The newest version of the IEC 60601-1 3rd edition (version 3.2) was recognized by the FDA in August 2020. On December 17, 2023, it will go into effect, which will impact all medical devices in production that are covered by the standard. With this latest publication, dozens of items were added or modified that were seen as too urgent to wait until the publication of Version 4.
The most notable changes in the IEC 60601-1 3.2 standard were in:
- Clause 2 (Normative References)
- Clause 3 (Terminology and Definitions)
- Clause 7 (Identification and Marking)
- Clause 8 (Protection Against Electrical Hazards)
- Clause 11 (Protection Against Excessive Temperatures and Other Hazards)
- Clause 13 (Hazardous Situations and Fault Conditions)
- Clause 14 (Programmable Electrical Medical Systems (PEMS).
This blog will cover the changes made to Clause 3.
What is the importance of IEC 60601-1 3.2 Clause 3?
Clause 3 covers the terminology and definitions that should be applied throughout the standard, so when a term is used or introduced, there is an expectation of how it should be understood.
The clause also makes connections to other standards and documents. By doing so, it creates a cohesive world of understanding between the standards instead of having slight variations or adding confusion with differing definitions.
Clause 3 – Terminology and Definitions Changes / Additions in 60601-1 3.2
Definitions referenced from ISO 14971:2019
Some of the definitions in Clause 3 reference ISO standard 14971:2019. This standard applies to risk management regarding medical devices, involving the terminology, process, and principles used with them, and includes in vitro diagnostic medical devices and software as a medical device in the categorization of medical devices. The process outlined in the document is meant to help manufacturers uncover potential hazards and risks in order to assess and control for risks, plus evaluate the controls used. Many of the definitions used in ISO 14971:2019 regarding hazards and risks are cited in Clause 3. The new references reflect the update to the standard. The previous version, ISO 14971:2007, has been withdrawn and replaced.
The definitions linked to ISO 14971:2019 include:
- Harm, hazard, and hazardous situations: The definition of “harm” was also expanded in Amendment 2 to include “or animals.” Note 1 on “hazardous situations” was also deleted.
- Objective evidence, procedure, process, and record: Note 1 was deleted on “procedure.” The rest were updated to reference the 2019 standard.
- Residual risk, risk analysis, risk assessment, risk control, risk evaluation, and severity: These were updated to reference ISO 14971:2019.
- Risk management and risk management file: Both definitions came with added notes in Amendment 2. For “risk management,” the note points out that the definition used in 60601-1 3.2 doesn’t “include planning for or monitoring of production and post-production information,” which is something that would be required under ISO 14971 compliance. A note has been added under “risk management file” about information that should be considered part of the file, including calculations and test results collected by the manufacturer – anything that’s safety-related should be included.
- Intended use vs. normal use: Note 2 has been added to the definition in Amendment 2 to make it clear that “intended use” holds a separate meaning from “normal use.” The intended use of a device involves what medical purpose the device serves, whereas normal use includes actions that aren’t part of the medical use, including maintenance and transportation.
- Manufacturer: The definition for “manufacturer” has been cited from ISO 14971:2019 with some adaptations to the notes. Some of the intricacies of the definition have been outlined in our Version 3.1 versus 3.2 blog.
- Verification: Notes were added to the definition of “verification” to better explain what objective evidence would be necessary to verify. The notes also mentioned that “qualification process” is another term that could be used for activities of verification, and that “verified” would be the label given to the process outcome.
Definitions referenced from IEC 62366-1:2015
The IEC standard 62366-1:2015 covers the usability engineering process for manufacturers of medical devices. This process regards the safety in usability of a medical device and covers how manufacturers can specify, analyze, evaluate, and develop the process for their devices.
Definitions referenced from the standard include:
- Usability: Amendment 2 has reworded the definition of usability, replacing the word “user” with “operator.”
- Usability engineering / human factors engineering: This definition has also been reworded slightly, with “medical devices” being replaced by “ME equipment” for a more specific scope.
- Usability engineering file: The update in Amendment 2 included the reference to the standard’s definition in brackets.
Introduction of new terminology and definitions
Definitions 3.148 – 3.154 were introduced in IEC 60601-1 3.2 and reference the following standards:
- Electromagnetic disturbance (IEC 60601-1-2:2014)
- High priority (modified from IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD2:2020)
- Information signal (IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD2:2020)
- Low priority (modified from IEC 60601-1-8:2006/AMD2:2020)
- Maximum equipment pressure: The following definition is original to the standard – “The maximum gauge pressure to which a part of ME EQUIPMENT can be subjected in NORMAL CONDITION and SINGLE FAULT CONDITION”
- Medium priority (modified from IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD2:2020)
- Safety sign (modified from ISO 7010:2019 – adds “general” to “gives a general or particular safety message”)
Updates to Clause 7
In addition to the revisions and additions in Clause 3, Clause 7 offers guidance for colors and meanings for indicator lights and alarm indicators that should be used on ME equipment. Table 2 provides information on names of certain lights, what color they should be to indicate different states, when they should be on or off, and whether they should be accompanied by a sound.
For example, a non-flashing, red “Warning” light should be used to help avoid a hazardous situation that could cause serious injury or death. For situations that could result in minor or moderate injury or equipment damage, a solid yellow “Caution” light should be used.
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