Battery Safety Testing for Medical Devices
Battery Safety Testing to the Requirements of IEC 62133
Ensure your device reaches its full potential throughout global markets with the expertise and support of a testing lab that has more than 50 years of involvement in both the medical device and energy storage industries. We can help you select the right battery for your device and provide testing to safety, performance and transportation standards, including IEC 62133.
- Devices with rechargeable batteries – including products certified to IEC 60601-1 – must comply with IEC 62133
- Devices with non-rechargeable lithium batteries must comply to IEC 60086-4
- Devices sold exclusively in North America may use UL 1642/2054, though this will limit your ability to sell your product internationally
It is important to note that lithium batteries have been identified as a Class 9 dangerous good, during transport. To be safely transported (by air, sea, rail or roadways), they must meet the provisions laid out in Standard UN 38.3.
*The Intertek legal entities that provide medical device management system certification services (including ISO 13485 and MDSAP) and Notified Body services (MDR 2017/745 and MDD 93/42/EEC) do not provide any consulting services. Clients who have used other Intertek legal entities’ consulting services are not eligible to receive management system certification services or Notified Body services from Intertek.