EMC China Lab

Medical Nebulizer China NMPA Registration Testing

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Update time : 2024-07-12

China JJR LAB Help medical nebulizer products to comply with regulations and verify quality and safety. The testing services that can be covered include: electrical safety, electromagnetic compatibility, environmental testing, medical nebulizer performance, biological evaluation, cleaning, disinfection and sterilization verification, packaging and transportation, and other testing services.

 

Risk level classification

In China’s medical device registration management, medical nebulizers are classified as Class II medical devices;

 

Medical Nebulizer China NMPA Registration Testing(图1)


Medical Nebulizer Registration Testing

JJRLAB can provide you with a one-stop registration and testing solution for [medical nebulizers]. The testing services that can be covered include: electrical safety, electromagnetic compatibility, environmental testing, medical nebulizer performance, biological evaluation, cleaning, disinfection and sterilization verification, packaging and transportation, and other testing services.

 

Common product standards

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

YY 9706.111-2021;IEC 60601-1-11:2015,AMD1:2020

Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home care environment

Environmental testing

GB/T 14710-2009

Environmental requirements and test methods for medical electrical appliances

performance

EN 13544-1-2007+A1-2009

Respiratory therapy equipment - Part 1: Nebulizing systems and their components

ISO 27427:2023

Anaesthetic and respiratory equipment Nebulizing systems and components

YY/T 1743-2021

Nebulizer systems and components for anesthesia and respiratory equipment

YY 0109-2013

Medical ultrasonic nebulizer

GB/T 14233.1-2022

Inspection methods for medical infusion, blood transfusion and injection equipment Part 1: Chemical analysis methods

YY 0671-2021

Medical devices Sleep apnea therapy masks and application accessories

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

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 18562 series

Biocompatibility evaluation of breathing gas pathways in healthcare applications 

Cleaning, disinfection 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, disinfection 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/T0681.3-2010/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 Disinfection

Microbial barrier testing

Packaging and shipping verification

GB/T 4857; astm d4169 series; ISTA series

Packing and shipping

Tips: The above standards only list the standards that are often involved in product technical requirements, not all standards.

 


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