IEC 60601-1 – The ultimate safety & performance guide

When it comes to choosing the right power supply for your product, safety concerns are key. You want to be certain that any power supply you use offers adequate protection.

This is a particularly important concern in medical applications. Medical equipment is designed to provide life-saving treatment and improve patients’ lives. The last thing you want is to compromise on safety and have a poor-quality power supply put people at risk.

For medical applications, IEC 60601-1 is the most widely recognised and adopted standard for medical equipment safety, including medical power supplies. It sets out detailed, stringent expectations for safety and performance across a broad range of categories. As a result, making sure you’ve met the necessary requirements can be a significant challenge.

In this post, we provide the ultimate guide to IEC 60601-1. We’ll look at how it’s evolved over time, and how you can be sure that any medical equipment you design or manufacture is fit for purpose – including the power supply.

What is IEC 60601-1?

IEC 60601-1 is a safety and performance standard for medical equipment established by the International Electrotechnical Commission (IEC). The IEC is a non-profit organization that publishes standards for electrical technology. The IEC standards are developed through the collaboration of experts from across the world and are widely recognised.

Because the IEC consists of 80 member countries, complying with IEC standards is essential to ensuring your equipment can be sold and used across the world – and IEC 60601-1 is no different. While the standard has minor variations in how it is implemented in the US, Canada and Europe, the underlying guidelines are similar. Its main purpose is to reduce the risk as much as possible for both patients and operators, as well as making product design 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. As a result, for a medical product to comply with IEC 60601-1, the power supply will need to be compliant, too.

IEC 60601-1, like most of the IEC’s standards, has been revised several times to keep it up to date with the latest developments with technology. So, before we look more closely at how you can ensure your medical power supplies meet IEC 60601-1, let’s explore how it has developed over time.

How has IEC 60601 changed over time?

1977 – Edition 1.0
The IEC first established standards for electrical medical equipment in 1977 with the publication of IEC 60601-1 (known as IEC 601 at the time). Their primary goal was to create standards for medical electric equipment used by qualified personnel. It addressed various aspects, including electrical safety, mechanical safety, and protection against electric shock, with the goal of reducing risk as much as possible.

• 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 was published in 1988. This revision focused on the safety of medical equipment in terms of its vicinity to the patient.

• 1991: The first amendment to the 2nd edition included updates to address the evolving technology of electromedical equipment.
• 1995: The second amendment to the 2nd edition added general medical equipment updates. A corrigendum to the 2nd edition was also added, which was intended to help simplify the interpretation and application of the General Standard.

• 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 took place 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 a 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 assess the significant changes between the third and second edition.
• 2013, 2014: Updates to address basic safety and performance of medical electrical equipment.

*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 to meet the requirements of the standard.

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. It forms part of the general standards, as it applies to all medical equipment. However, we’ll cover it separately here to highlight some of its key features – it’s a particularly important consideration when it comes to medical power supplies.

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.

The MOP standards cover a range of different aspects of equipment safety, with specific divisions for operator safety (MOOP) and patient safety (MOPP), recognising that the risks for each may be quite different. The manufacturer must identify whether they need to follow MOOP or MOPP guidelines depending on whether the equipment will be used in the vicinity of patients or not.

Let’s look at some of the broader MOP requirements, then consider MOOP and MOPP separately.

Creepage and Clearance Measures

One of the main specifications that MOP addresses is creepage and clearance. Creepage and clearance refer to the 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	Air Clearance
17VDC	12Vr.m.s.	0.8mm	0.4mm
43VDC	30Vr.m.s.	1mm	0.5mm
85VDC	60Vr.m.s.	1.3mm	0.7mm
177VDC	125Vr.m.s.	2mm	1mm
354VDC	250Vr.m.s.	3mm	1.6mm
566VDC	400Vr.m.s.	4mm	2.4mm
707VDC	500Vr.m.s.	5.5mm	3mm
934VDC	660Vr.m.s.	7mm	4mm
1061VDC	750Vr.m.s.	8mm	4.5mm
1414VDC	1000Vr.m.s.	11mm	6mm

 

Shock

Shock is a huge risk when it comes to medical supplies because 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 both 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.

Means of Operator Protection (MOOP)

Means of operator protection is the 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.

	Isolation	Creepage/Clearance	Insulation
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
210	150	1.0	2.0	1.3	2.6	2.0	4.0	3.2	6.4
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 special cases 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 the risk of electric shock if the patient comes into 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.

	Isolation	Creepage/Clearance	Insulation
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
17VDC	12Vr.m.s.	1.7mm	0.8mm	3.4mm	1.6mm
43VDC	30Vr.m.s.	2mm	1mm	4mm	2mm
85VDC	60Vr.m.s.	2.3mm	1.2mm	4.6mm	2.4mm
177VDC	125Vr.m.s.	3mm	1.6mm	6mm	3.2mm
354VDC	250Vr.m.s.	4mm	2.5mm	8mm	5mm
566VDC	400Vr.m.s.	6mm	3.5mm	12mm	7mm
707VDC	500Vr.m.s.	8mm	4.5mm	16mm	9mm
934VDC	660Vr.m.s.	10.5mm	6mm	21mm	12mm
1061VDC	750Vr.m.s.	12mm	6.5mm	24mm	13mm
1414VDC	1000Vr.m.s.	16mm	9mm	32mm	18mm
1768VDC	1250 Vr.m.s.	20mm	11.4mm	40mm	22.8mm
2263VDC	1600 Vr.m.s.	25mm	14.3mm	50mm	28.6mm
2828VDC	2000 Vr.m.s.	32mm	18.3mm	64mm	36.6mm
3535VDC	2500 Vr.m.s.	40mm	22.9mm	80mm	45.8mm
4525VDC	3200 Vr.m.s.	50mm	28.6mm	100mm	57.2mm
5656VDC	4000 Vr.m.s.	63mm	36mm	126mm	72mm
7070VDC	5000 Vr.m.s.	80mm	45.7mm	160mm	91.4mm
8909VDC	6300 Vr.m.s.	100mm	57.1mm	200mm	114.mm
11312VDC	8000 Vr.m.s.	125mm	71.4mm	250mm	142.8mm
14140VDC	10000 Vr.m.s.	160mm	91.4mm	320mm	182.8mm

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.

Collateral standards

The collateral standards cover specific aspects of the design and usage of medical devices. These will generally be applicable to a range of different devices, though not all standards will be relevant in every case.

There are 10 collateral standards in total, each of which is named using the form IEC 60601-1-x, where x equals the number of the collateral standard.

• IEC 60601-1-1 addresses medical electrical systems. It was 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 been incorporated into the third edition of IEC 60601-1.
• IEC 60601-1-2:2007 was introduced in 1993 to specify electromagnetic disturbance 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. Compliance with this standard ensures EMC Directive requirements are also met.
• IEC 60601-1-3:2008 covers radiation protection in diagnostic X-ray equipment. It ensures stray radiation is minimized to protect both patient and operator.
• IEC 60601-1-4 covers Programmable Electrical Medical Systems (PEMS), such as programmable software and hardware used in medical applications. This is no longer a standalone document and has been incorporated into the third edition of IEC 60601-1.
• IEC 60601-1-8:2007 covers the guidance and management of alarm systems within medical equipment and what the user should do if they encounter one.
• IEC 60601-1-9:2008 focuses on standards for Environmentally Conscious Design. It specifies how air, water, biosphere, use of raw materials, and transport and packaging should all be considered during the design of new products.
• IEC 60601-1-10:2008 sets out standards for Physiologic Closed Loop Controllers. It provides design criteria that should be considered for medical devices that control the parameters that they are measuring (such as a patient’s blood pressure or heart rate) so they are stable and reliable.
• IEC 60601-1-6:2010 focuses on usability. Manufacturers must take requirements in this collateral standard into consideration during the design process to improve ergonomics. It stresses that equipment should be intuitive and easy to use to avoid user error.
• IEC 60601-1-11:2010 covers home healthcare equipment being used by non-specialist users and deals with the possibility of poor wiring in the building where the equipment is located.

Particular standards

As discussed above, the particular standards focus on specific types of medical equipment. They cover the requirements for the basic safety and essential performance, and they take the form IEC 60601-2-xx, where xx is the number of the particular standard.

Particular Standard	Classification	Particular Standard	Classification	Particular Standard	Classification
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

How To Ensure IEC 60601-1 Compliance

Given the range of requirements outlined above it’s clear that achieving IEC 60601-1 compliance can be a challenging process. Below, we outline a step-by-step approach that will help ensure your medical products meet the necessary standards for safety and performance.

Step one: Identify the appropriate standard

Despite functioning as a universal standard, IEC 60601-1 is implemented differently case by case. Similarly, different aspects of the standard will apply depending on the type of device you’re producing and how it will be used.

So, the first step is to determine which standard is needed for your device and identify the relevant collateral and particular standards that apply. These 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.

Using planning tools like an isolation diagram can help during the early design phase to avoid expensive redesigns later down the line.

Step two: Classify critical components

Whatever the nature and application of your medical device, there will be a variety of critical components needed to ensure its proper function, including the appropriate power supply. Each of these components will have its distinct requirements, and at this stage you’ll want to obtain spec sheets for all of them.

Step three: Identify essential performance requirements

IEC 60601-1 defines essential performance as “performance of a clinical function, other than that related to basic safety, where loss or degradation beyond the limits specified by the manufacturer results in an unacceptable risk”. Essential performance typically applies to critical care equipment, but can also apply to less critical equipment as well.

In order to identify how (or if) essential performance applies to your device, you’ll need to perform a risk analysis and specify performance limits between fully functional and total loss in normal and single fault conditions. The risk management file will need to comply with ISO 14971, an international standard for risk management in medical devices.

Step four: Develop a test plan

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.

Step five: Review marking and labelling requirements

Following the test plan, marking and labelling requirements should be reviewed so that your device is properly labelled and documented. This will include a 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 the legibility and durability of markings is appropriate for the product and environment.

Step six: Review the construction of the device

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.

Step seven: Verify certification

You will then need to contact a certified test lab to verify your IEC 60601-1 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

Term	Description	Symbol
EUT	Equipment under testing; the equipment that is being tested	–
DUT	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	–
Patient Connection	Connections or metal parts intended to connect with the patient from the 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	–
Class I	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’
Creepage	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 where 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 the 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 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.

Let Wall Industries solve your medical power supply needs

Finding the right power supply for your medical device is essential to meeting IEC 60601-1 standards. But, as you can see, IEC 60601-1 compliance is no simple process. Meeting all the general, collateral and particular standards can potentially take a great deal of time and effort.

As a result, you’ll want to ensure you’re sourcing your medical power supplies from a reputable manufacturer – and one that can provide tailored, expert support when needed. That’s why Wall Industries is the perfect choice for your medical power supply requirements. We supply a wide range of medical power supplies suited to every purpose, as well as providing a modified and custom medical power supply design service.

Working with Wall Industries, you will benefit from our 60+ years of experience and a team of experts that can meet any of your medical power supply requirements. Browse our full range of medical power supplies, or get in touch today to discuss your requirements.