In June 2020, the IEC 62366-1 standard underwent some updates. The video below will go over the main changes between the new and old versions of the standard.

The video is an excerpt from the online course Introduction to Usability Engineering and IEC 62366-1. If you would like to know more about usability engineering, please take a look at the full course structure.

Let us look at the eight most important changes in the 1:2020 standard in order of importance.

1. The standard references the new risk management standard

One change to be aware of is that the standard now refers to the new version of the risk management standard instead of the old one. Therefore, some minor adjustments are related to changes that originally come from the risk management standard.

And one of the standard’s most often cited adjustments is the change in version number of the 14971 standard.

2. The definition of environment of use

Another important adjustment concerns the definition of the environment of use. In the original standard, the examples mentioned for the environment of use mainly concerned:

  • Location
  • Lighting
  • Noise
  • Temperature
  • Hygienic requirements
  • Frequency of use

One could say its sole focus was on the physical aspects of the environment.


Soft aspects are included in the definition

The 2020 amendment brings social factors into the environment of use, too. For example:

  • Is it a team or an individual?
  • Is the environment chaotic or calm?
  • What about the stress level and the shift duration?

These soft aspects have previously been included in non-medical device usability standards. It is a step in the right direction to think about these soft factors in medical settings as well.

3. Hazard-related scenarios of use

Another relevant change concerns the selection of hazard-related scenarios of use for the summative evaluation.

In addition to the two approaches in the 2015 version of the standard, the amendment introduces a third way of selecting relevant hazard-related scenarios of use to include in the summative evaluation.


The difference between the 2015 and 2020 versions

In the 2015 version of the standard, the manufacturer was either set to select all hazard-related scenarios of use or choose a subset of hazard-related scenarios of use based on the severity of the potential harm that usage errors could cause.

The 2020 version includes a third possibility, which is to select a subset of the hazard-related scenarios of use based on the severity of the potential harm and other circumstances specific to the medical device and manufacturer.

This leaves a lot more room for discussion. If one decides to go with the last version, it is recommended to provide a very good rationale for why those hazard-related scenarios of use were selected. This ensures that the discussion points follow the desired direction.

4. Changes in what you need for a usability test

Another big change concerns summative evaluation planning. Summative evaluation planning means that one decides and documents what and how the summative evaluation of a medical device will be performed.


Additional information is now required

A usability test is a method of exploring or evaluating a user interface with the intended users in a, mostly simulated, environment of use.

For this, two things are needed:

1. The test environment and conditions of use, and a reason that explains why they adequately represent the actual conditions of use.

2. The data collection method and subsequent analysis method for the observed errors of use.

With the updated standard, an additional four pieces of information are required:

1. Explain how the characteristics of the test participants represent the intended user profiles.

2. Justify how the test participants are grouped into distinct user groups that determine the number of test participants. This was a huge problem with the 2015 version of the standard as group users were put together as closely as possible to have a smaller number of participants.

3. To understand the test results, one has to define the correct use for each hazard-related scenario of use.

4. One has to outline the data collection method for the subsequent analyses of observed errors of use and user difficulties. It now goes beyond errors, and also includes identifying participant struggle areas. Once again – a step in the right direction to support good usability.

5. Analysis of errors

And this directly leads to the next adjustment concerning the analysis of errors. The 2015 version of the standard required an analysis of all errors of use. If the analysis showed results of a potentially hazardous situation, the root causes of those errors had to be analysed too.


Root cause as a source of an error of use

“Root cause” is the source of an error of use that needs to be eliminated to prevent the error from recurring in the future. Again, in the 2015 version of the standard, only errors of use needed to be considered in the analysis of errors and root causes.

This also goes for user difficulties in the new version of the standard. Remember: A user difficulty is a situation where the user struggles but does not make an actual error of use.


Close calls as a source of an error of use

To make the alignment with the FDA easier, the standard now includes a reference to the so-called “close calls”.

A close call is similar to a user difficulty but could also be an error of use that the user solves without help.

6. Clarification on primary operating functions

One thing that led to a lot of confusion between the original standard from 2007 and the one from 2015 was the term “primary operating functions”.

A primary operating function is a function that is directly related to the safety of the medical device. An example of this could be an alarm on a monitoring device.

The 2007 version of the standard required the identification of primary operating functions. The new version of the standard still refers to this term but does not clarify if primary operating functions have to be identified or not. As a result, many usability engineers were unsure of what to do.


Changes in the 2020 version of the standard

And that’s where the 2020 version comes into play! The 2020 version of the standard says that primary operating functions need to be defined in product-specific medical device safety standards and requires them to be used as an input to the usability engineering process.

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. Yet, other standards might require this. And if there is not a product-specific standard with primary operating functions for your type of product, then it has no primary operating functions.

7. Interaction between risk management and usability engineering

One thing that seems minor but is relevant is the change to the flowchart displaying the interaction between risk management and usability engineering.

What is new in the IEC 62366-1 AMD1 2020

For the first time, the flowchart considers the exchange between risk management and usability engineering in both directions. It also considers that the identified risks have an impact on the hazard-related scenarios of use that have not been depicted before.

Why should a usability engineer do that alone when the team responsible for risk management knows the criteria for the device’s risk acceptability best?

8. Additional user interface specification requirements

The last important update is in the user interface specification. This is a collection of design requirements that are specific to the medical device and describe technical characteristics of its user interface. This could be the shape or size of a button or the colour of a specific part.

In the 2015 version, it was only required that a user interface specification was established and maintained and includes detailed and testable design requirements for the user interface. These are related to the hazard-related scenarios of use and the errors of use as well as the user guide specification.

This remains in the 2020 version, but it additionally requires observed errors of use to be included in the user interface specification, instead of just considering them for the requirements.

This involves extra work, but it ensures the understanding of how error and requirement corelate.

These were the most important changes in the latest version of the IEC 62366-1 standard. If you would like to read more articles related to medical device development and usability engineering, take a look at our other published articles.

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Michaela Kauer Franz

Michaela Kauer-Franz

Dr. Michaela Kauer-Franz is a highly esteemed trainer, consultant, and entrepreneur in the medical device industry. She has vast hands-on experience, having developed, amongst other things, monitoring devices for ICU and NICUs, diabetes care products, and women’s health products.

Michaela Kauer-Franz has received numerous awards including the Red Dot Winner Interface Design Award and being nominated for the UX Design Award. She is a lecturer for the design of medical and critical user interfaces at the Technische Universität Darmstadt and part of the national standardization committees in Germany for Usability and User Experience.