Updates to IEC Standard 60601-1 3.2: Normative References
Here’s what you need to know about normative reference changes in Version 3.2 of IEC 60601-1
IEC 60601-1 Version 3.2 was recognized by the FDA in August 2020. Now that it’s been recognized, it will fully go into effect in the United States on December 17, 2023. With Amendment 2 came dozens of items that were added or modified. These items were seen as too urgent to wait for a Version 4 publication.
Most of the major changes to the 60601-1 standard came 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 the normative references outlined in Clause 2.
What are normative references in IEC standards?
In order to understand the latest version of the IEC standard, it’s necessary to reference all the other documents listed in this clause. They are considered “indispensable” when it comes to interpreting IEC 60601-1 3.2.
This newest version of the standard also includes a callout in Clause 2 about how any collateral standards that are published after Amendment 2 has come out should also apply to the standard. We should consider them as added to the list. Some of the normative references mentioned here have been updated since Version 3.2 was published.
Clause 2 – Normative References Changes
10 normative references have been introduced or altered from 3.1 to 3.2. Four references made in previous versions now have updated standard dates mentioned in this current publication.
This standard is mostly concerned with the safety and performance of medical electrical (ME) equipment and ME systems in the face of electromagnetic disturbances, both around the equipment and systems and emitted by them.
To ensure that basic safety and essential performance standards are met, this standard includes general tests & requirements that can be used to test ME equipment and ME systems. There were 9 basic substantive changes made in the 2020 version of this standard, including specification of immunity tests and test levels for several different scenarios and equipment configurations, plus how to identify whether immunity passed or failed.
While Version 3.2 references Amendment 1, there has since been a new amendment published in 2021.
This collateral standard is about diagnostic X-ray equipment, specifically, how to protect against unnecessary radiation levels for the patient, operators, staff, and the general public. While protection is important, it shouldn’t eclipse the benefit needed from the radiological procedure. The radiation protection guidelines mentioned in the standard only apply to X-radiation.
While particular equipment requirements were present in previous versions, they have been removed and will instead be covered in standards that should be used for specific types of equipment.
Usability is covered in this standard. Manufacturers are given a process to follow for analysis, specification, design, verification, and validation of usability for ME equipment and the basic safety and essential performance of devices. The standard covers how to assess or mitigate risks caused by usability problems that happen when the ME equipment is used correctly or in error – both identified as normal use. What isn’t covered is the process for abnormal use of equipment.
This standard is all about alarm systems and the requirements and tests to ensure that alarms are meeting safety and performance requirements. The guidelines include when alarm systems should be applied, alarm categories organized by urgency, as well as how alarm signals and control states should be marked and implemented for consistency across ME devices.
Updated from the 2007 version that was originally referenced in Clause 2, this standard is about optoelectronic devices, or photocouplers. It addresses photocoupler measuring methods, terminology, characteristics, safety tests, and essential ratings.
Four big updates were made in the most recent version, including some editorial corrections, a new alternative surge pulse Maximum surge isolation voltage (VIOSM) test method, and a data sheet for basic insulation rating that corresponds with the IEC standard 60664-1:2007, 126.96.36.199.
The safety and general requirements for information technology equipment, either mains-powered or battery-powered, are covered by this standard as long as their rated voltage is at or below 600 volts. The standard also applies to components and subassemblies that are incorporated into the equipment, but they aren’t expected to meet all aspects of the standard as long as the equipment in its complete form does.
The reference in Version 3.2 was to IEC 62133-2; however, since then, a new amendment was added in 2021 to this standard, which addresses safety requirements for portable sealed secondary lithium cells and batteries that have a non-acid electrolyte. These requirements and tests apply both in intended use conditions, as well as misuse that is “reasonably foreseeable.”
Significant technical changes have come with Amendment 1, including moving language for nickel systems into its own part (Part 1), coin cell requirements, mechanical tests for vibration and shock, and an update for assembling of cells into batteries, plus an addition to the bibliography for IEC TR 62914.
The life cycle requirements for medical device software are covered by this standard. Guidance includes how medical device software should be developed and maintained in two scenarios – when the software is a medical device, or when the software is embedded into a finalized medical device. Validation and final release are not addressed in the standard, even if the medical device is all software.
In Version 3.2 IEC 60950-1 is removed and replaced with IEC 62368-1:2018. This is a “hazard-based” standard that applies to electronic and equipment safety of all audio, video, information, and communication technology devices. It also acknowledges that the lines between Information and Communications Technology (ICT) and traditional AV guidelines are blurring. Devices that are covered by this standard wouldn’t exceed 600 volts. Safeguards against classified energy sources are outlined, as well as when to apply the safeguards.
The database for ISO 7000 includes graphical symbols that can be placed on equipment to help whoever’s using it understand more about its operation. Information on functions of symbols, how they’re intended to be used, other related symbols, and graphical representations of the symbols are contained in the standard, as well as reference numbers and titles. ISO 7000 is easily searchable to make it easier for manufacturers to find and use the symbols they need.
Revised dates to normative standards
Four standards have also been updated in Version 3.2. The new dates that are applicable to 60101-1 3.2 are in bold:
- IEC 60825-1:2014, Safety of laser products – Part 1: Equipment classification and requirements
- ISO 7010:2019, Graphical symbols – Safety colors and safety signs – Registered safety signs
- ISO 14971:2019, Medical devices – Application of risk management to medical devices
- ISO 15223-1:2016, Medical devices – Symbols to be used with medical device labels, labeling and information to be supplied – Part 1: General requirements
To learn more about this latest standard, visit our other blogs about IEC 60601-1 3.2:
- What the FDA Moving to IEC 60601-1 3.2 Means for Manufacturers
- Differences Between 3.1 and 3.2 Certification for IEC 60601-1
- Harmonized Standards for Medical Devices and IEC 60601-1 3.2