IEC 61010-1 Third Edition

3rd Edition Risk Assessment: What you need to know

The 3rd Edition of IEC 61010-1, Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements, and thus, all national versions of this standard, introduced a new element that was not included in previous editions, the Risk Assessment.  Since the release of the 3rd Edition, there have been varying interpretations regarding if and when a Risk Assessment is a requirement or merely an option.  The disagreements have occurred between different Certification Bodies, between test houses and manufacturers, and even within specific discrete entities.

Given this previous uncertainty and the possibility of inconsistently imposed requirements, MET Laboratories performed an in-depth review of the requirements of the standard.  The goal of this review was to develop a defined position regarding 61010-1 3rd Edition Risk Assessment requirements, to better meet our customers’ expectations of consistent interpretations across all of our Safety Laboratories.

To that end, MET Laboratories has determined that products or systems that have any of the following features will be required to have a Risk Assessment performed:

  • When human interaction with the equipment is required;
  • For equipment with displays, indicators, controls or terminals;
  • For equipment with moving parts that exceed limits set in Clauses 7.3.4 and 7.3.5, and;
  • For equipment with an energy protection level below 5J.

MET Laboratories anticipates that most 61010-1 3rd Edition projects will at least meet either or both of the first two items, and thus Risk Assessments will need to be performed and submitted with the project. To assist with this endeavor, Risk Assessment guidance is provided on the following pages, and additional assistance may be obtained by contacting your MET Labs representative.

The standard provides guidance in Clause 17 and Annex J, referencing several other guides and standards, but the basic requirement is that the Risk Assessment shall be carried out and documented to achieve at least a tolerable risk by an iterative process covering the following:

  • 1. Risk analysis

Risk analysis is the process to identify hazards and to estimate the risks based on the use of available information.

  • 2. Risk evaluation

Each risk analysis requires a plan to evaluate the estimated severity and likelihood of a risk, and to judge the acceptability of the resulting risk level.

  • 3. Risk reduction

If the initial risk level is not acceptable, steps shall be taken to reduce the risk. The process of risk analysis and risk evaluation shall then be repeated, including checking that no new risks have been introduced.

In graphical form, from Annex J:

The Risk Analysis step is used to identify hazards and determine what risks each hazard poses. For example, a moving part could cause crushing or entanglement, or a hot surface could cause burning to operators or passersby or ignition of an adjacent material.

The Risk Evaluation step involves some sort of calculation, based on the severity of harm from an event (J.1 below) and the likelihood of the event occurring (J.2 below), that determines whether a risk is acceptable to the manufacturer.

In this case the Probability is assigned a weight in column 1 and the Severity in row 5. The products of these weights are entered and a corresponding risk tolerance line is determined. Where to draw this line is a decision that is made by the manufacturer based on any relevant data or company processes or legal guidance is deemed prudent.

An alternative to Table J.3 is presented below.

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