Biomedical Engineering Reference
In-Depth Information
oximeters, battery-operated thermometers, MRI imaging systems, endoscopic cam-
eras, and infusion pumps. Accessories used with such equipment also fall under this
standard.
The IEC 60601 family of safety standards has a four-level structure:
1.
General Standard.
IEC 60601-1 entitled “Medical Electrical Equipment-
Part 1: General Requirements for Safety” addresses the general require-
ments for electromedical products. It also suggests ways to document
designs. The IEC 60601-1 Standard is accepted in nearly all markets for
supporting regulatory registrations and approvals either with national de-
viations (e.g., JIS T 0601-1 in Japan) or in its original form (e.g., in Bra-
zil). Common national deviations include the requirements of the electrical
code of the particular country, another national standard that may apply to
the product type or its components, and different national component re-
quirements (e.g., modifi ed marking requirements). ANSI/UL 60601-1 is the
U.S. national standard for safety testing electrical medical devices. CAN/
CSA C22.2 no. 601.1 is the equivalent standard in Canada. The European
Economic Council (EEC) publishes the Medical Devices Directives, which
declare EN 60601-1 (identical to IEC 60601-1) a harmonized standard.
2.
Collateral Standards.
Standards numbered IEC 60601-1-x contain hori-
zontal issues that deal with many different types of medical devices. Exam-
ples of collateral standards are
a. IEC 60601-1-2, Collateral Standard for Electromagnetic Compatibility;
b. IEC 60601-1-6, Collateral Standard: Usability;
c. IEC 60601-1-8, Collateral Standard: Alarms Systems—General
Requirements, Tests, and Guidance for Alarm Systems in Medical
Electrical Equipment and Medical Electrical Systems.
2.
Particular Standards.
Standards numbered IEC 60601-2-x provide require-
ments for a specific type of medical device. An example of particular stand-
ards is IEC 60601-2-33, entitled “Particular requirement for the safety of
magnetic resonance equipment for medical diagnostic,” to assure safety
in the MRI environment. Particular standards can amend, modify, and/or
supersede part of the requirements specified in IEC 60601-1.
3.
Performance Standards.
Standards numbered IEC 60601-3-X lay out per-
formance requirements for specifi c types of devices. IEC 60601-3-1, for ex-
ample, contains “essential requirements for the performance of transcuta-
neous oxygen and carbon dioxide partial pressure monitoring equipment.”
11.4.3 International Organization for Standardization (ISO)
The ISO is a worldwide federation of national standards bodies from nearly 140
countries that promotes the development of standardization and related activities
to facilitate the international exchange of goods and services and to develop in-
tellectual, scientific, technological, and economic cooperation. ISO members are
primarily the national standards bodies, and organizations representing social
and economic interests at the international level. ISO is supported by a central
