Glossary · ISO and IEC standards for MedTech and pharma
IEC 60601-1
Also known as: IEC 60601-1 edition 3.2, EN 60601-1, IEC 60601-1:2005+A1:2012+A2:2020, Medical electrical equipment general standard
IEC 60601-1 is the international standard for the basic safety and essential performance of medical electrical equipment and medical electrical systems. It is the general standard of the IEC 60601 family and is complemented by collateral standards (IEC 60601-1-x) and particular standards (IEC 60601-2-x).
- Standards
- MDR
In one sentence
IEC 60601-1 sets general requirements for basic safety and essential performance of medical electrical equipment, with collateral and particular standards.
Example
A manufacturer of a patient monitor tests electrical insulation and leakage currents to IEC 60601-1, EMC to IEC 60601-1-2 and alarm behavior to IEC 60601-1-8, and applies the particular standards for the monitored parameters.
How it applies
- Scope: Medical electrical (ME) equipment and ME systems, covering hazards such as electric shock, mechanical hazards, radiation, temperature, fire and hazardous outputs. The current consolidated version is edition 3.2 (2020).
- Family: Collateral standards cover cross-cutting topics, for example electromagnetic compatibility (IEC 60601-1-2), usability (IEC 60601-1-6, which refers to IEC 62366-1) and alarm systems (IEC 60601-1-8). Particular standards for specific equipment types take precedence over the general standard where they modify it.
- Risk management: Many requirements refer to the manufacturer's ISO 14971 process, for example to decide what is essential performance and which tests apply. Programmable systems refer to IEC 62304.
- Test reports: Conformity is usually shown with a test report from a test laboratory, often in the IECEE CB scheme format. A report shows conformity with the tested clauses, not with the MDR as a whole.
- Technical documentation: The standard sets requirements for markings and accompanying documents, including instructions for use and a technical description. These feed the labeling and IFU; the test report and the risk management file go into the technical documentation.
Basic safety vs. essential performance
Basic safety is freedom from unacceptable risk directly caused by physical hazards when the equipment is used normally or under a single fault condition. Essential performance is the clinical function whose loss or degradation beyond the limits the manufacturer specifies would result in unacceptable risk, such as the accuracy of a delivered dose. The manufacturer defines essential performance through risk management; it is not the same as all functions listed in the specification.