Medical devices and electronic equipment are highly regulated to ensure patient safety. The required certifications for medical electrical devices vary based on their physical environment, geographic location, and intended application. Some of the most common certifications include:
IEC 60601
UL 60601-1
CE Mark
RoHS Compliance
FCC Compliance
Navigating these certifications can be complex, often taking years to obtain. Below is an overview of the standard certifications applicable to medical computers. Many Estone medical computers include these certifications, though the specific requirements depend on the project.
IEC 60601: The Standard for Medical Electrical Equipment
IEC 60601 is the most widely recognized certification for medical equipment, established by the International Electrotechnical Commission (IEC). First introduced in 1977, it has undergone multiple updates to reflect advancements in healthcare technology.
The certification consists of two key parts:
IEC 60601-1: Covers “general requirements for basic safety and essential performance.”
IEC 60601-2: Specifies particular requirements for different types of medical devices.
IEC 60601-1 is considered the most critical part of the standard and is often referred to as the “bible” of medical electrical equipment standards. The latest version, 4th Edition, was published in 2015 and includes:
60601-1-1: Medical Electrical Systems
60601-1-2: Electromagnetic Compatibility
60601-1-3: Radiation Protection for Diagnostic X-Ray Systems
60601-1-4: Programmable Electrical Medical Systems
60601-1-6: Usability
60601-1-8: Medical Alarm Systems
60601-1-9: Environmentally Conscious Design
60601-1-10: Physiologic Closed-Loop Controllers
60601-1-11: Home Healthcare Equipment
60601-1-12: Emergency Medical Environment
While IEC 60601 is an internationally recognized standard, individual countries may have their own adapted versions with slight variations. For example, Canada requires bilingual safety instructions (French and English). The standard is named differently across regions:
Country/Region
Standard Name
United States
UL 60601-1
Canada
CAN/CSA C22.2 No. 60601-1
European Union
EN 60601-1
Israel
SI 60601 Part 1
Japan
JIS T0601-1
Australia/New Zealand
AS/NZ 3200.1.0
UL 60601-1: The U.S. Standard
UL 60601-1 is the U.S. adaptation of IEC 60601-1 and includes additional requirements unique to the country. For instance:
UL mandates that polymeric materials meet strict flammability thresholds.
X-ray equipment enclosures must have grounded enclosures around components operating at high voltages (above 600V AC, 850V DC, or 850V peak).
The name “UL” comes from Underwriters Laboratories Inc., a Nationally Recognized Testing Laboratory (NRTL) approved by the Occupational Safety and Health Administration (OSHA) in the United States.
CE Mark: Compliance in the European Economic Area
The CE mark ensures that products sold in the European Economic Area (EEA) meet high safety, health, and environmental protection standards. Though primarily an EEA requirement, CE marking is internationally recognized.
For medical devices, the CE mark confirms compliance with the European Medical Device Directives, indicating that the device meets essential safety and performance standards.
RoHS Compliance: Restriction of Hazardous Substances
RoHS (Restriction of Hazardous Substances) limits the use of specific hazardous materials in electrical and electronic products. Medical electronic equipment must comply with RoHS regulations, which became mandatory under CE certification after 2011.
RoHS 3, implemented on July 22, 2019, introduced additional restricted substances, further strengthening environmental and health protections.
FCC Compliance: Ensuring Safe Communication
The Federal Communications Commission (FCC) regulates communications by radio, television, wire, and satellite in the U.S. Most computing and communication devices, including medical computers, must comply with FCC regulations to be legally sold.
Medical computers must meet the appropriate FCC class:
FCC Class A: For business, industrial, and commercial environments.
FCC Class B: For residential use, with stricter electromagnetic interference limits (approximately 10 dB more restrictive than Class A).
Summary
Understanding and obtaining the correct certifications for medical computers is crucial for compliance, safety, and performance. Certification requirements vary by location and application, making it essential to plan ahead when developing or selecting medical computing solutions. Many Estone medical computers are designed to meet these standards, ensuring high-quality and compliant devices for healthcare environments.
