IEC 61010-2-101 is a harmonized standard for in vitro diagnostics (IVD). IVD manufacturers can use IEC 61010-2-101 to demonstrate conformity with the general safety and performance requirements of the IVD Regulation (IVDR).
The IEC 61010 family
Scope of application
IEC 61010 is a series of standards that formulates safety requirements for electrical equipment for measurement, control, and laboratory use. The term laboratory use is not only to be understood in the medical sense. For example, equipment for a food laboratory would also fall within the scope of the standards series.
IEC 61010-1: The general standard
The general standard IEC 61010-1 formulates the requirements for electrical(!) equipment and its accessories, such as protection against electric shock or protection against mechanical hazards.
IEC 61010-2-X: The particular standards
The Part 2-Standards addresses particular aspects of specific equipment and supplement or modify the corresponding clauses in IEC 61010-1, such as:
- IEC 61010-2-020: Laboratory centrifuges
- IEC 61010-2-033: Hand-held multimeters and other hand-held measuring instruments […].
- IEC 61010-2-061: Laboratory equipment for mixing and stirring
- IEC 61010-2-081: (Semi-)automatic laboratory equipment for analysis and other purposes
- IEC 61010-2-101: In vitro diagnostic (IVD) medical devices
IEC 61010-2-101: Particular requirements for IVD
Scope of application
IEC 61010-2-101 is harmonized for medical devices covered by the IVD Regulation.
Any medical device used as a reagent, reagent product, calibration material, control material, kit, instrument, apparatus, appliance, or system that is either used alone or in combination for the in vitro examination of specimens derived from the human body – including blood and tissue donations – following the intended purpose as defined by the manufacturer and used solely or principally to provide information
- on physiological or pathological conditions or
- on congenital anomalies or
- for the inspection of potential recipients for safety and compatibility, or
- for monitoring therapeutic interventions. […]
- The standard also applies to IVD devices intended to be used by lay persons (e.g., patients).
IVDR
Requirements of IEC 61010-2-101
IEC 61010-2-101 is intended to be used in conjunction with the general standard IEC 61010-1. The Part 2-101 supplements or modifies the corresponding clauses in IEC 61010-1. The tables of contents of both standards are identical. The mind map and the table below ilustrate the table of contents.
Where a particular subclause of Part 1 is not mentioned in the Part 2, that subclause applies as far as is reasonable. Where this the Part 2 states “addition”, “modification”, “replacement”, or “deletion” the relevant requirement, test specification or note in Part 1 should be adapted accordingly.
IEC 61010-2-101 leaves many chapters and subchapters unchanged and only states that the corresponding chapter of part 1 is applicable (“This clause of part 1 is applicable”).
IEC 61010-1: The general standard
Protection against physical hazards
IEC 61010-1 applies to electrical equipment. Accordingly, the standard describes safety requirements to control physical hazards such as:
- Electrical shock or burn
- Thermal energy, spread of fire
- Mechanical energy (fall, explosion, sharp corners, moving parts, ultrasound)
- Substances and materials (gases, liquids)
- Effects of fluids and fluid pressure
- Effects of radiation
The equipment must maintain safety against these hazards. The standard also describes under which conditions and how this is to be tested.
Similarities with and differences to IEC 60601-1
Similar to the IEC 60601-1, the IEC 61010-1 addresses physical hazards. A comparison of the chapter structure of the two standards clearly shows the similarities.
| IEC 61010-1 | IEC 60601-1 |
| 1 Scope and object | 1 Scope, object and related standards |
| 2 Normative references | 2 Normative references |
| 3 Terms and definitions | 3 Terminology and definitions |
| 4 General requirements | |
| 4 Tests | 5 General requirements for testing ME EQUIPMENT |
| 6 Classification of ME EQUIPMENT and ME SYSTEMS | |
| 5 MARKING and documentation | 7 ME EQUIPMENT identification, marking and documents |
| 6 Protection against electric shock | 8 Protection against electrical HAZARDS from ME EQUIPMENT |
| 7 Protection against mechanical HAZARDS | 9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS |
| 8 Resistance to mechanical stresses | 9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS |
| 9 Protection against the spread of fire | 11 Protection against excessive temperatures and other HAZARDS |
| 10 Equipment temperature limits and resistance to heat | 11 Protection against excessive temperatures and other HAZARDS |
| 11 Protection against HAZARDS from fluids | 9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS |
| 12 Protection against radiation, including laser sources, and against sonic and ultrasonic pressure | 10 Protection against unwanted and excessive radiation HAZARDS |
| 13 Protection against liberated gases, explosion and implosion | 11 Protection against excessive temperatures and other HAZARDS |
| 14 Components and subassemblies | 15 Construction of ME EQUIPMENT |
| 15 Protection by interlocks | |
| 16 HAZARDS resulting from application | 12 Accuracy of controls and instruments |
| 17 RISK assessment | 4.2 RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS |
| 14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) | |
| 16 ME SYSTEMS | |
| 17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS |
The IEC 60601-1 applies to medical electrical equipment with an applied part. This means it applies primarily to medical devices that necessarily come into contact with patients. In contrast, IEC 61010-1 assumes that only (healthy) users come into contact with the equipment. The requirements are correspondingly lower, for example, concerning leakage currents.
While IEC 60601-1 is harmonized, IEC 61010-1 is only indirectly mandatory via the harmonized individual standard.
