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Electrical safety standards
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.
In this standard, each instrument has a class:
Each patient applied part or patient lead has a type:
Leakage measurement limits have been developed for equipment types and measurements. They include:
The terminology used in IEC 60601.1 3rd Edition includes:
The figure above represents the impendence of a patient test load. Leakage current measuring devices use this impedance circuit for measurements.
Additional important points regarding IEC 60601.1 include:
A new IEC standard, IEC 62353, is used for medical device testing in hospitals. IEC 62353 was developed because IEC 60601.1 is a type-testing standard with no risk management criteria and is impractical for testing in the hospital environment.
IEC 62353 tests are performed on equipment prior to use on patients, during schedule periodic testing, and after repair. Thus, this standard is for field (hospital) testing and does not address equipment design. In Annex E of the document, the manufacturer is requested to provide information on testing interval and procedure based on risk, typical usage, and device history. The minimum testing requirement for life support and other critical equipment is every 24 months.
In the United States, there are several primary and secondary organizations setting standards:
Global harmonization of standards has led to the development of worldwide standards. Equipment in the regions listed below must be certified to the IEC60601-1 standard or the device cannot be sold in that country.
Electrical safety testing
Testing requirements and sequence according to IEC 62353 Annex C are shown below. Only measurement equipment that meets IEC 61010-1 should be used. The sequence outlined in the figure below should be followed. For example, protective earth resistance should be measured prior to leakage current measurements
General connections to an electrical safety analyzer (ESA) are shown in Figure 5. Consult the operational manual for specifics for your electrical safety analyzer. Documentation requirements for IEC 62353 include:
Computerized record-keeping systems are greatly preferred for data storage, search, review, and analysis. Note the device fields must be standardized.
The ESA609 integrates all functions needed to test medical devices when patient lead testing is not required, including:
Versatile to global electrical safety standards of choice, the ESA609 tests to ANSI/AAMI ES1, NFPA-99, and parts of IEC62353 and IEC60601-1.
To learn more about the ESA609 Electrical Safety Analyzer visit www.flukebiomedical.com/ESA609.