I frequently read articles that cite IEC 60601-1-2 as the sole EMC requirement for medical devices. However, anyone who believes that IEC 60601-1-2 covers all EMC requirements for medical devices may be overlooking something. Here's why.
When is IEC 60601-1-2 truly sufficient for your medical device?
For medical devices that must comply with IEC 60601-1, IEC 60601-1-2 is the supplementary standard for electromagnetic compatibility. This means that if the requirements of IEC 60601-1-2 are met, approval according to IEC 60601-1 can be obtained.
Why IEC 60601-1-2 is not sufficient for devices with Bluetooth, WLAN & Co.
Does your device contain wireless technologies such as Bluetooth or Wi-Fi? Then additional legal requirements apply. Similar to RoHS or REACH for materials, regulations also apply to wireless equipment. IEC 60601-1-2 alone is not sufficient to meet the legal requirements.
As soon as a device contains radio technology, it is considered a radio installation – and therefore further regulations apply. The relevant regulation is EU Directive 2014/53/EU (RED), implemented in Germany through the Radio Installations Act (FuAG).
Overview of EMC and radio requirements: IEC 60601-1-2, RED & other guidelines
- IEC 60601-1-2 → EMC for non-radio medical devices
- RED (2014/53/EU) → EMC + radio requirements for devices with radio technologies
- Other guidelines: RoHS, REACH, etc.
These legal regulations apply not only to medical devices but to all devices using wireless technologies. And although medical devices already have to meet strict requirements, even stricter limits or additional testing levels may be necessary here. The exact values depend on the specific device and its application.
EMC in practice: Which standards you really need to consider for approval
First, check which EMC requirements apply to your device. If it contains wireless technologies such as Bluetooth or WLAN, you must also consider the relevant ETSI standards (e.g., ETSI EN 301 489-1) in addition to IEC 60601-1-2.
In practice, we document all relevant requirements – including the RED – in the EMC test plan to ensure complete and safe approval.
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