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Iec 60601-1

IEC 60601-1 is a standard established by the International Electrotechnical Commission for the safety of medical electrical equipment. It includes general requirements for safety, collateral standards for basic safety and essential performance, and specific standards for various medical devices. The standard addresses key areas such as mechanical requirements, markings, earthing, and electrical safety to ensure patient safety during medical procedures.

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299 views19 pages

Iec 60601-1

IEC 60601-1 is a standard established by the International Electrotechnical Commission for the safety of medical electrical equipment. It includes general requirements for safety, collateral standards for basic safety and essential performance, and specific standards for various medical devices. The standard addresses key areas such as mechanical requirements, markings, earthing, and electrical safety to ensure patient safety during medical procedures.

Uploaded by

fiqri fadzil
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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IEC60601-1

International Electrotechnical Commission


History

 Was established on 26 june 1906 in


London, UK.
 By 1914 had formed 4 committees.
 The First World War was interrupt the
IEC work.
 The IEC resumed in 1919
 In 1923 the technical committees was
increased to 10.
What is IEC?

 Standard for Medical Electrical Equipment.


 Creates safety standard that work to improve the
quality of the equipment as well to improve human
safety.
Type of IEC

Collateral Specific
Standard Standard
60601-1-x 60601-2-x

General Performance
Requirement Standard
60601-1 IEC 60601-3-x

60601
IEC 60601-1 General
Requirement
 Covers all the general requirements for electrical
medical (or electromedical) products.
 Medical Electrical Equipment—Part 1: General
Requirements for Safety, is the cornerstone
document addressing many of the risks associated
with electrical medical equipment.
Collateral Standard
IEC 60601-1-x

 Collateral standards specify general requirements


for BASIC SAFETY and ESSENTIAL PERFORMANCE
that may deal with many different types of medical
devices.
IEC 60601-1-x Collateral Standards
IEC 60601- MEDICAL ELECTRICAL EQUIPMENT – PART 1:
1-1 GENERAL REQUIREMENTS FOR SAFETY 1: COLLATERAL
STANDARD: SAFETY REQUIREMENTS FOR MEDICAL
ELECTRICAL SYSTEMS

IEC 60601-1-2 MEDICAL ELECTRICAL EQUIPMENT – PART 1: GENERAL


REQUIREMENTS FOR SAFETY 2. COLLATERAL STANDARD:
ELECTROMAGNETIC COMPATIBILITY –REQUIREMENTS AND
TESTS

IEC 60601-1-3 MEDICAL ELECTRICAL EQUIPMENT – PART 1: GENERAL


REQUIREMENTS FOR SAFETY – COLLATERAL STANDARD:
GENERAL REQUIREMENTS FOR RADIATION PROTECTION IN
DIAGNOSTIC X-RAY EQUIPMENT

IEC 60601-1-4 MEDICAL ELECTRICAL EQUIPMENT: PART 1-4: GENERAL


REQUIREMENTS FOR COLLATERAL STANDARD:
PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
IEC 60601-2 Specific Standards

 Lay out requirements for a specific type of medical


device
IEC 60601-2-x Specific Standards
IEC 60601-2- MEDICAL ELECTRICAL EQUIPMENT - PART 2-1:
1 PARTICULAR REQUIREMENTS FOR THE SAFETY OF
ELECTRON CCELERATORS IN THE RANGE 1 MeV TO
50 MeV
IEC 60601-2-2 MEDICAL ELECTRICAL EQUIPMENT - PART 2-2: PARTICULAR
REQUIREMENTS FOR THE SAFETY OF HIGH FREQUENCY
SURGICAL EQUIPMENT

IEC 60601-2-3 MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR


REQUIREMENTS FOR THE SAFETY OF SHORT-WAVE THERAPY
EQUIPMENT IEC 60601-2-4 MEDICAL ELECTRICAL
EQUIPMENT PART 2: PARTICULAR

IEC 60601-2-4 MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR


REQUIREMENTS FOR THE SAFETY OF CARDIAC
DEFIBRILLATORS AND CARDIAC DEFIBRILLATORS -
MONITORS
Basic Area
IEC 60601 addresses four basic areas as they relate to
the safety of the patient that include:
1. Mechanical requirement
2. Markings
3. Earthing
4. Electrical
1. MECHANICAL REQUIREMENT

 Is the equipment enclosure strong enough to


endure the wear and tear of normal use?
 Are moving parts properly protected to ensure a
safety hazard is not created?
 Is the unit stable and lacking sharp corners, edges,
etc.?
2.MARKING

 IEC 60601 defines a list of data that must be


present on the product’s nameplate including
information on its electrical requirements, model
number, manufacturer, etc. In addition, IEC60601
defines test protocol for the durability of markings
to ensure that they are not erased or worn off
through normal use.
3. EARTHING
 Earthing defines how the device is attached to the earth
or safety ground connection of an electrical power
supply to provide safety in the event of an electrical
fault.

 IEC 60601 uses the term “applied part” to define how


the electrical device may come into contact with the
patient.

 Under IEC 60601, there are three types of Applied Parts


designated “B”, “BF”, and “CF”.

 Type CF Applied Parts are intended for direct contact


with the human heart.
3. EARTHING
 Type BF Applied Parts have conductive contact with the
patient in an external fashion such as an electrode used
for ECG or EEG applications.

 Type B Applied Parts are those easily or readily released


from the patient or not in conductive contact with the
patient.

 IEC 60601 specifies that Type BF and CF Applied Parts


must be “floating” or not connected to earth whereas
Type B Applied Parts may be (and often are) connected
to earth.
4. ELECTRICAL

 IEC 60601 addresses the actual issue of electrical


safety as it relates to the use of the medical
electrical equipment in the process of caring for the
patient.
 The compliance standard requires that the medical
system operate safely not only under normal
conditions but also in the event of what the IEC
calls a “single fault” condition.
SINGLE FAULT CONDITION

 Single faults are such occurrences as the failure of


a component or the shorting or failure of basic
insulation.
 IEC 60601 requires that in the event of a single
fault, no safety hazard (electrocution, fire, etc.) will
occur. These requirements do not pertain to
multiple independent faults known as a “double
fault” condition.
Other standard

 ANSI: American National Standard Institute


 AAMI: Advancement of Medical
Instrumentation
 BSI: British Standards Institute

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