Product info
- Product name:Equipo esterilizacion autoclave clase B 23 lt
- Product code:CC21070702
Packaging Specifications
- Outer Packaging Size:0.8 × 0.6 × 0.55 m
- Gross Weight:60 kg
- Net Weight:0 kg
- Volume:0.26
Description
Class B Autoclave Sterilizer 23L
Product Description
Class B Autoclave Sterilizer 23L, Model 23LD is a professional-grade medical device for healthcare use. Combining advanced biomedical technology and clinical expertise, it is manufactured in line with international medical device standards and regulatory requirements.
Engineered for reliable performance in demanding clinical environments, it adopts cutting-edge technology and user-friendly design to deliver optimal functionality for trained medical professionals. It is widely applicable to hospitals, clinics, diagnostic centers, imaging facilities and medical research institutions across the globe.
Developed via extensive research and clinical testing, it ensures patient safety, treatment efficacy and stable operation. Every unit undergoes strict quality inspection and meets or exceeds all international regulatory and quality standards.
Key Product Features & Specifications
- Professional-grade quality for healthcare applications
- Advanced technology for superior performance
- Comprehensive safety features to protect patients and operators
- Stable performance in harsh clinical environments
- Fully compliant with international standards and certified
- Ergonomic design for easy operation by qualified medical staff
Detailed Technical Specifications
表格
| Parameter | Specification |
|---|---|
| Product Name | Class B Autoclave Sterilizer 23L, Model 23LD |
| Product Type | Medical Device |
| Quality Standard | International Medical Device Standards (ISO 13485, ISO 10993) |
| Regulatory Certifications | FDA Approved, CE Marked, ISO 13485 Certified |
| Sterilization Method | Ethylene Oxide (EO) Sterilization or equivalent |
| Sterility Assurance Level | 10⁻⁶ (compliant with ISO 11135) |
| Shelf Life | 5 years from sterilization date under proper storage |
| Storage Conditions | Room temperature (15-25°C), dry place, away from direct sunlight |
Clinical Applications & Indications
Intended Use: This device shall be operated only by trained and qualified medical personnel in professional medical settings. It is used for diagnostic and therapeutic work in accordance with relevant medical regulations and clinical guidelines.
- Medical imaging: Diagnostic and therapeutic applications
- Clinical diagnosis: Patient assessment and examination
- Healthcare delivery: Professional medical services
- Patient care: All-round patient management
- Medical research: Clinical research and development
Product Advantages & Competitive Benefits
- Excellent overall performance
- Stable and consistent operation
- Intuitive interface and simple operation
- Complete safety certifications and regulatory compliance
- Professional technical support and after-sales services
- Durable structure for long-term service
- Full compliance with international medical device standards
Regulatory Compliance & International Certifications
This product complies with all international regulations and holds the following certifications:
- FDA Approval: Authorized by the U.S. FDA for commercial sales and clinical use in the United States
- CE Marking: Compliant with EU Medical Device Regulation, available for sales and use throughout the European Union
- ISO 13485: Manufactured under an ISO 13485 certified quality management system to ensure stable product quality
- ISO 10993: Compliant with medical device biocompatibility standards
- ISO 11135: Ethylene oxide sterilization process meets ISO 11135 requirements
- International Standards: Conforms to all applicable international medical device standards and regulations
Usage Guidelines & Best Practices
- Operator Training: Only trained and qualified personnel are permitted to operate the device, following relevant regulations and manufacturer guidelines.
- Safety Protocols: Strictly follow safety rules and operating instructions stated in the product manual and training materials.
- Maintenance & Calibration: Perform regular maintenance and calibration to maintain optimal performance, accuracy and service life.
- Quality Assurance: Use the device in accordance with medical regulations, quality standards and institutional rules.
- Professional Support: A dedicated team provides technical assistance, troubleshooting and professional training.
- Documentation: Keep complete records of usage and maintenance for regulatory compliance.
Quality Assurance & Performance Standards
All units are subject to rigorous testing and validation to guarantee reliable performance. Test items include:
- Functional performance and operational accuracy under clinical conditions
- Effectiveness of safety mechanisms and compliance inspection
- Durability and long-term reliability for clinical use
- Verification of regulatory compliance and relevant certifications
- Usability test of the operating interface
- Working performance and accuracy inspection
Professional Support & Services
We provide comprehensive services to ensure stable operation and good user experience:
- Technical Support: 24/7 technical consultation and troubleshooting
- Training Programs: Systematic training for operators and clinical staff
- Maintenance Services: Customized preventive maintenance plans
- Replacement Parts: Supply of genuine original parts and accessories
- Regulatory Assistance: Guidance on compliance and document arrangement
- Clinical Consultation: Professional advice to maximize device efficiency
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