We've all had the experience of getting a new gadget or piece of do-it-yourself furniture and wading through indecipherable instructions. Connecting part A to part B seems simple enough however, many times this simple task is impossible due to convoluted instructions that have been translated from English to some other language then back to English again.

This is OK for backyard swing sets and the "assembly required" bookshelf, we can get through it using intuition and familiarity with other similar objects we've seen. However, when it comes to medical equipment, surgical devices, and other tools used in life or death situations, poor translations cannot be tolerated.

The EN 15038 Certification

ISO Certified

In order to ensure quality translations for sensitive documents such as manuals for surgical and medical devices a standard was published. The EN 15038 is a standard for quality translation services designed specifically for the translation industry.

The translation of medical documents and medical device manuals intended for multinational distribution is very complex and demands strict attention to detail and adherance to subtle nuances of each language. Obviously mistakes can not be tolerated and companies that purchace a medical device need to be assured that the instructions they receive are exactly what the manufacturer intended. If the translation is not correct and something goes wrong due to misuse of the device that translation company is not liable, the medical facility is and could face charges as severe as wrongful death and malpractice.

EN 15038 standardizes terminology in multiple languages and creates a framework for interaction between manufacturers, translators and the buying customers. By adhering to these standards the translation company can not produce content that could be misleading or misinterpreted due to a nuance in the language of which there are many. Think about some of the oddities of our own language that we take for granted... their - there, two - too - to, desert - dessert, etc... now think about the ramifications of a simple gramatical mistake in an instruction manual for a medical device such as a laser, or a MRI software. 

By working with a translation company that is certified to EN-15038, manufacturers and customers and other stakeholders can have confidence that the translated documents and software that accompany the products are meeting the requirements that the translation industry believes to be necessary for the successful completion of a translation.

Something to keep in mind is that adherance to the EN 15038 regulations or certification to this standard is voluntary. Translation Service Providers are not required to implement the EN 15038 standard.