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Short answer: IEC 61010-1 is the general safety standard for electrical equipment for measurement, control and laboratory use. It aims to reduce hazards to the operator and the surrounding area to a tolerable level, and it excludes equipment within the scope of IEC 60601, the medical electrical equipment standard. The consolidated edition is 3.1 (2010 plus Amendment 1 of 2016).
General information about a standard, not medical, regulatory or purchasing advice. Whether a given instrument meets the standard is a question for its manufacturer’s documentation.
Definition and scope
The IEC webstore lists the title as “Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements.” In the text of Edition 3.0 (2010), clause 1.1.1 names three groups of equipment that fall inside the scope:
- electrical test and measurement equipment, including signal generators, measurement standards, power supplies for laboratory use, transducers and transmitters;
- electrical industrial process-control equipment;
- electrical laboratory equipment, defined as equipment that “measures, indicates, monitors, inspects or analyses materials, or is used to prepare materials, and includes in vitro diagnostic (IVD) equipment.”
The same clause adds that such equipment may be used outside laboratories; the example it gives is self-test IVD equipment to be used in the home. The standard is also described in its foreword as a group safety publication under IEC Guide 104.
What it covers: seven hazard classes
Clause 1.2.1 states the object of the standard: to ensure that hazards to the operator and the surrounding area are reduced to a tolerable level. Clauses 6 to 13 of Edition 3.0 organise the requirements by hazard, and Clause 16 (misuse and ergonomics) and Clause 17 (risk assessment) sit alongside them. Verification is by inspection, type tests, routine tests and risk assessment (clause 1.3), and clause 4.4 requires testing in single fault condition.
| Hazard class | Clause (Edition 3.0, 2010) |
|---|---|
| Electric shock or burn | 6 |
| Mechanical hazards | 7 and 8 |
| Spread of fire | 9 |
| Excessive temperature | 10 |
| Fluids and fluid pressure | 11 |
| Radiation, including lasers, sonic and ultrasonic pressure | 12 |
| Liberated gases, explosion and implosion | 13 |
Clause numbers are those of Edition 3.0; check the edition in your hands before citing a clause.
What the standard does not cover
Clause 1.2.2 lists what is outside its object: reliable function or performance that is not related to safety, the effectiveness of transport packaging, electromagnetic compatibility (the IEC 61326 series), and equipment for explosive atmospheres (the IEC 60079 series). A compliant instrument can therefore still need separate evidence of accuracy or EMC behaviour.
IEC 61010 vs IEC 60601
The exclusion is written into the scope. Clause 1.1.2 says IEC 61010-1 does not apply to equipment that falls within the scope of a list of other standards, and IEC 60601 (medical electrical equipment) is one of them. The Johner Institute, a medical-device consultancy, puts the practical dividing line at patient contact: devices with an applied part are covered by the IEC 60601-1 series, while IEC 61010-1 assumes that only healthy users come into contact with the device. Its examples:
| Device (Johner Institute example) | General safety standard it names |
|---|---|
| PCR test device | IEC 61010-1 |
| Laboratory blood glucose meter | IEC 61010-1 |
| Pipetting system, external blood gas analyzer | IEC 61010-1 |
| ECG machine (electrodes) | IEC 60601-1 |
| Respirator | IEC 60601-1 |
| Self-testing glucose meter (lancet) | IEC 60601-1, plus ISO 15197 |
The pattern in that table is that the same measurand can land in either standard depending on who touches the device and how. For the 60601 side, see IEC 60601-1 and the medical electrical equipment standard.
Editions and the Part 2 standards
Per the IEC webstore, the current consolidated version is IEC 61010-1:2010+AMD1:2016 CSV, Edition 3.1 (666 pages, publication date listed as 2017-01-10, stability date listed as 2026). It combines the 2010 edition, Amendment 1 (2016) and later corrigenda and an interpretation sheet. The third edition replaced the second (2001) as a technical revision. The webstore lists these changes:
- scope broadened to professional and non-professional products in any location;
- testing and measuring-circuit requirements moved to IEC 61010-2-030;
- insulation requirements (6.7) rewritten;
- mechanical hazard requirements (Clause 7) added;
- changes to radiation (Clause 12), a new clause on misuse and ergonomics (Clause 16) and a new Clause 17 for hazards not otherwise covered;
- new informative annexes E, H, I and J.
Part 1 is general; “Part 2” standards add requirements for particular equipment. Two matter most here. IEC 61010-2-030 holds the testing and measuring-circuit requirements. IEC 61010-2-101 is the IVD part, used in conjunction with IEC 61010-1; per the Johner Institute it adds chemical and biological hazards, sets no performance requirements, and its Section 17 requires ISO 14971 risk management.
Where it matters for labs, clinics and supply decisions
- Reading a datasheet or declaration: note which edition and which Part 2 standard is named. “IEC 61010-1” alone says nothing about the edition, and Edition 3.0 and 3.1 differ by Amendment 1.
- Environmental conditions: Edition 3.0, clause 1.4.1, defines normal conditions as indoor use, altitude up to 2 000 m and temperature from 5 °C to 40 °C. Use outside those conditions is outside what the standard assumes.
- Staff-facing hazards: the seven hazard classes above map neatly onto a bench inspection. For a general inspection routine, see the laboratory safety self-inspection checklist.
- Diagnostic equipment: IVD equipment is named in the laboratory-equipment scope; see what an in vitro diagnostic is and what counts as a medical device for the regulatory side, which this safety standard does not address.
Common misunderstandings
- “It certifies that the instrument works accurately.” No. Function and performance not related to safety are outside its object (clause 1.2.2).
- “It covers electromagnetic compatibility.” No. EMC sits in the IEC 61326 series.
- “Anything used in a clinic falls under IEC 60601.” Not by the scope text: laboratory equipment, including IVD equipment, is inside IEC 61010-1, while devices with patient-applied parts are treated under IEC 60601-1.
- “IEC 61010-1 and IEC 61010 are the same document.” IEC 61010 is a series; Part 1 is the general requirements and the Part 2 documents add particular ones.
FAQ
What is IEC 61010-1?
It is the general safety standard for electrical equipment for measurement, control and laboratory use, aimed at reducing hazards to the operator and the surrounding area to a tolerable level.
What is the difference between IEC 61010 and IEC 60601?
IEC 61010-1 covers test and measurement, process-control and laboratory equipment, including IVD equipment, and excludes equipment within the scope of IEC 60601. IEC 60601-1 is the standard for medical electrical equipment, and the Johner Institute places devices with an applied part under it.
Which edition of IEC 61010-1 is current?
The IEC webstore lists Edition 3.1, the consolidated IEC 61010-1:2010+AMD1:2016, as the version for sale, checked 2026-11-01. The listing shows a stability date of 2026.
Sources
- IEC Webstore, IEC 61010-1:2010+AMD1:2016 CSV, Consolidated version. Checked 2026-11-01.
- IEC 61010-1 Edition 3.0 (2010-06), preview PDF via VDE Verlag (clauses 1.1, 1.2, 1.3, 1.4). Checked 2026-11-01.
- Johner Institute, IEC 61010 IVD (consultancy article on the patient-contact dividing line, device examples and IEC 61010-2-101). Checked 2026-11-01.
