Material Composition | Medical devices (ECG adapters) | Industry: Stainless Steel (ISO 5832-1) ▲ Base: Medical-grade ABS/PVC (EN149-2001) ▲ Advanced: UV-coated ABS/PVC (ISO 10993) (Enhanced biocompatibility) | Lightweight, cost-effective, corrosion-resistant | Less flexible than silicone; EN149 may not align with device standards |
Disinfection Compatibility | Reusable medical tools | Industry: Chemical disinfectants (ethanol ISO 10993-5) ▲ Base: UV light (IEC 62351-8) ▲ Advanced: UV + chemical resistance (ISO 10993-5) (Withstands 50+ chemical exposures) | Non-corrosive, preserves material integrity | Requires UV equipment; chemical resistance adds cost |
Safety Compliance | Critical care environments | Industry: ISO 13485 ▲ Base: EN149-2001 (respiratory mask standard) ▲ Advanced: CE + ISO 13485 (Complies with medical device directives) | Regional regulatory alignment | Base EN149 may not apply to ECG adapters; Advanced requires additional testing |
Certification | Global medical markets | Industry: FDA, CE, ISO 13485 ▲ Base: FDA (RegistrationNumber) ▲ Advanced: FDA + CE + ISO 13485 (Ensures multi-regional use) | Regulatory approval for key markets | Base lacks CE for EU; Advanced increases cost |
Shelf Life | Short-term vs long-term use | Industry: 2 years (ISO 11607) ▲ Base: 1 year ▲ Advanced: 2 years (ISO 11607-compliant packaging; Maintains sterility longer) | Cost-effective for short-term needs | Base has shorter shelf life; Advanced requires better storage |
Instrument Classification | Hospitals requiring traceability | Industry: Class II ▲ Base: Class II ▲ Advanced: Class II with RFID traceability (ISO 15693; Enables digital tracking) | Meets regulatory requirements | Advanced adds complexity and cost; Base sufficient for basic needs |