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ISO 13485 and medical equipment development (ART543E)

In several articles we have described projects and procedures for the development of medical, hospital and even personal health equipment. Component manufacturers can source a multitude of resources from themselves as well as development and evaluation boards, as described above. However, it is not enough to develop equipment so that it is ready to be placed on the market. The need for standards to be followed requires special care that we address in this article.

Dealing directly with human health requires special care and attention both from those who manufacture the components used in an equipment also from the manufacturers of the equipment itself.

This means that equipment and components must follow strict standards that depend on the considered country.

Without your approval, manufactured equipment cannot be sold and used in environments of any kind. And for approval, it is necessary to follow certain procedures that the interested reader can access by looking for the specific documentation for his country.

But, for you who still have an idea in your head and are in the development phase of a project, you need to have something more in mind. Equipment for medical or hospital use must have a degree of reliability above that required for equipment for domestic use or even for military use.

Thus, there are ISO standards (International Organization for Standardization) that set industrial and commercial standards worldwide.

Founded in 1947, ISO sets several types of standards that are universally accepted and that basically consist of quality management. So, for medical applications, based on ISO 9001, we have ISO 13485 for medical applications.

While ISO 9001 is focused on general applications, ISO 13485 can only be implemented by companies that are focused on the production of medical devices.

 


 

 

See then that in addition to the advantages that a company that wishes to manufacture equipment for medical and hospital use, there are cases in which ISSO is mandatory to obtain the registration of a product in the local standardization entities, they must use components that are produced by the company that comply with ISO 13485.

 

 

The electronic part

Most medical, hospital and healthcare equipment have electronic resources ranging from simple motor control components to powerful processing boards using microcontrollers.

For the developer, it is an important practice to try to use components in their projects that comply with the ISO 13485 standard.

Mouser Electronics distributes a multitude of components from manufacturers that are compliant with ISO 13485. By consulting the lists of available components, the Mouser customer will have in the component description the information on their compliance with this standard or even access to suppliers that are proven to be compliant with it.

Below is an example, based on the huge inventory of components available from Mouser.

Initially, we researched a Texas Instruments component for heart rate monitoring applications. The AFE44410 consists of a Biosensor and beat monitor with several features. The datasheet was downloaded at: http://www.ti.com/lit/ds/symlink/afe4410.pdf

Looking for a pressure sensor we find the NPC-100 and NPC-120 series from Nova Sensor - Amphenol available from Mouser.

http://www.ti.com/lit/ds/symlink/afe4410.pdf

 

 


 

 

On Mouser’ sales page at https://br.mouser.com/Search/Refine?Keyword=NPC-100 . For example, we can access the T-type datasheet.

Another important medical component for applications is the Honeywell 24PC, a pressure sensor for use in respirators and ventilators, oxygen concentrators and nebulizers. Also suitable for use in CPAP.

Another series of miniature low-pressure sensors is Honeywell's 24PC, whose documentation can be accessed at: https://br.mouser.com/datasheet/2/187/Honeywell_sensing_board_mount_24pc-series_miniatur-1769813.pdf .