MEDICAL DEVICESControlled Environment Technologies
Industry
Medical Devices
Bioburden, particle and residue control in medical device manufacturing and assembly.
Datasheet per part number
Standards referenced
Recurring consumption
A medical device is manufactured twice: the product, and the record showing how it was made. Environmental cleanliness is part of both, because the microbial load the product carries into sterilisation determines whether the chosen sterilisation cycle is enough.
Products for this industry
VANTERIS 3-Ply Pleated Face Mask, BlueVNT-73P-BL-5017.5 × 9.5 cm
VANTERIS Polyester Wipe 9 × 9 inVTN-WP-PES-LS-999 × 9 in (228.6 × 228.6 mm)
VANTERIS Sticky Mat 24 × 36 in, BlueVTN-MAT-PE-STK-2436-BLU24 × 36 in
VANTERIS Beard Cover 18 in, WhiteVTN-AP-PP-BRD-UNI-WHT18 in
Typical challenges
- Bioburden before sterilisation
- Adhered particles on implantable product
- Extractables and biocompatibility
- Consumable traceability and change control
Reference standards
| ISO 13485 | Quality management system for medical devices. |
|---|---|
| ISO 11737-1 | Determination of the population of microorganisms on product. |
| ISO 10993 | Biological evaluation of medical devices. |
| IEST-RP-CC003 | Garment systems for cleanrooms and controlled environments. |