YY/T 1468-2016 English PDFUS$909.00 · In stock
Delivery: <= 6 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1468-2016: Oxygen concentrator supply systems for use with medical gas pipeline systems Status: Valid YY/T 1468: Historical versions
Basic dataStandard ID: YY/T 1468-2016 (YY/T1468-2016)Description (Translated English): Oxygen concentrator supply systems for use with medical gas pipeline systems Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C46 Classification of International Standard: 11.040.10 Word Count Estimation: 41,470 Date of Issue: 2016-01-26 Date of Implementation: 2018-01-01 Issuing agency(ies): State Food and Drug Administration Summary: This standard specifies the requirements for the design and installation of oxygen concentrator gas supply systems used in medical gas pipeline distribution systems that meet the requirements of ISO 7396-1 or GB 50751-2012. YY/T 1468-2016: Oxygen concentrator supply systems for use with medical gas pipeline systems---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.ICS 11:040:10 C46 Pharmaceutical Industry Standard of the People's Republic of China YY 1468-2016 for medical gas piping systems Oxygen concentrator gas supply system (ISO 10083:2006, MOD) According to the State Drug Administration medical device industry Standard Announcement (No: 76 of 2022), this standard is from From September 7, 2022, it will be converted into a recommended standard, no Enforce it again: 2016-01-26 release:2018-01-01 implementation Issued by China Food and Drug Administration table of contentsPreface III Introduction IV 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 General requirements 4 4:1 Safety and continuity of gas supply4 4:2* Alternative structures 4 4:3 Materials 5 4:4 System Design 5 4:5 Oxygen-enriched air (93% oxygen) index 5 5 Air supply source 6 5:1 General requirements 6 5:2 Main air supply source 6 5:3 Auxiliary air supply source 6 5:4 Alternate air supply source 7 5:5 Gas supply with cylinders 7 5:6 Siting of oxygen concentrator gas supply system 7 6 Component Requirements 8 6:1 Oxygen concentrator unit 8 6:2 Oxygen-enriched air (93% oxygen) tank 8 6:3 Oxygen Analyzer 8 6:4 Pressure relief valve 8 6:5 Stop valve 9 6:6 Sampling port 9 6:7 Pressure regulator 9 7 Monitoring and alarm system 9 7:1 General requirements 9 7:2 Monitoring and alarm signals 9 7:3 Operation alarm 9 7:4 Information signals 10 8 mark 10 9 install 10 YY 1468-2016 9:1 General requirements 10 9:2 Electrical system 10 10 Testing, Commissioning and Proving 10 10:1 General requirements 10 10:2 Tests and procedures 10 10:3 Performance Test 11 10:4 Test run and proof 12 11 Information provided by the manufacturer 12 11:1 Installation Guide 12 11:2 Instruction Manual 12 11:3 Preventive Maintenance Guidelines 12 11:4 Operational management information 12 11:5 As-built drawings 13 11:6 Electrical Schematic 13 11:7 Manufacturer announcement 13 12 Implementation of the use of oxygen-enriched air (93% oxygen) 13 12:1 Acceptance of oxygen-enriched air (93% oxygen) 13 12:2 Timing 13 12:3 Mixing of oxygen-enriched air (93% oxygen) and oxygen 13 12:4 Calibration of medical devices 13 12:5 Mark 13 12:6 Meet the requirements of ISO 7396-1 or GB 50751-201213 Appendix A (informative appendix) Schematic diagram of the oxygen concentrator gas supply system 14 Appendix B (informative appendix) General guidelines for gas supply system siting 22 Appendix C (Informative Appendix) Emergency Procedures Guide 23 Appendix D (informative) Test and commissioning procedures 25 Appendix E (Informative) Typical Forms for Oxygen Concentrator Gas Supply System Certification 26 Appendix F (informative appendix) recommended minimum requirements for preventive maintenance 29 Appendix G (Informative Appendix) Installation Suggestions 31 Appendix H (informative) Risk and risk management32 APPENDIX I (INFORMATIVE) RECOMMENDATIONS FOR SIZE AND CAPACITY33 Appendix J (Informative) Basic Principles 34 Reference 35 YY 1468-2016forewordAll technical contents of this standard are mandatory: This standard is drafted in accordance with the rules given in GB/T 1:1-2009: This standard uses the redrafted method to revise and adopt ISO 10083:2006 "Oxygen concentrator gas supply system for medical gas pipeline system System": The technical differences between this standard and ISO 10083:2006 and their reasons are as follows: --- Regarding the normative reference documents, this standard has made adjustments with technical differences to adapt to the technical conditions of our country and the situation of the adjustments The situation is reflected in Chapter 2 "Normative References", and the specific adjustments are as follows: ● Add normative references to GB 50751-2012 (see 4:4, 5:12, 7:1:1, 12:6); ● Add normative reference document WS1-XG-008-2012 (see 4:5:1, 10:3:4:2:2); ● Replace ISO 21969 (see 5:5:4) with YY/T 1440 (YY/T 1440-2016, ISO 21969:2009, MOD); ● Replace ISO 5145 (see 5:5:5) with GB 15383 (GB 15383-2011, ISO 5145:2004, NEQ); ● Replace ISO 10524-2 (see 6:7) with YY/T 1439:2 (YY/T 1439:2-2016, ISO 10524-2:2005, MOD); --- Deleted the related content of bottle filling (4:6, 7:3:1i in ISO 10083:2006), item 4, item 6 and Appendix J in 11:2: --- According to the relevant requirements of WS1-XG-008-2012, the content of the oxygen-enriched air (93%) index in Table E:1 has been modified: This standard makes the following editorial changes to ISO 10083:2006: ---Add relevant instructions in the second paragraph of the introduction; --- Delete or modify part of the content related to "country or region" in ISO 10083:2006; --- Corrected the editorial errors in ISO 10083:2006 (see Figure A:2); ---The international standards involved in the references have been adopted as national standards and industry standards: This standard is based on the corresponding national standards Standards and industry standards are used as references, and the order of references is adjusted: Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying these patents: This standard was proposed by China Food and Drug Administration: This standard is under the jurisdiction of the National Anesthesia and Respiratory Equipment Standardization Technical Committee (SAC/TC116): This standard was drafted: Shandong Shangjian Medical Technology Co:, Ltd:, Shanghai Medical Device Testing Institute: The main drafters of this standard: Ma Yanyan, Wang Wei: YY 1468-2016IntroductionThis standard is used to specify the oxygen concentrator gas supply system that supplies oxygen-enriched air (93% oxygen) to the medical gas pipeline distribution system (such as medical Molecular sieve oxygen generation system) minimum requirements for safety and performance: Specifies the minimum oxygen concentration for the gas produced by the oxygen concentrator gas supply system: Oxygen concentrators can be used to deliver enriched oxygen as a substitute for medical oxygen (such as "oxygen" in the Chinese Pharmacopoeia) to the medical gas pipeline system Air (93% oxygen), oxygen-enriched air (93% oxygen) is called "oxygen93percent" in the US Pharmacopoeia, that is, "oxygen 93%", and in the European Pharmacopoeia It is called "oxygen (93percent)", that is, "oxygen (93%)", and the oxygen concentrator can be used with a gas supply source containing 100% medical oxygen (ie: oxygen cylinders or cryogenic containers) in combination: According to the characteristics of the oxygen concentrator and the supply flow rate, the oxygen concentrator can supply products whose oxygen concentration changes within the specified range: Good quality: The decision to use oxygen-enriched air (93% oxygen) should be made at an early stage by the health care facility and is outside the scope of this standard: Whether to use rich Oxygen air (93% oxygen) and oxygen mixtures are also determined by the health care facility: The use of gas supply systems that include oxygen concentrators may require national Authority approval: This standard should not be considered as an endorsement or recommendation for another oxygen concentration: Gas supply systems with oxygen concentrators can be installed at the time of piping distribution system installation or as a replacement or addition to an existing gas supply system add: A gas supply system with an oxygen concentrator can be supplied as a package and can be installed by a third party: In this case, when connecting the air supply The manufacturer of the oxygen concentrator gas supply system must provide the installer with suitable instructions for installation and testing of the system to the piping distribution system and prior to use: when data: The purpose of this standard is to ensure that: ---Oxygen concentrator gas supply system is properly introduced into health care institutions; ---The quality of oxygen-enriched air (93% oxygen) delivered by the air supply system; --- Continuous supply of oxygen-enriched air (93% oxygen); --- Use suitable materials; ---Cleaning of components; ---Install correctly; ---Provide appropriate control, monitoring and alarm systems for the gas supply system; ---Testing, commissioning and proof: This standard is intended for use by those concerned with the design, construction, inspection or operation of health care facilities: those involved in the design, manufacture, calibration or testing of Personnel attempting to connect equipment to piping systems fed by oxygen concentrator gas supply systems should also be aware of the contents of this standard: Appendix J contains rationale for some of the requirements of this standard: Further explanation of the rationale for the requirements and recommendations contained in this standard is provided: Clauses marked with * after the clause number correspond to principles in Appendix J: The rationale for such requirements not only facilitates the correct use of this standard It can be used and can simplify subsequent modification: YY 1468-2016 for medical gas piping systems Oxygen concentrator gas supply system1 Scope1:1 This standard specifies the oxygen concentration used in medical gas pipeline distribution systems that meet the requirements of ISO 7396-1 or GB 50751-2012: The design and installation requirements of the compressor air supply system: 1:2 This standard is only applicable to the oxygen concentrator gas supply system (see 4:5:1) that produces oxygen-enriched air (93% oxygen): 1:3 This standard does not cover oxygen concentrators for home use: Note: The requirements for oxygen concentrators used at home are specified by YY 0732:2 Normative referencesThe following documents are indispensable for the application of this document: For dated references, only the dated version applies to this document pieces: For undated references, the latest version (including all amendments) applies to this document: GB 15383 Gas cylinder valve outlet connection type and size (GB 15383-2011, ISO 5145:2004, NEQ) GB 50751-2012 Technical Specifications for Medical Gas Engineering Application of YY/T 0316 Medical Device Risk Management to Medical Devices (YY/T 0316-2008, ISO 14971:2007, IDT) YY/T 0882 Compatibility of anesthesia and respiratory equipment with oxygen (YY/T 0882-2013, ISO 15001:2003, IDT) YY/T 1439:2 Medical gas pressure regulators Part 2: Manifold pressure regulators and pipeline pressure regulators (YY/T 1439:2-2016, ISO 10524-2:2005, MOD) YY/T 1440 High-pressure flexible connections for use with medical gas systems (YY/T 1440-2016, ISO 21969:2009, MOD) WS1-XG-008-2012 Oxygen-enriched air (93% oxygen) ISO 7396-1 Medical gas pipeline system Part 1: Medical gas pipeline for compressed gas and vacuum EN286-1 Simple unfired pressure vessels for storing air or nitrogen - Part 1: General pressure vessels (Simpleunfired3 Terms and DefinitionsThe following terms and definitions apply to this document: 3:1 Trial run commissioning Functional proof to verify that the agreed system characteristics are fulfilled and accepted by the user or his representative: YY 1468-2016 ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1468-2016_English be delivered?Answer: Upon your order, we will start to translate YY/T 1468-2016_English as soon as possible, and keep you informed of the progress. 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