IEC International Standards

for medical electrical

equipment and systems

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION

3, rue de Varembé
P.O. Box 131
CH-1211 Geneva 20
Switzerland

Tel: + 41 22 919 02 11
Fax: + 41 22 919 03 00 INTERNATIONAL
info@iec.ch
ELECTROTECHNICAL
www.iec.ch
COMMISSION
IEC International Standards
for medical electrical
equipment and systems

1
 medical electrical equipment
Founded in 1906, the International Electrotechnical
Commission (IEC) has 100 years of experience in
preparing International Standards for all fields of
electrotechnology.
IEC standards pass through a stringent process for
preparation and approval to ensure they are of the
highest quality and International Consensus. IEC
standards are truly international and can be used with
confidence anywhere by anyone, with the ultimate
result being improved health care for patients.
When appropriate, IEC also cooperates with ISO, the
International Organization for Standardization based
on the expertise each organization embodies. To
ensure that their International Standards fit together
seamlessly, they have a common set of rules for their
work. The working procedures for both organizations
are virtually identical and joint projects and standards
often combine expertise from both organizations.
2
Within the IEC, responsibility for medical electrical
equipment standards is the purview of Technical
Committee 62 and its subcommittees.
Regulators in the medical field have an important role in
protecting citizens in terms of safety and health. In part,
they accomplish this by specifying safety requirements
that medical electrical equipment, systems and software
must meet before it can be placed on the market.
Specifying these requirements for equipment and
software used in the field of medicine calls for specialized
knowledge. Today, the electrical equipment used in
clinics and hospitals often involves complex technology.
To ensure that regulations are relevant and meaningful,
many regulators have come to rely on expertise that
is embodied in medical electrical equipment safety
standards. The work that the IEC does in this field helps
regulators do their job more efficiently.
 medical electrical equipment
Founded in 1906, the International Electrotechnical
Commission (IEC) has 100 years of experience in
preparing International Standards for all fields of
electrotechnology.
IEC standards pass through a stringent process for
preparation and approval to ensure they are of the
highest quality and International Consensus. IEC
standards are truly international and can be used with
confidence anywhere by anyone, with the ultimate
result being improved health care for patients.
When appropriate, IEC also cooperates with ISO, the
International Organization for Standardization based
on the expertise each organization embodies. To
ensure that their International Standards fit together
seamlessly, they have a common set of rules for their
work. The working procedures for both organizations
are virtually identical and joint projects and standards
often combine expertise from both organizations.
2
Within the IEC, responsibility for medical electrical
equipment standards is the purview of Technical
Committee 62 and its subcommittees.
Regulators in the medical field have an important role in
protecting citizens in terms of safety and health. In part,
they accomplish this by specifying safety requirements
that medical electrical equipment, systems and software
must meet before it can be placed on the market.
Specifying these requirements for equipment and
software used in the field of medicine calls for specialized
knowledge. Today, the electrical equipment used in
clinics and hospitals often involves complex technology.
To ensure that regulations are relevant and meaningful,
many regulators have come to rely on expertise that
is embodied in medical electrical equipment safety
standards. The work that the IEC does in this field helps
regulators do their job more efficiently.
World’s leading experts

Working within TC 62, the world’s leading experts, who

are mostly hardware and software engineers, as well as
physicists and physicians, come from industry, hospitals,
test houses, consulting firms and governmental bodies,
so they have the specialized knowledge needed to
understand how this equipment should be designed,
produced, operated and maintained. Regulators from
Europe, North America and Asia also participate in this
work.

Because TC 62 brings together the world’s leading

experts in this field, IEC standards represent
international consensus on the best way to ensure
safety and performance of electrical equipment used
in medical practice.

5
World’s leading experts

Working within TC 62, the world’s leading experts, who

are mostly hardware and software engineers, as well as
physicists and physicians, come from industry, hospitals,
test houses, consulting firms and governmental bodies,
so they have the specialized knowledge needed to
understand how this equipment should be designed,
produced, operated and maintained. Regulators from
Europe, North America and Asia also participate in this
work.

Because TC 62 brings together the world’s leading

experts in this field, IEC standards represent
international consensus on the best way to ensure
safety and performance of electrical equipment used
in medical practice.

5
 Safety and performance

Prepared by TC 62, the main publication of the IEC
60601 family is, together with its collateral standards,
the essential foundation for standards for medical
electrical equipment and systems. Within the IEC
60601 series, the specific issues related to categories
of medical devices are addressed in detail in the 60601
collateral standards. Most IEC standards for this field
cover safety and performance for specific products,
such as diagnostic imaging, radiotherapy, nuclear
medicine, radiation dosimetry, electromedicine,
anaesthesia, critical care, surgery, artificial respiration,
paediatrics, hearing aids and medical lasers.
Regulators can refer to IEC standards in their legislation
as being the benchmark for safety, leaving them free
to concentrate on other aspects of their work. That
regulators in fact do so is clear from the worldwide
acceptance of IEC medical electrical equipment
standards in legislation. For example, 67 IEC standards
have been harmonized under the European Union’s
Medical Device Directive 93/42/EEC and 66 are
recognized consensus standards by the US Food and
Drug Administration.

The IEC 60601 family and the ISO 14971 series, which
reference the main IEC 60601 publication, enable
medical electrical equipment manufacturers to produce
safe and effective products, including complex systems
and assemblies.

6 3
 Safety and performance

Prepared by TC 62, the main publication of the IEC
60601 family is, together with its collateral standards,
the essential foundation for standards for medical
electrical equipment and systems. Within the IEC
60601 series, the specific issues related to categories
of medical devices are addressed in detail in the 60601
collateral standards. Most IEC standards for this field
cover safety and performance for specific products,
such as diagnostic imaging, radiotherapy, nuclear
medicine, radiation dosimetry, electromedicine,
anaesthesia, critical care, surgery, artificial respiration,
paediatrics, hearing aids and medical lasers.
Regulators can refer to IEC standards in their legislation
as being the benchmark for safety, leaving them free
to concentrate on other aspects of their work. That
regulators in fact do so is clear from the worldwide
acceptance of IEC medical electrical equipment
standards in legislation. For example, 67 IEC standards
have been harmonized under the European Union’s
Medical Device Directive 93/42/EEC and 66 are
recognized consensus standards by the US Food and
Drug Administration.

The IEC 60601 family and the ISO 14971 series, which
reference the main IEC 60601 publication, enable
medical electrical equipment manufacturers to produce
safe and effective products, including complex systems
and assemblies.

6 3
 IEC International Standards
for medical electrical
equipment and systems

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION

3, rue de Varembé
P.O. Box 131
CH-1211 Geneva 20
Switzerland

Tel: + 41 22 919 02 11
Fax: + 41 22 919 03 00 INTERNATIONAL
info@iec.ch
ELECTROTECHNICAL
www.iec.ch
COMMISSION