At In the development of (medical) devices, a recurring theme is the TightnessThis is a topic that is often underestimated and can cause unexpected problems, especially during the certification phase.
The term used is Tightness mostly as a colloquial synonym for the term Tightness. The Duden and relevant knowledge portals provide the following definition:
Property of substances not to allow gases, liquids, rays, etc. to penetrate or pass through.
The question "Is it tight?" is misleading. A more accurate formulation is "How tight is it?" Absolute tightness is neither theoretically nor practically feasible. An example of a situation where absolute tightness is not possible is Diffusion processes in materials.
Leakproofness is required and desired in many areas. Many medical devices transport, analyze, and process fluids. Unintentional exchange or mixing between the various substances must be prevented. Contamination of these substances by device components must not occur, and the substances must not damage the devices used. The cleaning, disinfection, or sterilization of medical devices must also be considered during development.
The tightness of a medical system can quickly become a complex issue with many different requirements and influencing factors.
IP protection class: “Tightness of enclosures”
To regulate the tightness of products against the ingress of foreign bodies and water, two standards are primarily used in Europe: EN 60529 and ISO 20653. Both standards are based on the so-called IP protection rating. ISO 20653 is primarily used for road vehicles and offers the corresponding special features. DIN EN 60529 regulates the protection provided by enclosures against contact, dust, and water. Two numbers are used for this.
The first digit indicates the protection against contact and dust of critical parts.
| 0 = no protection … 6 = dustproof |
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The second digit indicates protection against water in critical areas.
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0 = no protection … 9 = Protection against water during high-pressure/steam jet cleaning |
If a protection area is not defined, an X is used as a placeholder, for example, IP X2. The IP protection class is defined either by the applicable standard, for example, at least IP 22 for devices in household applications according to EN 60601-1-11, or during development based on the product requirements.
Ideally, the requirements are known early in the development process and can be incorporated throughout the entire development process. If this isn't the case, or if the requirements or intended use change, technologies exist that allow for retrofitting seals into an existing product.
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