IEC 61010-2-101:2018 PDF

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

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Title (English):

IEC 61010-2-101:2018

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 52
Publication date:: October 5, 2018
Edition:: IEC IS 61010 edition 3 version 1
ICS:: 11.040.55

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Description (English):

IEC 61010-2-101:2018 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. It has the status of a group safety publication, as specified in IEC Guide 104. This document has been prepared in close collaboration with Working Group CENELEC BTTF 88.1. This third edition cancels and replaces the second edition published in 2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: - adaptation of changes introduced by Amendment 1 of IEC 61010-1; - added tolerance for stability of AC voltage test equipment to Clause 6. This Part 2-101 is intended to be used in conjunction with IEC 61010-1. It was established on the basis of the third edition (2010) and its Amendment 1 (2016).

Technical details

Technical committee: TC 66 - Safety of measuring, control and laboratory equipment
SKU: IEC 61010-2-101:2018

Abstract

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.

Related standards

Standards mentioned in the description

Abstract

Overview

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.

IEC 61010-2-101:2018 PDF

Technical details

Abstract

Overview

Key topics and requirements

Practical applications and who uses it

Related standards

Related standards

Abstract

Overview

Key topics and requirements

Practical applications and who uses it

Related standards

Related standards

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General r…

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro…

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