Biomedical Electrical Safety Testing & Equipment Services
Precision Diagnostics Confident Care
Dallas, TX | Riverside, CA
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Welcome to Universal Biomedical, Where Safety Meets Precision
At Universal Biomedical, we bring decades of expertise and an unwavering commitment to the safety and quality of medical devices worldwide. Using state-of-the-art Fluke biomedical test equipment, we offer comprehensive electrical safety testing services that meet the highest industry standards.
Our Specialties:
• Annual Electrical Safety Testing Regular inspections to maintain compliance and ensure safety.• Line Isolation Monitor (LIM) Inspections Safeguarding patient environments with faultless isolation.• Transformer Infrared Thermal Inspections Advanced imaging to detect potential risks before they escalate.• Electrical Panel Thermal Testing Detailed evaluations to optimize functionality and prevent hazards.
With a global focus on quality assurance, we aim to protect the well-being of patients and staff alike. Trust Universal Biomedical—because safety should never be compromised.
Medical Equipment Parts and Services in Los Angeles
For all your medical equipment parts and services in Los Angeles, call us today. At UNIVERSAL Biomedical, we specialize in working with a wide array of biomedical equipment, regardless of make or model. In case we can't fix it, there's absolutely no charge—your satisfaction is our priority.
We service Los Angeles, Rivera Side County, San Bernardino County, Palm Springs, and San Diego.
We service Los Angeles, Rivera Side County, San Bernardino County, Palm Springs, and San Diego.
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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.
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In this standard, each instrument has a class:
- Class I—Live part covered by basic insulation and protective earth
- Class II—Live part covered by double or reinforced insulation
- Class IP—Internal power supply
Each patient applied part or patient lead has a type:
- Type B—Patient applied part earthed
- Type BF—Patient applied part floating (surface conductor)
- Type CF—Patient applied part floating for use in direct contact with the heart
Leakage measurement limits have been developed for equipment types and measurements. They include:
- NC—normal conditions
- SFC—single fault conditions
The terminology used in IEC 60601.1 3rd Edition includes:
- Protective earth resistance
- Touch current (formerly enclosure leakage current)
- Patient auxiliary current
- Earth leakage current
- Patient leakage current
- Mains on applied part (MAP)
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: • The use of up to 25 amperes ac for protective earth testing (this is a type-test and generally suitable for manufacturers) • Leakage current is measured at 100 percent of mains voltage • Performance of dielectric strength/insulation testing is measured at 110 percent of mains voltage.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:
1. National Fire Protection Association (NFPA): NFPA 99 Standard for Health Care Facilities is the primary standard addressing electrical safety testing required in health care institutions. Other publications include NFPA 70, National Electrical Code, and NFPA 70E, Electrical Safety in the Workplace.2. Association for the Advancement of Medical Instrumentation (AAMI): ANSI/AAMI ES1 Safe Current Limits for Electro-medical Apparatus is another commonly-accepted standard.3. Underwriters Laboratories (UL): UL544, Medical Equipment requirements, is a standard for manufacturers, not hospitals. These standards may be referenced by accreditation, code or regulatory organizations such as the Joint Commission, Occupational Health and Safety Administration or other organizations monitoring health care institutions in the United States.4. Canadian Standards Association (CSA): CAN/CSA C22.2 NO. 60601-1-08 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance (Adopted IEC 60601-1:2005, third edition, 2005-12)
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.
• USA uses UL2601-1 or ANSI/AAMI ES601 • Europe uses EN60601-1 • Canada uses CAN/CSA-C22.2 No. 601.1-M90
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