Medical Nebulizer China NMPA Registration Testing
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 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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