Code of China Chinese Standard Classification Professional Classification ICS Classification Latest
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Standard No. Title Price(USD) Delivery Status Add to Cart
YY 0945.2-2015 Medical electrical equipment―Part 2:Particular requirements for the safety of external cardiac pacemakers with internal power source $310.00 via email in 1~5 business day to be superseded
YY 1105-2008 Electric apparatus for gastric lavage $150.00 via email in 1~3 business day to be superseded
YY 9706.108-2021 Medical electrical equipment—Part 1-8:General requirements for basic safety and essential performance-Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems $900.00 via email in 1~5 business day valid
YY 9706.231-2023 Medical electrical equipment--Part 2-31: Particular requirements for thebasic safety and essential performance of external cardiac pacemakerswith internal power source $645.00 via email in 1~5 business day to be valid
YY 9706.278-2023 Medical electrical equipment--Part 2-78 : Particular requirements forbasic safety and essential performance of medical robots for rehabilitation,assessment,compensation or alleviation $900.00 via email in 1~8 business day to be valid
YY/T 0287-2003 Medical devices - Quality management systems - Requirements for regulatory purposes $280.00 immediately superseded
YY/T 0287-2017 Medical devices-Quality management systems- Requirements for regulatory purposes $140.00 immediately valid
YY/T 0316-2003 Medical devices -- Application of risk management to medical devices $370.00 via email in 1~5 business day superseded
YY/T 0316-2008 Medical devices - Application of risk management to medical devices $620.00 immediately superseded
YY/T 0316-2016 Medical devices-Application of risk management to medical devices $400.00 immediately valid
YY/T 0466.1-2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements $140.00 immediately to be superseded
YY/T 0466.1-2023 Medical devices―Symbols to be used with information to be supplied by the manufacturer―Part 1:General requirements $555.00 immediately to be valid
YY/T 0466.2-2015 Medical devices―Symbols to be used with medical device labels, labelling,and information to be supplied―Part 2:Symbol development,selection and validation $140.00 via email in 1~3 business day superseded
YY/T 0467-2003 Medical devices - Guide to the selection of standards in support of recognized essential principles of safety and performance of medical devices $300.00 via email in 1~3 business day superseded
YY/T 0467-2016 Medical devices-Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices $310.00 via email in 1~5 business day valid
YY/T 0468-2015 Medical devices―Quality management―Medical device nomenclature data structure $310.00 via email in 1~5 business day valid
YY/T 0595-2006 Medical devices-Quality management systems-Guidance on the application of YY/T0287-2003 $470.00 immediately superseded
YY/T 0595-2020 Medical devices—Quality management systems—Guidance on the application of YY/T 0287-2017 $1170.00 immediately valid
YY/T 0618-2007 Bacterial endotoxins—Test methodologies routine monitoring and alternatives to batch testing $345.00 via email in 1~5 business day superseded
YY/T 0618-2017 Test methods for bacterial endotoxins of medical devices―Routine monitoring and alternatives to batch testing $495.00 via email in 1~5 business day valid
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