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?
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.
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:
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.
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:
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.
Conclusion: There are four reasons why a manufacturer needs a Risk Assessment per 61010-1:
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.
CertifiGroup are experts in UL, CSA, CE, & International Certifications
CertifiGroup can help you develop a Risk Assessment for your product
CertifiGroup operates a complete Product Test & Certification Lab
CertifiGroup can certify or field label your products to UL & CSA standards
On-site, at your facility, or in our lab!