Electrosurgical Devices China NMPA Certification Testing

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Update time : 2024-06-08

China JJRLAB Help high-frequency surgical equipment to achieve product compliance and verify quality and safety. The testing services that can be covered include: electrical safety, electromagnetic compatibility, environmental testing, biological evaluation, sterilization verification, packaging and transportation, and other testing services.

Electrosurgical Devices China NMPA Certification Testing(图1)

Risk level classification

In the medical device registration management in my country: the risk level management category of high-frequency electrosurgical units is Class III; the risk level management category of high-frequency electrocautery devices is Class II.

High-frequency surgical equipment registration test

JJRlab can provide you with a one-stop registration and testing solution for high-frequency surgical equipment. The testing services covered include: electrical safety, electromagnetic compatibility, environmental testing, biological evaluation, sterilization verification, packaging and transportation, and other testing services.

Applicable standards for high-frequency surgical equipment

Test items	standard	standard name
EMC	yy 9706.102-2021；IEC60601-1-2:2014+A1:2020	Medical electrical equipment Part 1-2: General safety requirements Collateral standard: Electromagnetic compatibility requirements and tests
Safety	GB 9706.1-2020；IEC 60601-1:2005/COR3:2022	Medical electrical equipment Part 1: General requirements for basic safety and essential performance
	YY/T 9706.106-2021；IEC 60601-1-6:2010+A1:2013+A2:2020	Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral standard: Usability
	GB 9706.202-2021；EC 60601-2-2:2017/AMD1:2023	Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high-frequency surgical equipment and high-frequency accessories
	GB 9706.218-2021；IEC 60601-2-18:2009	Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
Foot switch	YY/T 1057-2016	General technical requirements for medical foot switches
Environmental testing	GB/T 14710—2009	Environmental test requirements and test methods for medical electrical appliances
Biological evaluation	GB/T 16886.1—2022	Biological evaluation of medical devices Part 1: Evaluation and testing in the risk management process
	GB/T 16886.5—2017	Biological evaluation of medical devices Part 5: In vitro cytotoxicity test
	GB/T 16886.10—2017	Biological evaluation of medical devices Part 10: Irritation and skin sensitization tests
	GB/T 16886.11-2021	Biological evaluation of medical devices Part 11: Systemic toxicity tests
	ISO 10993-1:2018	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
	ISO 10993-5:2009	Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
	ISO 10993-10:2021	Biological evaluation of medical devices Part 10: Tests for skin sensitization
	ISO 10993-23:2021	Biological evaluation of medical devices Part 23: Tests for irritation
	ISO 10993-11:2017	Biological evaluation of medical devices Part 11: Tests for systemic toxicity
Cleaning, disinfeJJRLABon and sterilization validation	GB 18280.2/ISO11137-2	Radiation sterilization dose setting
	GB/T 16886.7/ ISO 10993-7	Ethylene oxide sterilization residual (EO/ECH)
	WS 310.1/WS 310.2/WS 310.3/WS/T 367/GB 18278.1/AAMI TIR30:2011/(R)2016/ AAMI TIR 12-2020/ASTM F3208-20/ ISO 17664/ISO 20857/ISO 25424/ YY/T 0734/ YY/T 1495	Cleaning, disinfeJJRLABon and sterilization validation
Sterile Medical Device Packaging Validation	GB/T 19633.1/ISO 11607-1/YY/T0681.1-/ASTMF1980-16	Accelerated aging test
	GB/T 19633.1/ISO 11607-1/GB/T 19633.2/ISO 11607-2/YY/T0681.2/ASTM F88/F88M-15	Seal peel test (seal strength)
	YY/T 0681.3-2010/ASTMF1140/F1140M-13	Burst test and creep test
	YY/T 0681.4-2021/ASTMF1929-15	Dye penetration test (seal leakage)
	GB/T 19633.1/ISO 11607-1/YY/T 0681.5-/ASTMF2096/YY/T0681.9/ASTMF2054/F2054M	Vacuum leak test
	YY/T 0681.9	Seal burst test
	YY/T0681.11/ASTMF1886/F1886M	Visual test
	YY/T 0681.14/ ISO 11607-1/DIN 58953-6/GB/T 19633.1/ Technical Specifications for DisinfeJJRLABon	Microbial barrier testing
Packaging and shipping verification	GB/T 4857; ASTM D4169 series; ISTA series	Packing and shipping

Warm reminder: The above standards only list the standards that are frequently involved in product technical requirements, not all standards.

General sample requirements

A complete and working prototype. For other details, please consult JJRLAB online customer service.

Our advantage

1. JJRLAB has a team of professionally qualified and experienced technical experts to provide you with professional consultation and services.

2. JJRLAB has advanced laboratory equipment to ensure the accuracy and reliability of test data.

3. As a third-party testing and certification organization trusted by customers around the world, JJRLAB is your endorsement of quality.

4. With our global network of laboratories, we can provide you with a comprehensive one-stop testing and certification solution.

common problem

How long is the testing cycle for JJRLAB's medical device testing?

The actual cycle is determined by the entrusted product standards. Please contact JJRLAB customer service for confirmation.

What are the testing methods for JJRLAB medical device testing?

We conduct standard testing according to the export requirements of products and the requirements entrusted by customers.

Email:hello@jjrlab.com

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