MDR & ISO 13485
Cleanrooms for Medical Devices under MDR and ISO 13485
Since the EU Medical Device Regulation (MDR 2017/745) came into force, stricter requirements apply to the manufacture, documentation and traceability of medical devices. PETEK supports medical technology companies with cleanroom solutions that take these regulatory requirements into account from the outset.
Depending on the product classification (I, IIa, IIb, III) and sterilisation route, ISO class 7 or 8 environments are used. PETEK delivers the appropriate cleanroom — from a compact ISO 8 cell for plastic components to a fully qualified ISO 7 cleanroom for sterile single-use articles.
Our Focus Areas
Medical Technology — Cleanroom & Standards
Implants & Single-Use Articles
Joint implants, catheters, syringes and surgical instruments are manufactured in controlled environments to ISO 13485. PETEK realises ISO 7 cleanrooms with complete qualification documentation for Class III medical device manufacturing.
Diagnostics & In-Vitro Diagnostics
Test strips, reagents and analysers require particle-controlled production and filling environments. PETEK delivers tailor-made cleanroom solutions to ISO 14644 and IVDR 2017/746.
Assembly of Medical Devices
Electrical medical devices, pump systems and monitoring equipment are assembled in ISO 8 or ISO 7 cleanrooms. PETEK integrates cleanroom cells efficiently into existing production halls.
Packaging & Sterilisation
The packaging of sterile medical products prior to ETO or gamma irradiation takes place in cleanrooms with defined particle limits. PETEK plans and builds these packaging areas to ISO 14644 and EN 868.
Standards Expertise
Cleanroom Classes for Medical Technology
PETEK delivers cleanrooms of ISO classes 5 to 8 for medical device manufacturers. Which class is required depends on the product class, sterilisation route and applicable regulations (MDR, ISO 13485, ISO 14644).
- ISO 5 / ISO 7 — sterile single-use articles & implants
- ISO 7 / ISO 8 — assembly of medical devices
- ISO 8 — plastic components & technical parts
- ISO 13485-compliant documentation & traceability
- MDR 2017/745 — Classes I to III
- IQ/OQ/PQ qualification documentation included
Typical Applications:
- → Joint implants & orthopaedic products
- → Disposable syringes & catheters
- → Diagnostics & in-vitro test systems
- → Electrical medical devices & monitors
- → Sterile packaging prior to ETO/gamma irradiation
- → Endoscopes & surgical optics
Cleanroom for your medical technology production?
Our sales engineers are familiar with MDR requirements and ISO 13485 specifications. Contact us — free of charge and without obligation.