China medical device standards February 2023 updates cover 33 mandatory and recommended standards for specific medical electrical equipment. 32 standards were announced by the National Medical Products Administration (NMPA) on January 16, 2023, whilst the specific YY/T 1888-2023 standard for recombinant humanized collagen was later announced on January 28, 2023.
According to the China NMPA, the implementation of the new standards aims to:
- improve the quality of the products
- refine and clarify product requirements
- protect the patient’s safety when the respective product is in use
Here below is a breakdown of the new released standards for reference.
Mandatory industry standards for medical devices
- YY 0054-2023 Hemodialysis equipment
- YY 0777-2023 RF hyperthermia equipment
- YY 9706.230-2023 Medical electrical equipment – Part 2-30: Particular requirements for the basic safety and basic performance of automatic non-invasive sphygmomanometers
- YY 9706.246-2023 Medical electrical equipment – Part 2-46: Particular requirements for the basic safety and basic performance of operating tables
- YY 9706.249-2023 Medical electrical equipment – Part 2-49: Particular requirements for the basic safety and basic performance of multi-parameter patient monitors
- YY 9706.261-2023 Medical electrical equipment – Part 2-61: Particular requirements for the basic safety and basic performance of pulse oximetry equipment
- YY 9706.277-2023 Medical electrical equipment – Part 2-77: Particular requirements for the basic safety and basic performance of assistive surgical equipment using robot technology
Recommended industry standards for medical devices
- YY/T 0506.1-2023 Medical operating sheets, surgical gowns and clean clothing – Part 1: General requirements
- YY/T 0606.15-2023 Test method for evaluating matrix and scaffold immune response of tissue engineering medical products: lymphocyte proliferation test
- YY/T 0720-2023 General requirements for disposable packaging
- YY/T 0730-2023 Requirements for disposable tubing packages for cardiovascular surgical implants and artificial organs cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
- YY/T 0870.7-2023 Genetic toxicity test for medical devices Part 7: Alkaline comet test in mammals
- YY/T 1473-2023 Formulation of standards related to safety content in the work guide of medical device standardization
- YY/T 1842.7-2023 Medical devices – Connectors for delivery systems of medical fluid containers – Part 7: Connectors for intravascular infusion
- YY/T 1850-2023 Technical requirements and test methods of polyurethane condoms for men
- YY/T 1861-2023 Special technical requirements for medical image storage and transmission system software
- YY/T 1862-2023 Special technical requirements for coronary artery CT image processing software
- YY/T 1863-2023 Biological evaluation of nano-medical devices Release and characterization of silver nanoparticles and silver ions in nano-silver dressings
- YY/T 1867-2023 Sports medical implant with wire anchor
- YY/T 1869-2023 Detector array dosimetry system performance and test methods
- YY/T 1871-2023 Medical isolation clothing
- YY/T 1876-2023 Method for determination of DNA residue of animal-derived biomaterials in tissue engineering medical products: fluorescence staining method
- YY/T 1878-2023 Technical requirements for digitization of positron emission tomography device
- YY/T 1886-2023 Dental capsule amalgam
- YY/T 1106-2023 Electric operating table
- YY/T 1719-2023 General technical requirements for positron emission tomography and magnetic resonance imaging equipment
- YY/T 1840-2023 General specification for medical magnetic resonance imaging equipment
- YY/T 1888-2023 Recombinant humanized collagen
Industry standard for in vitro diagnostic reagents (IVD)
- YY/T 1199-2023 Triglyceride determination kit (enzymatic method)
- YY/T 1240-2023 D-dimer assay kit (immunoturbidimetry)
- YY/T 1789.6-2023 Methods for evaluating the performance of in vitro diagnostic test systems Part 6: Precision, diagnostic sensitivity and specificity of qualitative reagents
- YY/T 1868-2023 Hepatitis B virus core antibody detection kit (luminescent immunoassay)
- YY/T 1870-2023 General requirements for liquid chromatography-mass spectrometry determination kit
Further information
Read our article on the upcoming China medical electrical equipment GN9706 standard which comes into effect on May 1, 2023.
Read the full announcements on the recent China medical device standards released in January 2023:
- 32 medical device industry standards (No.8-2023) announced on January 16, 2023
- Medical device industry standard YY/T 1888-2023 (No.14-2023) released for recombinant humanized collagen on January 28, 2023
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