YY 0801.1-2010 English PDF

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YY 0801.1-2010: Terminal units for medical gas pipeline systems. Part 1: Terminal units for use with compressed medical gases and vacuum
Status: Obsolete

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 0801.1-2010	879	Add to Cart	4 days	Terminal units for medical gas pipeline systems. Part 1: Terminal units for use with compressed medical gases and vacuum	Obsolete

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Basic data

Standard ID: YY 0801.1-2010 (YY0801.1-2010)
Description (Translated English): Terminal units for medical gas pipeline systems. Part 1: Terminal units for use with compressed medical gases and vacuum
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C46
Classification of International Standard: 11.040.10
Word Count Estimation: 22,213
Date of Issue: 2010-12-27
Date of Implementation: 2012-06-01
Quoted Standard: GB/T 231.1-2009; GB 7144-1999; YY/T 0316-2008; YY/T 0799; ISO 7396-1-2007; ISO 11114-3-1997; ISO 15001-2003
Adopted Standard: ISO 9170-1-2008, MOD
Regulation (derived from): State Food and Drug Administration Notice 2010 No. 97
Issuing agency(ies): State Food and Drug Administration
Summary: This standard applies to: a) are expected to be used in line with ISO 7396-1 for medical gas pipeline systems, and to a terminal used for the following medical gases: 1) oxygen, 2) nitrous oxide, 3) medical air, 4) carbon dioxide, 5) an oxygen/nitrous oxide mixture [50%/50% (by volume)]. b) are expected to be used in line with ISO 7396-1 for medical gas pipeline system and is used on the following gases and use Terminal: 1) oxygen-enriched air, 2) driven surgical instruments used in air, 3) driven surgical instruments with nitrogen, 4) vacuum. (Note 1: The use of air-driven surgical instruments can use different names or symbols, such as instrument air, surgical air, air-driven, air and air -800 -700 Note 2: The requirements of this part can be used for any other gas terminal The guidance is used as a general, these other gases to be considered included in this section were). This section dedicated special attention to ensure that the gas component of the terminal to prevent these components and between different gas exchange between applications. This standard provides for the supply and treatment of surgical instruments driven nitrogen or air terminal requirements. This standard specifies the connection point for connecting the dedicated gas insert pieces of the requirements of the specific gas connection point is part of a terminal. This section has provided investment inserted components or terminal dedicated gas connection point size. (Note: Some items ship set the beat man and a dedicated gas connection point size of regional or national standards are given in the references). This part is not specified in the YY/T 0799 defined in NIST connector size. This part is not specified in the CGA (Compressed Gas Association) V-5 [12] as defined DISS connection dimensions.

YY 0801.1-2010: Terminal units for medical gas pipeline systems. Part 1: Terminal units for use with compressed medical gases and vacuum

---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.
Terminal units for medical gas pipeline systems.Part 1. Terminal units for use with compressed medical gases and vacuum ICS 11.040.10 C46 People's Republic of China pharmaceutical industry standards Medical gas pipeline system terminal Part 1. For compressed medical gases and Vacuum terminal Part 1. Terminalunitsforusewithcompressedmedicalgasesandvacuum (ISO 9170-1.2008, MOD) Issued on. 2010-12-27 2012-06-01 implementation State Food and Drug Administration issued

Table of Contents

Introduction Ⅲ Introduction Ⅳ 1 Scope 1 2 * Normative references 1 3 Terms and definitions 2 4 General requirements 4 4.1 Security 4 4.2 * Optional structure 4 4.3 material 4 4.4 Design Requirements 5 4.5 Structural requirements 8 5 Test methods 8 5.1 Overview 8 5.2 8 Durability Test 5.3 drop test 9 5.4 Connecting the force and torque test 11 5.5 Disconnect the power and torque test 11 5.6 Mechanical strength test 11 5.7 Leak Test 11 Special test 5.8 gas 12 5.9 effective connection test insert 12 Durability Test 5.10 logo and color code 12 6 marks, color code and packaging 12 6.1 mark 12 6.2 Color Code 12 6.3 Packaging 13 7 Information supplied by the manufacturer 13 Appendix A (informative) Fundamentals 14 Annex B (informative) environment 15 Annex C (informative) special national and regional electrical installation conditions 16 References 17

Foreword

YY 0801 the general title "medical gas pipeline system terminal," includes the following two parts. --- Part 1. for compressed medical gases and vacuum terminals; --- Part 2. Terminal for anesthetic gas purification system. This is Part 1 YY 0801 of. This section drafted in accordance with GB/T 1.1-2009 given rules. The partial modification of the use of ISO 9170-1.2008 "medical gas pipeline systems - Part 1 terminal. for compressed medical gases and vacuum Terminal "(in English). This part of ISO 9170-1.2008 as compared to the major differences include. --- ISO 9170-1.2008 Introduction The conversion of the present introduction, delete ISO 9170-1.2008 Foreword; --- ISO 9170-1.2008 international standard referenced, has been adopted as the corresponding national standards and industry standards, this section by reference These national standards and industry standards as the standard use; no correspondence now been adopted as national standards and industry standards, places cited With international standards as ISO standard use; --- ISO 9170-1.2008 in Table 2 "medical gases symbols and color code" color code to use GB 7144. International standards referenced in this section, let it be transformed into the same period after the implementation of national or industry standards. This part of the National Standardization Technical Committee on Narcotic breathing apparatus and (SAC/TC116) and focal points. This section is drafted. Draeger Medical Devices Co., Ltd., Shanghai Medical Device detection. The main drafters of this section. Ding Deping, Wang Wei.

Introduction

Terminal is the connection point on the medical gas pipeline system, where the operator to connect and disconnect the anesthesia machine, ventilator or other medical equipment Provisions for medical gas source. A faulty connection can cause harm to the patient or operator. Therefore, according to the basic requirements set forth in this section to Design, manufacture, installation and maintenance of the terminal and its components is very important. Special attention in this section. --- Material compatibility; --- Gas specificity; ---clean; ---test; --- Identification; --- Information. This section provides information to be provided to the test before installation and use of the terminal. Test before using the terminal for patient safety is to Crucial and necessary, and only in accordance with ISO 7396-1 completed a comprehensive test in order to use the terminal. Appendix A contains the basic principles of the part of some of the requirements. After the terms of number with an asterisk (*), there is a corresponding in Appendix A The basic principle, the basic principle is added in order to provide additional comments to explain the reason of this section contains the requirements and recommendations. Generally considered, Reason to know these requirements will not only help correct application of this section, and will speed up this part of the subsequent amendments. Medical gas pipeline system terminal Part 1. For compressed medical gases and Vacuum terminal

1 Scope

1.1 YY 0801 This part applies to. a) is expected to be used in medical gas pipeline system in compliance with ISO 7396-1, and for the following medical gas terminal. 1) oxygen; 2) nitrous oxide; 3) medical air; 4) carbon dioxide; 5) Oxygen/nitrous oxide gas mixture [50%/50% (by volume)]. b) expected to be used in medical gas pipeline system in compliance with ISO 7396-1, and used for the following purposes and gas terminal. 1) oxygen-enriched air; 2) with an air-actuated surgical instruments; 3) driving surgical instruments with nitrogen; 4) vacuum. Note 1. The use of air-driven surgical instruments may use different names or symbols, such as instrument air, air operation, air-driven, air and air -700 -800. Note 2. The requirements of this gas can be used as a guide to other terminals. As a general use, these other gases will be considered included in this section among. This part of the special focus on ensuring the gas component of the terminal dedicated to prevent these components are interchangeable between different gases and between uses. 1.2 part specifies requirements for supply and disposal driven surgical instruments nitrogen or air terminal. 1.3 standard specifies requirements for insert gas connection dedicated connection point, the connection point is part of a dedicated gas terminal. 1.4 section does not specify the size of the insert or dedicated gas terminal connection points. NOTE. Some regional regulations and special insert gas connection point size or national standards are given in the literature. 1.5 section does not specify the size of the joint NIST YY/T 0799 defined in the. 1.6 This section is not specified in the CGA (Compressed Gas Association) V-5 [12] defined size DISS fitting. 1.7 Part no requirement for anesthetic gas purification systems (AGSS) terminal YY 0801.2 involved. 2 * Normative references The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. Test Method. GB/T 231.1-2009 metallic materials Brinell hardness test - Part 1 (ISO 6506-1.2005, MOD) GB 7144-1999 cylinders color coded YY/T 0316-2008 medical device risk management to medical devices applications (ISO 14971.2007, IDT) YY/T 0799 medical gas low pressure hose assemblies (YY/T 0799-2010, ISO 5359.2008, MOD) ISO 7396-1.2007 Medical gas pipeline systems - Part 1. for compressed medical gases and vacuum pipeline system (Medical gaspipelinesystems-Part 1. Pipelinesystemsforcompressedmedicalgasesandvacuum) ISO 11114-3.1997 Materials and gas movable gas cylinders and valves compatibility test spontaneous combustion in oxygen atmosphere (Transportablegascylinders-Compatibilityofcylinderandvalvematerialswithgascontents-Part ......

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