Quality
How to Specify Medical Textile Components
In medical applications, repeatability and documented requirements are as important as the material itself.
Start with the intended application
The term “for the medical industry” covers products of very different risks: from packaging and organizational element to a component that touches the skin or works mechanically.
Do not assign textile webbing or elastic tapeWith the properties of the entire medical product without proper qualification. The regulatory requirements, standards and test plan shall be determined for the specific market and end product.
Parameters and materials
The design may include softness, dimensional stability, flexibility, friction resistance, colour repeatability, compatibility with cleaning and behaviour after cycles of use. If the item carries the load, it must be described numerically with the test method.
The choice of yarn, elastic threads, dyes and trims should be linked to the required documentation. Any additional adhesive, printing or hardware may require separate evaluation.
Sampling, traceability and change control
Once the sample has been approved, its version, specification and reception criteria should be recorded. It is important to trace the batch and the agreed method of informing about the change of raw material, construction or process.
The supplier’s documentation may support qualification but does not replace the test of the finished product. The scope of the inspection should correspond to the risks and requirements of the recipient.
- Intended use and contact with the user
- Critical parameters and their measurement methods
- Required documents, standards and language versions
- Sampling plan, tests and acceptance criteria
- Volume, packaging, batch identification and change control
How to prepare the first conversation
Send a drawing, photo or sample of the existing component, but also explain what is to be corrected. Specify the working conditions and consequences of any non-compliance. This allows you to quickly identify questions requiring answers before performing the test.
If a part of the requirements is confidential, the information necessary for the feasibility assessment may be started and the details provided in the agreed mode.
Frequently asked questions
Is the material certificate sufficient for a medical device?
No. The material document may be one of the evidence, but the qualification and conformity concern a particular product, application and market.
What does change control mean?
This is an agreed process of informing about modification of raw material, construction or production before the changed component reaches the recipient.
Should the reference sample have a number?
Such marking facilitates a clear link between the physical sample and specifications, orders and subsequent lots.