Urology Cystoscopy Endoscope Accessories Bridge for Customized Request Pediatric

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 optinum stainless steel material
Corrosion resistant
Tough construct
Superb workmanship

3 Various Type For Your Reference

FAQ

What are the international standards and certifications for urological surgical instruments?

The international standards and certifications for urological surgical instruments mainly include the following aspects:

Urological surgical instruments need to comply with the European CE certification, which is a necessary condition for entering the EU market.

The US Food and Drug Administration (FDA) has strict certification requirements for urological surgical instruments.

The International Organization for Standardization (ISO) has developed a series of standards related to medical devices. For example, ISO 8827:1988 specifies the dimensions and characteristics of various types of nails used in surgical procedures. In addition, ISO 9001-2008 is a standard for quality management systems, which all surgical instruments should meet. GB/T 2766-2022 is the Chinese version of the general requirements and test methods standard for non-cutting articulated instruments, which is applicable to various clinical departments and various surgical forms.

Including medical standards developed by the Spanish AEOR and UNEN, such as UNEN-EN ISO 13485, these standards play an important role in the field of medical and surgical instruments.

Certain specific urological surgical equipment also needs to comply with the corresponding international standards. For example, equipment such as bladder laser resectoscopes, morcellator lens kits, and ultrasonic knife systems must meet relevant technical requirements and obtain corresponding certifications.

In summary, the international standards and certifications for urological surgical instruments mainly cover CE certification, FDA certification, ISO standards, and other specific product certifications. These standards ensure the safety and effectiveness of surgical instruments and provide patients with high-quality medical services.

What are the specific requirements for urological surgical instruments in European CE certification?

Urological surgical instruments that undergo CE certification in Europe need to follow a series of strict requirements and processes. The following are the specific requirements:

Urological surgical instruments are medical devices, so the applicable EU medical device regulations need to be determined based on their risk level. From May 26, 2021, the new EU Medical Device Regulation (MDR 2017/745) replaces the previous directive (MDD 93/42/EEC) and becomes the main regulation.

Manufacturers need to conduct a detailed technical evaluation of the product and prepare corresponding test reports and documents. These documents include product design, manufacturing process, performance test results, and risk management reports.

Depending on the risk level of the product, the manufacturer needs to choose the appropriate compliance assessment procedure:

Class I devices: the manufacturer is responsible for it, that is, self-certification.
Class IIa devices: the notified body needs to intervene in the production stage.
Class IIb and III devices: the notified body needs to check the design and manufacturing.
Appoint an authorized representative located in the EU to ensure that the product complies with all relevant EU regulations and provide necessary support services.

You can adopt the "self-declaration" model or the third-party certification model. For high-risk Class III devices, third-party certification is usually required.

Finally, the manufacturer needs to submit all relevant documents to the notified body for review, and only after passing the review can the CE mark be obtained.

In short, CE certification of urological surgical instruments in Europe requires a rigorous evaluation and review process to ensure that the product meets the basic safety and performance requirements of the EU.

What are the latest certification standards and requirements of the US FDA for urological surgical instruments?

The latest certification standards and requirements of the US FDA for urological surgical instruments are mainly reflected in the following aspects:

Revision of the Quality Management System (QMSR) for Medical Devices: According to the FDA, the US Food and Drug Administration (FDA) revised the existing Quality Management System for Medical Devices (QSR 820) on January 31, 2024 and issued a final rule. This includes updates to the current good manufacturing practice (CGMP) requirements to more closely align with the international standards for medical device quality management systems used by many other regulatory agencies around the world.

Release of consensus standards for medical devices: It is mentioned that the FDA issued a Federal Register "Revision of the Consensus Standard List" on March 1, 2024, which is intended to help manufacturers who choose to declare compliance with consensus standards meet certain requirements for medical devices. Although the standards specific to urological surgical instruments are not listed in detail, the existence of consensus standards means that manufacturers need to follow these standards to ensure that their products meet FDA requirements.

Recognition of the ISO 18562 series of standards: It is pointed out that the FDA partially recognized the ISO 18562-1:2024 standard in March 2024, which is a new standard for respiratory equipment manufacturers. Although this does not directly involve urological surgical instruments, the update and recognition of ISO standards may affect medical devices in related fields, including urological surgical instruments.

Understanding the entire process of medical device registration: provides information on how to understand the entire process of medical device registration with the US FDA, which is necessary for any medical device manufacturer who hopes to enter the US market. Although there is no direct mention of specific requirements for urological surgical instruments, understanding the entire registration process is essential to ensure that the product meets FDA standards.

The latest certification standards and requirements of the US FDA for urological surgical instruments mainly involve updates to quality management systems, the publication of consensus standards, and the recognition of specific international standards.

What specific impact does the ISO 8827:1988 standard have on the design and manufacture of urological surgical instruments?

The ISO 8827:1988 standard has a significant impact on the design and manufacture of urological surgical instruments, mainly in the following aspects:

Dimension and tolerance specifications: This standard specifies in detail the dimensions, tolerances, and shapes of U-shaped staples used in orthopedics. These specifications ensure the interchangeability and compatibility of implants between different manufacturers, thereby improving the safety and effectiveness of surgery.

Standardization of forms and names: ISO 8827:1988 describes different forms of U-shaped staples and provides a unified standard for their names. This standardization helps doctors and engineers make more accurate decisions when selecting and using these implants.

Guidance on selection and use: The informative annexes accompanying the standard provide guidance on how to select and use U-shaped staples. This not only helps medical professionals better understand the characteristics of these implants, but also promotes the popularization of best practices.

General requirements and scope of application: ISO 8827:1988, as a general requirement, applies to all U-shaped staple implants related to orthopedics. This means that it provides a unified set of standards for the entire orthopedic field, thereby improving the overall quality of medical care.

What types of urological surgical instruments does the GB/T 2766-2022 standard apply to, and what are its main contents?

The GB/T 2766-2022 standard applies to non-cutting articulated instrument products, including but not limited to hemostatic forceps, needle holders, retractors and other clinical surgical essential instruments. These devices are widely used in various clinical departments and various surgical procedures in hospitals of all levels in all cities across the country.

The main contents of this standard include:

Material requirements: Specifies the material use requirements for non-cutting articulated devices.

General requirements: Specific general requirements are put forward for non-cutting articulated devices.

Test methods: Various test methods are described in detail to ensure that the products meet the relevant quality standards.

Marking requirements: Clear requirements are put forward for the identification and labeling of products.

What is the role of the UNEN-EN ISO 13485 standard in the field of urological surgical instruments and its impact on product quality management?

The role of the UNEN-EN ISO 13485 standard in the field of urological surgical instruments and its impact on product quality management are mainly reflected in the following aspects:

The ISO 13485 standard provides detailed requirements for the quality management system (QMS) of medical devices to ensure that the entire process from design, production to installation and maintenance meets quality requirements. This includes preparing quality manuals, policies and objectives, controlling document integrity, and emphasizing the role of management in developing and maintaining a quality management system.

EN ISO 13485:2016 has become the harmonized standard for EU Medical Device Directives such as MDD, AIMDD and IVDD, which means it helps organizations demonstrate their ability to provide medical devices that meet user and legal standards. In addition, the standard also incorporates the relationship with the provisions of MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Medical Device Regulation), further enhancing its applicability in the regulatory environment.

Implementing ISO 13485 and obtaining certification can significantly improve the operational efficiency and product quality of enterprises, thereby enhancing market competitiveness and customer trust. This not only helps to expand the potential market, but also improves the regulatory approval rate in major markets such as the EU and Canada.

In urology operating rooms, refined management can effectively improve the management quality of high-value medical consumables and the satisfaction of surgeons through the implementation of ISO 13485 standards, thereby improving the overall level of care management.

The ISO 13485 standard also covers the application of risk management, helping organizations identify and reduce potential risks and ensure the reliability and safety of products. In addition, it provides comprehensive product realization guidance with detailed specifications from customer requirements to the entire life cycle of design, manufacturing, installation and maintenance.

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