Medical device batteries

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IEC 60601-1

The general safety standard for medical electrical equipment, adopted in the US as ANSI/AAMI ES60601-1. It treats the battery as part of the device: clause 15.4.3 covers battery housings and venting, connection, protection against overcharge and excessive current, and requires lithium batteries to meet IEC 62133 or, for primaries, IEC 60086-4.

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.

Lithium–iodine cell

A 2.8 V solid-state primary cell in which a lithium anode meets an iodine–polymer cathode, and the lithium iodide that forms between them is both electrolyte and separator. It supplies only microamperes, but nothing gasses, so it can be sealed hermetically and last a decade or more; it has powered most cardiac pacemakers since the 1970s.

Lithium–silver vanadium oxide cell

The primary cell inside most implantable cardioverter-defibrillators: a lithium anode against silver vanadium oxide, Ag₂V₄O₁₁, in a liquid electrolyte. It idles for years at microamperes, then delivers pulses of one to three amperes for seconds to charge the shock capacitor, and its sloping discharge curve lets the device predict replacement. Newer designs blend in CFx for energy.

Traceability

Recording for each cell which material lots, machines and process conditions produced it, so a field failure can be traced to a batch and a recall limited to it. The EU battery passport extends this record to the cell’s whole 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. DOE/EPRI 2013 Electricity Storage Handbook in Collaboration with NRECA

   Sandia National Laboratories · 2013

   Topic background · Storage technologies and grid services. The publisher notes that its historical cost and deployment figures are outdated.