With the publication of the 3rd edition of IEC61010-1, and subsequent issuing of harmonized standards UL/CSA61010-1 and EN61010-1, two new sections were added to the standard: Section 16 “Hazards Resulting from Application” and Section 17 “Risk Assessment”. Both of these sections contain requirements related to the Risk Assessment (RA) for a piece of Laboratory, Test, Measurement, or Control Equipment. So does that mean all products that are evaluated for compliance with “61010-1” (UL/CSA/EN/IEC) must have a Risk Assessment?

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 a Risk Assessment. A 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.  See separate whitepaper #62 “What is a Risk Assessment” for additional details.

Specific Clauses:

The first reason why a product that uses UL61010-1, CSA61010-1, EN61010-1, or IEC61010-1 needs a Risk Assessment is to comply with one of the new clauses that allow using an RA as an alternative method of compliance. There are 3 well defined clauses in the standard that allow an RA to determine compliance as an alternative to the base requirement. These clauses are:

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 an RA 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 RA.
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; it also expands this clause to all optical radiation, not just UV – it is expected that EN, UL, & CSA standards will include this update in their next edition).

In each of these clauses, the Risk Assessment is an alternative to meeting the requirement in the standard. So if your product can withstand the 5J impact level and you do not have moving parts that can crush or otherwise penetrate the skin, an RA is not needed to comply with these clauses in the standard.

Section 16 – Hazards Resulting from Application: Section 16 contains two clauses that relate to the need for a Risk Assessment. Let’s examine each:

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 but the concept is not. 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, an RA would not be required by this clause. Will certification agencies simply accept a written statement from the manufacturer to satisfy compliance with this clause?
2. If the manufacturer determines the product has a reasonably foreseeable misuse that is not covered by the body of this standard, an RA 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. This is the third reason why you would need a Risk Assessment. Note that the RA 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? Does the convention in which the controls are expected to be operated lead to a hazard not already addressed by the standard?
4. Arrangement of terminals – do the type, identification, and arrangement of terminals lead to a hazard not already addressed by the standard?

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, an RA would not be required by this clause. Will certification agencies simply accept a written statement from the manufacturer to satisfy compliance with 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. This is the fourth reason why you would need a Risk Assessment. Note that the RA could simply address the hazards not already covered by the standard.

Conclusion: There are four reasons why a manufacturer needs a Risk Assessment per 61010-1:

1. As an option in lieu of complying with clauses 7.3 (moving parts) or 8.1 (less than 5J enclosure impact protection).
2. If the product has a “reasonably foreseeable misuse” not anticipated by the standard.
3. If the product has ergonomics hazards not already addressed by the standard.
4. If the product presents other hazard risks not addressed by the standard.

Summary:

It is important to note that if any of these 4 situations apply, the standard only requires a Risk Assessment that was created using an iterative process that includes Risk Analysis, Risk Evaluation and Risk Reduction steps. A limited RA that only covers the particular clause, misuse, or hazard that follows this process is all that is necessary. For products where none of these situations are present, it would seem appropriate for Certification agencies to accept written statements instead of requiring a complete RA just to show that there are no misuse conditions, ergonomics issues, or hazards not already addressed by the standard.

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