Chapter 4:

Standards

Standards are used to give a baseline performance that needs to be met in order to ensure the safe use of
medical equipment. A medical equipment maintenance program needs to meet or exceed all local standards.
All relevant standards should be reviewed to ensure program compliance. The following Chapter discusses
some standards that biomedical personnel should be familiar with.

IEC 60601-1
The International Electrotechnical Commission, IEC, is a worldwide organization that promotes global stan-
dardization in the electronics industry. IEC 60601-1, titled Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance, addresses medical equipment design in relation
to safety and serves as the foundation for safe manufacturing practices. This standard is mainly used in the
design and manufacture of medical equipment.
In 2005, the third edition of 60601-1 was published. The goal of the standard is to provide general
requirements for medical device safety assurance, and serves as the foundation for more specific standards.
This edition combines product requirements with manufacturing processes, such as risk management, and
addresses essential performance, including parts of the device that come in direct contact and can harm the
patient and/or operator.
The rationale behind the standard is to identify specific hazards associated with medical equipment and
to define an acceptable level of risk for each hazard. Additionally, it provides an objective test to determine
if the risks have been acceptably minimized, without defining how to minimize risks. This standard is not
intended to be used alone, as it addresses general safety issues applied broadly across medical equipment.
More specific standards need to be applied, depending on the medical equipment.
The 60601 family of standards contains collateral and particular standards. Collateral standards contain
requirements in addition to the parent standard. These standards are general in nature, like the parent
standard, and are applicable to all medical equipment. Particular standards contain requirements that are
exceptions to the parent and collateral standards. These types of standards are specific to a device type. IEC
60601 is the parent standard. Collateral standards are labeled as 60601-1-xx and particular standards are
labeled as 60601-2-xx, with xx denoting a specific document.
IEC 60601-1 is mainly used by manufacturers of medical equipment. Medical equipment that is manu-
factured to this standard has been subjected to rigorous safety and performance tests and has met quality
assurance specifications.

IEC 62353
IEC 62353 is an international standard published by the International Electrotechnical Commission, a world-
wide organization that promotes global standardization in the electronics industry. The standard addresses
the testing of medical equipment before first use, after servicing, or periodic safety inspections.
The standard specifies how to test for electrical safety and gives limits for acceptable measurements. Spe-
cific tests for measuring the protective earth resistance, leakage current, applied part leakage current, and
insulation resistance are outlined. These terms are defined as:
Protective earth resistance
Often referred to as ground wire resistance. Resistance between any conductive part of the equipment and
the protective connector of the main power supply plug, the protective connector of the appliance inlet, or
the protective conductor permanently connected to the supply mains.
Equipment leakage current
Current flowing from the supply mains to earth through the protective earth conductor and accessible con-
ductive parts.

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Applied part leakage current
Often referred to as lead leakage, the current flowing from the supply mains and accessible conductive parts
to the applied parts, or patient leads.
Insulation resistance
The resistance of the insulation between the supply mains and protective earth, the supply mains and
accessible conductive parts, or the supply mains and the patient leads. The insulation resistance is calcu-
lated by applying a voltage and measuring the resulting current.
IEC 62353 sets specific limits for electrical safety testing: the protective earth resistance should not exceed
300 mW, leakage current for Class I medical equipment should not exceed 500 µA using the direct measure-
ment method and leakage current for Class II medical equipment should not exceed 100 µA.
Electrical safety testing is discussed in detail in Chapter 5 of this manual, Electrical Safety. IEC 62353 goes
on to further specify that safety related functions of the equipment must be inspected. The standard does not
specify which functions need to be tested or how often, only that the device functionality should be tested.
The standard also specifies that safety inspections need to be documented.

NFPA 99
The National Fire Protection Agency is an international organization that advocates the consensus of codes
and standards for fire, electrical, and building safety. NFPA building codes have been adopted in the United
States. The standard NFPA 99, Standard for Health Care Facilities, establishes criteria to minimize the risk of
fire, explosion, and electrical hazards in health care facilities.
NFPA 99 covers nearly all aspects of fire safety in the hospital environment including building electrical
systems, vacuum and gas systems, and emergency management. It is important to note that this is a volun-
tary standard. However, many localities have adopted NFPA 99 as part of their fire codes.
NFPA 99 includes a Chapter on electrical equipment that is of particular interest to biomedical equipment
technicians. This Chapter specifically covers the performance, maintenance, and testing of electrical equip-
ment used within the hospital. Numerical criteria are given for electrical safety testing. NFPA 99 section 8.4
states that the ground wire resistance of medical equipment should be less than 0.5 W. It goes on to specify
the chassis leakage current should not exceed 300 µA.

The Joint Commission

The Joint Commission is a regulatory body that evaluates and accredits health care organizations in the
United States. The Joint Commission’s mission is to improve the safety and quality of healthcare provided to
the public. Currently, a system of unannounced surveys is used to promote continued compliance of the Joint
Commission’s regulations.
The Joint Commission releases annual National Patient Safety Goals relating to pertinent healthcare quality
issues. The National Patient Safety Goals are eventually included in the Joint Commission’s regulations. The
Joint Commission’s regulations include a chapter on the health care environment. This chapter specifically
addresses medical equipment, device maintenance, and how to minimize risk. A common benchmark used in
the United States is the completion of scheduled maintenance. The Joint Commission requires 100 percent of
life support equipment to receive scheduled maintenance and at least 90 percent of non-life support equip-
ment to receive scheduled maintenance.

ISO 9001
Published by the International Organization for Standardization, the ISO 9000 family of standards addresses
various aspects of quality management. Of particular interest is ISO 9001, which sets out the requirements of
a quality management system. The ISO 9000 standards are written in such a way as to be able to be applied
across any industry, and any size organization. The standard is based on a process approach to quality man-
agement and continual improvement of the organization, and is intended to produce consistent, high quality
products and services.
ISO 9001 has begun to be adopted into the health care industry in the United States. The DNV, Det Norske
Veritas, is another regulatory body for accrediting health care facilities, similar to the Joint Commission. They
received deemed status for accrediting health care facilities in the United States in 2008. Accreditation with
the DNV will lead to ISO certification for the health care facility.

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