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

医用气体管道系统终端 第1部分:用于压缩医用气体和真空的终端

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

December 27, 2010

Implementation date

June 1, 2012

Scope

YY 0801.1-2010 is the English-translated version of 医用气体管道系统终端 第1部分:用于压缩医用气体和真空的终端.

YY 0801.1-2010 is the Chinese pharmaceutical industry standard for the terminal units of a medical gas pipeline system built to ISO 7396-1, the outlets at which compressed medical gases and vacuum are taken from the pipeline.

It is the first part of the YY 0801 series and sets the requirements for terminal units for oxygen, nitrous oxide, medical air, carbon dioxide, their mixtures and vacuum, covering the gas-specific connection that prevents interchange, the flow and the pressure drop, the leakage, the mechanical strength and the endurance of the connection, the marking and the information supplied. Issued on 27 December 2010, it applies from 1 June 2012.

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Document preview — YY 0801.1-2010

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

  • Foreword
  • Introduction
  • 1 Scope

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.

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.

1 Scope

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.

ISO 11114-3:1997 Materials and gas movable gas cylinders and valves compatibility test spontaneous combustion in oxygen atmosphere (Transportablegascylinders-Compatibilityofcylinderandvalvematerialswithgascontents-Part

1.1 YY 0801 This part applies

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.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.

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