YY/T 0893-2023 English PDFUS$419.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0893-2023: Gas mixers for medical use - Standalone gas mixers Status: Valid YY/T 0893: Historical versions
Basic dataStandard ID: YY/T 0893-2023 (YY/T0893-2023)Description (Translated English): Gas mixers for medical use - Standalone gas mixers Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C46 Classification of International Standard: 11.040.10 Word Count Estimation: 22,284 Date of Issue: 2023-03-14 Date of Implementation: 2024-05-01 Older Standard (superseded by this standard): YY/T 0893-2013 Issuing agency(ies): State Drug Administration Summary: This standard specifies the performance and safety requirements for self-contained gas mixers intended for mixing oxygen with another medical gas. This document does not apply to sets of flow meters with independent control of the flow of each gas, independent gas mixers for mixing oxygen and ambient air, independent gas mixers with more than two different gas inlets, independent gas connected to an oxygen concentrator mixer. YY/T 0893-2023: Gas mixers for medical use - Standalone gas mixers---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.ICS11:040:10 CCSC46 Pharmaceutical Industry Standard of the People's Republic of China Replace YY/T 0893-2013 Medical Gas Mixer Standalone Gas Mixer (ISO 11195:2018, MOD) Released on 2023-03-14 2024-05-01 Implementation Released by the State Drug Administration table of contentsPreface I Introduction III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 2 4 * Basic performance requirements 3 5 General requirements 3 6 Material 3 7 Normal working status 4 8 Requirements for air inlet pressure 4 9 reverse airflow 5 10 * leak 5 11 Alarm system 5 12 *Oxygen concentration indication accuracy 6 13 Air source failure 7 14 Gas connection 7 15 Air inlet filter 7 16 flow controller 8 17 Low pressure hose assembly 8 18 Electrical Safety 8 19 mark 8 20 Attachment 9 Appendix A (Informative) Basic Principles 12 Appendix B (Informative) Definitions of Terms Correspondence Table 14 Appendix C (Normative) Test method for transmission gas, leakage and gas source failure alarm duration 15 Reference 16forewordThis document is in accordance with the provisions of GB/T 1:1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules for Standardization Documents" drafting: This document replaces YY/T 0893-2013 "Medical Gas Mixer Independent Gas Mixer", and is consistent with YY/T 0893-2013 In addition to structural adjustments and editorial changes, the main technical changes are as follows: a) Changed the scope to indicate that this document applies to stand-alone gas mixers designed to mix oxygen with other medical gases, excluding An independent gas mixer connected to an oxygen concentrator (see Chapter 1, Chapter 1 of the:2013 edition); b) Changed the definition (see 3:8, 3:1 of the:2013 edition); c) Added basic performance requirements (see Chapter 4); d) increased risk management and usability (see 5:1 and 5:2); e) Added materials (see Chapter 6); f) Added the requirement for air inlet pressure (see Chapter 8); g) Changed the requirements for reverse airflow (see Chapter 9, Chapter 6 of the:2013 edition); h) Added electric alarm system and non-electric alarm system (see 11:1 and 11:2); i) Changed the requirements for the high-voltage alarm state (see 11:3, 5:2 of the:2013 edition); j) Increased differential pressure alarm state (see 11:4); k) Changed the requirements for the gas source failure alarm state (see 11:5, 12:1 of the:2013 edition); l) The requirements for gas source failure have been changed (see Chapter 13, 12:2~12:5 of the:2013 edition); m) A gas outlet fitting is added and the gas outlet fitting is specified for use with a stand-alone gas mixer with an integral flow controller (see 14:2); n) The requirements for marking and accompanying documents have been changed (see Chapters 19 and 20, Chapters 14 and 15 of the:2013 edition): This document is modified to adopt ISO 11195:2018 "Medical Gas Mixer Independent Gas Mixer": Compared with ISO 11195:2018, the main technical differences of this document are as follows: --- In order to adapt to the technical conditions of our country, the normative references have been adjusted with technical differences, as follows: ● Replace ISO 9170-1 with YY 0801:1, which adopts the international standard; ● Replaced ISO 15001 with YY/T 0882, which is equivalent to the international standard; ● Replaced ISO 14971 with YY/T 0316, which is equivalent to the international standard; ● Replace IEC 60601-1-8:2012 with YY 9706:108-2021, which adopts the international standard; ● Replace ISO 5359 with YY/T 0799, which adopts the international standard; ● Added normative references to GB/T 3767-2016; ● The normative reference document GB 9706:255 has been added; ● The normative reference document GB 50751 has been added; ---In order to adapt to my country's national conditions, the "color should meet the requirements of ISO 5359" in 19:1 and 19:5 of ISO 11195:2018 is modified to "The color should meet the requirements of GB 50751": Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying patents: This document is proposed by the State Drug Administration: This document is under the jurisdiction of the National Anesthesia and Respiratory Equipment Standardization Technical Committee (SAC/TC116): This document was drafted by: Shanghai Institute of Medical Device Testing, Ningbo David Medical Device Co:, Ltd:, Jierui Enterprise (Shanghai) Ltd: The main drafters of this document: Zhang Chunyuan, Guo Yongbing, Wang Yongyi, Fu Qiang, Wang Wei, Qian Xinyi, Shi Dongzhuo: The release status of previous versions of this document and the documents it replaces are as follows: ---First published as YY/T 0893-2013 in:2013; --- This is the first revision:IntroductionA known hazard associated with the use of independent gas mixers is reverse air flow from one inlet to the other, which will cause Contamination of one gas supply system with another gas and delivery of wrong gas mixtures, resulting in injury to the patient: Due to this danger consequences, this document pays particular attention to minimizing reverse airflow: Although innovation in design will bring performance advantages, however, it is also easy to compete with this The design specified in the file conflicts: Such innovation cannot be stopped: If technological and process developments go beyond the current use of water level, they should still meet the safety and performance requirements given in this document: If these technologies and processes are significantly different from those specified in this document Likewise, this document may be modified or revised to include these technologies and processes: The rationale for some requirements of this document is given in Appendix A: These requirements are indicated by an asterisk (*) after the article number in the text: See Appendix B for an index of terms defined in this document: Medical Gas Mixer Standalone Gas Mixer1 ScopeThis document specifies the performance and safety requirements for self-contained gas mixers intended to mix oxygen with another medical gas: This document does not apply to: a) Flow meter group with independent control of each gas flow; b) a separate gas mixer for mixing oxygen and ambient air; c) an independent gas mixer with more than two different gas inlets; d) A separate gas mixer connected to the oxygen concentrator:2 Normative referencesThe contents of the following documents constitute the essential provisions of this document through normative references in the text: Among them, dated references For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document: GB/T 3767-2016 Acoustic sound pressure method Determination of sound power level of noise source and sound energy level Approximate free field above the reflecting surface Process method (ISO 3744:2010, IDT) GB 9706:1-2020 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1: 2012, MOD) Note: There is no technical difference between the referenced content of GB 9706:1-2020 and the referenced content of IEC 60601-1:2012 GB 9706:255 Medical Electrical Equipment Part 2-55: Particular Requirements for Basic Safety and Essential Performance of Respiratory Gas Monitors (GB 9706:255-2022, ISO 80601-2-55:2018, MOD) GB 50751 Technical Specifications for Medical Gas Engineering YY/T 0316 Application of medical device risk management to medical devices (YY/T 0316-2016, ISO 14971:2007, IDT) YY/T 0799 Medical gas low-pressure hose assembly (YY/T 0799-2010, ISO 5359:2008, MOD) YY 0801:1 Terminals of medical gas piping system Part 1: Terminals for compressed medical gas and vacuum (YY 0801:1- 2010, ISO 9170-1:2008, MOD) YY/T 0882 Compatibility of anesthesia and respiratory equipment with oxygen (YY/T 0882-2013, ISO 15001:2003, IDT) YY 9706:108 Medical Electrical Equipment Part 1-8: General Requirements for Basic Safety and Essential Performance Collateral Standard: General Requirements Requirements, tests and guidelines for alarm systems in medical electrical equipment and medical electrical systems (YY 9706:108-2021, IEC 60601-1-8: 2006/Amd1:2012, MOD) ISO 7396-1 Medical gas pipeline system Part 1: Medical compressed gas and vacuum pipeline system (Medicalgas pipeline ISO 10524-1 Pressure regulators for medical gases Part 1: Pressure regulators and pressure regulators with flow meter devices (Pres- flow-meteringdevices) ISO 11114-3 Gas cylinders - Compatibility of cylinder and valve materials with the gas they contain - Part 3: Non-metallic materials in an oxygen atmosphere ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0893-2023_English be delivered?Answer: Upon your order, we will start to translate YY/T 0893-2023_English as soon as possible, and keep you informed of the progress. 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Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.Question 5: Should I purchase the latest version YY/T 0893-2023?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0893-2023 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically. |
