YY/T 1743-2021 English PDFUS$889.00 · In stock
Delivery: <= 7 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1743-2021: Anaesthetic and respiratory equipment - Nebulizing systems and components Status: Valid
Basic dataStandard ID: YY/T 1743-2021 (YY/T1743-2021)Description (Translated English): Anaesthetic and respiratory equipment - Nebulizing systems and components Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C46 Word Count Estimation: 48,445 Issuing agency(ies): State Drug Administration YY/T 1743-2021: Anaesthetic and respiratory equipment - Nebulizing systems and components---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.Anaesthetic and respiratory equipment - Nebulizing systems and components ICS 11.040.10 C46 People's Republic of China Pharmaceutical Industry Standards Nebulization systems and components for anesthesia and respiratory equipment (ISO 27427.2013, MOD) Released on 2021-03-09 2023-05-01 implementation Issued by the National Medical Products Administration Table of contentsForeword Ⅲ Introduction Ⅴ 1 Scope 1 2 Normative references 1 3 Terms and definitions 2 4 General requirements and test requirements 4 4.1 Risk Management 4 4.2 Test methods and alternative methods 4 4.3 Electrical safety 5 4.4 Safety of machinery 5 4.5 Pneumatic safety 5 4.6 Prevent unconscious adjustment 5 4.7 Availability 5 5 Sign 6 5.1 Symbol 6 5.2 Marking on the device 6 5.3 Labels on packaging or individual packaging 6 5.4 Instructions for use, inserts and accompanying documents 7 6 Structural requirements 9 6.1 Material 9 6.2 Connector 10 6.3 Control knob 12 7 Cleaning, sterilization and disinfection 12 8 Biocompatibility 12 Appendix A (Informative Appendix) Basic Principles 13 Appendix B (Normative Appendix) Diameter of Respirable Fractional Particles 17 Appendix C (Normative Appendix) Test methods for aerosol particle output and spray rate 18 Appendix D (Normative Appendix) Test Method for Particle Diameter 21 Appendix E (informative appendix) Hazard identification in risk assessment 28 Appendix F (informative appendix) Classification of general atomization equipment 32 Appendix G (informative appendix) Environmental aspects 34 Appendix AA (informative appendix) Reference to basic principles 36 Reference 41ForewordThis standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard uses the redrafting method to modify and adopt ISO 27427.2013 "Atomization System and Components for Anesthesia and Respiratory Equipment". The technical differences between this standard and ISO 27427.2013 and the reasons are as follows. ---Regarding normative references, this standard has made adjustments with technical differences to adapt to my country's technical conditions and adjustments. The situation is collectively reflected in Chapter 2 "Normative Reference Documents", and the specific adjustments are as follows. ● Replace IEC 60601-1.2005 with GB 9706.1-2020 which is modified to adopt international standards (see 4.4, 5.1, 5.2.2, 5.4.2, 8.2); ● Replace ISO 10993-1 with GB/T 16886.1 (see 8.1); ● Replace ISO 17665-1 with GB 18278.1 (see 7.1); ● Replace ISO 11135-1 with GB 18279.1 (see 7.1); ● Replace ISO 11137-1 with GB 18280.1 (see 7.1); ● Replace ISO 11137-2 with GB 18280.2 (see 7.1); ● Replace ISO 11137-3 with GB/T 18280.3 (see 7.1); ● Replace ISO 11607-1 with GB/T 19633.1 (see 7.2); ● Added GB 50751 (see 4.5); ● Replace ISO 14971 with YY/T 0316 (see 4.1.1); ● Replace ISO 5367 with YY 0461 (see 6.2.2.1); ● Replace ISO 15223-1 with YY/T 0466.1 (see 5.1); ● Replace IEC 60601-1-2.2006 A1.2012 with YY 9706.102 (see 5.4.8); ● Replace EN556-1 with YY/T 0615.1 (see 7.1); ● Replace IEC 60601-1-8 (see 5.4.7) with YY 9706.108-2021 modified to adopt international standards; ● Replace ISO 23328-1 with YY/T 0753.1 [see C.3, D.4.1e)]; ● Replace EN15908.2010 and CGAV-5-2005 with YY/T 0799 (see 6.2.1); ● Replace ISO 9170-1 with YY 0801.1 (see 6.2.1); ● Replace ISO 15001 with YY/T 0882 (see 6.1.1); ● Replace ISO 80369-1 with YY/T 0916.1-2014 which is equivalent to the international standard [see 6.2.1d), 6.2.2.2)]; ● Replace ISO 5356-1 with YY/T 1040.1 (see 6.2.2.2); ● Replace ISO 5356-2 with YY 1040.2 (see 6.2.2.2); ● Replace IEC 62366 with YY/T 1474 (see 4.7.1); ● Use YY/T 9706.106 instead of IEC 60601-1-6 (see 4.7.1). This standard also made the following editorial changes. ---Add the description of Appendix E and Appendix G in the introduction; ---ISO 27427.2013 has made corresponding amendments to the special requirements for atomization equipment entering the European Union, and deleted 5.3 "Note" in and amended the relevant expressions in 5.4.1c) about entering the European Union; ---Modified the editorial errors in D.3.2.5, changed "(15±5)%L/min" to "15L/min, allowing a relative error of ±5% difference". Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Anesthesia and Respiratory Equipment Standardization Technical Committee (SAC/TC116). Drafting organizations of this standard. Shanghai Medical Device Testing Institute, Omron Healthcare (China) Co., Ltd. The main drafters of this standard. Wang Wei, Zhang Weiqi, Fu Guoqing, Liu Liang.IntroductionAtomization equipment is widely used to provide medicines and vaccines in spray form to humans through the respiratory system. Nebulizing equipment is also used for diagnostic purposes, Use radioisotopes for lung stimulation tests. These drugs can take the form of solutions, suspensions or emulsions. Spray inhalation is certain The preferred route of administration of the drug. Some drugs are used to treat systemic diseases, and some drugs are used to treat respiratory diseases. In order to achieve For long-term therapeutic effects, the spray particles must be deposited in specific parts of the respiratory tract. Particles of different diameters tend to deposit in the respiratory system The same part, therefore, the performance characteristics and intended use of the atomizing device must be defined by the manufacturer and specified in the accompanying documents. This standard was developed to cover "universal" nebulization equipment, and is based on adult test parameters, which may be consistent with pediatric or infant patient populations. The test parameters are different. This standard is designed to ensure that the various test results announced by the manufacturer are meaningful to users and buyers of atomizing equipment. The goal of this standard is to ensure. ---Atomization equipment is suitable for the intended use disclosed by the manufacturer; ---Safety, especially the safety of electric atomization equipment; ---Compatibility between the component material and the liquid medicine; and ---The biocompatibility of the component materials in contact with the human body. In this standard, the content related to the basic principles described in Appendix A is indicated by an asterisk (*). Appendix E gives information about hazard identification in the risk assessment. Appendix G gives information on terms related to the environment. Nebulization systems and components for anesthesia and respiratory equipment1 ScopeThis standard specifies the general atomization system that is expected to deliver liquid to the human body in the form of a spray continuously or triggered by breathing through the respiratory system. Safety and performance testing requirements. This standard applies to pneumatic atomization equipment, which can be powered by compressors, piping systems, cylinders, etc., as well as electric atomization equipment (such as rotary Turntable, ultrasonic, vibrating screen (active and passive), and capillary device] or manual atomization equipment. This standard does not specify the minimum performance of the atomization system. This standard does not apply to nasal washing equipment. This standard does not apply to equipment intended to provide moisture or hydration only by providing water in the form of aerosol particles. Note. Refer to ISO 8185[3] for such equipment. This standard does not apply to specific drug delivery nebulization devices or their components (e.g. metered-dose inhalers, metered-dose liquid inhalers, dry powder inhalers)2 Normative referencesThe following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document. GB 9706.1-2020 Medical electrical equipment Part 1.General requirements for basic safety and basic performance (IEC 60601-1. 2012, MOD) GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in the Process of Risk Management (GB/T 16886.1- 2011, ISO 10993-1.2009, IDT) GB 18278.1 Sterilization of Medical and Health Products Moisture Heat Part 1.Development, Validation and Routine Control Requirements for the Sterilization Process of Medical Devices Seek (GB 18278.1-2015, ISO 17665-1.2006, IDT) GB 18279.1 Sterilization of medical and health care products ethylene oxide Part 1.Development, validation and routine control of the sterilization process of medical devices System requirements (GB 18279.1-2015, ISO 11135-1.2007, IDT) GB 18280.1 Sterilization radiation of medical and health care products Part 1.Development, validation and routine control requirements for the sterilization process of medical devices Seek (GB 18280.1-2015, ISO 11137-1..2006, IDT) GB 18280.2 Medical and health care products sterilization radiation Part 2.Establishment of sterilization dose (GB 18280.2-2015, ISO 11137-2. 2006, IDT) GB/T 18280.3 Medical and health care products sterilization radiation Part 3.Dose measurement guidelines (GB/T 18280.3-2015, ISO 11137-3.2006, IDT) GB/T 19633.1 Terminally sterilized medical device packaging Part 1.Requirements for materials, sterile barrier systems and packaging systems (GB/T 19633.1-2015, ISO 11607-1.2006, IDT) GB 50751 Technical Specification for Medical Gas Engineering YY/T 0316 Application of medical device risk management to medical devices (YY/T 0316-2016, ISO 14971.2007 correction Version, IDT) YY 0461 Breathing circuit for anesthesia machine and ventilator (YY 0461-2003, ISO 5367.2000, IDT) YY/T 0466.1 Medical devices are used for medical device labeling, marking and providing information symbols. 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