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?

The IEC first established standards for electrical medical equipment in 1977

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.

The first full revision to IEC 60601-1 was published in 19881988 – 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.

The third revision to IEC 60601-1 took place in 2005.

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.

What are the standards specified in IEC 60601-1?

Overall, IEC 60601-1 specifies requirements for both 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 addresses general requirements, but it can be further divided into two subsections of more specific standards; collateral and particular standards:

  • General standards: These cover the fundamental requirements that apply to all medical equipment. This section sets out the basic principles of safety and protection, as well as defining key terms and principles.
  • Means of protection (MOP): Forming part of the general standards, this section deals with how medical equipment – including power supplies – should protect those in the vicinity. It has separate sections to deal with operator and patient safety.
  • Collateral standards: These cover high-level regulatory requirements that relate to specific aspects of the medical equipment that is tested to IEC 60601-1. They usually deal with specific features or aspects of product design that will be relevant for a wide variety of medical equipment.
  • Particular standards: These supplement the collateral standards to provide safety and performance standards for specific medical equipment such as mechanical ventilators, cardiac defibrillators, infant incubators, electrocardiographs, medical beds, and X-ray equipment.

As you can see, IEC 60601-1 is a very in-depth standard. While this is beneficial when it comes to ensuring the safety of medical equipment, it can make meeting compliance much more difficult for manufacturers.

Let’s look at each section in turn and break down what’s included in more detail.

General standards

The general standards outlined in IEC 60601-1 cover the essential requirements that are applicable to all forms of medical equipment. This section provides the scope and the fundamental expectations of the other standards, as well as giving definitions of key terms.
Some of the general requirements covered in IEC 60601-1 include:

Protection Against Electrical Hazards

IEC 60601-1 outlines protections and limitations that medical equipment will need to have in relation to electrical hazards like shock, water/particulate matter, and leakage current. It also outlines the standards required for methods of protecting against electrical hazards, including protective earthing, MOOP, MOPP, leakage, insulation, creepage and air clearances, and layout. See below for more detail on these measures.

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) from the low voltage output. Isolation helps prevent voltages from passing between components and can help prevent electrical shock and break ground loops. According to IEC 60601-1, medical equipment needs to isolate its circuits from 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 could cause serious harm. Leakage requirements in a medical power supply are determined by IEC 60601-1.

See Table Below.

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
AC 100µA 500µA 100µA 500µA 10µA 50µA
Patient Leakage Current From patient connection to earth DC 10µA 50µA 10µA 50µA 10µA 50µA
AC 100µA 500µA 100µA 500µA 10µA 50µA
Caused by an external voltage on SIP/SOP AC 10µA 50µA 10µA 50µA 10µA 50µA
DC 100µA 500µA 100µA 500µA 10µA 50µA
Total Patient Leakage Current* With same type of applied part connected together AC 50µA 100µA 50µA 100µA 50µA 100µA
DC 500µA 1000µA 500µA 1000µA 50µA 100µA
AC 50µA 100µA 50µA 100µA 50µA 100µA
DC 500µA 1000µA 500µA 1000µA 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 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 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
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
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.

IEC 60601-1 - The ultimate safety & performance guide

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