Product Description: CSD alcohol wipes contain 75% alcohol solution and are used for local skin cleaning and disinfection before medical procedures such as injections, acupuncture, and blood glucose testing. They can also be used to wipe instruments and dashboards to reduce the chance of bacterial infection.
Purpose: CSD alcohol wipes are suitable for cleaning, disinfecting, and inhibiting bacteria on skin surfaces and instruments; for skin disinfection and cleaning before invasive examinations.
Directions for Use: Take out a CSD alcohol wipe and wipe directly on the skin, hands, or instruments to achieve cleaning and disinfection.
Warnings and Precautions: This product is for external use only. (Avoid using on mucous membranes such as eyes and lips.)
China Surgical Dressings Center Co., Ltd.
The product underwent relevant testing and evaluation during the design and development verification stage. All test results met the specified acceptance criteria, as detailed below:
1. In Vitro Cytotoxicity Test (ISO 10993-5)
Acceptance Criteria: Non-cytotoxic.
Result: Passed.
2. Skin Sensitization Test (ISO 10993-10)
Acceptance Criteria: No skin sensitization reaction.
Result: Passed.
3. Skin Irritation Test (ISO 10993-23)
Acceptance Criteria: No skin irritation reaction.
Result: Passed.
4. Alcohol Concentration Test
Acceptance Criteria: Alcohol concentration between 70.5% and 82.5%.
Result: Passed.
5. Stability Tests
(1) Tensile Strength Test
Acceptance Criteria: > 1 kgf
Result: Passed.
(2) Burst Test
Acceptance Criteria: ≥ 4 kPa
Result: Passed.
(3) Creep Burst Test
Acceptance Criteria: ≥ 3.2 kPa
Result: Passed.
(4) Seal Strength Test
Acceptance Criteria: ≥ Average 150 g/in
Result: Passed.
All testing results complied with the applicable specifications and acceptance criteria.
The product has successfully passed relevant verification tests, including biocompatibility evaluations (cytotoxicity, skin irritation, and skin sensitization), alcohol concentration testing, and stability testing, to ensure product quality and stability.
For quality-related abnormal events, a CAPA (Corrective and Preventive Action) system has been implemented to address and prevent issues. Through systematic root cause analysis, the system is designed to both prevent the recurrence of identified problems and proactively mitigate potential risks, thereby ensuring process and product compliance.
Risk management analysis is conducted in accordance with ISO 14971 to evaluate hazards, potential risks associated with product use, and corresponding risk control measures. The scope of application covers all or part of the product life cycle, from design and development through end-of-life.
By collecting and reviewing customer complaint records, TFDA defective product and adverse event reports, product quality abnormality records, customer satisfaction surveys, and recall event data, root cause analysis is conducted and corrective actions are established to reduce the occurrence of product quality issues.
