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YY/T 0799-2010: Low-pressure hose assemblies for use with medical gases
YY/T 0799-2010
Low-pressure hose assemblies for use with medical gases
ICS 11.040.10
C46
People's Republic of China pharmaceutical industry standards
Low pressure hose assemblies for medical gases
(ISO 5359.2008, MOD)
Issued on. 2010-12-27
2012-06-01 implementation
State Food and Drug Administration issued
Table of Contents
Preface Ⅰ
Introduction Ⅱ
Overview 0.1 Ⅱ
Standardization Ⅱ 0.2 threaded connector for hose assemblies
1 Scope 1
2 Normative references 1
3 Terms and definitions 2
4 General requirements 4
5 Test Method 14
6 logo, color labeling and packaging 16
7 Information supplied by the manufacturer 18
Appendix A (informative) Fundamentals 19
Annex B (informative) environment 20
Annex C (informative) According to color identification and medical gases term report 21 differences among regions and countries
References 23
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This revised standard adopts the International Standard ISO 5359.2008 "medical gas low pressure hose assemblies" (in English).
This standard and ISO 5359. compared to 2008, the main differences include.
--- ISO 5359.2008 standard introduction to the conversion-oriented introduction, delete ISO 5359.2008 Foreword.
--- ISO 5359. ISO 2008 international standard referenced, has been adopted as the corresponding national standards and industry standards, in order to lead this part
Use these national standards and industry standards as the norm; now no correspondence has been adopted as national standards and industry standards, places cited
With international standards as ISO standard use.
--- The ISO 5359.2008 standard in Table 6 are identified by colors according to EN1089-3.2004 according to GB 7144-1999.
This standard by the National Standardization Technical Committee on Narcotic breathing apparatus and (SAC/TC116) centralized.
This standard was drafted. Shanghai Medical Device Testing, Shanghai Medical Devices Co., Ltd.
The main drafters of this standard. Wang Wei, Fu Guoqing.
introduction
0.1 Overview
The standard-setting, because of the need for a secure way to connect medical devices to a fixed or medical gas pipeline systems
Other medical gas supply system to meet the different transport gas, or different kinds of pressure with gas hose assemblies shall exchange requirements.
Fixed medical gas pipeline, once installed, can not be free to move, and follow the prescribed procedures used in order to prevent cross with medical gases
Mix or the possibility of contamination. However, within a relatively short period of use, hose assemblies frequently with medical devices and stationary gas pipe
Connect, Disconnect appears natural wear and tear, misuse and abuse issues.
While recognizing No system is absolutely safe, this standard was included to prevent the use of hose assemblies brought predictable
The necessary provisions hazards. The operator should be constantly alert to the possibility of damage due to external factors, therefore, we should carry out regular inspections and maintenance to
To ensure that this continues to meet the requirements of the standard hose assemblies.
The standard pay particular attention to the following issues.
--- Suitability of the material;
--- Gas specificity;
--- Cleanliness;
---test;
--- Identification;
--- Information.
This standard requires certain basic principles are given in Appendix A. These terms used in the text, "*" indicates.
0.2 Standardization hose assemblies for threaded joints
Although there are expectations of a unified international standard threaded joint, but the current situation is not yet ripe to develop uniform standards. however,
With the rapid increase in the number of national standards, eventually it may lead to cross for different gas components mix between risk and therefore,
The criteria for selecting three nipple system.
Three kinds of non-interchangeable connector system are. DISS (diameter limit security system), NIST (non-interchangeable screw) and SIS
(Fittings limit system). Table 1 and Table 5 details the gases and gas mixtures DISS, NIST and SIS connectors available. NIST
Size fittings in Table 2, Table 3 and Table 4 and Figure 2, 3, 4 and 5 are given in Fig.
As an alternative to the threaded joint, special gas "quick connector" can be used for air intake hose assemblies (vacuum when the outlet), that is,
Hose assembly for connecting to the fixed pipeline. In any health care institutions, inter-quick connector systems of different designs are not interchangeable.
Low pressure hose assemblies for medical gases
1 Scope
* 1.1 This standard specifies the requirements for low-pressure hose assemblies for the following medical gases.
---oxygen;
--- Nitrous oxide (laughing gas);
--- Medical air;
--- Helium;
---carbon dioxide;
--- Xenon;
--- Special gas mixture of the gas;
--- Enriched air;
--- Driving surgical instruments air;
--- Driving surgical instruments with nitrogen;
---vacuum.
Its main purpose is to ensure that specific gas, to prevent cross-connection between different gas transmission systems. These hose assemblies intended for most
Great work pressure is less than 1400kPa place.
1.2 This standard specifies the thread are not interchangeable with medical gases (NIST) connectors, diameter limit safety system (DISS) connectors and
Fittings Limit System (SIS) joint configurations, and provides non-interchangeable threaded (NIST) connectors size.
1.3 This standard does not specify.
--- Surgical instrument for driving coaxial hose air supply and discharge requirements;
--- Conductivity requirements.
1.4 This standard does not specify the intended use of the hose assembly.
NOTE. provides some examples of the intended use of the following criteria.
A) between the terminal equipment and medical equipment (ISO 9170-1, GB 9706.28 [7], GB 9706.29 [8]);
Between the terminal device b) fixed piping system and the system (ISO 7396-1 [10], YY 0733 [13]);
Between c) a second terminal equipment and terminal equipment (ISO 7396-1);
Between emergency and maintenance inlet d) emergency supply system and piping systems (ISO 10524-1 [12], ISO 7396-1);
Between e) emergency supply systems and medical devices (ISO 10524-1, ISO 10524-3 [16], GB 9706.28, GB 9706.29).
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.
GB 7144-1999 cylinders color logo
GB/T 9575-2003 industrial and general rubber plastic hose diameters and tolerances, and tolerances on length (ISO 1307.1992)
GB/T 5563-2006 Rubber and plastic hoses and hose assemblies - Hydrostatic testing (ISO 1402.1994, IDT)
GB/T 14905-1994 Rubber and plastics hoses - Determination of adhesion between layers (ISO 8033.1991)
Part 1 YY 0801.1-2010 medical gas pipeline system terminal. for compressed medical gases and vacuum terminals
(ISO 9170-1.2008, MOD)
YY/T 0316-2008 medical device risk management to medical devices applications (ISO 14971.2007)