Medical Nebulizer China NMPA Registration Testing

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