General, collateral and particular standards explained
IEC 60601-1 (general) · 60601-1-x (collaterals) · 60601-2-x (particulars)
The short answer
The 60601 family has three layers. The general standard (60601-1) applies to essentially all ME equipment. Collateral standards (60601-1-x) supplement or modify it for cross-cutting topics such as EMC or usability. Particular standards (60601-2-x) supplement or modify both for a specific device type. Where a particular standard exists, the general standard must not be applied alone.
The three layers
| Layer | What it covers | Examples |
|---|---|---|
| General standard — 60601-1 | Basic safety + essential performance for (nearly) all ME equipment | IEC 60601-1 (3rd ed. + A1 + A2) |
| Collateral standards — 60601-1-x | Cross-cutting topics that supplement/modify the general standard across all device types | -1-2 EMC · -1-6 usability · -1-8 alarm systems · -1-11 home environment · -1-12 EMS |
| Particular standards — 60601-2-x | Device-specific requirements that supplement/modify both general and collaterals | -2-4 defibrillators · -2-24 infusion pumps · -2-25 ECG · -2-2 HF surgical equipment |
The one rule that matters
Where a particular standard (60601-2-x) exists for your device type, you must apply it together with the general standard — the general standard alone is not enough. The particular standard may tighten, relax or replace individual requirements of the general standard.
Common misconception
A collateral standard is not a "version" of 60601-1. 60601-1-2 (EMC) and 60601-1-6 (usability) are standalone standards applied together with the general standard — not instead of it. Treat them as additional, parallel requirement sets.
How to determine your applicable standards
- Start with the general standard 60601-1.
- Check which collaterals (60601-1-x) are relevant to your device (at minimum EMC, often usability).
- Check whether a particular standard (60601-2-x) exists for your device type — if so, it is mandatory to add it.
- Document the list of applicable standards with rationale — test labs and notified bodies expect this overview.
Frequently asked questions
What is the difference between a collateral and a particular standard?
A collateral (-1-x) addresses a cross-cutting topic across all device types (e.g. EMC). A particular (-2-x) addresses a single device type (e.g. infusion pumps) and can adapt the general and collateral standards for that device.
Do I have to apply all collateral standards?
No — only those relevant to your device. EMC (-1-2) is almost always relevant; usability (-1-6) applies to devices with an operator interface; the home environment (-1-11) only if the device is used outside professional facilities.