Making Sense of Regulations for Medical Device Batteries
Today’s medical devices are more sophisticated than ever, contributing to early diagnosis of diseases and more efficient delivery of treatment to help people live longer, healthier lives. Battery-powered medical devices in particular, such as automatic external defibrillators, surgical power tools, pacemakers, robotic cameras, insulin pumps, and glucose monitors are among the many technological advancements redefining 21st century healthcare. They perform life-saving and life-sustaining functions and offer a level of convenience as they can be used inside and outside of healthcare facilities.
As MedTech innovation ramps up, manufacturers need to remain up-to-speed on the various requirements for medical device batteries, including those related to performance, safety, and transportation.
Referred to as the “bible” of medical electrical equipment standards, ANSI/AAMI ES 60601-1 outlines the general requirements for basic safety and essential performance of medical devices that require an electrical outlet or a battery. The standard includes a risk management model, a concept for essential performance to help measure a device’s effect on user and patient safety, and methods for manufacturers to demonstrate equivalent safety or alternate means of compliance.
Clause 126.96.36.199 in the standard requires lithium batteries to comply with IEC 60086-4, Primary Batteries – Part 4: Safety of Lithium Batteries or IEC 62133, Secondary Cells and Batteries Containing Alkaline or Other Non-acid Electrolytes. The former outlines tests and requirements for primary lithium batteries to help ensure their safe operation under intended use and reasonably foreseeable misuse. The latter specifies requirements and tests for the safe operation of portable sealed secondary lithium cells and batteries containing non-acid electrolyte under intended use and reasonably foreseeable misuse.
Lithium based batteries can be dangerous to transport given their high energy density and flammable electrolyte. These batteries are regulated by various transportation agencies such as the International Civil Aviation Organization (ICAO), International Air Transport Association (IATA), International Maritime Organization (IMO), and the United States Department of Transportation (DOT). They all require testing to UN 38.3 to help ensure safe shipping.
UN 38.3 requirements include eight tests, with the first five needing to be performed in sequential order using the same samples:
- Altitude simulation
- Thermal test
- External short circuit
- Impact/crush (primary and secondary cells only)
- Overcharge (secondary batteries only)
- Forced discharge (primary and secondary cells only)
The latest edition features some significant changes. For instance, the minimum peak acceleration level for shock testing of large batteries has been reduced, with the shock pulse now based on constant energy rather than constant acceleration. In addition, short circuit test temperature conditions to allow for testing inside or outside of a temperature chamber or oven have now been clarified; samples may be preconditioned and then tested at ambient temperatures. For battery assemblies with capacities greater than 6,200 Watt-hours, testing or engineering demonstration requirements are added to address overcharge, short circuit and over-discharge between batteries within an assembly.
Battery Requirements from the FDA
Many medical products, including battery-powered medical devices, are regulated by the Federal Drug Administration (FDA). Before these products can enter the U.S. market, manufacturers must demonstrate in their submissions that their product complies with the applicable consensus standards the FDA has recognized, such as:
- IEC 62133, Secondary Cells and Batteries Containing Alkaline or Other Non-acid Electrolytes
- IEC 60086-4, Primary Batteries – Part 4: Safety of Lithium Batteries
- IEC 60086-5, Primary Batteries – Part 5: Safety of Batteries with Aqueous Electrolyte
- IEC 62485-X, Safety Requirements for Secondary Batteries and Battery Installations
- UL 1642, Lithium batteries
- UL 2054, Household and Commercial Batteries
In addition to battery specific standards, there are standards that include battery requirements in the dental, ophthalmic, and physical medicine fields. These currently include, but are not limited to:
- ISO 20127, Dentistry – Powered Toothbrushes – General Requirements and Test Methods
- ISO 15004-1, Ophthalmic Instruments – Fundamental Requirements and Test Methods – Part 1: General Requirements Applicable to all Ophthalmic Instruments
- ISO 7176-25, Wheelchairs – Part 25: Batteries and Chargers for Powered Wheelchairs.
Requirements from the FAA
The Federal Aviation Administration (FAA) regulates products operated on airplanes. Automatic External Defibrillators (AED), for example, are required to meet TSO-C142a which requires testing to RTCA DO-227, Minimum Operational Performance Standards for Non-Rechargeable Lithium Batteries. The standard outlines the requirements, tests, and evaluation criteria to help ensure that products powered by non-rechargeable lithium batteries operate safely under conditions encountered in routine aviation operations. RTCA DO-227 also provides guidance on design, safety, handling, and storage.
How CSA Group Can Help
Built on nearly a century of public trust and exceptional customer service, we can help you earn your customer’s trust and demonstrate safety across the value chain through our comprehensive testing & certification services. As a leader in standards development and performance & safety testing of battery and energy storage systems in North America, we can help improve your product’s speed to global markets by leveraging our IECEE CB Scheme accreditation and CSA Group’s international certification team to help you comply with international regulations. We can also provide assistance in meeting United Nations (UN) requirements for battery transportation as detailed in UN 38.3.
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