Electrical Safety Check in Health Care Environment, S.Saenz. Projet d'Intégration, MASTER Management des Technologies en Santé (MTS), UTC, 2006-2007

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ELECTRICAL SAFETY CHECK IN HEALTH CARE ENVIRONMENT
S. Saez
Référence bibliographique à rappeler pour tout usage : Electrical Safety Check in Health Care Environment, S.Saenz. Projet d'Intégration, MASTER Management des Technologies en Santé (MTS), UTC, 2006-2007 URL : https://www.utc.fr ; Université de Technologie de Compiègne
Résumé L’équipement électrique médical peut présenter une gamme de dangers pour les malades, utilisateurs, ou le personnel de service. La plupart de ces types de risques sont communs à une grande partie des types d'équipement électrique médical, pendant que d´autres sont spécifiques à certaines catégories d´équipements. Les risques communs typiques sont les Problèmes Mécaniques, le Risque de feu ou l'explosion, l'Absence de Fonction, la production Excessive ou insuffisante, l'Infection, l'Usage Impropre, le Risque d'exposition aux courants de défaut. Il y a des agences qui font les règles pour réaliser la certification dans le système de santé. Ces certifications ont le but d’empêcher les accidents et d´améliore le niveau de soin donné aux malades. Mots clés: la certification, l'ingénierie clinique, dispositifs médicaux, la qualité.
ABSTRACT Medical electrical equipment can present a range of hazards to the patient, the user, or to service personnel. Many such hazards are common to many or all types of medical electrical equipment, whilst others are peculiar to particular categories of equipment. Typical common hazards are Mechanical Hazards, Risk of fire or explosion, Absence of function, Excessive or insufficient output, Infection, Misuse, Risk of exposure to spurious electric currents. There are agencies that make the rules to achieve certification in health system. Those Certifications have the purpose to prevent accidents and improve the level of care given to patients. Key words: certification, clinical engineering, medical device, quality.

Acknowledgment

I want to thank all those who have been with me in this phase of learning, especially two people that helped me a lot during my stay in the United States of America.

I want to thank also to the responsible for the master, Mr. Georges Chevallier and Mr. Gilbert Farges.

I want to thank my friends in Europe, especially my class of masters and all those from all over the word, who have been next to me all this time, and who made my stay in France even more pleasant, contributing always with a good sprit in this process of cultural expansion.

To National Technological University of Argentina, by their management and support in the exchange of students on a worldwide basis.

By I finalize and the most important, the family, from my parents to my brothers, who have made all the problems I faced light, helping me with love and giving me forces in every moment.

Thanks a lot Family.

Table of Contents

Introduction
The Company
The Health Care Facility Electrical Safety Program
Electrical Safety Program Rationale
Basic Elements of an Electrical Safety Program
Recommended Steps for Implementing an Effective Program
Electrical Safety Requirements
Classification of Health Care Facility Locations
Emergency Power System Locations
Anesthetizing Locations-Nonflammable
Ambulatory Health Care Facility Locations
Critical Care Locations
General Care Locations
Nonpatient Care Locations
Wet Locations
Scheduling Of Tests
Recommended Test Schedules
Equipment Test Procedures
Incoming Equipment Inspection
Rental Equipment Inspection
Device Inspection and Testing
Nonpatient Care Equipment Inspection and Testing
Computerized Maintenance Management System
Sources of Codes, Standards, and Regulations
American National Standards Institute
The National Fire Protection Association
Joint Commission on Accreditation of Health Care Organizations
Underwriters Laboratories
Association for the Advancement of Medical Instrumentation
Occupational Safety and Health Administration
Conclusion
Appendix
Forms
Glossary
Bibliography

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Introduction

During my professional internship, I worked as a biomedical engineer at the biomedical department of the KMA Corporation. There I had the chance to experience the professional life in the United States of America, by developing maintenance tasks, tests, controls and repairs. Our customers were big hospitals, clinics and medical centres from different areas of the USA. This added a quota of enthusiasm since I got to travel around USA and see how tasks are accomplished in different ways in each medical centre.
To be able to do my work correctly on the field, I had to read regulations, manuals and procedures that are in use in USA, which are written by agencies with an important trajectory and they are controlled very rigorously.
The objective of these agencies is to ensure a quality of high performance in medical devices and medical installations. Controls are carried out on the electric part, and they concern correct calibration, lost of current or a badly operation. The inspections are carried out regularly, and their reports are stored in an informatics system, which contains all information concerning the tests, including parameters, values, etc. Then, if the medical device passes the test, a sticker with the approving mark and the date of the next control is attached on the device. The tests are carried out using Fluke devices, which are well known for their high quality and reliability. These devices are sent to Fluke Biomedical periodically for their control and calibration in order to guarantee their correct operation.
These controls are very important since there have been serious cases of burns and deaths in hospitals. Since everyone reacts in a different way to electric current stimulus, it is necessary to conduct such controls, in order to avoid any kind of serious injury to patients, especially the most sensitive ones.
In the next pages all information about the agencies, norms, procedures and forms relating to a biomedical engineer that develops his career in the United States doing electric safety checks are reported.

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The Company

Healthcare Professionals Serving Your Unique Needs
KMA Remarketing Corporation was founded in 1993 by healthcare professionals who recognized two fundamental principles. The first is the great need for affordable, quality medical, EMS (Emergency Medical Service) and rescue products throughout the world. The second was the awareness of the tremendous amount of equipment available from many sources throughout the United States and Canada. With these necessary elements of supply and demand present, the company was born.
KMA Remarketing Corporation Has Been Developed on the Cornerstones of Integrity, Diligence, Cost Containment and Quality Products. The culmination of such ideals ultimately leads to the highest levels of customer satisfaction. More importantly, with over 10 years of combined experience as healthcare providers ourselves, the management team at KMA Remarketing Corporation never loses its vision for providing quality patient care. This commitment to both the professional health care provider and the patient is what; we feel, sets KMA Remarketing Corporation apart from all other pre-owned medical equipment and services companies.

The Biomedical Engineering Department boasts:
-A state-of-the-art facility that houses a refinishing shop -- complete with painting and sandblasting booths and an upholstery area -- and an electrical shop with testing, repairing and calibration stations.
-An advanced, computer-generated, interactive medical asset management system.
-A staff of skilled, highly educated and certified biomedical engineering technicians whose work meets or exceeds the standards set forth by such professional organizations as JCAHO, AAACH, AAMI and NFPA.
-Professional liability insurance coverage for every project.
KMA Remarketing Corporation's unique combination of modern facilities and highly educated professional staff enables us to proudly offer you the following biomedical engineering services:
-Equipment de-installation, removal and re-installation.
-Equipment repairs (on-site or mail-in)
-Temporary equipment replacement (during repair).
-Comprehensive service contracts or "per-diem" service work.
-Routinely scheduled preventative maintenance.
-A complete refurbished program to restore equipment to like-new condition.
-Electrical safety checks.
-Replacement parts and service/operators' manuals.
From the initial inventory and tagging of every item in your facility, to preparing professional advertising campaigns, through aggressive marketing sales and collection of funds, to the final stages of equipment deinstallation, crating, removal and global shipping arrangements, KMA Remarketing Corporation manages your project from start to finish in an organized, calm, safe and professional manner. KMA is always working hard to generate the highest possible monetary recovery for your assets. Issues with environmental protection agencies, unions, insurance, security, technical deinstallations and accurate record keeping are laid to rest by our expert staff. Our management team keeps you informed about the project's progress every step of the way with frequent reports and strategic meetings.
KMA Remarketing Corporation will either buy your surplus medical equipment at fair market value -- or, provide you with a comprehensive surplus asset management contact for your organization, which will be customized to meet your specific needs.
Regardless of which option you choose, you can be assured that KMA Remarketing Corporation will eliminate the hassle associated with managing the disposition of your surplus medical assets. As logistical experts who are highly creative in our approach to problem solving, we are reactive and sensitive to the needs of modern medical facilities as they strive to succeed in a constantly changing healthcare arena.
-We pay up front with certified funds.
-We are insured, and provide documentation of liability coverage for every project.
-We are knowledgeable and experienced professionals with significant healthcare backgrounds.
-Our courteous and efficient approach to customer service is second to none.
Products & Equipment

• Anesthesia equipment
• Beds
• Cardiology equipment
• Chiropractic equipment
• Dental Equipment
• Dialysis equipment
• Disposables/consumables
• EMS equipment
• Endoscopy equipment
• Exam room furnishings
• Home healthcare equipment
• Infusion therapy
• Laboratory equipment
• Lasers
• Maternity/infant care equipment
• Monitors/defibrillators
• Neurology equipment
• Ophthalmic equipment
• Patient room furniture
• Physical and occupational therapy equipment
• Radiology equipment
• Respiratory equipment
• Sterilization equipment
• Stretchers
• Surgical equipment
• Ultrasound equipment
• Veterinary equipment
• Waiting room furniture

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The Health Care Facility Electrical Safety Program

ELECTRICAL SAFETY PROGRAM RATIONALE

Regulatory codes and accreditation standards, as well as prudent practice, make it mandatory to maintain a well-documented inspection and testing program to ensure that the health care facility’s electrical distribution system and electrically-powered devices are free from fire and shock hazards.
This paper has been compiled from currently promulgated codes and standards and is offered as an example to establishing and maintaining electrical safety in a health care facility.
An increased sensitivity to electrical safeguards among regulatory agency inspectors and escalating confusion as to what constitutes a reasonable electrical safety program are the legacy of a period of intense publicity surrounding the “microshock hazard” issue. This paper provides relevant information and practical help in understanding the issues and instituting the proper response for both patients and staff. I have assimilated existing standards and responsible common sense recommendations into a plan to achieve electrical safety without placing an unnecessary burden on the limited resources of the health care facility.
After several years of determined investigation, no statistical evidence has been developed to substantiate the belief that microshock is a significant hazard comparable to other types of electrical hazards, such as macroshock and electrical burns, in the health care facility. Much attention has been given, however, to the so-called “microshock hazard.” This concern was based primarily on the realization that catheterized patients with a low-resistance conducting pathway from outside the body into the blood vessels close to the heart could be electrocuted by current levels that are well below the normal levels of sensation.
Quite frequently, electrical safety programs are focused on continuous electrical shock as the reason for its existence. However, static electric shock, electrical fires, and electrical burns should also be considered in the design of an electrical safety program.
There is reasonable nationwide consensus on the nature of electrical shock in the health care facility and on acceptable test procedures and test standards.
This consensus is expressed by the ANSI/AAMI Safe current limits for electromedical apparatus standard (ES1:1993), the National Fire Protection Association NFPA-99 standard, and the Underwriters Laboratories UL60101-1 standard.

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BASIC ELEMENTS OF AN ELECTRICAL SAFETY PROGRAM

All safety programs should take into account the actual situations prevailing in each health care facility. Like the codes and standards on which they are based, the specific recommendations presented here should be regarded as minimum or generally accepted requirements.
A comprehensive health care facility electrical safety program should include:
1. Periodic checks of the equipment and environment in all areas of the health care facility (patient and nonpatient locations) with properly documented test results maintained on file.

2. Electrical safety requirements as a part of all purchase orders for new equipment. When possible, medical equipment that is labeled by recognized testing laboratories should be purchased. All new equipment should be tested for compliance before it is installed in patient care areas.
3. Staff orientation and training should include the generic, “safe use” guidelines such as the safe operation of medical device as well as guidelines specific to particular devices such as electrosurgical or electrophoresis units. In-service programs should provide periodic safety updates that include past experiences and hazards associated with new devices.
4. Investigation of reported electrical (and other) hazards through existing incident reporting and hazard alert notification systems. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) places great emphasis on the effective use of a health care facility’s Environment of Care Safety committee to investigate and implement remedial action to resolve any hazardous conditions in the facility.

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RECOMMENDED STEPS FOR IMPLEMENTING AN EFFECTIVE PROGRAM

The approach outlined below reflects an appropriate order of priority for implementing an effective electrical safety program. However, only completion of the entire schedule can ensure the safety of patients, visitors, and employees and meet regulatory requirements and accreditation requirements.
1. Identify the group and individual within the medical equipment management program responsible for electrical safety. Typically, this is the clinical engineering department, the biomedical equipment technology department, or an independent service organization.
Occasionally, in smaller health care facilities, it is the utilities management department. Whichever group has the responsibility should also have the person(s) qualified to perform the tasks. A BMET or clinical engineer is generally trained to have such qualifications.
2. Review all codes, standards, laws, and guidelines applicable to electrical safety in health care facilities.
3. Classify the different areas of the health care facility according to the “Classification of Health Care Facility Locations” scheme in the “Electrical Safety Requirements” section of this paper, and submit any necessary policy statements for approval by the health care facility administration. This step determines which electrical safety test standards and requirements should be used at each location.
4. Implement the recommended schedules, procedures, and documentation as contained in the “Scheduling of Tests,” and “Equipment Test Procedures” sections.
5. All new equipment should meet the appropriate electrical safety standard. Ensure that the purchase order includes reference to such a standard and that the equipment is, in fact, checked prior to patient use.
6. Review the health care facility’s current provisions for electrical safety orientation and training. Even a minimal-level orientation program can be effective in upgrading electrical safety in the health care facility.
7. Review the activities of the health care facility’s safety committee with respect to electrical safety. Institute an incident review procedure and a record of actions for unusual circumstances. Be aware of the reporting requirements mandated by the state, FDA, and JCAHO and report electrical incidents as is appropriate.

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Electrical Safety Requirements

CLASSIFICATION OF HEALTH CARE FACILITY LOCATIONS

Classification Definitions

Emergency power system locations

The “emergency power system location” is intended to cover requirements for the emergency power generator, battery backup system and its components, and central distribution network, including main disconnects, transfer switches, main feeder, and panel board circuit breakers for all locations in which it may be required.
NOTE—Within the Patient Care Locations listed on the following pages, there is a patient care vicinity. This vicinity is a space extending 6 feet (1.8 m) horizontally beyond the normal location of the patient, chair, table, treadmill, or other device that supports the patient during examination and treatment, and extending 7.5 feet (2.3 m) vertically from the floor.
Anesthetizing locations
An “anesthetizing location” is an area of the hospital that has been designated by the hospital to be used for the administration of nonflammable inhalation anesthetic agents in the course of examination or treatment, including the use of such agents for relative analgesia. Traditionally, this refers only to the operating rooms and delivery rooms. However, with the advent of changing patient populations and new technologies, we now see delivery of inhalation anesthesia in other areas, such as emergency and medical imaging sites (e.g., X-ray, magnetic resonance imaging).
NOTE—Advancements in anesthesia now include the use of drugs for deep sedation/anesthesia.
Similar to an inhalation anesthetic, the drugs produce a depression of consciousness during which the patient cannot be aroused easily and does not respond to repeated or painful stimulation.

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Anesthetizing locations—nonflammable

The “anesthetizing location—nonflammable” classification covers anesthetizing locations that, by issuance of a hospital policy, are posted to be used only for nonflammable anesthetizing agents. Since flammable anesthetics are no longer used in the United States, precautions for flammable anesthetizing locations have been removed from the body of NFPA 99.

Ambulatory health care facility

“Ambulatory health care facility” is defined by JCAHO as “all type of health care services provided to individuals on an outpatient basis.” Ambulatory care services are provided in many settings. An “ambulatory health care facility” is defined by NFPA 99 as a building, or part thereof, used to provide services or treatment to four or more patients at the same time and meeting either criterion below:
• Those facilities that provide, on an outpatient basis, treatment for patients that renders them incapable of taking action for self-preservation under emergency conditions (e.g., a fire) without assistance from others.
• Those facilities that provide, on an outpatient basis, anesthesia, that renders the patients incapable of taking action for self-preservation under emergency conditions without the assistance of others.

Critical care locations

“Critical care locations” include all patient areas classified as critical care sites by hospital policy, or where patients are subjected to invasive procedures and directly connected to power line-operated medical devices. For the purposes of NFPA 99, the use of IV needles and catheters, endoscopes, colonoscopes, and urinary catheters are not considered invasive. Critical care locations typically include operating and delivery rooms, and intensive care, cardiac care, emergency departments, and cardiac catheterization areas. With a few exceptions, the electrical construction provisions of these areas have basically the same requirements as the general care areas.

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General care locations

“General care locations” are those patient care locations where patients are intended to be in contact with ordinary electrical appliances (lamps, beds, televisions, etc.) or be connected to medical devices. This does not include nursing stations since they are not patient care locations.

Nonpatient care locations

Areas where patients are not normally cared for or treated, such as administrative offices, laboratories, nursing stations, storage areas, kitchens, corridors, lounges, dining rooms, or plant equipment areas, are considered “nonpatient care locations.”

Wet locations

“Wet locations” include patient care areas normally subject to wet conditions, including standing fluids on the floor or drenching of the work area, either of which condition is intimate to the patient or staff.
The governing body of the health care facility may elect to include such areas as hydrotherapy areas, dialysis laboratories, and certain wet laboratories under this definition.

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Scheduling of Tests

RECOMMENDED TEST SCHEDULES

The following tables list the maintenance schedules specified in current codes and standards. These intervals are dynamic and may be changed if organizational experience justifies longer or shorter intervals and the change in intervals is approved by the health care facility’s safety committee.

Testing Interval

Test Procedure

Report Form

1 months***

Isolated power systems

Isolated Power System Form

HCFDI*

Receptacle testing, including ground continuity

Receptacle Testing & System

Grounding Inspection Form

HCFDI*

System grounding

Receptacle Testing & System

Grounding Inspection Form

6 months**

Device ground resistance

Electrical Safety Inspection Form

6 months**

Device chassis leakage current

Electrical Safety Inspection Form

6 months**

Isolated power systems (simulated

fault test)

Isolated Power System Form

HCFDI*

Ground fault circuit interrupters

(GFCIs)

Receptacle Testing & System

Grounding Inspection Form

12 months**

Conductive flooring and antistatic accessories—in nonflammable anesthetizing locations with conductive floors

Conductive Floors & Equipment Form

Table 1 - Anesthetizing, Critical Care, Wet Areas and Ambulatory Care Locations

Maximum Interval	Test Procedure	Report Form
12 months**	Device ground resistance testing	Electrical Safety Inspection Form
12 months**	Device chassis leakage current	Electrical Safety Inspection Form
HCFDI*	Ground fault circuit interrupter (GFCI)	Receptacle Testing & System Grounding Inspection Form
HCFDI*	Receptacle testing including ground continuity	Receptacle Testing & System Grounding Inspection Form

Table 2 - General Patient Care Locations

Maximum Interval	Test Procedure	Report Form
HCFDI*	Receptacle testing and system grounding	Receptacle Testing & System Grounding Inspection Form
HCFDI*	Nonpatient care equipment inspection procedure	Nonpatient Care, Line-Powered Equipment Inspection Form

Table 3 - Non Patient Care Locations

*HCFDI (Health Care Facility Defined Interval). NFPA 99/02/4.3.4.1.3 states that non hospital-grade receptacles in patient care areas are to be tested at 12 month intervals.
**NFPA 99/02/8.5.2.1.2.2 identifies these intervals but then provides the exception that the health care facility can adjust these intervals if documentation justifies the change.
***NFPA 99/02/4.3.3.3.2.2 and 4.3.3.3.2.3 states that if line isolation monitors are installed, they should be tested monthly.

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Equipment Test Procedures

The checklists and forms used in below are intended to illustrate the type of information that might appropriately be collected during equipment test procedures. Individual institutions may freely modify these materials for their use or adopt other methods of recording information, such as use of a computerized maintenance management system (CMMS).
This section also provides guidance to those who are writing or adopting equipment test procedures for their institutions. Note that there is no national requirement to document any of the numerical values measured during these procedures, but individual institutions may elect to do so.

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INCOMING EQUIPMENT INSPECTION

Purpose
To confirm that all electrical equipment (new or otherwise) being introduced into patient care locations of the hospital for the first time meet applicable standards for electrical safety.
Procedure
Use the Electrical Safety Inspection Form and the Incoming Equipment Inspection Form.
1. Confirm equipment meets all of the electrical safety requirements specified by the health care facility on the Electrical Equipment Purchasing Requirements Form. Note the results on the Incoming Equipment Inspection Form.
2. Conduct applicable electrical safety test procedures described in this area. Record results on the Electrical Safety Inspection Form.
3. Conduct any applicable functional test procedures as specified in the health care facility’s medical equipment management plan. Record results as specified in the plan.
4. Assign an equipment identification number as specified in the health care facility’s medical equipment management plan. Record information in the medical equipment inventory.
5. Perform all other tagging, labeling, documentation, and other procedures as specified in the health care facility’s medical equipment management plan.
NOTE—New equipment failing performance tests should be withheld from service until remedial action has been taken. In general, problems found should be corrected by the vendor.

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RENTAL EQUIPMENT INSPECTION

Purpose
To confirm all electrical equipment introduced into the health care facility on a short-term basis (e.g. rental equipment) meets applicable standards for electrical safety.
Procedure
Inspection of equipment from preferred vendors, as defined in the health care facility’s medical equipment management plan, is not required. Equipment from all other sources shall be tested using the Incoming Equipment Inspection procedure defined above.

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DEVICE INSPECTION AND TESTING

General Overview
The responsibility for safety testing of the facility may rest with the facility engineer, clinical engineer, or BMET. Responsibility for safety testing of medical devices most frequently rests with the clinical engineer or BMET. There is an assumption that independent and appropriate safety inspections of equipment and facility will ensure an acceptable electrical safety level. This section will focus on the safety inspection and testing of medical devices and equipment.
Electrical Shock Fundamentals
Understanding cause(s) of a continuous electrical shock—either macro or micro—helps in understanding the methods for the measurement of leakage current. The fundamental conditions that must exist before an electrical shock can occur are two conductive surfaces must encounter the body simultaneously. One surface must be electrified, and the second must provide a return pathway through the body; that is, one must be the source, and the second, the sink. The leakage current tests performed on a device attempt to determine if the conductive surfaces can be the source of electricity (chassis leakage or lead leakage measurements) or a sink (isolated lead measurements). Since any grounded surface can be a return pathway for the leakage currents, we need only determine that, in fact, the surface is grounded.
Reasoning Behind Test Methods
Testing methods and current limits for conductive or insulated surfaces to determine their status as either a sink or a source for leakage currents is well described in several national standards. They are excellent educational resources and provide the reasoning behind the use of these methods and limits. The two most prominent are listed below:
Safe current limits for electromedical apparatus (ANSI/AAMI ES1:1993), available from the Association for the Advancement of Medical Instrumentation (www.aami.org).
Health Care Facilities Handbook (7th edition), based on NFPA 99 (2002 edition), available from the National Fire Protection Association (www.nfpa.org).

Scope and Purpose
Scope
This procedure covers electrical safety inspection and testing of patient care and nonpatient care devices and equipment. Caution: Do not make leakage current measurements while the patient is connected to the device.
Purpose
The purpose of this procedure is to:
• identify and use appropriate sensory inspection techniques
• ensure devices and equipment meet electrical safety standards for leakage current and grounding; and
• ensure devices have proper labeling.
Test Equipment
• Ohmmeter (capable of accurately measuring 0 to 0.5 ohms)
• Electrical safety analyzer (or equivalent test setup).
Inspection Procedure Steps
Form
Use the Electrical Safety Inspection Form.
Record sensory inspection deficiencies.
Fundamental
Inspect extension cords following steps 1.0 and 2.0, only.
By performing the electrical safety inspection in a specific sequence, you may detect and correct a deficiency prior to it being presented as a hazard during the inspection.
Perform the inspection in the following order:
• Sensory Inspections
• Power Cord Ground Resistance Testing
• Chassis Leakage Current Testing
• Lead Leakage Testing
• Lead Isolation Testing

Sensory Inspections
General
With sensory inspections, you use all of your senses:
sight for broken ground pins or cuts in cords, hearing for rattles in plugs or inside chassis, smell for detection of smoky smells or spilled chemicals, and touch for warm cords or plugs.
NOTE—The sections below correspond to the numbered sections of the Electrical Safety Inspection Form.

1.0 Cord and Plug Inspections
Look for:
• Broken pins
• Bent pins
• Discoloration of the pins that may suggest they have become extremely hot, i.e. possible loose plug terminals; also consider they may have been generated by loose terminals on the receptacle
• Loosened terminals (while holding the cord near the plug, snap the plug “smartly” and listen for terminal rattles inside the plug that suggest loosened terminals)
• Mechanical damage to the casing
• Broken or loosened strain relief
• Cord pulled from the strain relief and exposed wires
• Warm plug or cord (if the device has been in operation and you have just removed it from the receptacle)
• Cuts in cords that expose inner wires
• Deterioration of the cord due to aging or chemicals
NOTE—If plugs are changed, properly rewire and test the grounding resistance prior to putting the device back into service.

2.0 Device Enclosures and Controls and their Area of Use
Look for:
• Looseness of the cord connector (if the power cord is detachable) when withdrawing it from the socket of the device; damage to the connector or socket
• Obvious damage to outer casing (chassis)
• Obvious damage to terminals, meters, switches, connectors, etc.
• Unusual noises, such as a rattle inside the case
• Loose or missing parts, i.e. knobs, dials, terminals, etc.
• Residue of fluid spillage, i.e. coffee, sterilants, water, chemicals, etc.
• Use of devices for inappropriate storage, such as fluids or clothing
• Burning or smoky smells, particularly from ventilation holes
• Notes white taped to the device that suggest device deficiencies or operator concerns (in aprevious study, it was determined that nurses frequently put white tape on devices for three purposes: (1) to communicate information to other nurses; (2) to repair a device; and (3) to modify their environment, i.e. hold stacked devices in place, hold sponge cushions on corners of devices hung too low from the ceiling, etc.)

3.0 Accessory Inspection
Look for:
• Obvious damage to outer insulations or casings
• Loose or missing parts
• Loose screws, connections, and cables from strain relief
• Patient leads with male ends; only older accessories will have leads with male ends (when discovered, they should be replaced with leads that have female ends, called protected leads)
4.0 Battery Inspection
Batteries are intended to ensure the continued operation of a device when it is not plugged into normal power. When not in use, chargers should be plugged into a receptacle to allow charging.
• Make sure the device is plugged into a receptacle and the Charge lamp or Battery lamp is lit. If the Charge lamp is on but the device has not been used recently, the battery may need replacement.
• If the power cord is detachable, make sure that it is properly inserted into its device connector.
Follow the manufacturer’s instructions for other tests, such as unplugging the power cord, turning the device on, and operating it for several minutes on battery and observing its function.
5.0 Label Inspection
Look for:
• readability (cleaning of devices frequently makes labels unreadable)
• assurance that all required labels are on the device (you may only know from comparison with other or similar devices that a Caution, Warning, or Instruction label is missing)

Power Cord Ground Resistance Testing
Form
Use section 6.0 of the Electrical Safety Inspection Form.
Fundamental
The receptacle grounding is carried to the device chassis through the plug ground pin and power cord ground wire. This “safety” ground pathway carries the normal leakage currents or any fault currents that might be present on the chassis safely away from the operator and patient to the earth ground.
Any breaks in this pathway may expose the operator and patient to these electrical currents. This procedure measures the quality of one part of the grounding pathway from plug grounding pin to the chassis.

Figure 1

Procedure
The power cord ground should be measured with the ohmmeter by connecting one lead to the plug grounding pin and the other to the exposed conductive surface (see Figure 1—Typical test setup). The measured resistance should be less than 0.5 ohm.
If a special grounding terminal is available on the chassis, use it as a second measuring point. This type of terminal will provide the best grounding point available. If you use any other surface, be sure it is not anodized, painted, or covered over with insulating materials. Remember that some exposed metal is for decorative purposes and does not conductively connect with the inner chassis and is not likely to become energized. Such materials are not required to be grounded. Other conductive surfaces, such as name plates and screws, may fit this same category.
While measuring, flex the cord near the plug strain relief and near the cord entrance into the device. If the resistance varies significantly, you may have detected a loosened terminal or broken wire.
Some low-voltage devices or double-insulated devices do not have grounding wires, and this design may be acceptable. However, if they do have a ground wire, test it and document your tests as indicated in this procedure.

Chassis Leakage Current Testing
Form
Use section 6.0 of the Electrical Safety Inspection Form.
Fundamental
This measurement determines whether, under the single fault condition of a broken ground, the device appropriately limits the flow of current from chassis to ground.
Procedure
Chassis leakage current tests shall be performed during an incoming inspection or following any repair or other maintenance that may have affected lead isolation. They may also be performed on a periodic basis, as appropriate.
Chassis leakage current tests shall be performed under the following conditions (see Figure 2— Typical test setup).
AC power shall be provided from a grounded power distribution system with nominal line voltage; the isolated power system found in some operating rooms and other locations cannot be used.
Using the typical test setup, open the ground connection and measure the chassis leakage current with the power off and again with it on. Turn the device off and reverse the polarity; repeat the measurements with the power off and again with it on. Record the maximum leakage current reading on the form (the maximum acceptable leakage is 300 µA).

Figure 2

Lead Leakage Testing (Nonisolated Leads)
Form
Use Electrical Safety Inspection Form.
Fundamental
This measurement determines whether, under the single fault condition of a broken ground, the conductive leads of a device without an isolated input will appropriately limit the flow of current from leads to ground and from lead to lead.
NOTE—Only devices with isolated leads should be used with intracardiac electrodes or catheters.
Procedure
Lead leakage current tests shall be performed during a receiving inspection, or following a repair or other maintenance action that may have affected lead leakage. They may also be performed on a periodic basis, as appropriate.
The tests shall be performed under the following conditions (see Figure 3—Typical test setup).
AC power shall be provided from a grounded power distribution system with nominal line voltage; the isolated power system found in some operating rooms and locations cannot be used.
Use the typical test setup and make the test between each patient lead and ground and between combined patient leads and ground. Measure lead leakage current with the power on and the ground wire both open and closed. Turn the device off and reverse the polarity; repeat the measurements. Record the maximum leakage current reading on the form (the maximum acceptable leakage is 100 µA). Measure the lead leakage between one lead (not the grounded lead) and each other lead with the ground wire open and closed. Record the maximum leakage current reading on the form (the maximum acceptable leakage is 50 µA).

Lead Leakage Testing (Isolated Leads)
Form
Use Electrical Safety Inspection Form.
Fundamental
This measurement determines whether, under the single fault condition of a broken ground, the conductive leads of a device with an isolated input will appropriately limit the flow of current from the leads to ground and from lead to lead.
Note- Only devices with isolated leads should be used with intracardiac electrodes or catheters.

Figure 3

Procedure
Lead leakage tests shall be performed during an incoming inspection, or following a repair or other maintenance action that may have affected lead leakage. They may also be performed on a periodic basis, as appropriate.
The tests shall be performed under the following conditions (see Figure 4—Typical test setup).
AC power shall be provided from a grounded power distribution system with nominal line voltage; the isolated power system found in some operating rooms and other locations cannot be used.
Using the typical test setup, measure lead leakage current of individual leads with the power on and the ground wire both open and closed. Turn the device off and reverse the polarity; repeat the measurements. Record the maximum leakage current reading on the form (the maximum acceptable leakage is 10 µA with the ground wire closed and 50 µA with the ground wire open).
Measure the lead leakage between one lead (not grounded) and each other lead with the ground wire open and closed. Record the maximum leakage current reading on the form (the maximum acceptable leakage is 10 µA with the ground wire closed and 50 µA with the ground wire open).
NOTE—There is no requirement that lead leakage tests be performed on isolated leads with all leads connected together.

Lead Isolation Testing
Form
Use Electrical Safety Inspection Form.
Fundamental
This measurement determines whether, under the normal condition of the ground wire intact, the conductive leads of a device with an isolated input will appropriately limit the flow of current into the device.
NOTE—Only devices with isolated leads should be used with intracardiac electrodes or catheters.
Procedure
Lead isolation tests shall be performed during an incoming inspection or following any repair or other maintenance that may have affected lead isolation.
They may also be performed on a periodic basis, as appropriate.
The tests shall be performed under the following conditions (see Figure 5—Typical test setup). AC power shall be provided from a grounded power distribution system with nominal line voltage; the isolated power system found in some operating rooms and other locations cannot be used.

Figure 4

Using the typical test setup, momentarily apply nominal line voltage from each lead to ground. The normal accessories provided with the device should be used. The ground wire should be closed and the power on. Record the maximum leakage current reading on the form (the maximum acceptable sink current is 50 µA).
CAUTION—During these measurements, it is possible to contact the applied 120 VAC. Keep your hands and body clear of the leads while the voltage is applied.

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NONPATIENT CARE EQUIPMENT INSPECTION AND TESTING

Form
Use the Nonpatient Care, Line-Powered Equipment Inspection Form.

Nonpatient care equipment in patient care vicinities
Facility-owned, nonpatient care appliances that will be allowed in a patient care vicinity might include floor scrubbers, carpet cleaners, maintenance-type equipment, food service carts, and the like.
Leakage current testing of these devices should be made following the procedures described above for measuring chassis leakage currents in patient care equipment. The maximum acceptable leakage is 500 µA.
Power cord ground resistance testing should be made following the procedure described above for measuring ground resistance in patient care equipment. Ground resistance measurements should not exceed 0.5 ohm.
Household and office-type appliances outside the patient care vicinity
Household and office-type appliances are allowed inside a patient room if located outside the patient care vicinity. Appliances that are not normally equipped with a grounding conductor are allowed.
The leakage current and grounding resistance (if applicable) of these appliances are not generally addressed by health care codes and standards. An inspection procedure for these appliances, using a modified version of the sensory inspection techniques, ground resistance measurements, and chassis leakage current measurements, may be adopted by the health care facility, dependent on local needs.

Figure 5

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COMPUTERIZED MAINTENANCE MANAGEMENT SYSTEM

A computerized maintenance management system (CMMS) is an effective means for establishing an inventory of medical devices, organizing scheduled maintenance activities, and recording maintenance results for incoming inspections, scheduled maintenance, and unscheduled (corrective) maintenance.
Electrical safety testing, along with functional testing, is generally regarded as a component of the scheduled maintenance program. Electrical safety testing is also a component of incoming equipment inspections. Therefore, scheduling and documentation of electrical safety procedures is often accomplished through the CMMS.
Typically, each particular CMMS has on-screen and/or printed forms that contain information similar to that contained in the forms in this Electrical Safety Manual. The electrical safety procedures described in this part should be adapted to work with the features of the CMMS used by the health care facility.
A full discussion of CMMS programs is beyond the scope of this manual. The following publication provides excellent material on the application of MMS programs in clinical engineering.
Computerized Maintenance Management Systems for Clinical Engineering (2003 edition), available from the Association for the Advancement of Medical Instrumentation (www.aami.org).

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Sources of Codes, Standards and Regulations

AMERICAN NATIONAL STANDARDS INSTITUTE
(URL http://www.ansi.org)
For a standard to become known as an “American National Standard,” it must be recognized and accepted by the American National Standards Institute (ANSI). ANSI is an umbrella organization that coordinates all standards developed by public and private organizations to eliminate inconsistency and redundancy. To qualify for recognition by ANSI, the standard must have been developed through balanced representation so that a national consensus can be said to exist, and must be subject to a periodic review so that it is kept current.

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NATIONAL FIRE PROTECTION ASSOCIATION
(URL http://www.nfpa.org)
The National Fire Protection Association (NFPA) is a respected and widely recognized voluntary, nonprofit organization with membership open to individuals and organizations that are interested in promoting fire safety. It is neither a governmental body nor a regulatory or enforcing agency. Its original mission in the area of fire protection and prevention has been expanded over time to include electrical safety.
The standards published by the NFPA are developed through an organizational framework that is intended to ensure that they are drafted by knowledgeable individuals and made available for public review prior to adoption. Because of this formal process, NFPA standards are generally considered to be “national consensus standards.”
The NFPA documents primarily applicable to electrical safety in health care facilities are:
•    National Electrical Code (NFPA 70)
•    Standard for Health Care Facilities (NFPA 99)
•    Electrical Safety in the Workplace (NFPA 70E)
These standards are available from the National Fire Protection Association, One Batterymarch Park, Quincy, MA 02269-9703.

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JOINT COMMISSION ON ACCREDITATION OF HEALTHCARE ORGANIZATIONS
(URL http://www.jcaho.org)
Status
Applicable to a variety of health care organizations on a voluntary basis. Accreditation programs are available for ambulatory care, assisted living, behavioral health care, home care, hospital, laboratory, long term care, managed care, and office-based surgery organizations.
Enforcing agency
None (voluntary).
Standard preparation
Standards are prepared by and available from the Joint Commission on Accreditation of Healthcare Organizations, One Renaissance Blvd., Oakbrook Terrace, IL 60181.

History
Incorporated in 1952 to establish standards of patient care for United States health care facilities.
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) is a voluntary, nonprofit organization that surveys hospitals on a fee-for-service basis. Accreditation confers “deemed” status for reimbursement by Medicare and other federally funded programs. JCAHO accreditation is also often a prerequisite for participation in commercial health insurance and managed care programs and for association with medical and nursing training programs.
Standards relating to electrical safety are primarily found in the Environment of Care section of the manual for each accreditation program. The Environment of Care standards address medical equipment management and utility system management, as well as of environmental and employee safety, security, fire safety, hazardous materials and waste, and emergency management.
The electrical safety issues are addressed similarly in all accreditation manuals but most comprehensively in the hospital accreditation manual:
• 2004 Comprehensive Accreditation Manual for Hospitals (CAMH)
• 2004 Comprehensive Accreditation Manual for Ambulatory Care (CAMAC)
In 2004, JCAHO made substantial changes in its Environment of Care section, particularly with regard to compliance scoring guidelines. JCAHO standards are focused on patient care processes, including those related to patient safety, and based on a continuous cycle of performance improvement.

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UNDERWRITERS LABORATORIES
(URL http://www.ul.com)

Medical Electrical Equipment—Part 1: General Requirements for Safety (UL 60601-1)
Status
Medical equipment has long been addressed by UL 544. However, UL 544 is no longer being used to evaluate medical equipment and will be withdrawn January 1, 2005. As of that date, UL 60601-1 will be used to evaluate medical equipment in the United States. UL 60601-1 is the U.S. version of IEC (International Electrotechnical Commission) 60601- 1 and represents an effort to promote international harmonization of standards while recognizing unique national factors.

Enforcing agency
None, unless incorporated into the requirements of a regional enforcement agency.
Availability
Available from Underwriters Laboratories, 1655 Scott Blvd., Santa Clara, CA 95050-4169.

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ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION
(URL http://www.aami.org)

Safe current limits for electromedical apparatus (ANSI/AAMI ES1:1993)
Status
Approved by ANSI.
Enforcing agency
None, unless incorporated into the requirements of a regional enforcement agency.

Availability
Available from the Association for the Advancement of Medical Instrumentation (AAMI), 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795.
Requirements
This standard sets the risk current limits and refereed test methods for electromedical apparatus intended for use in the patient care vicinity, and also sets limits for nonpatient-contact electromedical apparatus. It applies to line- and battery-powered apparatus and to apparatus used singly or with properly connected accessory equipment. It is intended for use in design qualification by the device manufacturer.

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OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION
(URL http://www.osha.gov)

29 CFR 1910 – Occupational Safety and Health Standards
Subpart S – Electrical
Status
Presently effective in all 50 states, except where state preemption is allowed. OSHA’s mandate is to promote a safe working environment for employees.
Enforcing agency
Occupational Safety and Health Administration (OSHA).
Availability
Available from Superintendent of Documents, U.S.
Government Printing Office, Washington, D.C. 20402.
Requirements
This regulation currently has two major parts:
Design Safety Standards for Electrical Systems and Safety-Related Work Practices.

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Conclusion

Working in United States in the medical area has been a very interesting and enriching experience. Observing the application of laws, norms, and procedures relating to the professional activity was an important complement in my education. Sharing the work professionals of different areas gave me a global vision of the biomedical engineer.
We worked following standards of important associations, like JCAHO and others.
All the certification processes are very interesting, they involve many areas in health care environment, they are precise and very well elaborate, but a little expensive, both in the implementation and in expenses they requires. On the other side they help to have medical devices and medical installations in perfect operation, which guarantees an excellent standard of healthcare facilities.
Hospitals and clinics are really motivated to reach those standards, even because some of them allow reimbursements as Medicare organisations.
All this, including the instrumentation we used there, helped me to understand the importance of checking and controlling facilities, to reach the highest level of quality and to continuously improve safety and quality of healthcare provided to the public.

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Appendix

Forms

General Note—computerized equipment management systems have replaced many of these forms. Use of “exception-type” reporting makes many of these forms superfluous. In spite of these caveats, the forms listed can provide a valuable quick reference to those persons performing testing even if they do not fill out the forms.

LIST OF FORMS
• Receptacle Testing & System Grounding Inspection Form
• Isolated Power System Form
• Conductive Floors & Equipment Form
• Electrical Safety Inspection Form
• Nonpatient Care, Line-Powered Equipment Inspection Form
• Electrical Equipment Purchasing Requirements Form
• Incoming Equipment Inspection Form (1 of 2)
• Incoming Equipment Inspection Form (2 of 2)

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Glossary

Ampacity : The current, in amperes, that a conductor can carry continuously under conditions of use without exceeding its temperature rating.
Analgesia, Relative : A state of sedation and partial block of pain perception produced in a patient by the inhalation of concentrations of nitrous oxide insufficient to produce loss of consciousness (conscious sedation).
Anesthetic : As used in [NFPA 99, Standard for Health Care Facilities], applies to any inhalation agent used to produce relative analgesia or general anesthesia.
Antistatic : Opposing the buildup of static electricity.
Authority having jurisdiction (AHJ) : In general, a federal, state, or local department or individual which has the legal or regulatory authority to enforce a code or standard. The AHJ might also be an insurance office, accrediting body, or other entity.
Branch circuit : The circuit conductors between the final overcurrent device protecting the circuit and the outlets.
Chassis : Generally identifies the main frame or structure (frequently metal) of an electrical device or appliance that contains or holds the electrical components.
Circuit breaker : A device designed to open and close a circuit by nonautomatic means and to open the circuit automatically on a predetermined overcurrent without damage to itself when properly applied within its rating.
Conductive : Able to readily transmit an electric charge. See also, Conductive flooring.
Conductive flooring : A floor constructed of material that creates a high-resistance path to ground to prevent the accumulation of electrostatic charge in flammable anesthetizing locations.
Continuity : A continuous electrical connection.
Continuous electric shock : An electric shock that involves a continuously applied voltage such as from an alternating or direct current source, in contrast to a static electric shock which is due to an impulse voltage of relatively short duration.
Cover plate : A cover placed over the receptacles, switches, etc., that are installed in electrical boxes.
Cranking capacity : The capacity of a battery to provide adequate current for cranking an internal combustion engine.
Critical branch : A subsystem of the emergency system consisting of feeders and branch circuits supplying energy to task illumination, special power circuits, and selected receptacles serving areas and functions related to patient care, and that are connected to alternate power sources by one or more transfer switches during interruption of the normal power source.
Critical care areas : Those special care units, intensive care units, coronary care units, angiography laboratories, cardiac catheterization laboratories, delivery rooms, operating rooms, postanesthesia recovery rooms, emergency departments, and similar areas in which patients are intended to be subjected to invasive procedures and connected to line-operated patient-care-related electrical appliances.
Critical system : A system of feeders and branch circuits in nursing homes and custodial care facilities arranged for connection to the alternate power source to restore service to certain critical receptacles, task illumination, and equipment.
Double-insulated appliances : Appliances where the primary means of protection against electrical shock is not grounding. The primary means is by the use of combinations of insulation and separation spacings in accordance with and approved standard.
Emergency power system : See Essential electrical system.
Emergency system : A system of circuits and equipment intended to supply alternate power to a limited number of prescribed functions vital to the protection of life and safety
Equipment system : A system of feeders and branch circuits arranged for delayed, automatic, or manual connection to the alternate power source and that serves primarily 3-phase power equipment.
Essential electrical system : A system comprised of alternate sources of power and all connected distribution systems and ancillary equipment, designed to ensure continuity of electrical power to designated areas and functions of a health care facility during disruption of normal power sources, and also designed to minimize disruption within the internal wiring system.
Explosionproof apparatus : Apparatus enclosed in a case that is capable of withstanding an explosion of a specified gas or vapor that may occur within it and of preventing the ignition of a specified gas or vapor surrounding the enclosure by sparks, flashes, or explosion of the gas or vapor withing, and that operates at such an external temperature that a surrounding flammable atmosphere will not be ignited thereby.
Extension cord : A cord-connector assembly that extends the location of electrical power from a wall receptacle to a distant location; it typically has one male connector and one or more female connectors.
Fault current : A current in an accidental connection between an energized and a grounded or other conductive element resulting from a failure of insulation, spacing, or containment of conductors.
Feeder : All circuit conductors between the service equipment, the source of a separately derived system, or other power supply source and the final branch-circuit overcurrent device.
Flammable : A combustible that is capable of easily being ignited and rapidly consumed by fire.
Gage : American wire gage (AWG). A method for expressing the size of electrical conductors.
General care areas : Patient bedrooms, examining rooms, treatment rooms, clinics, and similar areas in which it is intended that the patient shall come into contact with ordinary appliances such as a nurse-call system, electric beds, examining lamps, telephones, and entertainment devices.
Ground continuity : Continuous electrical connection to earth ground.
Ground fault circuit interrupter (GFCI) : A device intended for the protection of personnel that functions to de-energize a circuit or portion thereof within an established period of time when a current to ground exceeds some predetermined value that is less that that required to operate the over current protective device of the supply circuit.
Grounding system : A system of conductors that provides a low-impedance return path for leakage and fault currents.
Hazardous area in a flammable anesthetizing location : The space extending 152 cm (5 feet) above the floor in a flammable anesthetizing location.
Health care facility : Any facility intended for patient care including acute care hospitals, out-patient clinics, surgery centers, assisted living facilities, nursing homes, and the like.
Hospital grade : A term used to identify the construction quality of a receptacle or plug approved for use in a hospital and determined by the Underwriters Laboratories testing standards.
Hot and neutral conductors : Wires carrying electricity from the main panelboard. The neutral conductor is connected to the earth (ground) at the building entrance. The hot conductor is measured at a voltage relative to the neutral (grounded) conductor.
Impedance : Impedance is the ratio of the voltage drop across a circuit element to the current flowing through the same circuit element. The unit of impedance is the ohm.
Invasive : With regard to electrical safety, a procedure in which the protective resistance of the skin is breached and conductive paths exist to the interior of the body.
Investigative device : A device, not yet approved by the FDA for sale, that is being investigated in a clinical study guided by an institutional review board.
Isolated power system : A system comprising an isolating transformer or its equivalent, a line isolation monitor, and its ungrounded circuit conductors.
Isolation transformer : A transformer of the multiple-winding type, with the primary and secondary windings physically separated, that inductively couples its ungrounded secondary winding to the grounded feeder system that energizes its primary winding.
Labeled : Equipment or materials to which has been attached a label, symbol, or other identifying mark of an organization acceptable to the authority having jurisdiction and concerned with product evaluation, that maintains periodic inspection of production of labeled equipment or materials, and by whose labeling the manufacturer indicates compliance with appropriate standards or performance in a specified manner.
Lead leakage : Current leakage present on the leads of a medical device.
Leakage current : Any current, including capacitively coupled current, not intended to be applied to a patient, that is conveyed from exposed conductive parts of an appliance to ground or to other accessible parts of an appliance.
Life safety branch : A subsystem of an emergency system consisting of feeders and branch circuits, meeting the requirements of Article 700 of NFPA 70, National Electrical Code, and intended to provide adequate power needs to ensure safety to patients and personnel, and that is automatically connected to alternate power sources during interruption of the normal power source.
Life support equipment, electrical : Electrically powered equipment whose continuous operation is necessary to maintain a patient’s life.
Line isolation monitor (LIM) : A test instrument designed to continually check the balanced and unbalanced impedance from each line of an isolated circuit to ground and equipped with a built-in test circuit to exercise the alarm without adding to the leakage current hazard.
Listed : Equipment, materials, or services included in a list published by an organization acceptable to the authority having jurisdiction and concerned with evaluation of products or services, that maintains periodic inspection of production of listed equipment or materials or periodic evaluation of services, and whose listing states either that the equipment, material, or service meets identified standards or has been tested and found suitable for use in a specified manner.
Nonflammable : An adjective describing a substance that will not burn under the conditions set forth in the definition of flame resistant.
Outlet : A point on the wiring system at which current is taken to supply utilization equipment.
Outpatient : A patient that does not remain in the health care facility overnight.
Overcurrent : Any current in excess of the rated current of equipment or the ampacity of a conductor. It may result from overload, short circuit, or ground fault.
Overcurrent device : An electrical component, such as a fuse or circuit breaker, that activates when an overload condition occurs.
Overload : Operation of equipment in excess of normal, full-load rating, or a conductor in excess of rated ampacity that, when it persists for a sufficient length of time, would cause damage or dangerous overheating. A fault, such as a short circuit or ground fault, is not an overload.
Panelboard : A single panel or group of panel units designed for assembly in the form of a single panel, including buses an automatic overcurrent devices, and equipped with or without switches for the control of light, heat, or power circuits; designed to be placed in a cabinet or cutout box placed in or against a wall, partition, or other support; and accessible only from the front.
Patient care vicinity : A space, within a location intended for the examination and treatment of patients, extending 6 ft (1.8 m) beyond the normal location of the bed, chair, table, treadmill, or other device that supports the patient during examination and treatment and extending vertically to 7 ft 6 in (2.3 m) above the floor.
Patient lead, isolated : A patient lead whose impedance to ground or to a power line is sufficiently high that connecting the lead to ground, or to either conductor of the power line, results in current flow below a hazardous limit in the lead.
Physical integrity : As it relates to receptacles, the mechanical condition of a receptacle and its installation, e.g., loose installation, fractured body, and the like.
Plug, attachment plug, or cap : A device that, by insertion in a receptacle, establishes connection between the conductors of the attached flexible cord and the conductors connected permanently to the receptacle.
Receptacle : A receptacle is a contact device installed at the outlet for the connection of an attachment plug.
Receptacle outlet : An outlet where one or more receptacles are installed.
Redundant ground : A second ground conductor installed in parallel with the first conductor.
Relative humidity : The ratio of the quantity of water vapor present in a given volume to the quantity which must be present to saturate the same volume; expressed as a percent.
Resistance : The property of a material that opposes the movement of electric charges; measured in ohms.
Retention force : The force required to remove a testing pin from a receptacle contact.
Simulated loads : Resistive/capacitive loads that are substituted for normal facility loads during certain testing procedures.
Static electricity : Electricity that is generated by the movement of one insulation material over another, such as is acquired by the human body while walking over a nonconductive surface.
Strain relief : A component located at the cable entrance to a plug, chassis, enclosure, or the like, whose purpose is to prevent the mechanical stress placed on the cord from being transmitted to the wires that are connected inside the plug or chassis.
Switchgear : A general term covering switching and interrupting devices and their combination with associated control, instrumentation, metering, protective, and regulating devices.
Tamper resistant : An adjective describing receptacles with shutters or similar means to prevent insertion of objects into the contacts.
Total hazard current : The hazard current of a given isolated system with all devices, including the line isolations monitor, connected.
Transfer switch : A device for transferring one or more load conductor connections from one power source to another.
Trip or tripping : Opening of a circuit breaker or GFCI when certain electrical parameters of the component are exceeded.
Watertight : Constructed so moisture will not enter the enclosure under specified test conditions.
Wet locations : A patient care area that is normally subject to wet locations [sic] while patients are present including standing fluids on the floor or drenching of the work area, either of which is intimate to the patient or staff.

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