The small but significant Difference between EN 13485 and EN ISO 13485

EN ISO 13485 is widely known in the medical device sector. It is the standard that describes the requirements for a quality management system (QMS) for medical device manufacturers. It specifies requirements for the development, implementation and maintenance of QMS to ensure the quality, safety and effectiveness of medical devices throughout their entire life cycle. But what is EN 13485?

EN 13485

If you search for EN (without ISO) 13485, perhaps because you forgot to add 'ISO' and "google" it, for example, you will be directed to a standard that provides information on "Thermometers for measuring the ambient or internal temperature for the transport, storage and distribution of temperature sensitive goods - Tests, performance, suitability".

What is the content of this EN 13485?

This document specifies the technical and functional characteristics of thermometers of all types (electronic, mechanical, etc.) intended for the transport, storage and distribution of temperature-sensitive goods and for measuring the ambient and internal temperature of products between -80 °C and +85 °C.

It specifies the test methods that enable the conformity of the devices with the performance and usability requirements to be determined.

It applies to the entire thermometer and the entire display device(s). The temperature sensor(s) may be integrated into the thermometer or separate from it (wired or wireless external temperature sensor(s)). It does not specify the position of the thermometer and its temperature sensors with regard to types of use such as transport, storage and distribution.

NOTE: Examples of the transport, storage and distribution of temperature-sensitive goods between -80 °C and +85 °C include chilled, frozen, deep-frozen and flash-frozen food; ice cream; fresh and hot food; medicines; blood and organs; chemicals; biological products; electronic and mechanical devices; flowers, plants and flower bulbs; raw materials and liquids; animals; works of art and furniture.

And what happens if, instead of EN 13485, you accidentally enter a '6' as the last digit instead of a '5' at the end, i.e. you search for EN 13486?

EN 13486

This takes you to another standard, also related to thermometers: "Temperature recorders and thermometers for measuring the ambient or internal temperature for the transport, storage and distribution of temperature sensitive goods - Periodic verification".

In terms of content, this document specifies the verification procedure for temperature recording devices and thermometers for measuring air and product temperatures between -80 °C and +85 °C, which are intended for use in transport, storage and distribution facilities for temperature-sensitive products and comply with standards EN 12830 and EN 13485 (measurement classes and ranges) and others used for the transport, distribution and/or storage of temperature-sensitive products. It specifies the test procedures used to verify the conformity of the devices with the class requirements defined in EN 12830 and EN 13485.
NOTE: Examples of the transport, storage and distribution of temperature-sensitive products between -80 °C and +85 °C include chilled, frozen, deep-frozen and flash-frozen food; ice cream; fresh and hot food; medicines; blood and organs; chemicals; biological products; electronic and mechanical devices; flowers, plants and bulbs; raw materials and liquids; animals; works of art and furniture.

The standards are available for purchase from DINMedia. They may also be relevant in the GMP and GDP environment, but are not legally binding.  

Conclusion: The minor differences between EN 13485 and EN ISO 13485 can cause confusion. When searching for standards quickly, it can sometimes be really important to enter the correct names of the standardisation organisations involved in the standards in question.