Medical Pressure Regulators
MDR-Ready by Design – the medical pressure regulators of the Pure Flow Line
Regulatory requirements in medical technology are constantly increasing. The MDR, as well as standards such as DIN EN ISO 10993, 15001, and 18562, are increasing the effort required for the development, qualification, and approval of medical devices. For manufacturers, this often means longer development times, more complex documentation processes, and higher costs.
With the new Pure Flow Line pressure regulators, Kendrion combines precise pressure control with regulatory compliance. Medical-grade materials, clean manufacturing in controlled environments, and development in accordance with MDR and relevant ISO standards support more efficient integration into medical systems. Thanks to their compact design and light weight, our Pure Flow pressure regulators are particularly easy to integrate into a wide variety of device architectures. The strategic use of plastic components also makes them a cost-effective and cost-optimized alternative to all-metal pressure regulators.
The Pure Flow Pressure Regulators have been developed specifically for sensitive medical applications such as respiration, dialysis, or analytics. They ensure precise and reliable pressure control of medical gases such as air, oxygen, and CO₂, thereby contributing to stable processes in numerous critical medical devices.
When flow changes, pressure stays stable.
NEW: High-Flow Pressure Regulator of the Pure Flow Line
With the new High Flow Pressure Regulator, Kendrion expands its Pure Flow Line with a high-performance solution for flow rates from 0.1 to 250 l/min.
- Stable pressure control under dynamic flow conditions
- Cost-optimized design with high functionality
- Easy integration through flexible connection options
Pressure, but precisely regulated
In many industrial and medical applications, precise pressure control is key. Whether the medium is air, CO₂ or liquids, it is essential that fluctuating inlet pressure is reliably reduced to a stable output level.
Mechanical diaphragm pressure regulators excel in this area, offering excellent control accuracy, a robust design and compatibility with multiple media.
Florian Falk, the product manager, provides valuable insights into modern pressure regulator solutions and explains their advantages for sensitive applications such as analytical or medical technology.
Turning pressure into trust
Components that come into direct or indirect contact with patients are subject to comprehensive regulatory requirements. This also applies to pressure regulators, which are used in ventilators, oxygen concentrators, or anesthesia devices.
As soon as a component comes into contact with patient-related media – whether gas or liquid – strict requirements apply regarding material purity, media quality, and absence from harmful substances.
Tobias Klapetke, Kendrion's Segment Manager for Fluid Technology, explains the relevant DIN EN ISO standards and the resulting challenges for manufacturers and suppliers.
Inside pressure regulator manufacturing
Pressure regulators may be small in size, but they play a vital role in ensuring the safety and reliability of medical and industrial systems. Especially in sensitive applications such as medical technology, every detail matters – from the choice of materials to the way each component is tested. Behind every regulator lies a highly controlled manufacturing process that combines engineering expertise, precision, and documented quality.
Sven Desens, head of Fluid Technology at Kendrion, takes you inside the production of modern pressure regulators and shows how raw materials are transformed into reliable components for critical applications.
Why do medical devices require special pressure regulators?
Why do medical devices require special pressure regulators?
Medical devices require pressure regulators when a high or fluctuating inlet pressure needs to be reliably reduced to a stable outlet pressure. In medical applications, selection also depends on pressure accuracy, flow behaviour (rate), media compatibility, material selection, cleanliness, documentation, and the requirements of the complete medical device.
What is the Pure Flow pressure regulator 48.3?
What is the Pure Flow pressure regulator 48.3?
The Pure Flow 48.3 is a compact, flange-mounted pressure regulator for low-to-medium flow applications. It is positioned for sensitive medical and life-science applications and is designed for precise pressure control in a compact installation space. The regulator uses selected materials and controlled manufacturing processes.
How does Kendrion support with selection and qualification?
How does Kendrion support with selection and qualification?
Kendrion provides technical data and application expertise and also offers the opportunity to discuss specific requirements with experts. Key factors include the medium, inlet and outlet pressure, flow rate, material, seals, installation space, interfaces, and documentation requirements. Taking these factors into account early in the development process enables technical integration and qualification.
