Design Article
Developing medical sensors compliant with global requirements
James McKenna, Honeywell
3/6/2013 10:56 AM EST
Materials/regulatory compliance affect global manufacturers
In the European Union (EU), for example, government regulators are much more likely to ban a substance based on a small amount of data that indicates it can be harmful or hazardous. While the EU is a big market for medical devices with its well-funded / high-quality healthcare systems, device manufacturers must ensure that their products meet EU regulations before they can operate in that environment.
Two regulations that impact the global electronics industry include the “Restriction on the Use of Certain Hazardous Substances (RoHS) Directive”, which aims at restricting the levels of six chemicals historically used in electronics manufacturing, and the “Registration, Evaluation, Authorization and Restriction of Chemical Substances” (REACH) regulation, which provides the framework to hold the industry responsible for controlling its use of hazardous substances in the EU, affecting materials use in end- products and manufacturing processes. If global manufacturers and resellers want to sell into the EU, they must comply with these regulations.
Sensor manufacturers have to be fully informed of materials selection, supply chain and manufacturing processes to ensure that they adhere to European material compatibility regulations. This is particularly important for sensors as they often come in contact with a patient's air or fluid pathways, because sensors need to be positioned as close to the fluids (blood, infectious materials, saline, etc.) as possible to ensure the most precise and accurate measurements.
This also drives the need for RoHS-compliant liquid media compatible sensors for medical equipment ranging from chemical analyzers to ventilators. And since cost is always an issue, the sensor product line also needs to offer a variety of options for characteristics such as outputs, pressure types, pressure ranges, mounting options and packaging styles to meet country requirements.
Product platforms that offer multiple options and parts to meet country-specific requirements also help engineers meet price points set in different regions of the world. It also allows them to scale up or down, depending on the application and country requirements.
Figure 2: Honeywell's HumidIcon digital humidity/temperature sensors provide two functions in a single small package and operate down to 2.3Vdc.
As an example, respiratory equipment designs can vary significantly from country to country, requiring different packaging styles. A flexible sensor should offer packaging options for both integrated manifold designs used in western countries, and legacy designs that incorporate lots of tubing and connections often found in less developed countries.
In the European Union (EU), for example, government regulators are much more likely to ban a substance based on a small amount of data that indicates it can be harmful or hazardous. While the EU is a big market for medical devices with its well-funded / high-quality healthcare systems, device manufacturers must ensure that their products meet EU regulations before they can operate in that environment.
Two regulations that impact the global electronics industry include the “Restriction on the Use of Certain Hazardous Substances (RoHS) Directive”, which aims at restricting the levels of six chemicals historically used in electronics manufacturing, and the “Registration, Evaluation, Authorization and Restriction of Chemical Substances” (REACH) regulation, which provides the framework to hold the industry responsible for controlling its use of hazardous substances in the EU, affecting materials use in end- products and manufacturing processes. If global manufacturers and resellers want to sell into the EU, they must comply with these regulations.
Sensor manufacturers have to be fully informed of materials selection, supply chain and manufacturing processes to ensure that they adhere to European material compatibility regulations. This is particularly important for sensors as they often come in contact with a patient's air or fluid pathways, because sensors need to be positioned as close to the fluids (blood, infectious materials, saline, etc.) as possible to ensure the most precise and accurate measurements.
This also drives the need for RoHS-compliant liquid media compatible sensors for medical equipment ranging from chemical analyzers to ventilators. And since cost is always an issue, the sensor product line also needs to offer a variety of options for characteristics such as outputs, pressure types, pressure ranges, mounting options and packaging styles to meet country requirements.
Product platforms that offer multiple options and parts to meet country-specific requirements also help engineers meet price points set in different regions of the world. It also allows them to scale up or down, depending on the application and country requirements.
Figure 2: Honeywell's HumidIcon digital humidity/temperature sensors provide two functions in a single small package and operate down to 2.3Vdc.
As an example, respiratory equipment designs can vary significantly from country to country, requiring different packaging styles. A flexible sensor should offer packaging options for both integrated manifold designs used in western countries, and legacy designs that incorporate lots of tubing and connections often found in less developed countries.
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WKetel
3/12/2013 9:10 PM EDT
All of those regulations are why my product won't be sold to EU residents. They can lease them, but if they choose to get rid of them they must be returned. Of course, my products are well worth repairing and being re-sold here, or leased to some other EU party. Now I am waiting for the leasing to become ilegal as well. Then they will need to purchase the much more expensive products from others.
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