IEC 62366-1:2015 new information on the usability standard (2023)

The standard on the usability engineering process, IEC 62366-1:2015, has been amended several times since it was published in 2015. Corrections were made in 2016 in the form of the corrigendum. With 2020 amendment (AMD1:2020) resulted in significant changes that manufacturers of medical devices now need to familiarize themselves with.

The following article

  • lists all of the important changes to IEC 62366-1:2015 and explains them,
  • provides information about the status of harmonization.

1. Background and objective of IEC 62366-1:2015

The usability engineering process described by IEC 62366-1:2015 aims to ensure that risks that may arise when using medical devices are minimized. The target audience for the standard is manufacturers of medical devices and also technical committees that are responsible for the creation of specific standards for medical devices.

IEC 62366-1:2015 is the successor to 62366:2007. To clean up the normative part, the new version of IEC 62366 is made up of two parts:

  • the standard itself (IEC 62366-1) and
  • the informative technical report (IEC 62366-2).

2.The significant changes introduced by AMD1:2020

Since IEC 62366-1:2015 was published, experts have identified a total of 22 problems. These have now been remedied by the corrections.

In summary, the significant changes are as follows:

(Video) Short course on Usability Engineering for Medical Devices and IEC 62366-1

  • Editorial changes
    Many of the changes to IEC 62366-1:2015 are merely editorial in nature; e.g. references and years have been updated and passages of text have been reformulated.
  • Scope of application
    The scope of application of the standard has changed. It now no longer comprises merely physical hazards, but also dangers of any type (including psychological hazards).
  • Definitions
    The definitions of “accompanying documentation” and “use environment” have been expanded and the definition of the term “user profile” has been changed.
  • New terms
    There have been changes to the wording of the standard, including the introduction of new terms. Among other things, the terms “user group” and “critical task” have been introduced, and “close call” is now mentioned.
  • New requirements
    There are new requirements for the planning of usability tests within the scope of the summative evaluation and the recording of use difficulties. In addition to the use errors, these must now be recorded in the summative evaluation.
  • Risk management and documentation obligation
    Riskcontrol now also includes training sessions and the documentation obligation for amendments to the usability engineering effort has been lifted.

Links to the standard texts

An overview of the topic of the usability of medical devices can be found in our overview article.

3. The changes in detail




Clause1 - Scope

Comment 1

“Purely physical hazards” deleted, so hazards of any kind are included

Clause3 - Terms

3.2 Accompanying documentation

The definitions of accompanying documentation has been expanded

3.20 Use environment/Note 1 to entry

The definition of use environment conditions has been changed

3.29 User profile

Focus placed on the individual characteristics of the user

Clause4 - Fundamental principles

4.1 General requirements

  • 4.1.2 Risk Control as it relates to User Interface Design

Training of users introduced as a risk control measure

4.3 Tailoring the usability engineering effort

Changes to the usability engineering effort no longer need to be documented in the UE file

Clause5 – Usability engineering process

5.7 Establish user interface evaluation

  • 5.7.1 General

The term “user group” has been introduced

5.7.3 Summative evaluation planning

New requirements for summative usability tests have been introduced, including recording use difficulties

5.9 Performing summative evaluation

Recording of the use difficulties in the summative evaluation is mentioned

Annex A (informative) – general introduction and justification

Rationale for definition 3.11 – primary operating function

Primary operating functions do not need to be determined

Rationale for definition 3.22 – use scenario

The term “critical task” has been introduced

Graphic A.4

Relationship between IEC 62366-1 and ISO 14971 shown for the types of use

Graphic A.5

Cooperation between risk management and usability engineering

Changes to hazard-based use scenarios, risk management measures and user interface evaluation

Rationale for Clause5.7.3 – Summative evaluation planning

Use difficulties and close calls taken into account

Annex B (informative) – examples of possible hazardous situations

Table B.1

Here, the word “physical” in connection with hazards has been removed, so now theoretically subsequent psychological damage can also be included that occurs as a result of use errors.

a) Clause1: All types of hazards are included

  • According to note 1 in the first clause, hazards in general are no longer limited to physical hazards. “Direct physical hazards” has been removed from the current version of the standard, so hazards of all types are now included.
  • This is also highlighted by the change in Table B.1 in Annex B, which shows examples of possible hazardous situations. Here, the word “physical” in connection with hazards has been removed, too,so now theoretically subsequent psychological harm can also be included that occurs as a result of use errors.

b) Clause3: New terms and definitions

Clause3 of IEC 62366-1:2015 sets out terms and definitions. Here, too, there have been some updates.

Expansion of the definition of accompanying documentation

The definition of “supporting documentation” from Clause3.2 has been expanded such that it now covers materials containing information about the decommissioning and disposal in addition to those relating to the installation, use, and maintenance of a medical device.

Change to the definition of use environment conditions

  • In Clause3.20, the use environment continues to be defined as “actual conditions and setting in which users interact with the medical device”.
  • The definition of the “conditions” that make up the use environment, though, has changed. Note1 to entry clearly states that social features of the use environment such as team work vs. individual use, chaos vs. calm and the stress level play a role in this.

Focus on the individual properties of the user

  • The definition of the user profile from 3.29 has changed. The second half of the sentence relating to the user no longer links the characteristics of the user to the requirements of the job or the working conditions, but rather to attributes such as knowledge, skills, and abilities that may have an impact on design decisions (relating to the user interface (UI)).
    The properties therefore now specifically relate to the individual user.

“knowledge, skills, and abilities, which can have a bearing on design decisions”

  • The rationales on Clause 3 from Annex A that are not normative but merely informative in nature are also worth noting. Here, the changes relate to the definition of the primary operating function (3.11) and the use scenario (3.22).

Primary operating functions do not need to be determined

In the rationaleof the primary operating functions in Annex A, it is predominantly the handling of the primary operating functions that has changed. The rationale of Clause3.11 now clearly states that these do not have to be determined according to IEC 62366-1:2015. Instead, hazard-based use scenarios shall beidentified, described, and evaluated.
There are, however, exceptions to this:

  • In deviation from this, the primary operating functions must be taken into account if they are listed in other product-specific standards and are therefore relevant to the usability engineering process.
  • The determination of the primary operating functions is therefore not necessary according to IEC 62366-1:2015, but may under certain circumstances be required in connection with other standards.

Introduction of the term “critical task”

In the rationale of the use scenario (3.22) in Annex A, the term “critical task” was also introduced.

(Video) What is new in the IEC 62366-1 AMD1:2020?

This describes a task in a hazard-related use scenario in which a use error could lead to significant damage when the task is completed.

c) Clause4: New information relating to the general principles

Training of users as a risk control measure

In Clause4.1.2, which relates to risk management in connection with the design of the user interface, in addition to the existing risk management options [a) “safe design and production”, b) “protective measures”] the option “training of users” has been added in c) in addition to “information on safety”.

Point c) now says:

“Information for safety and, where appropriate, training of users“.

Change in usability engineering effort no longer in the UE file

According to Clause4.3, changes to the usability engineering effort no longer need to be documented in the user engineering (UE) file. This is not an essential requirement in the sense of the standard.

d) Clause5: Changes to the usability engineering process

There have also been some changes in Clause5 on the usability engineering process.

Introduction of the term “user group”

When creating a plan for the user interface evaluation (5.7.1 General), the terminology has changed. If usability tests are part of the plan (formative and summative evaluation), it is necessary to document which user groups are included in the test.

  • This Clauseused to state “user” and “user profile”. These have now been exchanged by “user group”, whichmust be documented accordingly. This is rather more of a formal change that will be reflected accordingly when the UE file is created.
  • There has also been a corresponding change in Clause5.7.3 e), which addresses in greater detail what needs to be taken into account when planning usability tests as part of the summative evaluation in terms ofuser groups.

New requirements for summative usability tests, including recording use difficulties

Clause 5.7.3 relates to the planning of the summative evaluation. The requirements for implementing summative usability tests have changed. The requirement is now for

(Video) Usability engineering according to IEC 62366-1

  • the representative nature of the test participants to be ensured,
  • there to be an rationale of why the user groups have been selected in this way,
  • the correct use to be defined, and
  • not just use errors to be recorded, but also use difficulties.

Use difficulties and close calls

The rationale of 5.7.3 in Annex A addresses the term “use difficulty” in greater detail.

  • Use error
    According to this, a use difficulty occurs typically only temporarily during the use of the medical device and is overcome by the user. If the use difficulty continues, this can become a use error or failure if the user is not able to complete the task as a result. Searching for a function (as a use difficulty) could represent a use error (failure) in the case of time-critical tasks.
  • Close call
    A use difficulty where a user almost commits a use error while performing a task, but is able to prevent this is sometimes called a “Close Call”.
    The formulation therefore suggests that Close Calls can also be caused by use difficulties.

Recording ofuse difficulties in the summative evaluation

Use difficulties are also more important when carrying out the summative evaluation (5.9). The results of the summative evaluation not only need to be analyzed in terms of use errors, but it is also necessary to analyze whether there were any use difficulties. This was notas explicitly mentioned in theprevious version of the standard.

Note 1 on this is also important on this, the wording of which is identical to the close call already mentioned from Annex A:

“A use difficulty where a user almost commits a use error while performing a task, but recovers in time to avoid making the use error is sometimes called a ‘close call’.“

Source: IEC 62366-1:2015+AMD1:2020

e) Changes in the explanatory graphics in Annex A

Rationale of the connection between IEC 62366-1 and ISO 14971 for the types of use

A new graphic A.4 was introduced in the informative (informative) Annex A, which explains the relationship between the “type of use” in IEC 62366-1 and the concept of “reasonably foreseeable misuse” in ISO 14971. To some extent this is an expansion of the graphic in the Clause“Terms 3.1 – abnormal use”.

The graphic introduces two updates:

  1. Firstly, a distinction is made between reasonably foreseeable and not reasonably foreseeable use. The former means the normal (intended) use and the abnormal use. Correct use, in other words error-free, and the "incorrect use" (use error) are still classified as normal use.
  2. What really is new is that use errors in normal/intended use and the so-called “abnormal use” are nowattributed to “reasonably foreseeable misuse” (from ISO 14971).

What does that mean for users of this standard?

This is a little unclear. Where is the difference to be set between abnormal use and use with errors? Does the user/manufacturer now need to predict potential abnormal use and check forin usability tests. Certainly not. The fact that abnormal use should now be reasonably foreseeable in addition to possible use errors (or maybe not foreseeable) results in a lack of clarity.

(Video) Medical Device Usability: Highlights of European Regulations and the Latest Standards

Relationship between risk management and usability engineering strengthened

Graphic A.5 has also been changed, albeit only minimally. It clarifies the processes and links between risk management and usability engineering steps. There is a new focus on mutual exchange. When identifying hazards, scenarios, and user interface (UI) features relevant to safety, it is sensible to collaborate.

  • Exchange between risk management and usability engineering
    It has been recognized that there must be increased mutual exchange of information between risk management and usability engineering and not merely one-sided communication to risk management. Arrows towards the usability process have thereforebeen added. This relates to the activities such as“identify safety-related (UI) characteristics and features” and the determination of known and foreseeable hazards and hazardous situations.
  • Risk management and summative evaluation
    A new link between assessment of the risk of hazards in risk management as an input for the determination and description of hazard-related scenarios for the summative evaluation has also been added on the usability side. The reason for this is that the assessment of risks by risk management can be important particularly when selecting scenarios (keyword: criticality).

Changes to hazard-based use scenarios, risk control measures and user interface evaluation

Also in connection with Graphic A.5, we emphasize that the hazard-related use scenarios, risk management measures and the user interface evaluation should be adapted and improved on a continuous (iterative) basis using the results of the formative evaluation.

4. Current information onendeavors to harmonizethe IEC 62366-1:2015

The most important things first:

Unfortunately, harmonization has come to a halt since quite some time. This applies both to this standard and to other standards that were already harmonized with the MDD and need to be harmonized again.

ENISO14971 should be harmonized first to pave the way for other standards on the harmonization list. The current IEC 62366-1 is closely linked to this standard. Efforts are underway for other standards such as IEC 60601. As yet, however, all harmonization efforts have failed due to continuous content-related differences with the European Commission in terms of compatibility with the requirements of the MDR – despite all of the efforts to generate formulations compatible with the MDR in additional annexes.

Unfortunately, the way forward remains unclear, although a start has been made with other standards (as of September 2021). However, the validity and applicability of IEC 62366-1 is not affected by the harmonization process.

More information is available in the updated article Harmonized standards: evidence for medical device manufacturersand in the Regulatory Radar.

(Video) SYS-048 Usability Procedure

5. Conclusion

Amendment AMD1:2020 in particular introduced numerous changes into IEC 62366-1:2015 that must be taken into account in the usability engineering process. Most of these changes provide helpful clarifications and improvements. Some, such as the changes to Graphic A.4 in Annex A, raise more questions than they answer. The process of harmonizing the usability standard, which is urgently needed, continues to be delayed.


What is IEC 62366-1 summary? ›

IEC 62366-1:2015 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY.

What is IEC 62366 usability specification? ›

The usability engineering process found in IEC 62366 consists of a series of steps to ensure that the UI of a medical device has been rigorously evaluated for user and patient safety: Define intended users, use environments, and user interface. Identify use-related hazards. Identify and categorize critical tasks.

What is IEC 62366-1 2015 Amendment 1 2020? ›

The 62366–1:2015/AMD1:2020 requires that hazard-related scenarios of use are defined, but it does not require that primary operating functions are identified.

What is abnormal use IEC 62366? ›

The FDA guidance and IEC 62366-1 agree that Abnormal Use includes intentional actions that are beyond reasonable means of risk control by the manufacturer.

Is 62366 harmonized? ›

IEC 62366:2007 is a harmonized standard, which means it is a European standard developed by one of the European standardization organizations at the request of the European Commission.

Which is the comprehensive FDA data base for Med Dev mandatory reports and many voluntary reports? ›

The MAUDE database houses MDRs submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.

How many formative usability tests are required by FDA and other regulators who enforce IEC 62366 1? ›

Formative Evaluation

Both the FDA and IEC 62366-1 require formative and summative usability evaluations. It is recommended to perform formative usability tests iteratively at different points in development with 1-2 participants per iteration, so that a total of 4-10 participants are tested.

What is the sample size for IEC 62366? ›

Calculating Sample Size

Based on this calculation, 62366-2 suggests that many usability problems can be discovered with sample sizes in the range of five to eight participants, which has been the industry standard in formative studies for many years.

What is medical device usability? ›

Usability testing enables a medical device design team to improve the usability of their device to meet acceptable standards of risk. Successful formative testing typically requires five to eight end-users, making the number of iterations flexible for the product development team.

What is a Class 1 exempt medical device? ›

Class I Medical Devices

A Class I medical device are those devices that have a low to moderate risk to the patient and/or user. Today, 47% of medical devices fall under this category and 95% of these are exempt from the regulatory process.

What does class II in FDA parlance mean for medical devices? ›

FDA classifies into class II devices for which general controls alone are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and for which there is sufficient information to establish special controls to provide such assurance.

What is the difference between abnormal use and use error? ›

There are two components to the scope of “misuse” – Use Error and Abnormal Use. Use Error refers to unintentional mistakes that can happen during use. Abnormal Use refers to intentional acts of misuse, such as not following directions, and/or using the medical device for a different off-label purpose.

Why are some medical devices required to have an IDE before performing a clinical trial? ›

An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data.

How do I become an usability engineer? ›

Today, many usability engineers have master's degrees in cognitive, experi- mental, or organizational psychology. Other common college majors include computer science, human factors engineering, information science, and human-computer interaction.

Is IEC 62366-1 2015 harmonized? ›

Well the IEC 62366-1:2015 is not yet harmonized by the European Union, however, a manufacturer may decide to apply the new standard to show compliance, e.g. when the medical device is also marketed in the US.

What is the difference between IEC 62366 and ISO 14971? ›

The IEC 62366-1 is a process standard that establishes the requirements of how usability engineering work should be conducted. In other words, it is similar to ISO 14971, only with a narrower scope that only relates to the user interface.

What is the HS code for medical devices? ›


What are the four major processes that FDA inspect as part of the QSIT approach? ›

QSR subsystems: A QSIT inspection focuses on 4 major subsystems of the Quality System that establish the basis for what FDA inspectors will review: (1) Management Controls, (2) CAPA, (3) Design Controls and (4) Production and Process Controls.

How do I know if my device is FDA approved? ›

To search for FDA-approved or FDA-cleared products by device name or company name:
  1. Go to the Devices@FDA Database.
  2. In the Enter a search term in the space below field, type the name of the device or the company name. ...
  3. Click Search.
Mar 3, 2021

Who provides data for FDA approval? ›

It is the responsibility of the company seeking to market a drug to test it and submit evidence that it is safe and effective. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the sponsor's NDA containing the data and proposed labeling.

How many test users is usually enough in a usability evaluation studies? ›

For really low-overhead projects, it's often optimal to test as few as 2 users per study. For some other projects, 8 users — or sometimes even more — might be better. For most projects, however, you should stay with the tried-and-true: 5 users per usability test.

What are the four 4 principles of usability testing? ›

1) Determine whether testers can complete tasks successfully and independently. 2) Assess their performance and mental state as they try to complete tasks, to see how well your design works. 3) See how much users enjoy using it. 4) Identify problems and their severity.

What are the 4 types of usability test questions? ›

To help guide usability testing, there are four types of usability test questions:
  • Screening questions.
  • Pre-test questions.
  • In-test questions.
  • Post-test questions.
Feb 23, 2020

What is a good sample size for an evaluation? ›

A good maximum sample size is usually around 10% of the population, as long as this does not exceed 1000. For example, in a population of 5000, 10% would be 500. In a population of 200,000, 10% would be 20,000.

How would you define usability? ›

What — Definition of Usability. Usability is a quality attribute that assesses how easy user interfaces are to use. The word "usability" also refers to methods for improving ease-of-use during the design process.

How is usability testing performed? ›

Typically, during a test, participants will try to complete typical tasks while observers watch, listen and takes notes. The goal is to identify any usability problems, collect qualitative and quantitative data and determine the participant's satisfaction with the product.

Why does usability matter for medical devices? ›

The fact is, usability testing can be an important tool that helps you effectively anticipate problems with your point-of-care diagnostic or medical device before they even occur and ultimately optimize your chances for success in the market.

What are the 3 categories of medical instruments? ›

There are 3 classes of medical devices:
  • Class I devices are low-risk devices. Examples include bandages, handheld surgical instruments, and nonelectric wheelchairs.
  • Class II devices are intermediate-risk devices. ...
  • Class III devices are high-risk devices that are very important to health or sustaining life.

Do Class 1 devices require FDA approval? ›

Class 1 medical devices are devices with low or moderate risk to patient health and safety. 47% of approved medical devices are Class 1, and 95% of these devices are exempt from the PMA pathway to regulatory approval. Class 1 device manufacturers are required to register their device with the FDA, however.

Do medical devices need FDA approval? ›

In the U.S., FDA regulates the sale of medical device products. Before a medical device can be legally sold in the U.S., the person or company that wants to sell the device must seek approval from the FDA.

What are 3 different types of applications for medical devices submitted to the FDA? ›

The most common types of premarket submissions include:
  • 510(k) (Premarket Notification)
  • PMA (Premarket Approval)
  • De Novo Classification Request.
  • HDE (Humanitarian Device Exemption)
Oct 3, 2022

Do Class 2 devices need FDA approval? ›

Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval.

What are Class 1 Class 2 and Class 3 devices? ›

FDA Medical Device Classifications

Class I: A medical device with low to moderate risk that requires general controls. Class II: A medical device with a moderate to high risk that requires special controls. Class III: A medical device with high risk that requires premarket approval.

What is use error 62366? ›

According to IEC 62366-1:2015, the definition of use error is the following: “USER action or lack of USER action while using the MEDICAL DEVICE that leads to a different result than that intended by the MANUFACTURER or expected by the USER.” Meanwhile, the FDA defines use error as a “user action or lack of action that ...

What are use errors examples? ›

An example of use error occurs when the needle used for pricking your finger uses an alternate mechanism for puncturing the skin. A situation like this could arise if a company decides to change the location of the ejecting and puncture buttons on a device.

Is use error a hazard? ›

For example, if a user withdrew the wrong volume of medication into the device (use error), the device would deliver the incorrect dose to the patient (hazardous situation), leading to harm. Notably, you might identify several hazardous situations for each use error.

What qualifies for IDE exemption? ›

Under section §812.2(c) of the IDE regulations, studies exempt from the IDE regulations include diagnostic devices if the testing: is noninvasive; does not require an invasive sampling procedure that presents significant risk; does not by design or intention introduce energy into a subject; and.

Do medical devices require informed consent? ›

1. The Food and Drug Administration (FDA) The FDA regulates medical devices and — as the name implies — pharmaceutical companies in the United States. It requires informed consent for all the subjects of all the studies leading up to a product's approval.

What is one of the three requirements that the sponsor must demonstrate in the IDE application? ›

The sponsor is required to submit:
  • Identification of the investigational site.
  • Certification of IRB approval. ...
  • Information updating the initial IDE application (if the investigation is changed)
  • A description of any modifications required by the IRB as conditions of approval.
Nov 25, 2020

What are the 3 categories of usability? ›

The three overall usability testing types include:
  • Moderated vs. unmoderated.
  • Remote vs. in person.
  • Explorative vs. comparative.
Feb 2, 2022

What are the 5 components of usability? ›

While the ISO definition has three aspects, Nielsen divides usability into five elements, so-called attributes, which can be measured and used to specify usability objectives. They are learnability, efficiency, memorability, errors and satisfaction.

What are the 5 usability principles? ›

The 5 principles of web usability. Web usability can be broken into five key principles: availability, clarity, recognition, credibility and relevance.

What are the objectives and scope of Medical Device Directive 93 42 EEC? ›

The Directive 93/42/EEC applies for the placing on the market and launching of medical devices and their accessories. Product placement on the market cannot be prevented by any EU country if a device caries a CE mark which is a confirmation that this device meets the basic requirements according to Annex 3.

What are the three components including its description in the frameworks of ISO 9241 11? ›

ISO 9241-11

There are three components in the framework: System Effectiveness to examine the users' ability to complete the given tasks, System Efficiency to examine the required user resources to complete the tasks, and System Satisfaction to record the users' opinions and feedback.

How many essential requirements are there in MDD? ›

There are 23 SPRs in the MDR, whereas there are 13 ERs in the MDD and 16 in the AIMDD. The scope and topics are consistent overall with the ERs of the Directives. However, there are a few notable exceptions.

What is difference between MDD and MDR? ›

While the MDD focused on getting a product to market, the MDR expands to consider the full product lifecycle: development, testing, manufacturing, commercialization, efficacy, safety, and long-term use. This is not to say that the MDD ignored those elements of medical device regulation and use.

How many classification rules are in the MDD? ›

MDR Device Classification Rules

The MDR will contain 22 rules for classification – four more than the previous Medical Device Directive (MDD). All of the rules are based on the potential risks associated with the device, its technical design, and how the device is manufactured. Rules 1 – 4 cover non-invasive devices.

What are the three main measures of usability in the ISO definition? ›

The original definition of usability was embodied in ISO 9241 Part 11 as a combination of effectiveness, efficiency, and satisfaction.

What are usability standards? ›

These standards define the content of the context of use, user needs, user requirements , user interaction specification, user interface specification, user report format, and field data report.

What is the ISO standard for usability? ›

The effectiveness, efficiency and satisfaction with which specified users achieve specified goals in particular environments.


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