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YY 0801.2-2010 English PDF

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YY 0801.2-2010: Terminal units for medical gas pipeline systems. Part 2: Terminal units for anaesthetic gas scavenging systems
Status: Obsolete
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YY 0801.2-2010English959 Add to Cart 5 days [Need to translate] Terminal units for medical gas pipeline systems. Part 2: Terminal units for anaesthetic gas scavenging systems Obsolete YY 0801.2-2010

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Basic data

Standard ID YY 0801.2-2010 (YY0801.2-2010)
Description (Translated English) Terminal units for medical gas pipeline systems. Part 2: Terminal units for anaesthetic gas scavenging systems
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C46
Classification of International Standard 11.040.10
Word Count Estimation 24,261
Date of Issue 2010-12-27
Date of Implementation 2012-06-01
Quoted Standard GB/T 231.1-2009; YY/T 0316-2008; ISO 7396-2-2007; ISO 8835-3-2007; ISO 15001-2003
Adopted Standard ISO 9170-2-2008, IDT
Regulation (derived from) State Food and Drug Administration Notice 2010 No. 97
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the expectations in line with ISO 7396-2 with the anesthetic gas purification system requirements and the size of the terminal. The power means is based in part on the upstream or downstream of the terminal provides two types of terminals. This section also provides a dedicated connection point type matching pieces (insert) the requirements and dimensions, the type of dedicated connection points are part of a terminal. This section does not require ISO 7396-2 defined terminal nominal operating pressure range. 1. 5 part does not apply YY 0801. 1 for compressed medical gases and vacuum terminal requirements.

YY 0801.2-2010: Terminal units for medical gas pipeline systems. Part 2: Terminal units for anaesthetic gas scavenging systems


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Terminal units for medical gas pipeline systems.Part 2. Terminal units for anaesthetic gas scavenging systems ICS 11.040.10 C46 People's Republic of China pharmaceutical industry standards YY 0801.2-2010/ISO 9170-2.2008 Medical gas pipeline system terminal Part 2. Terminal for anesthetic gas purification system Part 2. Terminalunitsforanaestheticgasscavengingsystems (ISO 9170-2.2008, IDT) Issued on. 2010-12-27 2012-06-01 implementation State Food and Drug Administration issued

Table of Contents

Preface Ⅰ Introduction Ⅱ 1 Scope 1 2 * Normative references 1 3 Terms and definitions 4 General requirements 5 4.1 Security 5 4.2 * Optional structure 5 4.3 material 6 4.4 Design Requirements 6 4.5 Structural requirements 10 5 Test methods 11 5.1 Overview 11 5.2 Durability Test 11 5.3 drop test 11 Test Method 5.4 Connecting Power 11 Standard Test Method for separating force of 12 5.5 5.6 Mechanical strength test 12 5.7 Leak Test 12 12 5.8 Type-specific tests 5.9 insert receptacle effective connection test 13 5.10 collected or processed hose and hose into the connection test body 13 Durability Test 5.11 logo and color code 13 6 marks, color code and packaging 13 6.1 mark 13 6.2 Color Code 13 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 17 References 18 YY 0801.2-2010/ISO 9170-2.2008

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 2 YY 0801 of. This section drafted in accordance with GB/T 1.1-2009 given rules. This section identical with the international standard ISO 9170-2.2008 "medical gas pipeline systems - Part 2 terminal. for anesthetic gas net System Terminal "(in English). This part of ISO 9170-2.2008 as compared to the major differences include. --- ISO 9170-2.2008 Introduction The conversion of the present introduction, delete ISO 9170-2.2008 Foreword; --- ISO 9170-2.2008 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; 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. YY 0801.2-2010/ISO 9170-2.2008

Introduction

Terminal for anesthetic gas purification systems (AGSS) is the connection point on the anesthetic gas purification system, where the operator to connect And off to the treatment of medical anesthetic gases and steam from the anesthesia or other medical devices; where, a wrong connection can be patient Harm. Therefore, according to the basic requirements specified in this part of the design, manufacture, installation and maintenance of the terminal and its components it is very important. Special attention in this section. --- Material compatibility; --- Type specificity; --- Insert member size and type specific connection points; ---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, in accordance with ISO 7396-2 we must complete 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 (*) are appropriate 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. YY 0801.2-2010/ISO 9170-2.2008 Medical gas pipeline system terminal Part 2. Terminal for anesthetic gas purification system

1 Scope

1.1 YY 0801 This section specifies the requirements expected to be used in anesthetic gas purification system complies with ISO 7396-2 in the terminal and size. 1.2 A power plant is part of the upstream or downstream of the terminal provides for two types of terminals. 1.3 section also specifies the type of dedicated connection points counterpart (insert) the requirements and the size of the type of dedicated connection point is a terminal section. 1.4 section does not specify the nominal working pressure range defined by ISO 7396-2 terminals. 1.5 Part no provisions YY 0801.1 for compressed medical gases and vacuum terminal requirements. 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) YY/T 0316-2008 medical device risk management to medical devices applications (ISO 14971.2007, IDT) ISO 7396-2.2007 Medical gas pipeline systems - Part 2. anesthetic gas scavenging disposal systems (Medicalgaspipeline systems-Part 2. Anaestheticgasscavengingdisposalsystems) ISO 8835-3.2007 for inhalation anesthesia systems - Part 3. Active anesthetic gas purification system delivery and collection system (In- halationalanaesthesiasystems-Part 3. Transferandreceivingsystemsofactiveanaestheticgasscav- engingsystems) ISO 15001.2003 Anaesthetic and respiratory equipment oxygen compatibility (Anaestheticandrespiratoryequipment-Com- patibilitywithoxygen)

3 Terms and Definitions

The following terms and definitions apply to this document. Note. a term with a typical example of anesthetic gas purification system diagram shown in Figure 1. 3.1 AGSS1 type terminal AGSStype1terminalunit The connection point between the collection systems and processing systems by the operator to make the connection and disconnection. See Figure 2. 3.2 AGSS1L type terminal AGSStype1Lterminalunit For use in low-flow processing system terminals. 3.3 AGSS1H type terminal AGSStype1Hterminalunit Terminal in a high traffic handling system. YY 0801.2-2010/ISO 9170-2.2008

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