Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements

EN IEC 61010-1   establishes general safety requirements for the following types of electrical equipment and their accessories, wherever they are intended to be used. The most common types of equipment covered under this standard are:

              a) Electrical test and measurement equipment

              b) Electrical industrial process-control equipment

              c) Electrical laboratory equipment

Currently the new 3rd edition cancels and replaces the second edition published in 2001. It constitutes a technical revision. This edition includes some significant changes, as well as numerous other changes.

– The scope of the standard has been expanded to include all locations where these products may be used, so that both professional and non-professional versions of these products are within the scope.

– Requirements for reasonably foreseeable misuse and ergonomic aspects have been added (Clause 16).

– A new Clause 17 has been added to deal with hazards and environments not covered by the standard, along with a new informative Annex J dealing with risk assessment.  All products that are applicable under the IEC 61010-1 standard must now consider both these areas for formal compliance

Risk Assessments:

Manufacturers of this type of equipment have not typically prepared a Risk Assessment for their products. In fact, many manufacturers of this type of product do not know what a Risk Assessment is or how to prepare one. The risk assessment is a method to identify all hazards and quantify their level of risk within a product. This typically involves a written summary of the potential hazards associated with a product, with a numerical assessment of the likelihood of occurrence and severity of injury presented from each hazard.  

 Specific Clauses:

  1. Clause 7.3 – Moving parts that can crush or otherwise penetrate the skin not complying with clauses 7.3.4 and 7.3.5 may use a risk assessment as an alternative method to determine compliance.
  2. Clause 8.1 – Enclosure protection level not complying with the specified 5J impact force is permitted if justified in a risk assessment.
  3. Clause 12.3 – Products that emit UV (note – edition 3.1 of IEC61010-1 published in Dec. 2017 removes the reference to use of a risk assessment and replaces it with a measurement)

Section 16 – Hazards Resulting from Application: contains two clauses that relate to the need for a risk assessment.

a) Clause 16.1 – Reasonably Foreseeable Misuse: 

This clause simply says that if there is a reasonably foreseeable misuse of the product that is not addressed by the standard, that section 17 is applicable. The term “reasonably foreseeable misuse” is new to this standard. This standard has always had the requirement that all single fault conditions be considered, which includes product misuse. This term expands on the single fault premise, but puts the onus on the manufacturer to identify whether the product can be misused in a manner not anticipated by the standard.

  1. If the manufacturer determines that there are no reasonably foreseeable misuses that are not covered by the body of this standard, a risk assessment would not be required by this clause
  2. If the manufacturer determines the product has a reasonably foreseeable misuse that is not covered by the body of this standard, a risk assessment is needed to evaluate the associated hazards, risk level, and mitigation methods. This is the second reason why you would need a risk assessment to verify compliance with this standard. Note that the RA could be limited to only address the new misuse condition.

b) Clause 16.2 – Ergonomic Aspects:

Clause 16.2 addresses ergonomic concerns that could give rise to a hazard. If the manufacturer determines the product presents ergonomics hazards not already covered by the body of this standard, an RA is needed to evaluate the associated hazards, risk level, and mitigation methods. Note that the risk assessment could be limited to only address the ergonomics based hazard. Manufacturers are required to consider at least these four areas of ergonomics:

  1. Limitation of body dimensions – can variability in human body dimensions of the user lead to a hazard not already addressed by the standard? (i.e. reach, access, etc.)
  2. Displays and indicators – are displays and indicators located, organized, colored, or otherwise physically or visually designed in a manner that presents a hazard not already addressed by the standard?
  3. Accessibility and conventions of controls – are controls located, organized, colored, or otherwise physically or visually designed in a manner that presents a hazard not already addressed by the standard?
  4. Arrangement of terminals –

 Section 17 – Risk Assessment:

This section simply states that “if examination of the equipment shows that hazards not fully addressed in clauses 6 to 16 might arise, then a Risk Assessment is required”. No other requirements are provided in this section.

  1. If the manufacturer determines that there are no hazards presented by the product that are not fully addressed in Clauses 6 – 16, a risk assessment would not be required by this clause.
  2. If the manufacturer determines there are hazards presented by the product that are not fully addressed in Clauses 6 – 16, an RA is needed to evaluate the associated hazards, risk level, and mitigation methods.

The new requirements are more stringent and place more responsibility on the manufacturer when determining intended use and potential hazards and risk. Contact D.L.S. today at 847-537-6400 to determine the extent of the risk assessment and the requirements that alleviate hazardous situation and allow compliance under EN IEC 61010-1