency electric surgical knife manufacturers in addition to IEC 60601-2-2 standards apply, but also applies to IEC 60601-1 and IEC 60601-1-X series of standards. Up to 100 years in June, China's Department of Health acknowledgment of IEC 60601 series of standards has reached more than 60 items (see acknowledgment of standard medical equipment database: http: // , while the European Union EN 60601-1 or our CNS 14509 are also in accordance with IEC 60601-1 as Yanni's harmonized standards. The following table lists the common standard IEC 60601-1-X for reference:

編號 主要內容
IEC 60601-1-2
Electromagnetic Compatibility
IEC 60601-1-3
Diagnostic X-ray equipment for radiation protection
IEC 60601-1-6
IEC 60601-1-8
Warning system
IEC 60601-1-9
Reduce environmental hazards
IEC 60601-1-10
Closed loop control system
IEC 60601-1-11
Home medical equipment applicable standards

Although the standard will be adjusted in accordance with advances in technology content, and revision of times, but consistent with its main structure, so the next table summary chapter IEC 60601-1 standards described below for reference:

Chapters Summary Chapters Summary

Basic requirements

  • Classification
  • Identification,labeling , documentation
  • Input Power
Flammable anesthetic mixture burn hazards protection
Environmental conditions
Overheat protection and other safety hazards
Protection against electric shock hazards
Protection and the dangers of operating data output accuracy
Protective mechanical hazards
Abnormal operating and fault conditions; environmental testing
Protection of unnecessary or excessive radiation hazards
construction requirements

Source and Further Reading

     Acknowledgment of standard medical equipment database
     ISO ISO
     100 annual Hsinchu Biomedical Science Park Industrial Consulting Services