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Oxygen concentrator supply systems for use with medical gas pipeline systems
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Basic data | Standard ID | YY 1468-2016 (YY1468-2016) | | Description (Translated English) | Oxygen concentrator supply systems for use with medical gas pipeline systems | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C46 | | Classification of International Standard | 11.040.10 | | Word Count Estimation | 41,466 | | Date of Issue | 2016-01-26 | | Date of Implementation | 2018-01-01 | | Quoted Standard | GB 15383; GB 50751-2012; YY/T 0316; YY/T 0882; YY/T 1439.2; YY/T 1440; WS1-XG-008-2012; ISO 7396-1; ISO 14644-1-1999; EN 286-1 | | Adopted Standard | ISO 10083-2006, MOD | | Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the design and installation requirements for the oxygen concentrator gas supply system for medical gas piping distribution systems complying with the requirements of ISO 7396-1 or GB 50751-2012. This standard applies only to the oxygen concentrator supply system (see 4.5.1) for the production of oxygen-enriched air (93% oxygen). This standard does not cover the use of oxygen concentrators at home. | YY 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.
Oxygen concentrator supply systems for use with medical gas pipeline systems
ICS 11.040.10
C46
People's Republic of China Pharmaceutical Industry Standard
Used for medical gas piping systems
Oxygen concentrator gas supply system
(ISO 10083..2006, MOD)
2016-01-26 release
2018-01-01 implementation
State Food and Drug Administration issued
Directory
Preface III
Introduction IV
1 Scope 1
2 normative reference document 1
3 Terms and definitions 1
4 General requirements 4
4.1 Safety and continuity of gas supply 4
4.2 * alternative structure 4
4.3 Materials 5
4.4 System Design 5
4.5 Oxygen-enriched air (93% oxygen) index 5
5 supply source 6
5.1 General requirements 6
5.2 Main supply air supply 6
5.3 Auxiliary supply source 6
5.4 standby air supply 7
5.5 Gas supply with gas cylinders 7
5.6 Oxygen concentrator supply system location 7
Component requirements
6.1 Oxygen concentrator unit
6.2 Oxygen-enriched air (93% oxygen) tank 8
6.3 Oxygen Analyzer 8
6.4 Pressure relief valve 8
6.5 globe 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 signal 10
8 mark 10
9 Installation 10
9.1 General requirements 10
9.2 Electrical system 10
10 test, test run and proof 10
10.1 General requirements 10
10.2 Testing and Procedures 10
10.3 Performance Testing 11
10.4 commissioning and certification
11 Information provided by the manufacturer 12
11.1 Installation Guide 12
11.2 User's Manual 12
11.3 Preventive Maintenance Guide 12
11.4 Operation and management information 12
11.5 Completed drawings 13
11.6 Electrical Schematic Figure 13
11.7 Manufacturer Announces 13
12 Oxygen-enriched air (93% oxygen) used in the implementation of 13
12.1 Acceptance of oxygen-enriched air (93% oxygen) 13
12.2 Timing 13
12.3 Oxygen-enriched air (93% oxygen) and oxygen mixture 13
12.4 Calibration of Medical Devices 13
12.5 mark 13
12.6 Complies with ISO 7396-1 or GB 50751-2012
Appendix A (informative) Oxygen concentrator gas supply system
Appendix B (informative) General guidelines for site selection of gas supply systems
Appendix C (informative) Guidelines for Emergency Procedures 23
Appendix D (informative) Test and commissioning procedures 25
Appendix E (informative) Typical form for proof of gas supply system for oxygen concentrators
Appendix F (informative) Minimum requirements recommended for preventive maintenance 29
Appendix G (informative) Installation proposal 31
Appendix H (informative) Risk and risk management 32
Appendix I (informative) Size and capacity recommendations 33
Appendix J (informative) Basic principles 34
Reference 35
Foreword
The technical content of this standard is mandatory.
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard uses the re-drafting method to modify the use of ISO 10083..2006 "for the medical gas pipeline system oxygen concentrator supply system
System ".
The technical differences between this standard and ISO 10083..2006 are as follows.
--- on the normative reference documents, the standard made a technical differences in the adjustment to meet China's technical conditions, adjust the situation
The situation is reflected in Chapter 2, "Normative references", as follows.
● Increase the normative reference document GB 50751-2012 (see 4.4, 5.12, 7.1.1.1, 12.6);
• Increase the normative reference document WS1-XG-008-2012 (see 4.5.1, 10.3.4.2.2);
Replace ISO 21969 with YY/T 1440 (YY/T 1440-2016, ISO 21969..2009, MOD) (see 5.5.4);
Replace GB 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);
--- Removal of the relevant contents of the filling (ISO 10083..2006, 4.6, 7.3.1i), 11.2, item 4, item 6 and appendix J.
- Revised Oxygenated Air (93%) in Table E.1 according to the relevant requirements of WS1-XG-008-2012.
This standard makes the following editorial changes to ISO 10083..2006.
- to add the relevant statement in the second paragraph of the introduction;
- delete or modify the contents of ISO 10083..2006 relating to "country or region";
Fixed an editorial error in ISO 10083..2006 (see Figure A.2);
--- reference to the international standards involved in the literature, there are corresponding to be used as national standards and industry standards, the standard to the corresponding national standard
The quasi-industry standard is used as a reference and adjusts the order of the references.
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This standard is proposed by the State Food and Drug Administration.
This standard is nationalized by the National Standardization Technical Committee on Anesthesia and Respiratory Equipment (SAC/TC116).
The standard drafting unit. Shandong Shangjian Medical Technology Co., Ltd., Shanghai Medical Devices Testing Institute.
The main drafters of this standard. Ma Yanyan, Wang Wei.
Introduction
This standard is used to specify the supply of oxygen-enriched air (93% oxygen) oxygen concentrator gas supply system to the medical gas piping distribution system (eg medical
Molecular sieve oxygen system) safety and performance of the minimum requirements. Specifies the minimum oxygen concentration of the gas supply system for the gas concentrator gas supply system.
Oxygen concentrators can be used to deliver oxygen to the medical gas piping system as a substitute for medical oxygen (eg, "oxygen" in Chinese Pharmacopoeia)
Air (93% oxygen), oxygen-enriched air (93% oxygen) is known in the US Pharmacopoeia as "oxygen93percent", "oxygen 93%", in the European Pharmacopoeia
Is referred to as "oxygen (93percent)", "oxygen (93%)", and the oxygen concentrator is available with an air supply source containing 100%
Cylinders or cryogenic containers).
Depending on the characteristics of the oxygen concentrator and the supply flow, the oxygen concentrator can supply a change in the oxygen concentration within a specified range
Product gas.
The decision to use oxygen-enriched air (93% oxygen) should be made by the health care organization at an early stage and not within the scope of this standard. Whether to use rich
Oxygen air (93% oxygen) and oxygen mixture is also determined by the health care agency. The use of a gas supply system containing an oxygen concentrator may require a country
Authority approval.
This standard should not be considered a recognition or recommendation for another oxygen concentration.
The gas supply system with an oxygen concentrator can be installed at the time of installation of the piping distribution system or as an alternative to the existing gas supply system
plus. A gas supply system with an oxygen concentrator can be provided as a complete set of equipment and can be installed by a third party. In this case, connect the gas supply
The system to the piping distribution system and before use, the manufacturer of the oxygen concentrator gas supply system must provide the installer with the appropriate installation and testing
When the information.
The purpose of this standard is to ensure that.
- Oxygen concentrator gas supply system is properly introduced into the health care facility;
- the quality of oxygen-enriched air (93% oxygen) delivered by the gas supply system;
--- Oxygen-enriched air (93% oxygen) continuous supply;
--- use the right material;
--- cleaning of components;
--- proper installation;
- Provide appropriate control, monitoring and alarm systems for the gas supply system;
--- test, test run and prove.
This standard is intended for use by the design, construction, inspection or operation of the health care organization. Those involved in the design, manufacture, calibration or testing
It is also clear that the personnel of the equipment connected to the piping system supplied to the gas supply system of the oxygen concentrator should also be aware of the contents of this standard.
Appendix J contains a description of the requirements of certain requirements of this standard. Provides a further explanation of the principles of this standard that contain requirements and recommendations.
The chapter marked with * under the chapter number corresponds to the principle in Appendix J. The basic principles of such requirements are not only conducive to the correctness of this standard
Use, and can simplify the subsequent changes.
Used for medical gas piping systems
Oxygen concentrator gas supply system
1 Scope
1.1 This standard specifies the oxygen concentration of a medical gas piping distribution system for compliance with ISO 7396-1 or GB 50751-2012
Design and installation requirements for the compressor gas supply system.
1.2 This standard applies only to the production of oxygen-enriched air (93% oxygen) oxygen concentrator gas supply system (see 4.5.1).
1.3 This standard does not include oxygen concentrators for use at home.
Note. The requirements for the use of oxygen concentrators at home are specified by YY 0732.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
GB 15383 Cylinder valve outlet connection type and dimensions (GB 15383-2011, ISO 5145..2004, NEQ)
Technical specification for medical gas engineering GB 50751-2012
YY/T 0316 Medical Device Risk Management for Medical Devices (YY/T 0316-2008, ISO 14971..2007, IDT)
YY/T 0882 Compatibility of anesthesia and breathing equipment with oxygen (YY/T 0882-2013, ISO 15001..2003, IDT)
YY/T 1439.2 Medical gas pressure regulators - Part 2. Busbar pressure regulators and piping pressure regulators (YY/T
1439.2-2016, ISO 10524-2..2005, MOD)
YY/T 1440 High pressure flexible connection 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 piping systems - Part 1. Medical compressed gas and vacuum piping (Medicalgaspipeline
systems-Part 1. Pipelinesforcompressedmedicalgasesandvacuum)
ISO 14644-1..1999 Clean rooms and associated control environments - Part 1. Air cleanliness classifications (Cleanroomsandassoci-
atedcontroledenvironments-Part 1. Classificationofaircleanliness
EN286-1 Simple, non-subject pressure vessel for storage of air or nitrogen Part 1. General pressure vessel (Simpleunfired
pressurevesselsdesignedtocontainairornitrogen-Part 1. Pressurevesselsforgeneralpurposes
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Trial run commission
Functional proof to verify that the agreed system characteristics are met and accepted by the user or his representative.
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