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YY/T 1440-2016 English PDF

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YY/T 1440-2016: High-pressure flexible connections for use with medical gas systems
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PDF similar to YY/T 1440-2016


Standard similar to YY/T 1440-2016

YY/T 1543   YY/T 0799   YY 0671.1   YY/T 1439.2   YY/T 1438   

Basic data

Standard ID YY/T 1440-2016 (YY/T1440-2016)
Description (Translated English) High-pressure flexible connections for use with medical gas systems
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C46
Classification of International Standard 11.040.10
Word Count Estimation 14,195
Date of Issue 2016-01-26
Date of Implementation 2017-01-01
Quoted Standard GB 15383-2011; GB 50751-2012; YY/T 0316-2008; YY/T 0822-2013; ISO 407-2004; ISO 7396-1-2007
Adopted Standard ISO 21969-2009, MOD
Regulation (derived from) China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies) State Food and Drug Administration
Summary This standard is applicable to the high pressure flexible connection of the maximum nominal filling pressure of 25 000 kPa at 15 �� C and for the following medical gas cylinders or cylinders: - Oxygen; - Nitrous oxide (Aeration gas); - air for breathing; - helium; - carbon dioxide; - xenon; - mixture of the above gases; - air for driving surgical instruments; - nitrogen for driving surgical instruments; Oxygen-enriched air (93% oxygen). This standard applies to high-pressure flexible connections where gas cylinders or cylinders are intended to be connected to the busbars, which are contained in the gas source of the medical gas piping system conforming to ISO 7396-1: 2007. This standard applies to the expected connection of cylinders to a pressure regulator fitted with ISO 10524-1

YY/T 1440-2016: High-pressure flexible connections for use with medical gas systems

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High-pressure flexible connections for use with medical gas systems ICS 11.040.10 C46 People's Republic of China Pharmaceutical Industry Standard High pressure flexible connections for use with medical gas systems (ISO 21969..2009, MOD) 2016-01-26 release 2017-01-01 Implementation State Food and Drug Administration issued Directory Preface I 1 Scope 1 2 * normative reference document 1 3 Terms and definitions 1 4 Terminology 2 5 General requirements 3 5.1 security 3 5.2 Optional structure 3 5.3 Material 3 5.4 Design requirements 4 5.5 Structural requirements 5 Test Method 5 6.1 Overview 5 6.2 Type test 5 7 mark, color identification and packaging 8 7.1 mark 8 7.2 Color identification 8 7.3 Packing 8 8 Information provided by the manufacturer 9 Appendix A (informative) Basic principles 10 Reference 11

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. This standard adopts the re-drafting method to amend the use of international standards ISO 21969..2009 "with the medical gas system with the use of high-pressure flexible Connection "(English version). The technical differences between this standard and ISO 21969..2009 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. • The national standard GB 15383-2011 is replaced by the non-equivalent ISO 5145..2004 international standard ISO 5145. 2004 [see 5.4.1, 5.4.2.1b)], and delete the words "shall have gas specificity" in 5.4.1 and the relevant national or regional (See ISO /T R7470), and 5.4.2.1b) in the "special medical gas" and "or related national or regional standards (see ISO /T R7470) "; • Replace ISO 32. 1977 (see 7.2.1, Table 2) with GB 50751-2012 and delete the "or region or country" in 7.2.1 standard". This standard is compared with ISO 21969..2009, made the following editorial changes. --- According to the national drug standard WS1-XG-008-2012, 1.1 will be "oxygen-enriched air" to "oxygen-enriched air (93% oxygen)"; - Added in Chapter 2 "Note. Appendix A contains the basic principles of certain requirements of this standard."; --- removed in 5.3.3 "Note. The temperature range required by the environmental conditions of each country or region may be different." - Removed the "regional or national regulations" in 5.4.4; --- ISO 21969..2009 cited in the international standards, there are corresponding to be used as national standards and industry standards, the standard to reference These national standards and industry standards as a standardized use; there is no corresponding to be used as national standards and industry standards, then cited Use the international standard as a normative use; --- in the standard text after the reference to the document to increase the number; --- 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. Shenzhen Mindray Biomedical Electronics Co., Ltd., Shanghai Medical Devices Testing Institute, Jie Rui Enterprise (Shanghai) Limited company. The main drafters of this standard. Li Xinsheng, Wang Wei, Hu Yuegang, Ma Xiaojian, Fu Guoqing. High pressure flexible connections for use with medical gas systems

1 Scope

1.1 This standard applies to the expected and 15 ° C maximum nominal filling pressure of 25000 kPa for the following medical gas cylinders or gas High-pressure flexible connection of the bottle group. ---oxygen; --- nitrous oxide (nitrous oxide); --- breathe air; Helium ---carbon dioxide; --- xenon; A mixture of the above gases; Driving air for surgical instruments; - Driving surgical instruments with nitrogen; Oxygen-enriched air (93% oxygen). 1.2 This standard applies to high-pressure flexible connections where the gas cylinders or cylinders are to be connected to the busbars, which are included in ISO 7396-1. 2007 medical gas pipeline system within the gas source. 1.3 This standard applies to medical equipment (such as anesthesia) that is intended to connect cylinders to pressure regulators fitted with ISO 10524-1..2006 Workstations or ventilators). 1.4 This standard does not apply to the high pressure flexible connection of the intended filling cylinders and does not apply to the low pressure hose specified in YY/T 0799-2010 Component. 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 15383-2011 Cylinder valve outlet connection type and dimensions (ISO 5145..2004, NEQ) Technical specification for medical gas engineering GB 50751-2012 YY/T 0316-2008 Medical Device Risk Management for Medical Devices (ISO 14971..2007, IDT) YY/T 0882-2013 Compatibility of anesthesia and breathing equipment with oxygen (ISO 15001..2003, IDT) ISO 407..2004 Small medical cylinders Needle guide valve connector (Smalmedicalgascylinders-Pin-indexyoke- typevalveconnections ISO 7396-1..2007 Medical gas piping systems - Part 1. Piping systems for medical compressed gas and vacuum (Medical gaspipelinesystems-Part 1. Pipelinesystemsforcompressedmedicalgasesandvacuum) Note. Appendix A contains the basic principles of certain requirements of this standard.

3 terms and definitions

The following terms and definitions apply to this document.

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