China National Standards

China Single use medical Industry Standards English PDF List


  •  China "Single use medical" Industry Standards English PDF List:
  • Standard  Code Standard Title Standard Class Order
    YY 0970-2023 Sterilization of healthcare products - Liquid chemical sterilants for single-use medical devices of animal origin - Requirements for the characterization, development, validation and routine control of medical device sterilization processes {译}
    医疗保健产品灭菌 一次性使用动物源性医疗器械的液体化学灭菌剂 医疗器械灭菌过程的特征、开发、确认和常规控制的要求
    China Pharmaceutics Industry Standards
    Single use medical

    English PDF
    YY/T 0616.5-2019 Medical gloves for single use—Part 5:Test method for permeation of chemicals under conditions of continuous contact
    一次性使用医用手套 第5部分:抗化学品渗透 持续接触试验方法
    China YY-Medicine & Medical Device Industry Standards
    Single use medical

    English PDF
    YY/T 0616.4-2018 Medical glove for single use—Part 4:Test method for the puncturation resistance
    一次性使用医用手套 第4部分:抗穿刺试验方法
    China YY-Medicine & Medical Device Industry Standards
    Single use medical

    English PDF
    YY/T 0616.3-2018 Medical gloves for single use—Part 3:Determination of real time expiration dating of mature medical gloves stored under typical warehouse conditions
    一次性使用医用手套 第3部分:用仓贮中的成品手套确定实际时间失效日期的方法
    China YY-Medicine & Medical Device Industry Standards
    Single use medical

    English PDF
    YY/T 0969-2013 Single-use medical face mask
    一次性使用医用口罩
    China Medicine & Medical Device Standards
    Single use medical

    English PDF
    YY 0970-2013 Sterilization of single- use medical devices incorporating materials of animal origin. Validation and routine control of sterilization by liquid sterilants
    含动物源材料的一次性使用医疗器械的灭菌液体灭菌剂灭菌的确认与常规控制
    China Medicine & Medical Device Standards
    Single use medical

    English PDF
    SN/T 0678-2008 Rules for the inspection of single-use medical rubber examination gloves for import and export
    进出口一次性使用橡胶检查手套检验规程
    China Import Export Inspection Standards
    Single use medical

    English PDF
    SN/T 0323.2-2007 Rules for the inspection of medical equipment for import and export. Part 2: Sterile hypodermic syringes for single use
    进出口医疗器械检验规程 第2部分:一次性使用无菌注射器
    China Import Export Inspection Standards
    Single use medical

    English PDF
    SN/T 0323.1-2007 Rules for the inspection of medical equipment for import and export. Part 1: Infusion and transfusion sets for single use
    进出口医疗器械检验规程 第1部分:一次性使用输液(血)器
    China Import Export Inspection Standards
    Single use medical

    English PDF
    YY/T 0616-2007 Medical gloves for single use. Requirements and testing for biological evaluation
    一次性使用医用手套生物学评价要求与试验
    China Medicine & Medical Device Standards
    Single use medical

    English PDF

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