This product is sintered with calcium phosphate salts at high temperatures, with open pores, which is suitable for filling bone defects. It can be absorbed and replaced by the human body during bone healing.
Oriental Resources Development Limited Biomedical Factory
Acceptance criteria for biological testing:
SAL (Sterility Assurance Level) 10^-6
Standard for Biocompatibility:
Cytotoxicity Test-ISO 10993-5
Intracutaneous Irritation Test-ISO 10993-10
Skin Sensitization Test(Maximization Method)-ISO 10993-10
Acute Systemic Toxicity, Systemic Injection Test-ISO 10993-11
Subacute Intravenous toxicity 14days
Genotoxicity
Bone Implant Test-90 days, with histopathology-ISO10993-6
Pyrogen test
usability (IEC 62366-1)
Stability test
Porosity Test
pH test
Compressive strength
X-ray diffraction analysis
Packaging integrity test: Dye penetration, seal strength
Risk analysis: Identifying hazards and hazardous situations that may affect safety and efficacy
The probability and the severity of Risk: Qualitative or quantitative categorization of probability of occurrence of harm and severity of harm.
Risk control: Develop risk response strategies, include Avoid, Transfer, Mitigate and Accept.
Monitoring and feedback: Continuously monitors risk situation and effectiveness of the controls.
Confirm that risk management information is effectively promoted in the organization.
Report risk situation and effectiveness of the controls to the top management.
Provide risk management training to improve employees' risk awareness.
Develop culture of risk management to involves all employees in the risk control process.
Execute according to our " Post-market Surveillance Practice"
1 Purpose: The information associated with the usage of products is collected in an appropriate way, such as dealing with customer complaints, returned goods or product recall, after products are shipped, and the information collected is fed back to the product design and manufacturing stages to ensure product safety and performance.
2 Scope: Medical products sold domestically by the Biomedical Group.
1 Advisory notice: (Definition of Medical Device Quality Management System Guidelines)
A notice issued to provide the information and/or suggestion for the action(s) to be taken for the use, modification, handling or return of the products.
2 Recall: Medical device recycling and disposal measures.
If a medical product violates the provisions of Paragraph 3 of Article 58, one or more of the following actions shall be taken to meet the requirements of the medical device recycling and disposal regulations.
