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Medical device testingList and introduce project standards
Medical device testingList and introduce project standards
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Medical device testingList and introduce project standards

List of relevant testing items of 100 inspectionsThird-party testing institutions support sample sending and door-to-door testing, mainly providing sample testing services for companies, enterprises, public institutions, individual businesses, and university scientific research, and reporting CMA/CNAS/CAL qualifications, which are true and effective.

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version of the testing cycle: 3-15 working days (expedited available)

Report qualification: CNAS, CMA, CAL, etc

Where do medical device testing go? Baijian Material Testing Agency can provide medical device testing services. It is a CMA qualification certification agency, high-tech enterprise, and third-party material laboratory. In response to problems encountered in product development and quality control, it provides comprehensive solutions such as composition testing, product testing, product testing, and instrument testing. The equipment is complete, and the scientific research team is strong. Test reports can be issued within 7-15 working days. It supports scanning codes to check authenticity, and nationwide on-site sampling Sending samples for testing services, with short testing cycles, low testing costs, and scientific and accurate testing data

Test cycle: 7-15 working days

Test cost: Engineers develop experimental plans and provide quotations based on customer testing needs and experimental complexity.

 &Nbsp; Medical device testing scope

Household medical devices, dental medical devices, pet medical devices, pharmaceutical medical devices, medical devices, sterile medical devices, oral medical devices, implanted medical devices, disposable medical devices, etc

 &Nbsp; Medical device testing projects

Safety testing, voltage withstand testing, availability testing, commercial sterility testing, biocompatibility testing, reliability testing, performance testing, insulation resistance testing, leakage protection testing, electromagnetic compatibility (EMC) testing, aging testing, bench testing, high-voltage electrostatic testing, sealing testing, operating noise testing, leakage current testing, mechanical performance testing, stability testing, ethylene oxide testing, Cleaning life test, grounding resistance test, airtightness test, seismic test, shell stiffness test, fluorescent penetration test, safety protection test, functional test, etc. (For more projects, you can consult an online laboratory engineer to provide you with detailed answers.)

 &Nbsp; What are the functions of the 100% inspection test report? What problems can we help you solve< p> 1. Sales and use. (Selling one's own products and issuing third-party testing reports to make customers more confident in the quality of their products)

2. Research and development for use. (During the research and development process, some challenging problems are encountered, which can be solved through testing report data to shorten the research and development cycle and reduce research and development costs.)

3. Improve product quality. (By comparing test data, identify the problems with one's own product, improve product quality, and reduce production costs)

4. Use of research paper data

5. Bidding and bidding (the 100% inspection cycle is relatively short, the inspection cost is low, and the recognition is relatively high, which is particularly suitable for bidding)

 &Nbsp; Testing Standards for Medical Devices

GB/T16886.1-2011 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing during Risk Management

GB/T16886.3-2019 Biological Evaluation of Medical Devices Part 3: Genetic Toxicity Carcinogenicity and Reproductive Toxicity Tests

GB/T16886.4-2003 Biological Evaluation of Medical Devices - Part 4: Selection of Blood Interaction Tests

GB/T16886.5-2017 Biological Evaluation of Medical Devices - Part 5: In vitro Cytotoxicity Tests

GB/T16886.6-2015 Biological Evaluation of Medical Devices - Part 6: Post Implantation Local Reaction Tests

GB/T16886.7-2015 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide

GB/T16886.9-2017 Biological Evaluation of Medical Devices Part 9: Qualitative and Quantitative Framework for Potential Degradation Products

GB/T16886.10-2017 Biological Evaluation of Medical Devices Part 10: Irritation and Skin Sensitization Tests

GB/T16886.11-2011 Biological Evaluation of Medical Devices Part 11: Systemic Toxicity Tests

GB/T16886.13-2017 Biological Evaluation of Medical Devices Part 13: Polymer Medical Devices Qualitative and Quantitative Evaluation of Degradation Products of Medical Devices

GB/T16886.18-2011 Biological Evaluation of Medical Devices Part 18: Chemical Characterization of Materials

GB/T16886.19-2011 Biological Evaluation of Medical Devices Part 19: Physical Chemistry of Materials Morphological and Surface Characterization

GB/T18457-2015 Stainless Steel Needles for Manufacturing Medical Devices

GB24627-2009 Nickel Titanium Shape Memory Alloy Processing Materials for Medical Devices and Surgical Implants

GB27949-2020 General Requirements for Medical Device Disinfectants

Function of testing report:

1. Project bidding: Issue authoritative third-party CMA/CNAS qualification report

2. Online e-commerce platform entry: Quality inspection report recognized by major e-commerce platforms

3. Used as a sales report: issuing legally effective testing reports to make consumers more confident

4. Papers and research: Provide professional personalized testing needs

5. Judicial services: providing scientific, fair, and accurate testing data

6. Industrial problem diagnosis: Verify the troubleshooting and correction of industrial production problems

100% inspection and testing process:

1. Telephone communication and confirmation of requirements

2. Recommend solutions and confirm quotations

3. Mail samples and arrange testing

4. Progress tracking and result feedback

5. Provide reports and after-sales service

6. If urgent or priority processing is required

Testing and testing characteristics:

1. The testing industry is fully covered, meeting different testing needs

2. Fully cover the laboratory and allocate localized testing nearby

3. Engineers provide one-on-one services to make testing more accurate

4. Free initial testing, with no testing fees charged

5. Self service order delivery for free on-site sampling

6. Short cycle, low cost, and attentive service

7. Possess authoritative qualifications such as CMA, CNAS, CAL, etc

8. The testing report is authoritative and effective, and is generally used in China

Baijian is a comprehensive testing service platform, bringing together many CNAS, CMA, CAL and other qualification testing institutions all over the country.