Nonwoven materials for medical and hygiene converters
Medical buyers need barrier performance and documents. Both are grade specific. This page explains what to ask for and where the supplier's responsibility stops.
At a glance
Specification at a glance
| Requirement | How it is specified | Who proves it |
|---|---|---|
| Liquid barrier | Hydrostatic head, named method | Material test report |
| Microbial barrier | Standard specific test | Device or material test, per standard |
| Breathability | Air permeability range | Material test report |
| Strength | MD and CD tensile minimums | Material test report |
| Sterilisation | Method compatibility | Device manufacturer validation |
| Biocompatibility | Standard specific | Device manufacturer |
Ask for the scope, not just the certificate
An ISO 9001 certificate covers a management system for a defined scope. It does not state that a specific SMS grade passes EN 13795 or ASTM F2407. Buyers who use the certificate as product proof usually discover the gap during their own audit, at the worst possible moment.
Ask two questions: which product does this report cover, and which test method and date does it cite. A supplier who can answer both is a supplier who will survive your audit.
Where the material supplier stops
We supply nonwoven material and the data we hold for that grade. The finished device is designed, validated, sterilised and registered by the device manufacturer, and that is where the regulatory obligation sits.
We state this plainly because a buyer who assumes otherwise builds a compliance file on a foundation that will not hold.
Hygiene products outside the device rules
Diapers, sanitary products, adult incontinence and protective covers are not medical devices in most markets, but they carry their own expectations: skin contact, odour, absorbency and strength in use. The specification discipline is the same, the documentation burden is lighter.
For those products the deciding tests are usually strike through, rewet and tensile, measured on the finished structure rather than on the raw roll.
Send the standard your product must meet
Structure, gsm, barrier test method and standard give us enough to tell you what data exists.
Questions
Common questions
Do you have EN 13795 tested material?
Ask for the specific grade and the report. We confirm whether a current report exists for that grade and method rather than implying the whole range is covered.
Can you supply material for surgical gowns?
SMS and SMMS structures are used for gowns. Whether a grade is suitable depends on the standard the gown must meet and the testing the device maker performs.
Who arranges third party testing?
Either side, agreed before the sample is prepared. Named lab and named method, written in the enquiry.
Do you supply sterilised material?
No. Sterilisation is a device process, carried out by the device manufacturer.