IEC 61010-2-101:2018

Overview

IEC 61010-2-101:2018 is the third-edition, group safety publication that defines particular safety requirements for electrical equipment used for in vitro diagnostic (IVD) medical purposes, including equipment intended for self-testing by lay users. Published by the IEC in 2018, this Part 2 standard is intended to be used in conjunction with IEC 61010-1 and supplements or modifies Part 1 to address IVD-specific hazards and use scenarios. Significant changes in this edition include adaptation to Amendment 1 of IEC 61010-1 and an added tolerance for stability of AC voltage test equipment.

Key topics and requirements

This standard focuses on practical safety and documentation requirements for IVD electrical equipment. Key technical topics include:

• Scope and definitions specific to IVD devices (e.g., SAMPLE ZONE, LOADING ZONE, self-test IVD).
• Tests and performance verification required to demonstrate safety under normal and fault conditions.
• Protection against electric shock, mechanical hazards, and temperature/heat effects.
• Resistance to mechanical stress, spread of fire, and protection against fluids and foreign objects.
• Radiation, sonic/ultrasonic protection, and control of liberated gases/substances.
• Components, interlocks, and protective measures for hazards resulting from application.
• Marking and documentation requirements: manufacturer identification, model/serial or batch code, explicit IVD and self-test identification, consumable expiry instructions, and use of internationally recognized symbols.
• Risk management and RISK assessment consistent with IVD device use and biohazard risks.
• Special additions addressing biohazards and hazardous chemical substances within the equipment scope.

Practical applications and who uses it

IEC 61010-2-101 is used by:

• Manufacturers and designers of IVD analysers, point-of-care instruments, and self-test devices to ensure product safety from design through documentation.
• Compliance and regulatory teams preparing technical files and instructions for use.
• Test laboratories and certification bodies performing safety testing and conformity assessment in combination with IEC 61010-1.
• Safety engineers and risk managers conducting RISK assessments for biohazardous handling within equipment.
• Procurement and clinical engineering groups evaluating equipment safety features and labeling.

Practical uses include design validation, labelling/marking compliance, test-plan development, and supplier specifications for consumables and connectors (e.g., gas and liquid connections).

Related standards

• IEC 61010-1 (base safety requirements for measurement, control and laboratory equipment)
• ISO 14971 (medical device risk management) - normative reference added
• ISO 18113-5 (IVD labelling for self-testing instruments)
• ISO 13857 (safety distances to prevent access to hazard zones)

Keywords: IEC 61010-2-101, IVD safety requirements, in vitro diagnostic equipment, self-test IVD, laboratory equipment safety, IEC 61010-1, medical device risk assessment.