Translating Safety Critical Information for Global Compliance

As a regulatory subject matter expert, on Electronic and Electrical Equipment, I have seen an increase in confusion over global translations for various product information. This includes, but is not limited too, translating labels, translating safety sheets and translating users guides. Product teams seem to be confused as to what is required? what is provided additionally for risk mitigation and In what form is this information supposed to be provided to the users? This article will dive into what the regulations are, how a regulatory subject matter expert like myself interprets said regulations and what is the most efficient practice for most EEE manufacturers.

Lets start by explaining the basic requirements structure for Electrical and Electronic Equipment (EEE). All products must meet the Essential Requirements for each market they are sold into. These Essential Requirements reference the need for a quality process and quality product. To show compliance to these Essential Requirements a manufacturer must choose all Directives/Regulations that are applicable to the scope of the product being sold. If we look at Europe as an example, this can include Electromechanical safety (LV Directive), Electromagnetic Compatibility (EMC Directive) and Environmental safety (RoHS, REACH, WEEE). Note that most other global markets copy these requirements for themselves.

If we further focus our attention on the Low Voltage Directive, we will find requirements on safety critical information and the translation of said information into local languages;

Chapter 2: Obligations of Economic Operators

Article 6 Obligations of manufacturers

7. Manufacturers shall ensure that the electrical equipment is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. Such instructions and safety information, as well as any labelling, shall be clear, understandable and intelligible

The guidance on how to meet these various directives/laws can be found in the internationally harmonized standards (Refer to IECEE.org). Speaking specifically to the electromechanical safety portion of the essential requirements, we will utilize the IEC61010-1 standard for Laboratory and Industrial Control Equipment for this discussion (standards can differ depending on your product scope). If we start by digging into clause 5, it covers  “documentation necessary for safety purposes”. The following bullets are various topics that are considered safety critical.

  • Intended use
  • Technical specifications
  • Name and address of legal manufacturer
  • Information to mitigate risks
  • Safety required accessories
  • Guidance on how to confirm if the unit is operating safely if hazards could happen otherwise
  • Instructions for moving/carrying
  • Equipment ratings
  • Equipment Installation
  • Equipment Operation
  • Equipment maintenance/service

Note: Reference the IEC61010-1 standard for more details on each of these categories

Also within clause 5 we see a very important sentence;

“Printed information is required for all information necessary for safety that might not be available in electronic form at the time it is needed. The documentation shall be delivered with the equipment. Consideration shall be given to the ability of the Responcible Body to read the media”

If we review both the above statement and definition of safety critical information from clause 5.0 of the IEC61010-1 standard we come to two conclusions; 1. Said information needs to be printed in a hard copy with the product and 2. The same information needs to be translated into the necessary local languages.

Now we get into the current confusion around these rules. Much of the information required in clause 5.0 of the IEC61010-1 standard is spread out between various product documents such as Users Guides,  Data sheets, Quick Start Guides, Marketing documents and so forth. Thus, meeting conclusionary statements 1 and 2 above become very complicated, expensive and timely. We would essentially need to print and translate all the product documents to comply.

To try and mitigate this issue, some EEE manufacturers have been creating a separate, printed and translated safety sheet with the products Caution, Warning and Danger statements. Unfortunately, this still does not cover all the information deemed safety critical in clause 5.0. Thus, a manufacturer is still forced to translate their full users guide as well as the safety sheet, or face non compliances. Essentially forcing the manufacturer to translate more documents than need be, costing unnecessary time and money.

To fully align with the regulations outlined above, a manufacturer should move towards a more structured approach. This should include;

  1. ALL applicable information as seen from clause 5.1 to 5.5 within the IEC61010-1 standard must be consider Safety Critical, not just warning, caution and danger statements.
  • This information should be consolidated onto one single document called a Safety Instruction Sheet, or similarly defined title.
  • Information within the Safety Instruction Sheet should not be duplicated on any other document unless absolutely necessary.

Note: The Regulatory officer should oversee this Safety Instruction Sheet and make sure it stays compliant with changing regulations. If information on this safety sheet is updated but duplicate information on another document is not, there could be a potential for conflicting safety information.

  • The Safety Instruction Sheet should be translated into the applicable languages for the global markets in which the product is sold (~27 languages for global distribution)
  • The Safety Instruction Sheet should be printed (hard copy) and provided directly with the product.

Author: Brett

Brett Gagnon is currently one of the global subject matter expert for electrical equipment and electrical medical devices at Merck KGaA Darmstadt Germany, otherwise known as Millipore Sigma within North America. He has an Electrical Engineering degree from Wentworth Institute of Technology and a Masters of Business from Southern New Hampshire University. Mr Gagnon has a background in the ATIC (Assurance Testing Inspection Certification) industry based on previous years working for Intertek Testing Services NA Inc out of the Boston Ma area. During his time at Intertek he became a CB certified engineer evaluating products to medical, laboratory, IT, and Industrial standards. He also has a knowledge base in laser, Ingress Protection testing and wireless radio registration. Additionally Mr. Gagnon was a Field label and Special Inspection agent reviewing large custom equipment for national safety approvals in North America.