Which quality certifications have Osen Medical’s hospital beds obtained?

Quality certifications serve as a critical gateway for hospital beds to access global markets, as they validate a product’s adherence to stringent safety and performance benchmarks. Osen Medical’s hospital beds have secured three core certifications that underscore their quality: CE (for the European Union), FDA (for the United States), and ISO 13485.

CE certification mandates strict compliance with the Medical Device Regulation (MDR) 2017/745. Key compliance tests include ensuring the safety of lifting mechanisms (preventing sudden drops), the sturdiness of guardrails (withstanding 100kg of impact), and the flame resistance of mattresses (in line with EN 1021-1 standards). Osen’s hospital beds successfully pass all these rigorous assessments, enabling their legal sale across EU member states.

FDA approval entails rigorous scrutiny of product design, manufacturing workflows, and clinical evidence. Osen’s electric hospital beds fully meet FDA’s electrical safety standards (IEC 60601-1), boasting an insulation resistance of no less than 10MΩ to eliminate electric shock risks. The FDA also verifies the precision of key functions, such as height adjustment (with an error margin of ±1cm) and side-turn angles (ranging from 0° to 45°).

ISO 13485 certification encompasses the full spectrum of the quality management system, spanning from raw material procurement to after-sales service. Osen’s production process undergoes annual audits to retain this certification, ensuring consistent quality control across every batch of products.

Beyond these certifications, Osen’s hospital beds undergo supplementary tests to further guarantee reliability. These include noise level monitoring (capped at ≤50 decibels during operation), load-bearing capacity verification (supporting no less than 200kg), and corrosion resistance assessment (validated via a 48-hour salt spray test). Each certified hospital bed is clearly labeled with certification marks and a unique serial number, enabling full lifecycle traceability.

Collectively, these certifications underscore Osen’s unwavering commitment to quality, earning the trust of medical institutions across more than 100+ countries worldwide.