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
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About This Item
IEC 61010-2-101:2018 sets out particular safety requirements for electrical equipment for measurement, control, and laboratory use when that equipment is intended for in vitro diagnostic medical applications. For engineering teams, compliance staff, and procurement reviewers, it provides a focused technical reference for evaluating whether an IVD device has been designed and assessed with appropriate safety considerations. IEC 61010-2-101:2018 is especially relevant when organizations need a clear basis for technical review, documented evaluation, and conformity assessment preparation.
What is IEC 61010-2-101:2018?
IEC 61010-2-101:2018 is the part of the IEC 61010 series that addresses particular requirements for in vitro diagnostic (IVD) medical equipment. It is used alongside the broader safety framework for measurement, control, and laboratory equipment, with attention to the specific risks and operating conditions associated with diagnostic applications. The document supports technical validation, risk management, and compliance workflows by defining the safety-related requirements that may be considered during design review, testing workflows, and certification-oriented assessment.
Applications of IEC 61010-2-101:2018
This technical document is commonly relevant to manufacturers, test laboratories, and product teams working on IVD medical equipment that incorporates electrical, control, or laboratory functions. It may be used during product development, verification activities, and regulatory preparation to help align safety evaluation with the intended use of diagnostic systems. It is also useful for procurement and quality teams that need a clear compliance reference when reviewing engineering documentation, selecting products, or confirming that documented testing supports operational consistency.
Why is IEC 61010-2-101:2018 important?
The main value of IEC 61010-2-101:2018 is that it helps organizations structure safety assessment for IVD equipment in a consistent and technically defensible way. By tying particular requirements to the equipment category, it supports safer design decisions, clearer testing criteria, and more reliable conformity assessment preparation. It can also reduce ambiguity in procurement and quality assurance processes, where teams need to compare technical claims against a recognized compliance reference and confirm that safety expectations are addressed appropriately.
- Particular safety requirements for in vitro diagnostic medical equipment
- Useful for technical review, verification activities, and documented evaluation
- Supports compliance workflows and conformity assessment preparation
- Relevant to electrical equipment used in measurement, control, and laboratory contexts
- Publication Date: 2018-05-10
- Standard Status: Original
- Publisher: IEC
- Edition: 3
- This Version: IEC 61010-2-101:2018 (2018-05-10)
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