A review of the standard for medical electrical equipment and medical power supplies and how it has changed over the years.
What is IEC 60601-1?
IEC 60601-1 is the safety and performance standard set by the International Electrotechnical Commission (IEC) that medical electrical equipment must comply with before use. The IEC is a collaboration of experts from across the world that sets international standards for electrotechnology components, systems, and equipment that companies typically need to comply with in order to ensure their product is safe to use.
There are different versions of IEC 60601-1 across the USA, Canada and the EU, but they all contain very similar information about medical safety guidelines. The main purpose of IEC 60601-1 is to reduce risk when using the product as much as possible for both patient and operator, as well as making product design and use more user-friendly.
In terms of power supplies, they are considered a component that will be used in the final piece of medical electrical equipment. Since, the medical product will need to comply IEC 60601-1, the power supply will need to comply as well in order to remain compliant. IEC 60601-1 has been revised several times to keep it up to date with the latest developments with technology.
What is the timeline of IEC 60601?
1977 – Edition 1.0
The IEC first set up the standards for electrical medical equipment in 1977 with their publication of IEC 60601-1 (known as IEC 601 at the time). The primary goal of this standard was to create standards for medical electrical equipment for the general medical environment that is being used by qualified personnel. It provides guidelines for safe and reliable operation and has the ultimate goal of removing as much risk as possible during the use and operation of medical electrical equipment.
- 1984: The first amendment to IEC 60601-1 was added in 1984. This amendment addressed requirements for medical electron accelerators.
1988 – Edition 2.0
The first full revision to IEC 60601-1 occurred in 1988. This revision focused on the safety in terms of vicinity to the patient.
- 1991: First amendment to the 2nd edition included updates to address evolving technology of electromedical equipment.
- 1995: Second amendment to the 2nd edition including general medical equipment updates. Corrigendum to the 2nd edition also added which is intended to help simplify interpretation and application of the General Standard.
2005 – Edition 3.0
The third revision to IEC 60601-1 happened in 2005. This edition focused more on risk management and adding means of patient protection (MOPP) and means of operator protection (MOOP). For certain equipment, requirements are supplemented or modified by special requirements of collateral or particular standard.
- 2006, 2007, 2008, 2009: Updates to address basic safety and performance of medical electrical equipment.
- 2012: Amendment 1 provides a tool to asses the significant changes between the third and second edition.
- 2013, 2014: Updates to address basic safety and performance of medical electrical equipment.
What is specified in IEC 60601-1?
Overall, IEC 60601-1 specifies requirements for basic safety and essential performance of medical electrical equipment. It covers specifications on everything from insulation, leakage current, shock, creepage, and air clearances, to product layout, environment, and design. The standard is divided into two subsections containing collateral standards and particular standards.
Collateral standards: Cover high level regulatory requirement that relates to safety of the most of the medical equipment that is tested to IEC 60601-1. These specify design standards for medical devices and are not necessarily pass/fail standards. There are 10 major collateral standards:
IEC 60601-1-x, where x equals the number of the collateral standard;
IEC 60601-1-1: Addresses medical electrical systems. First introduced in 1992 and revised in 1995 and 2000. It has since been withdrawn and is no longer a standalone document. The information in IEC 60601-1-1 has incorporated into the third edition of IEC 60601-1.
IEC 60601-1-2:2007: Introduced in 1993 to specify electromagnetic disturbances requirements and tests for electromagnetic compatibility (EMC) of medical equipment, medical electrical systems, information technology equipment for medical applications and any equipment used in medical electrical systems. Revised in 2001, 2004, 2010, 2014, and 2020. Equipment will not generate unwanted electromagnetic radiation and will not be unduly affected by it. Compliance with this standard ensures EMC Directive requirements are also met.
IEC 60601-1-3:2008: Radiation protection in diagnostic x-ray equipment; ensures stray radiation is minimized to protect both patient and operator.
IEC 60601-1-4: Programmable Electrical Medical Systems (PEMS). Standard for software. This is no longer a standalone document and has been incorporated into third edition of IEC 60601-1.
IEC 60601-1-6:2007: Usability; Manufacturers must take requirements in this collateral standard into consideration during the design process to increase ergonomics. Equipment should be intuitive and easy to use to avoid user error.
IEC 60601-1-8: 2007: Medical alarms; guidance and management of alarm systems within medical equipment and what the user should do if they encounter one.
IEC 60601-1-9: 2008: Environmentally Conscious Design; air, water, biosphere, use of raw materials, and transport and packaging should all be considered during design of new products.
IEC 60601-1-10: 2008: Physiologic Closed Loop Controllers; design criteria that should be considered for medical devices that control the parameters that they are measuring so they are stable and reliable.
IEC 60601-1-11: 2010: Home healthcare equipment; addresses safety of home healthcare equipment being used by non-specialist users and possibility of poor wiring in building.
Particular standards (IEC 60601-2-xx): provide additional information to collateral standards with about 80 particular standards that cover safety standards and performance for specific medical equipment such as mechanical ventilators, cardiac defibrillators, infant incubators, electrocardiographs, medical beds, X-ray equipment:
The following cover the requirements for the basic safety and essential performance for certain medical equipment: IEC 60601-2-xx, where xx equals number of the particular standard.
|1||Electron accelerators 1MeV to 50MeV||23||Transcutaneous partial pressure monitoring equipment||46||Operating tables|
|2||High frequency surgical equipment and high frequency surgical accessories||24||Infusion pumps and controllers||47||Ambulatory electrocardiographic systems|
|3||Short-wave therapy equipment||25||Electrocardiographs||49||Multifunction patient monitoring equipment|
|4||Cardiac defibrillators||26||Electroencephalographs||50||Infant phototherapy equipment|
|5||Ultrasonic physiotherapy equipment||27||Electrocardiographic monitoring equipment||52||Medical Beds|
|6||Microwave therapy equipment||28||X-ray tube assemblies for medical diagnosis||54||X-ray equipment for radiography and radioscopy|
|8||Therapeutic X-ray equipment 10kV to 1MV range||29||Radiotherapy simulators||57||Non-laser light source equipment intended for therapeutic, diagnostic, monitoring, and cosmetic/aesthetic use|
|10||Nerve and muscle stimulators||31||Cardiac pacemakers with internal power source||62||High intensity therapeutic ultrasound (HITU) equipment|
|11||Gamma beam therapy equipment||33||Magnetic resonance equipment for medical diagnosis||63||Dental extra-oral X-ray equipment|
|12||Critical care ventilators||34||Invasive blood pressure monitoring equipment||64||Light ion beam medical electrical equipment|
|13||Anesthetic systems||36||Equipment for extracorporeally induced lithotripsy||65||Dental intra-oral X-ray equipment|
|16||Haemodialysis, haemodiafiltration, and haemofiltration equipment||37||Ultrasonic medical diagnostic and monitoring equipment||66||Hearing instruments and hearing instrument systems|
|17||Automatically controlled brachytherapy afterloading equipment||39||Peritoneal dialysis equipment||68||X-ray based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment|
|18||Endoscopic equipment||40||Electromyographs and evoked response equipment||75||Photodynamic therapy and photodynamic diagnosis equipment|
|19||Infant incubators||41||Surgical luminaires and luminaires for diagnosis||76||Low energy ionized gas hemostasis equipment|
|20||Infant transport incubators||43||X-ray equipment for interventional procedures||83||Home light therapy equipment|
|21||Infant radiant warmers||44||X-ray equipment for computed tomography||84||Emergency and transport ventilators|
|22||Surgical, cosmetic, therapeutic, and diagnostic laser equipment||45||Mammographic X-ray equipment and mammographic stereotactic devices|
Means of Protection (MOP)
Means of protection (MOP) was added to IEC 60601-1 to address the risk of patients and equipment operators coming in contact with lethal mains voltage of medical devices. MOP can be achieved through protective earth connection (which protects against electrical shock), safety insulation, and minimum creepage and clearance distances. MOP can be classified as either 1 x MOP, which has basic insulation, or 2 x MOP, which has reinforced insulation.
One of the main specifications that means of protection addresses is creepage and clearance. Creepage and clearance in a supply offer space between conductive parts in a supply. Creepage measures this distance along the surface insulation, while clearance measures it through the air. It is important for medical equipment to have proper creepage to protect against deterioration caused by tracking, and proper clearance in order to prevent dielectric breakdown within the supply.
Minimum Creepage Distances and Air Clearances Between Parts of Opposite Polarity of the Mains Port
Working Voltage – Up to and Including
|Working Voltage – Up to and Including||Creepage Distance|| |
The manufacturer of the medical product is the one that will determine the likelihood of their product to come in contact with patient and operator, and whether operator protection (MOOP) or patient protection (MOPP) is needed.
Means of Operator Protection (MOOP)
Means of operator protection is that standard of protection that provides safety measures for the operator of medical equipment. This means it will be necessary for equipment that will not be in contact with a patient. If used in a laboratory setting 2 x MOOP is sufficient to protect the operators of the equipment.
There are basic insulation standards (1xMOOP) and reinforced insulation standards (2xMOOP) that can be applied to medical equipment. Products will also need to have minimum air clearances from the mains part in order to comply with MOOP.
|1 x MOOP||1500VAC||2.5mm/2mm||Basic|
|2 x MOOP||3000VAC||5mm/4mm||Double|
Minimum Air Clearances Providing MOOP from the Mains Part
|Working Voltage – Up to and Including||Nominal Mains Voltage ≤150V (Mains transient Voltage 1500V)||150V < Nominal Mains Voltage ≤ 300V (Mains Transient Voltage 2500V)||300V < Nominal Mains Voltage ≤600V (Mains Transient Voltage 4000V)|
|Voltage Peak or DC||Voltage r.m.s. (sinusoidal)||Pollution Degrees 1 and 2||Pollution Degree 3||Pollution degrees 1, 2, and 3||Pollution degrees 1, 2, and 3|
|V||V||One MOOP||Two MOOP||One MOOP||Two MOOP||One MOOP||Two MOOP||One MOOP||Two MOOP|
|450||300||1 MOOP 3.2, 2 MOOP 6.4||3.2||6.4|
|840||600||1 MOOP 3.2, 2 MOOP 6.4|
|1400||1000||1 MOOP 4.2, 2 MOOP 6.4|
|2800||2000||1 or 2 MOOP 8.4|
|7000||5000||1 or 2 MOOP 17.5|
|9800||7000||1 or 2 MOOP 25|
|14000||10000||1 or 2 MOOP 37|
|28000||20000||1 or 2 MOOP 80|
* Air clearances for working voltages above 20kVr.m.s. or 28 KVDC can be prescribed by particular standards if necessary.
Note: Air clearances are a function of peak voltage in the circuit. The r.m.s. voltage column is provided for the special case where the voltage has a sinusoidal waveform.
Means of Patient Protection (MOPP)
Means of patient protection will be necessary for equipment that will come into contact with patients. It reduces the leakage currents and risk of electric shock if the patient may come in contact with conductive parts and AC currents. The most stringent requirements will be needed for electrocardiogram, applied parts, floating cardio, and type CF parts. The safest applied parts are F-type isolated applied parts in which patient connections are isolated from other parts of the equipment.
Like means of operator protection, means of patient protection has basic insulation standards (1xMOPP) and reinforced insulation standards (2xMOPP) to follow.
|1 x MOPP||1500VAC||4mm/2.5mm||Basic|
|2 x MOPP||4000VAC||8mm/5mm||Double|
Minimum Creepage Distances and Air Clearances Providing MOPP
|Working Voltage – Up to and Including||Working Voltage – Up to and Including||Spacing Providing One MOPP||Spacing Providing Two MOPP|
|Creepage Distance||Air Clearance||Creepage Distance||Air Clearance|
A product with 2 x MOPP will usually have the highest level of protection for a medical setting. It has the most stringent requirements of the MOP classifications including 4000VAC isolation, and creepage distance of 8mm.
Medical equipment needs to be tested to meet proper temperature, humidity, and atmospheric pressure conditions as indicated by IEC 60601-1.
Protection against Electrical Hazards
IEC 60601-1 outlines protections and limitations that medical equipment will need to have for electrical hazards like shock, water/particulate matter, and leakage current. It also outlines the standards required for methods of protecting against electrical hazards like protective earthing, MOOP, MOPP, leakage, insulation, creepage and air clearances, and layout.
Protection Against Mechanical Hazards
Medical equipment needs to have proper protection against certain mechanical hazards such as moving parts, expelled parts, instability, acoustic energy and vibration, and pneumatic and hydraulic pressure. IEC 60601-1 addresses the hazards that are associated with these moving parts and how the risk created from moving parts coming in contact with one another can be reduced.
Protection Against Unwanted/Excessive Radiation
Medical equipment is prone to exposure to unwanted or excessive radiation, given the environment it is used in. IEC 60601-1 outlines radiation limitations for x-radiation, alpha, beta, gamma and neutron particle radiation, microwave radiation, infrared radiation, and UV radiation.
Isolation is the separation of incoming high voltage (mains) to the low voltage output. Isolation helps prevent voltages from passing between components and can help prevent electrical shock and breaks ground loops. According to IEC 60601-1, medical equipment needs to isolate its circuits form the supply mains on all poles simultaneously and have very low leakage current.
Leakage current is the current that still flows input to output during supply operation. It is important for leakage current in medical power supply to be low because any additional current that reaches the patient or the caregiver, that is not intended, could cause serious harm. Leakage requirements in a medical power supply are determined by IEC 60601-1.
|Current||Description||Type B Applied Part||Type BF Applied Part||Type CF Applied Part|
|Normal Conditions||Single Fault Conditions||Normal Conditions||Single Fault Conditions||Normal Conditions||Single Fault Conditions|
|Patient Auxiliary Current||DC||10µA||50µA||10µA||50µA||10µA||50µA|
|Patient Leakage Current||From patient connection to earth||DC||10µA||50µA||10µA||50µA||10µA||50µA|
|Caused by an external voltage on SIP/SOP||AC||10µA||50µA||10µA||50µA||10µA||50µA|
|Total Patient Leakage Current*||With same type of applied part connected together||AC||50µA||100µA||50µA||100µA||50µA||100µA|
*These values are only applicable to equipment having multiple applied parts.
Note: Above chart is based on information from IEC 60601-1 Ver. 3 and may not necessarily be the most current information.
To help reduce leakage current, medical power supplies should be properly grounded, double insulated or reinforced for to meet the requirements of the standard.
Shock is a huge risk when it comes to medical supplies because shock an electric shock from a power supply could severely harm a patient or caregiver. Means of Operator Protection (MOOP) and Means of Patient Protection (MOPP) laid out in IEC 60601-1 outline how supplies can be designed and tested to reduce the risk of electric shock to both the operator and the patient. Both MOOP and MOPP have to meet specific dielectric strength, creepage/clearance, and protective earth connection requirements to be certified as IEC 60601-1 and appropriate for medical devices.
Properly isolating components like the AC input, DC output, and the supply itself can help reduce the risk of shock and damage to the supply. Isolation is especially important around conductors.
What is Required for IEC 60601-1 Compliance?
Gaining IEC 60601-1 compliance can be a difficult and long process. The first step to in the process is to determine which standard is needed for your device. Factor such as country and application will determine which IEC 60601 classification is needed. Particular standards and collateral standards will also need to be determined at this stage. This will include more specific requirements such as electric shock, applied parts, protection against harmful matter such as water and particulate matter, humidity test, mode of operation, isolation etc. Planning tools like an isolation diagram can help during the early design phase to avoid expensive redesigns later down the line.
The next step toward achieving IEC 60601-1 compliance is to classify the critical components will be needed for your device and to get the spec sheets for them. These components can include flammable components, line filters, mains components etc.
After that, essential performance will need to be identified and documented to help determine a test plan for your device. This will include performing risk analysis per essential performance clauses and specifying performance limits between fully functional and total loss in normal and single fault conditions. Essential performance typically applies to critical care equipment, but can also apply to less critical equipment as well. The risk management file will need to comply with ISO 14971. After this step has been completed, a test plan can be drafted.
IEC 60601-1 requires ‘type testing’ which means a test must be performed on a representative sample of the device to determine if it meets requirements of the standards. The test plan can cover tests for multiple standards, with the only exception being EMC (IEC 60601-1-2) which requires a separate test plan.
Following the test plan, marking and labeling requirements should be reviewed so that your device is properly labelled and documented. This will include review of the markings on your device, the user manual and/or quick start guides, technical description, collateral and particular standard labelling requirements, and readability requirements. It should be ensured that legibility and durability of markings is appropriate for the product and environment.
The next item that will need to be reviewed is the construction of the device against IEC 60601-1 standards. This includes items like spacing, power supply, physical requirements, and enclosure materials. Following this step, you can finalize the risk management file and essential performance, making any necessary updates. You may also want to consider pre-testing your device, in-house or by using a lab.
You will then need to contact a test lab to verify certification. Make sure you have spare parts on hand, drawings and labels, and supporting documentation. Production line test equipment must also be set up to meet IEC 60601-1. The test lab will then determine if you have reached IEC 60601-1 certification. Please note, these steps are just a general guideline. More details can be found on this website.
IEC 60601-1 Glossary of Terms
|EUT||Equipment under testing; the equipment that is being tested|| |
|Device under testing; device that is being tested||–|
|Applied part||Part of equipment that is designed to, or is likely to, come into physical contact with the patient|| |
|Connections or metal parts intended to connect with the patient from applied part||–|
|Patient Environment||Area in which patient can come to contact with medical equipment or contact between people touching the medical equipment and the patient can occur|| |
|F-Type Applied Part||Applied part that is electrically isolated from earth and other parts of medical equipment. Floating F-type parts are either Type BF or Type CF applied parts|| |
|Type B Applied Part||Applied part complying with specifications against electric shock; earth referenced; not suitable for direct cardiac application|
Type BF Applied Part
|F-Type applied part that complies with a higher degree of protection against shock than Type B; not suitable for direct cardiac application|
|Type CF Applied Part|| |
F-Type applied part the complies with the highest degree of protection against electric shock than Type B
Medical electrical equipment
|Equipment used for diagnosing or monitoring patients powered by one connection to main supply; contact with patient is not necessarily required||–|
|Medical Electrical system|| |
Combination of equipment in which at least one is classified as medical electrical equipment and is connected by functional connection or use of multiple portable socket outlets
|Protection against electrical shock by basic insulation through connecting exposed conductive parts to protective earth in fixed wiring of an installation.|
|Class II||Protection against electrical shock by supplementary insulation (more than basic insulation). No provision for connection of exposed metalwork of equipment to protective conductor and no reliance on precautions taken in fixed wiring of installation. Class II is also known as ‘double insulated’|
|Shortest distance between two conductive parts that is measured along the surface of insulation||–|
|Clearance||Shortest distance between two conductive parts through the air|| |
Ingress Protection (IP)
|Protection against fluids and dust|| |
IEC 60601-1 FAQs
What is the difference between EN 60601-1 and IEC 60601-1?
EN 60601-1 is the European version of IEC 60601-1. As of the end of December 2017, medical device manufacturers must comply with EN 60601-1 3rd edition. This version, save for a few differences, requires compliance to the same safety, performance, and electromagnetic compatibility standards as IEC 60601 3rd edition.
European medical device manufacturers must also comply with CE in addition to EN 60601-1. The EU CE marking indicates compliance with relevant product directives, relevant performance and safety standards, and that it will not endanger lives or property. EU Medical Devices Regulation covers the standards of safety, efficacy, quality, and performance for the specific type of medical device.
What applications and environments require IEC 60601-1 compliance?
IEC 60601-1 is required for medical electrical equipment. A list of specific devices and applications are covered in the particular standards. Compliance will also be needed for any environment that electrical medical devices are used. This includes professional healthcare facilities, home healthcare, and special environments.
Professional healthcare facilities have an attending medical staff and include hospitals, dental offices, and intensive care units.
Environments classified as home healthcare include dwellings where patients are present or a dwelling in which they live. In these environments, equipment is being used by non-specialists and there may be poor electrical supplies, so this needs to be taken into before use. More information on home healthcare is outlined in IEC 60601-1-11.
Special environments refer to anywhere that there may be a high level of electromagnetic disturbance or where high-power medical equipment is used.
What are the particular standards?
The particular standards provide additional information to collateral standards. There are about 80 particular standards that cover safety standards and performance for specific medical equipment such as cardiac defibrillators, infant incubators and warmers, dental equipment, physiotherapy equipment, microwave therapy equipment, ventilators, infusion pumps, mammography equipment, operating tables, electrocardiographs, medical beds, and X-ray equipment. A full list can be found earlier in this article.
What is the global adoption timeline for IEC 60601-1?
Due to the complicated nature of achieving IEC 60601-1 compliance, many countries have adopted to the most recent update on different timelines. Below is the timeline of adaptation for the United States, Canada, European Union, Japan, South Korea, China, Taiwan, and Brazil.
What role does risk management play in IEC 60601-1?
The 3rd edition of IEC 60601-1 places the determination of risk level on the manufacturer of the medical device. IEC 60601-1 specifies that the ‘risk management process shall be performed according to ISO 14971’. This means that in order to get IEC 60601-1 certification, a device must comply with ISO 14971. Obtaining ISO 14971 certification is an asset, but it is not required for a safety test lab to verify compliance of a product.
Under the standards of risk management in IEC 60601-1, manufacturers will determine the acceptable level of risk, and design their product to meet what is specified in ISO 14971. However, a third-party certifier will be the one to determine if they actually meet the proper requirements of ISO 14971, that they have followed the proper procedures for the Risk Management Plan for the Product, and that their risk management file addresses any 60601 requirements associated with the risk. More details on ISO 14971 can be found here.
The most up to date information on IEC 60601-1 can be found on the IEC website for download.
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