YY 0801.2-2010Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (English PDF)
医用气体管道系统终端 第2部分:用于麻醉气体净化系统的终端
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
December 27, 2010
Implementation date
June 1, 2012
Scope
YY 0801.2-2010 is the English-translated version of 医用气体管道系统终端 第2部分:用于麻醉气体净化系统的终端.
YY 0801.2-2010 is the Chinese pharmaceutical industry standard that sets the requirements and the dimensions for the terminal units of an anaesthetic gas scavenging system built to ISO 7396-2.
It is the second part of the YY 0801 series and covers the two types of terminal unit defined by whether the powered device lies upstream or downstream of them, the gas-specific connection, the flow the unit must pass and the pressure it may develop, the leakage, the mechanical strength and the marking. Issued on 27 December 2010, it applies from 1 June 2012.
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Document preview — YY 0801.2-2010
National Standard of the People's Republic of China
- ICS
- 11.040.10
- Classification
- C 46
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- Introduction
- 1 Scope
- 2 * Normative references
- 3 Terms and definitions
- 4 General requirements
- 4.1 Security
- 4.2 * Optional structure
- 4.3 material
- 4.4 Design Requirements
- 4.5 Structural requirements
- 5 Test methods
- 5.1 Overview
- 5.2 Durability Test
- 5.3 drop test
- 5.6 Mechanical strength test
- 5.7 Leak Test
- 12
- 5.8 Type-specific tests
- 5.9 insert receptacle effective connection test
- 5.10 collected or processed hose and hose into the connection test body
- 6 marks, color code and packaging
- 6.1 mark
- 6.2 Color Code
- 6.3 Packaging
- 7 Information supplied by the manufacturer
- Appendix A (informative) Fundamentals
- Annex B (informative) environment
- Annex C (informative) special national and regional electrical installation conditions
- References
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.
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.
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.
1.4 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.
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)
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.
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.
ISO 7396-2:2007 Medical gas pipeline systems - Part 2.
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
For use in low-flow processing system terminals.
3.3 AGSS1H type terminal
Terminal in a high traffic handling system.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.
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