Battery knowledge · Stationary, industrial and product standards
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.
- Also called
- ISO 13485:2016, medical device quality management
Example
Stationary, industrial and product standards: an example situation
A cell-level test does not establish fire performance or commissioning requirements for a complete installation.
Read ISO 13485 alongside IEC 60601-1 in this context. 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.
Use in Lemonergy
Match scope to product and installation.
This is a reference concept. No executable Lemonergy block has been verified for this term.
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.
- 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.
- Energy Storage System Testing and Certification
UL Solutions
Topic background · System safety scope of UL 9540 and relationships to battery and power-conversion standards.