IEC 60601-1

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IEC 60086

The IEC series for primary batteries. Part 1 sets the electrochemical system letters, designations and test conditions; part 2, split in 2026 into parts 2-1 and 2-2, the dimensions and performance of each standard size; part 3 watch batteries; part 4 the safety of lithium primaries; part 5 the safety of aqueous ones. Medical and equipment standards cite part 4.

IEC 62133

The safety standard for portable sealed cells and batteries, part 2 covering lithium systems. Passing it is a basic requirement for consumer products, and it is often the first safety certification a new cell obtains.

ISO 13485

The quality-management standard for designing and making medical devices, current edition 2016. Built on ISO 9001 but stricter on risk management, design control, supplier control and traceability of every component and lot, it is what battery-pack makers supplying medical manufacturers are expected to hold; the US FDA’s quality rule has incorporated it since 2026.

Medical device batteries

Batteries for devices from infusion pumps and portable monitors to pacemakers. External equipment uses rechargeable packs tested to IEC 62133 and approved as part of the device under IEC 60601-1, built under ISO 13485 with full traceability; implants use hermetic primary cells such as lithium–iodine and lithium–silver vanadium oxide, chosen for years of predictable life.

References & further reading

Further reading on this topic

These sources provide broader context; they are not presented as citations for every statement in this entry.

1. IEC 62619:2022 — Safety requirements for secondary lithium cells and batteries, for use in industrial applications

   International Electrotechnical Commission · 2022

   Topic background · Industrial and stationary lithium-battery safety scope; excludes road vehicles where their dedicated standard applies.

2. Energy Storage System Testing and Certification

   UL Solutions

   Topic background · System safety scope of UL 9540 and relationships to battery and power-conversion standards.