YY/T 0799-2010 (YY/T0799-2010, YYT 0799-2010, YYT0799-2010) & related versions
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Low-pressure hose assemblies for use with medical gases
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YY/T 0799-2010
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YYT 0799-2010
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YY/T 0799-2010: PDF in English (YYT 0799-2010)
YY/T 0799-2010
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.10
C 46
Low-pressure hose assemblies for use with
medical gases
(ISO 5359.2008, MOD)
ISSUED ON. DECEMBER 27, 2010
IMPLEMENTED ON. JUNE 1, 2012
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 4
0.1 General ... 4
0.2 Standardization of screw-threaded connectors for use in hose assemblies ... 4
1 Scope ... 6
2 Normative references ... 7
3 Terms and definitions ... 8
4 General requirements ... 11
5 Test methods ... 24
6 Marking, color coding and packaging ... 27
7 Information to be supplied by the manufacturer ... 29
Annex A ... 30
Annex B ... 31
Annex C ... 32
Bibliography ... 34
Foreword
This Standard is drafted according to the provisions given in GB/T 1.1-2009.
This Standard modifies and adopts international standard ISO 5359.2008 “Low-pressure
Hose Assemblies for Use with Medical Gases” (English version).
Compared with ISO 5359.2008, main differences of this Standard include.
— Convert the introduction of ISO 5359.2008 into introduction of this Standard; delete
the foreword of ISO 5359.2008.
— For ISO international standards that are cited in ISO 5359.2008, if there are
corresponding national standards or industrial standards, then this Standard cites
such national standards or industrial standards as the reference norms; if there is no
existing corresponding national standard or industrial standard, the such cited ISO
international standards are cited as the reference norms.
— Change the color mark in table 6 of ISO 5359.2008 from .according to EN
1089-3.2004” to “according to GB 7144-1999”.
This Standard shall be under the jurisdiction of National Technical Committee of
Anesthesia and Respiratory Equipment Standardization (SAC/TC 116).
Drafting organizations of this Standard. Shanghai Testing & Inspection Institute for
Medical Devices, and Shanghai Medical Instruments Co., Ltd.
Main drafters of this Standard. Wang Wei, and Fu Guoqing.
Introduction
0.1 General
This Standard has been prepared in response to the need for a safe method of connecting
medical equipment to a fixed medical gas pipeline system or other medical gas supply
system such that hose assemblies carrying different gases, or the same gas at different
pressures, cannot be interchanged. Fixed medical gas pipelines, once installed, are rarely
disturbed and are subjected to commissioning procedures to avoid the possibility of
cross-connections or contamination of the medical gas conveyed. However, hose
assemblies are subjected to physical wear and tear, misuse and abuse throughout their
relatively short service life and are frequently connected to, and disconnected from, the
medical equipment and the fixed pipeline.
While recognizing that no system is absolutely safe, this Standard includes those
requirements considered necessary to prevent foreseeable hazards arising from the use
of hose assemblies. Operators should be continually alert to the possibility of damage
being caused by external factors, and therefore regular inspection and repair should be
undertaken to ensure that hose assemblies continue to meet the requirements of this
Standard.
This Standard pays particular attention to.
— suitability of materials;
— gas-specificity;
— cleanliness;
— testing;
— identification;
— information supplied.
Rationales for some of the requirements of this Standard are given in Annex A. Such
requirements are indicated by the asterisk (*) after the clause number in the main text.
0.2 Standardization of screw-threaded connectors for use in hose assemblies
Whilst the desirability of achieving agreement on a single International Standard for
screw-threaded connectors has never been in doubt, the present pattern of usage has
made such agreement impossible. Nevertheless, fears that proliferation of national
standards or practices will eventually result in potentially dangerous cross-connection
between components for different gases have led to the choice of three screw-threaded
connector systems for inclusion in this Standard.
The three systems of connectors, which are non-interchangeable, are diameter-index
safety system (DISS), non-interchangeable screw-threaded (NIST) and sleeve indexed
system (SIS). Tables 1 and 5 detail those gases and gas mixtures for which DISS, NIST
and SIS connectors have been allocated. Dimensions of NIST connectors are given in
Tables 2, 3 and 4 and Figures 2, 3, 4 and 5.
As an alternative to the screw-threaded connector, a "quick connector" which is
gas-specific can be used at the inlet (outlet for vacuum) of the hose assembly, i.e. to
connect the hose assembly to the fixed pipeline. Quick-connector systems of differing
design should be non-interchangeable with each other in any one healthcare facility.
Low-pressure hose assemblies for use with
medical gases
1 Scope
1.1* This Standard specifies requirements for low-pressure hose assemblies intended for
use with the following medical gases.
— oxygen;
— nitrous oxide;
— medical air;
— helium;
— carbon dioxide;
— xenon;
— specified mixtures of the gases listed above;
— oxygen-enriched air;
— air for driving surgical tools;
— nitrogen for driving surgical tools;
— vacuum.
It is intended in particular to ensure gas-specificity and to prevent cross-connection
between systems conveying different gases. These hose assemblies are intended for use
at maximum operating pressures of less than 1400 kPa.
1.2 This Standard specifies the allocation of (NIST), (DISS), (SIS) connectors to medical
gases and specifies the dimensions of non-interchangeable screw-threaded (NIST)
connectors.
1.3 This Standard does not specify.
— requirements for coaxial hoses used for the supply and disposal of air for driving
surgical tools;
— requirements for electrical conductivity.
1.4 This Standard does not specify the intended uses of hose assemblies.
NOTE. Some examples of intended use are specified in following standards.
a) between a terminal unit and medical equipment (ISO 9170-1, GB 9706.28 [7], GB
9706.29 [8]);
b) between the fixed pipeline system and a terminal unit of that system (ISO 7396-1[10], YY
0733[13]);
c) between a terminal unit and a second terminal unit (ISO 7396-1);
d) BETWEEN an emergency supply AND an emergency and maintenance inlet point of a
pipeline system (ISO 10524-1[12], ISO 7396-1);
e) between an emergency supply and medical equipment (ISO 10524-1, ISO 10524-3[16],
GB 9706.28, GB 9706.29).
2 Normative references
The articles contained in the following documents have become part od this document
when they are quoted herein. For the dated documents so quoted, all the modifications
(including all corrections) or revisions made thereafter shall be applicable to this
document.
GB 7144-1999 Colored cylinder mark for gases
GB/T 9575-2003 Colored cylinder mark for gases (ISO 1307.1992)
GB/T 5563-2006 Rubber and plastics hoses and hose assemblies – Hydrostatic
testing (idt ISO 1307.1992)
GB/T 14905-1994 Rubber and plastics hose — Determination of adhesion between
components (ISO 8033.1991)
YY 0801.1-2010 Terminal units for medical gas pipeline systems — Part 1.Terminal
units for use with compressed medical gases and vacuum (ISO 9170-1.2008, MOD)
YY/T 0316-2008 Medical devices — Application of risk management to medical
devices (ISO 14971.2007)
ISO 15001 Anesthetic and respiratory equipment — Compatibility with oxygen
EN 1089-3.2004 Transportable gas cylinders — Gas cylinder identification (excluding
LPG) — Part 3. Color coding
AS 2896-1998 Medical gas systems — Installations and testing of non-flammable
medical gas pipeline systems
condition in which a single means for protection against a safety hazard in equipment is
defective or a single external abnormal condition is present
3.16
SIS connector
sleeve-index system connector
any of a range of male and female components intended to maintain gas-specificity by the
allocation of a set of different diameters to the mating connectors for each particular gas
3.17
socket
female part of a terminal unit which is either integral or attached to the base block by a
gas-specific interface and which contains the gas-specific connection point
3.18
terminal unit
outlet assembly (inlet for vacuum) in a medical gas supply system at which the operator
makes connections and disconnections
4 General requirements
4.1 Safety
Hose assemblies shall, when transported, st...
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| Standard ID | YY/T 0799-2010 (YY/T0799-2010) | | Description (Translated English) | Low-pressure hose assemblies for use with medical gases | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C46 | | Classification of International Standard | 11.040.10 | | Word Count Estimation | 28,234 | | Date of Issue | 2010-12-27 | | Date of Implementation | 2012-06-01 | | Quoted Standard | GB/T 7144-1999; GB/T 9575-2003; GB/T 5563-2006; GB/T 14905-1994; YY 0801.1-2010; YY/T 0316-2008; ISO 15001; EN 1089-3-2004; AS 2896-1998 | | Adopted Standard | ISO 5359-2008, MOD | | Drafting Organization | Shanghai Medical Device Testing | | Administrative Organization | National Standardization Technical Committee of Anaesthetic and respiratory equipment | | Regulation (derived from) | State Food and Drug Administration Notice 2010 No. 97 | | Issuing agency(ies) | China Food and Drug Administration | | Summary | This standard provides for the following medical gas pressure hose assemblies requirements: Oxygen, nitrous oxide (laughing gas), medical air, helium, carbon dioxide, xenon, dedicated the gas mixture, enriched air, driven surgery Devices with air, driven surgical instruments with nitrogen, vacuum. This standard provides for medical gases are not interchangeable threaded (NIST) connectors, diameter limit safety systems (DISS) connectors and fittings Limit System (SIS) connector configuration, and provides non-interchangeable screw (NIST) connector size. This standard does not specify: surgical instruments used to drive air supply and emission requirements for coaxial hose, conductivity requirements. This standard does not specify the intended use of hose assemblies. |
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