Surgical Instruments Urology Resectoscope Working Element with OEM Acceptable

1 Introduction:
If you are looking for minimally invasive surgery medical instruments with good quality, competitive price and reliable service. Wanhe medical is manufaturing these for you. We provide general and professional laparoscopic instruments with CE, FDA approved.

2 Specifications
Adopt 3Cr13, 304, 630 stainless steel material
Tough construction
Corrosion resistant
High durability
Safety application

FAQ

Update of medical device performance test methods and standards

The update of medical device performance test methods and standards is a complex and ongoing process involving multiple aspects and requirements. The following is a detailed answer to this question based on the data:

1. Test methods and steps
When conducting medical device performance testing, it is necessary to first formulate a clear test plan, including determining the test objectives, selecting appropriate test methods, preparing test samples, and setting up the test environment. The experimental design should ensure that the performance of medical devices can be fully and accurately evaluated.

2. The importance of standardization
Many relevant standards for medical device performance testing have been formulated, which provide detailed test methods and requirements to make the test results comparable. For example, the ISO 10993 standard covers biocompatibility testing, mechanical strength testing, durability testing and other aspects. In addition, the GB 9706.1-2020 series of standards has also been released and will be implemented from May 1, 2023. Its supporting parallel standards and special standards are being released one after another.

3. Biocompatibility testing
Biocompatibility testing is an important means of evaluating whether materials will cause adverse reactions after contact with organisms. Commonly used biocompatibility testing methods include skin irritation tests, cytotoxicity tests, and orthopedic implant tests. These tests can understand the irritation and toxicity of materials to human tissues.

4. Special requirements for artificial intelligence medical devices
For medical devices that use artificial intelligence technology, such as lung imaging assisted analysis software, there are special algorithm performance testing methods. These methods specify the intended use, test conditions, and specific test indicators to ensure the high-quality development of products. For example, the YY/T 1858-2022 standard describes in detail the algorithm performance testing methods for these software.

5. International standards and regulations
Internationally, the European Union (EU) and the United States (FDA) have corresponding medical device performance testing standards and guidelines. For example, the EU's (EU) 2017/746 regulation provides standards and general specifications for device performance testing. The "Coronary, Peripheral and Neurovascular Guidewires - Performance Testing and Recommended Labeling Guide" issued by the FDA also provides specific methods and recommendations.

6. Continuous Improvement and Update
Clinical evaluation is the process of evaluating and analyzing clinical data of medical devices to verify their safety and performance. It runs through the entire life cycle of medical devices and updates risk analysis and instructions based on newly obtained clinical safety and performance information. In addition, SFDA may update relevant standards based on changes in international standards and changes in market demand.

Conclusion
The update of medical device performance test methods and standards is a dynamic process that requires continuous adjustment and improvement in combination with the latest scientific research, technological advances, and regulatory requirements. By strictly following standardized test methods and continuous clinical evaluation, the safety and effectiveness of medical devices can be ensured, thereby better serving patients and the development of the medical industry.

What are the latest updates to the ISO 10993 standard in medical device performance testing?

The latest updates to the ISO 10993 standard focus on ISO 10993-17:2023, which has been updated in terms of toxicological risk assessment of medical device components. Specifically, information on the update and review focus of ISO 10993-17:2023 standard is provided, which shows that the standard has been updated in terms of chemical characterization data of implantable devices, exemption of some biocompatibility tests, basic process of chemical characterization, etc.

In addition,
the revision status of ISO 10993 series of standards is mentioned, including major revisions to the irritation and skin allergy test part (ISO 10993-10), and basic evaluation concepts using chemical analysis. This shows that ISO 10993 standard has been updated in terms of chemical characterization and biosafety assessment methods.

The updated content of ISO 10993 series of standards is further supplemented, especially in terms of chemical characterization, providing three new professional competence tests: total immersion method for extractable substances, quantitative and qualitative analysis of extractables and permeables, quantitative analysis of multiple elements, etc.

The latest updates of ISO 10993 standard mainly involve toxicological risk assessment of medical device components, chemical characterization, modification of biosafety assessment methods, and introduction of professional competence test plan in chemical characterization.

Since the implementation of the GB 9706.1-2020 series of standards, what specific impacts have they had on medical device performance testing?

Since the implementation of the GB 9706.1-2020 series of standards, it has had a significant impact on medical device performance testing. The following are the specific impacts:

The GB 9706.1-2020 standard was officially implemented on May 1, 2023. This standard not only strengthens the basic safety and basic performance requirements of medical electrical equipment, but also indicates that my country's medical device industry will enter a stage of high-quality and rapid development.

The new national standard GB 9706.1-2020 has increased the requirements for risk management. The written warnings or contraindications in the product manual should be clearly stated in the manual only when the conclusion is that the risk is unacceptable after risk management analysis.

According to the new national standard, in vitro diagnostic equipment is not applicable to the GB 9706.1-2020 standard.

During the implementation of the standard, there are differences in the understanding of the content of the standard by the drug supervision and administration department, the technical review department, and the medical device inspection agency, which may affect the implementation of the standard.

The training content of the comparison between the new and old standards includes how to implement the test items required by the standards in the design, as well as countermeasures and classic case sharing for the test items that often fail to meet the standards for medical electrical products.

Under the new regulations, enterprises need to pay attention to electromagnetic compatibility supervision and countermeasures, and carry out electromagnetic compatibility design and verification in the relevant design and development process.

The new standard adds environmental awareness design requirements to ensure the safety and reliability of medical electrical equipment and systems in different environments.

What are the changes in the latest international standards and regulations in terms of biocompatibility testing?

In terms of biocompatibility testing, the latest international standards and regulations have changed significantly, especially the update of the ISO 18562 series of standards. These changes are mainly reflected in the following aspects:

Update of test requirements: The ISO 18562 series of standards revised in 2024 provides comprehensive guidance on the biocompatibility assessment of medical devices and respiratory gas pathways and updates the test requirements.

Introduction of new terms: The new version of the standard introduces new terms to more accurately describe related concepts and test methods.

Consideration of device aging and life cycle effects: The standard adds considerations for device aging and the effects of the entire life cycle, which means that manufacturers need to consider these factors during the design and testing phase.

New challenges in toxicological assessment methods: New toxicological assessment methods are proposed, which may affect how manufacturers conduct risk assessments and product development.

Testing for volatile organic compounds (VOCs): ISO 18562-3:2024 specifies in detail the testing of volatile organic compound emissions in the air circuit of medical devices and their components or accessories used to provide respiratory care or supply substances to patients through the respiratory tract in all environments.

Detailed provisions for flow rate selection: For active medical devices, such as ventilators, the standard specifies in detail how to select the test flow rate, taking into account factors such as flow, volume and pressure.

Principles of biological assessment in the risk management process: ISO 18562-1:2024 specifies the general principles of biological assessment in the risk management process of medical device air circuits, their components or accessories.

Annex mapping of regulatory requirements: A new informative annex has been added to help understand the regulatory requirements related to the standard.

What are the new developments or improvements in the algorithm performance test methods for artificial intelligence medical devices?

The algorithm performance test methods for artificial intelligence medical devices have developed and improved significantly in recent years, mainly in the following aspects:

Standardization and normalization:

The "YY/T 1907-2023" standard describes in detail the algorithm performance test methods for coronary CT image processing software using artificial intelligence technology. This standard applies to software products that post-process coronary CT images.
Similarly, the "YY/T 1858-2022" standard also specifies the algorithm performance test methods for lung image-assisted analysis software, including test indicators and calculation methods for application scenarios such as target detection, region segmentation and measurement, and image classification.
Multi-scenario application testing:

In the use of supercomputing platforms and AI algorithm verification research, test methods for multiple algorithm application scenarios, such as target detection, region segmentation and measurement, image classification, etc., are proposed, and corresponding test indicators and calculation methods are formulated for each scenario.
Quality characteristic testing:

The test content is not limited to the functionality of the algorithm, but also includes its quality characteristics such as robustness, generalization, and reasoning efficiency. For example, in stress testing, the stability of the algorithm is evaluated by selecting specific stress samples; at the same time, the algorithm repeatability and consistency may also be tested.
Error statistics and evaluation:

Statistics and evaluation of algorithm errors is another important direction for improvement. This includes detailed recording and analysis of the performance of the algorithm in actual applications to ensure its accuracy and reliability.
Industry consensus and innovation:

The expert consensus document points out that as the research and development and transformation of artificial intelligence medical devices enter an active period, the performance evaluation methods of products need to be standardized and urgently need innovation. This innovation aims to promote industry development, support supervision, and improve product quality.
What are the differences or supplements between the European Union (EU) Regulation 2017/746 and the FDA's "Coronary, Peripheral and Neurovascular Guidewires - Performance Testing and Recommended Labeling Guidelines" in terms of medical device performance testing?
There are significant differences and supplements between the European Union (EU) Regulation 2017/746 and the FDA's "Coronary, Peripheral and Neurovascular Guidewires - Performance Testing and Recommended Labeling Guidelines" in terms of medical device performance testing.

First, from the scope of application of the regulation, the EU Regulation 2017/746 is mainly aimed at in vitro diagnostic medical devices (IVDs), and its purpose is to ensure that these devices meet high quality and safety standards before entering the market. The regulation emphasizes the data reliability and robustness of performance studies and requires manufacturers to provide detailed information to help users make medical decisions. In addition, the regulation also stipulates specific requirements for self-testing or near-patient testing devices. In contrast, the FDA's "Coronary, Peripheral and Neurovascular Guidewires-Performance Testing and Recommended Labeling Guide" focuses on specific types of vascular interventional devices, such as coronary, peripheral and neurovascular guidewires. The guide replaces the old version of the 1995 guide and recommends performance tests such as coating integrity and particle detection. It represents the FDA's current views on the topic. Although it is not mandatory, it provides a reference standard for the public and the FDA. Secondly, in terms of the specific content of performance testing, the EU regulation focuses more on overall performance evaluation and data reliability. For example, it requires all in vitro diagnostic medical devices to pass rigorous performance testing before entering the market and needs to add the CE mark. At the same time, the regulation also contains open clauses that allow different interpretations to better adapt to different situations.

The FDA's guidance focuses more on performance test methods and labeling recommendations for specific devices. For example, it details how to conduct coating integrity and particulate testing and recommends the use of alternative methods to meet the requirements of relevant regulations. This targeted guidance helps manufacturers better understand and comply with FDA regulations.

Finally, in terms of regulatory requirements, the EU regulations emphasize the importance of post-market surveillance and require manufacturers to take preventive or corrective measures when necessary.

The FDA's guidance focuses more on the results of performance testing and its impact on the public rather than specific regulatory measures.

The European Union (EU) Regulation 2017/746 and the FDA's Coronary, Peripheral and Neurovascular Guidewires - Performance Testing and Recommended Labeling Guide have different focuses on medical device performance testing: the former covers the performance evaluation and data reliability of in vitro diagnostic medical devices more comprehensively, while the latter focuses on performance test methods and labeling recommendations for specific devices.

For more photos and details please contact me:
Company Name: Tonglu Wanhe Medical Instruments Co., Ltd.
Sales: Aiden