Certification requirements depend on the target market. It must comply with a defined set of international standards that govern its design, performance, and safety.
In Europe, EU MDR and EN ISO standards apply. In North America, CGA standards are the reference framework.
Equipment that does not meet the certified standard requirements of its target market cannot be placed on the market or used in clinical settings.
Rotarex Meditec products are designed and manufactured in compliance with the following standards and directives:
- EU MDR (Medical Device Regulation): European market compliance for medical devices. Rotarex Meditec received its MDR certificate in January 2025. Certified by TüV Süd.
- EN ISO 10524-1 / EN ISO 10524-3: Pressure regulators for use with medical gases.
- EN ISO 10297: Cylinder valves for gas cylinders, specification and type testing.
- EN ISO 15996: Residual pressure valves, requirements and testing.
- EN 849 / EN ISO 407: Pin index safety systems for small medical gas cylinders.
- TPED Directive: Transport pressure equipment directive for cylinder valves.
- DIN 477 / CGA: Connection standards for cylinder valve outlets.
Full traceability documentation, material certification, and technical dossiers are available to support regulatory submissions and compliance audits in all markets.
UDI labelling and QR code are included on all products, ensuring full device identification and traceability across the supply chain
For a complete overview of Rotarex certifications, visit the certifications page.