Compliance
EN 13795 and EN 14683: where the fabric stops and the device starts
Both standards apply to finished medical devices, not to rolls of fabric. A supplier can provide material that supports compliance; only the device manufacturer can claim it.
At a glance
Specification at a glance
| Standard | Covers | Key tests | Owner |
|---|---|---|---|
| EN 13795 | Surgical drapes, gowns, clean air suits | Liquid penetration, microbial penetration, clean air particle release, tensile | Device manufacturer |
| EN 14683 | Medical face masks | Bacterial filtration efficiency, breathing resistance, splash resistance, microbial cleanliness | Device manufacturer |
| ISO 10993 | Biological evaluation | Cytotoxicity, irritation, sensitisation | Device manufacturer |
| ISO 13485 | Quality management for devices | Process control, traceability, change control | Manufacturing site |
What the fabric contributes
For drapes and gowns the fabric provides liquid barrier at a given hydrostatic head, strength at a given weight, and low particle release. For masks it provides filtration efficiency and a pressure drop the wearer can tolerate. Each is a measurable material property, and each has to be tested on the finished article as well.
The material data helps the converter design the product; it does not certify it.
The documentation chain
Device manufacturers are audited on traceability, change control and supplier control. In practice that means the fabric arrives with a batch reference, a COA against an agreed specification, and a notification when anything about the grade changes. A supplier who changes a finish without telling the customer breaks the chain even if the fabric is fine.
What to ask a fabric supplier
The test methods used for barrier and strength, the batch traceability, the change notification process, and whether the site holds a quality system certificate with a scope that covers the material. If any of those four is missing, the audit will find it later.
The supplier documents an audit asks for
Batch COA against the agreed specification, material declarations for the fibre and finish, a change notification record, and the quality system certificate with its scope. An auditor will ask for the last three deliveries, not the best one.
Tell us the application and the acceptance test
The reply names a grade we can run, the tolerance we can hold and a lead time, or says plainly that we cannot make it.
Questions
Common questions
Can you certify a fabric to EN 13795?
No, and no fabric producer can. The standard applies to the finished drape or gown. What we provide is material test data and batch documentation supporting the converter's certification.
Which mask standard applies in Europe?
EN 14683 for medical face masks, with three types depending on bacterial filtration and splash resistance. Community and workplace masks are covered by different specifications entirely.
Do you notify customers of grade changes?
For medical and tender programmes, yes, before the change takes effect. It is part of the order terms rather than a favour.