The IEC 60601-1 standard is one of the commonly applied standards in the field of medical devices. It defines the safety and essential performance requirements applicable to electromedical equipment. First published in 1977, the IEC 60601-1:2005 version corresponds to revision 3.0. It is required for the CE certification of an electro-medical device.

It is the “umbrella standard” for a series of standards concerning basic safety and essential requirements, and collateral standards supplement 60601-1 on specific points, such as 60601-1-8 for alarm systems, 60601-1-6 dedicated to suitability for use, and 60601-1-11 for electro-medical devices used in the home.

EN 60601-1:2006 (European version of IEC) is recognized by the bodies responsible for assessing the conformity of medical devices. It is a harmonized standard that provides appropriate responses to many requirements for medical devices (MD).

Scope

60601-1 applies to electromedical devices, as the name suggests:

• electro-: this immediately brings to mind devices connected to the electrical network, but it can also refer to an internal power supply (battery). The device must also have an applied part (a part in contact with the patient), or transfer energy to/from the patient, or detect such a transfer.
• -medical: the standard broadly follows the definition of medical devices applicable in Europe.

Standard drafting committees

NF EN 60601-1 has three levels of drafting:

• Firstly, international: IEC 60601-1:2005 is drafted by committee SC62A of the IEC (International Electrotechnical Commission).
• Then European: EN 60601-1:2006 is drafted by committee CLC/TC62 of Cenelec. This standard is harmonized with the requirements of several European regulations, including mdeical devices, applicable to medical devices.
• And finally, national level (e.g. French): NF EN 60601-1:2007 is drafted by the AFNOR UTE/UF62 committee, which was formed from the merger of AFNOR and UTE.

Note that NF EN is simply the French version of standard EN, while EN contains the same requirements as standard IEC with the addition of the correspondences between the requirements of the standard and those of various European directives. The requirements expressed by these three standards are therefore strictly the same.

Essential definitions

Chapter 3 provides 139 definitions, many of which are taken from other standards (such as safety standards specific to a type of device). Some terms are taken from specific standards (in particular ISO 14971 on risk management). Below are some general explanations necessary for understanding the standard:

• Basic safety: this is the aim of the game: to avoid unacceptable risk under normal conditions of use or in the event of a first fault.
• Essential performance: the performance of the MD necessary to avoid unacceptable risk. It is easier to think in terms of “what the device must not do”; for example, a surgical robot must not make any unintended movements.
• Accessible parts: anything that can be touched by the patient or any other person. Obviously, such parts must not present excessive temperatures or dangerous electric currents.
• Applied parts: a part of the MD that, under normal conditions of use, is necessarily in contact with the patient. The hazards to be addressed are the same as for accessible parts, with even more stringent control measures due to the frequency of contact.
• Component with high reliability characteristics: a component which, due to its characteristics, cannot present any defect that compromises safety.
• Accompanying document: this refers to instructions for use or summary sheets. This type of document is very important for informing the user about the correct conditions of use and the risks associated with the medical device, even though the use of these documents to reduce risks has been greatly devalued since the latest version of Directive 93/42 and, by extension, since the 2013 version of standard EN ISO 14971 on risk management.
• Initial failure condition: the MD is in its initial failure condition when an anomaly occurs (typically a technical failure). Careful attention should be paid to the initial failure conditions of the measures put in place to reduce risks.
• Service life: the period of use specified by the manufacturer.
• Intended use: conditions of use specified by the manufacturer.

For the record: the concept of patient is extended here to include people and animals, whereas the European definition of medical devices limits the scope to humans.

Contents of 60601-1

General requirements

It should be noted that:

• The manufacturer must define the essential performance and the expected service life.
• The manufacturer may apply requirements other than those of the standard if this is in line with risk reduction.
• The MD must remain safe in a first failure condition.
• Components critical to safety must comply with specific standards and/or be tested.

The purpose of the standard is therefore clear: to reduce risks. Compliance with many of the requirements is verified by inspection of the risk management file.

Standards referenced

Verifying compliance with the requirements of IEC 60601-1 requires reference to other standards, mainly:

• ISO 14971 for risk management
• IEC 60601-1-2 for electromagnetic compatibility (emission and immunity)
• IEC 60601-1-6 for evaluation of suitability for use (with reference to 62366-1)
• IEC 60601-1-8 for alarm systems

Note: as mentioned, NF EN 60601-1 reproduces the requirements of IEC 60601-1 word for word, so these are “IEC” standards that are referred to. You can, of course, use the EN or NF EN versions.

Test requirements

These requirements must be taken into account by the testing laboratory that will test the equipment. Please note that the device will be tested in its least favorable configuration (electrical and environmental conditions, layout, with or without accessories, etc.).

Product description

• Classification: The electrical class, IP rating, type of applied part, and other more specific points must be defined. Many of the requirements of the standard depend on these classifications.
• Safety description: Applied parts, essential performance, initial failure conditions, high-fidelity components, critical components, etc. must be defined. In most cases, this information will be included in the risk management file.

Marking & Instructions for use

The form (resistance, legibility, etc.) and content (requirements depending on the nature of the device) are addressed.

• Marking: The requirements concern both external marking (identification plate, symbols used for the human-machine interface) and internal marking (this may concern hazardous elements such as heating elements or live parts).
• Instructions for use: The instructions for use shall contain warnings for the user, protective measures to be taken, a description of the normal conditions of use, etc. Technical instructions are also subject to requirements.

Protection against hazards

Chapters 8 to 11 list the requirements and verification methods applicable to the device.

• Electrical hazards: insulation, earthing, leakage currents, accessible voltages, wiring, etc. This is particularly difficult when the device is connected to the mains. An accredited laboratory is generally required for electrical safety tests, as such laboratories have the appropriate equipment that complies with metrological standards.
• Mechanical hazards: anything that moves, cuts, crushes, pinches, stings, etc. This also includes device instability, falling, parts under pressure, resistance to static force, etc.
• Hazards due to radiation: all electromagnetic waves are covered: from ultraviolet to infrared, not forgetting X-rays, alpha, beta, gamma, etc.
• Other: excessive temperature, fire protection, gas, biocompatibility of materials used, penetration of water or particles, etc.

Programmable electro-medical systems

Applicable as soon as the device has a programmable element (which is the case for almost all electrical medical devices today). It is common to prefer EN 62304 to define the requirements applicable to software, as the requirements are better explained and more detailed.

Other

• Order specifications: the idea is to address hazards related to intentional or unintentional exceeding or incorrect values of a device’s “output value” (example of an output value: the power of a laser used in ophthalmic care).
• Construction: the term should be taken in its broadest sense: many constraints must be addressed during design and not during assembly, as the term might suggest. We will look at the risks associated with the sequencing of commands and indicators, control devices, maintenance, resistance to falls and rough handling, connectors, etc.
• EM systems: requirements when several devices are connected to each other; this chapter is very much focused on “electrical problems.”

How to approach 60601-1?

A manufacturer cannot claim compliance with 60601-1 without going through “laboratory testing.” This step is painful because it is expensive and, in most cases, will require follow-up sessions. Before going to the laboratory, the manufacturer can do the following:

• Determine what is applicable to the product
• Document the nature of the device and its use
• Add to the risk management file
• Prepare the fitness for use assessment
• Take into account the performance requirements in the product specifications
• Develop the labeling and documentation, taking into account the requirements

And, depending on the complexity/hazardousness of the device, a “pre-assessment” in the form of an “engineering day” with the laboratory can avoid unpleasant surprises during pre-production testing.