Biomedical Engineering Reference
In-Depth Information
1. The International Electromedical Commission (IEC, www.iec.ch) is respon-
sible for electrotechnical sector;
2. The International Telecommunication Union (ITU, www.itu.int/) is respon-
sible for the telecommunications technologies (discussion is beyond the
scope of this topic);
3. The International Organization for Standardization (ISO, www.iso.org/) is
responsible for all other sectors.
In the international standards, medical devices are defined as any instrument,
apparatus, appliance, material, or other article (including the software necessary
for its proper operation) used for human beings for any of the following purposes:
Diagnosis, prevention, monitoring, treatment or alleviation of disease, injury
or handicap, or compensation for injury or handicap;
Investigation, replacement, or modification of the anatomy or of a physi-
ological process;
Control of conception.
Verification and validation should be part of a medical manufacturer's quality
management system. The assumption is that a design firm will have a quality man-
agement system so that requirements called for in the IEC standard will be included
in the design, verification, and validation of the medical device. Although it is not
a requirement to follow international standards, there are a number of reasons to
comply with the standard:
1. If the company is in compliance with different applicable international
standard during the development of a new product, it is presumed to be the
best guarantee of a fl awless evaluation report.
2. There is no need to reinvent the wheel when standards are designed espe-
cially for medical device companies.
3. The certification of compliance automatically improves the perception of
the company and its products.
11.4.2 International Electromedical Commission (IEC)
The IEC consists of more than 50 countries. Within the IEC, responsibility for med-
ical electrical equipment standards is within the purview of Technical Committee
62. The IEC has developed a series of safety standards and regulations specifically
for electromedical equipment. Standards can enable electrical and electronic equip-
ment to work together no matter where it is designed, manufactured, assembled, or
used. The IEC defines medical electrical equipment in IEC 60601-1 clause 2.2.15
as [5]: “equipment, provided with not more than one connection to a particular
supply main and intended to diagnose, treat, or monitor the patient under medical
supervision and which makes physical or electrical contact with the patient and/
or transfers energy to or from the patient and/or detects such energy transfer to or
from the patient.” Examples of electromedical products include ventilators, pulse
