EMC China Lab

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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