Product info
- Product name:Pipette, can be sterilized whole
- Product code:CC21070506
Packaging Specifications
- Outer Packaging Size:0.28 × 0.09 × 0.05 m
- Gross Weight:0.25 kg
- Net Weight:0 kg
- Volume:0
Description
Fully Sterilizable Pipette - Product Description
1. Product Introduction
The fully sterilizable pipette is a professional medical device for healthcare applications. Developed with advanced biomedical technologies and rich clinical experience, it is manufactured in compliance with international medical device standards and regulations.
It delivers stable performance in harsh clinical environments. Combining cutting-edge technology and user-friendly design, it is easy to operate for qualified medical professionals. Widely adopted in hospitals, clinics, diagnostic centers, imaging departments and medical research institutions worldwide, this product has undergone comprehensive research, development and clinical tests to ensure patient safety, reliable treatment effect and stable operation. Every unit passes strict quality inspections and meets or exceeds international regulatory and quality requirements.
2. Key Product Features
- Professional medical grade quality for various healthcare applications
- Adopts advanced technology to achieve excellent overall performance
- Built-in safety design to protect patients and operators
- Stable performance in demanding medical working environments
- Complies with international standards and holds official certifications
- Ergonomic design for easy operation by qualified medical staff
3. Detailed Technical Specifications
表格
| Parameter | Specification |
|---|---|
| Product Name | Fully Sterilizable Pipette |
| 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 method |
| Sterility Assurance Level | 10⁻⁶ (Compliant with ISO 11135) |
| Shelf Life | 5 years from the sterilization date under proper storage conditions |
| Storage Conditions | Room temperature (15-25°C), dry environment, keep away from direct sunlight |
4. Clinical Applications
Intended Use: This product shall only be operated by trained and qualified medical personnel in formal medical institutions. All operations must follow medical device regulations and clinical guidelines for diagnostic and therapeutic work.
- Medical Imaging: Auxiliary work for diagnosis and treatment
- Clinical Diagnosis: Patient examination and condition assessment
- Healthcare Delivery: Professional medical care services
- Patient Care: Comprehensive patient management
- Medical Research: Clinical research and development
5. Product Advantages
- Outstanding imaging and diagnostic capabilities
- Stable and consistent working performance
- Intuitive interface and simple operation
- Full compliance with safety regulations and complete certifications
- Professional technical support and comprehensive supporting services
- Robust structure for long service life
- Fully compliant with international medical device standards
6. Regulatory Compliance & International Certifications
This product meets all international regulatory requirements and holds the following authoritative certifications:
- FDA Approval: Authorized for commercial sales and clinical use in the United States
- CE Marking: Compliant with EU Medical Device Regulations, available for circulation and use across the European Union
- ISO 13485: Manufactured under certified quality management system to ensure stable product quality
- ISO 10993: Compliant with biocompatibility standards for medical devices
- ISO 11135: The ethylene oxide sterilization process conforms to relevant standards
- International General Standards: Compliant with all applicable international medical device regulations and specifications
7. Usage Guidelines & Precautions
- Personnel Requirements: Operators must receive professional training and hold valid qualifications, and abide by relevant regulations and manufacturer’s instructions
- Safety Protocols: Strictly follow safety rules and operating procedures stated in product manuals and training documents
- Maintenance & Calibration: Perform regular maintenance and calibration to maintain product performance and accuracy, and extend service life
- Quality Control: Use the product in accordance with medical device regulations, quality standards and internal institutional rules
- Technical Support: Professional team provides assistance, troubleshooting and operational training
- Documentation Management: Properly retain records of usage and maintenance to meet compliance and quality control requirements
8. Quality Assurance & Performance Standards
Every fully sterilizable pipette undergoes rigorous testing and verification covering the following items:
- Functional and accuracy tests under clinical working conditions
- Effectiveness inspection of safety protection devices
- Durability and long-term reliability tests for clinical use
- Verification of regulatory compliance and relevant certifications
- Practicality and usability tests of the operating interface
- Inspection of image quality and diagnostic accuracy
9. Professional Support & Services
We provide a full range of supporting services to ensure stable product operation:
- Technical Support: 24/7 technical consultation and troubleshooting
- Training Programs: Complete professional training for operators and medical staff
- Maintenance Services: Customized preventive maintenance plans to keep the product in optimal condition
- Replacement Parts: Genuine original components and matching accessories
- Regulatory Assistance: Guidance on regulatory compliance and document arrangement
- Clinical Consultation: Professional clinical advice to maximize product application value
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