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1、AReference number ISO 9170-1:1999(E) INTERNATIONAL STANDARD ISO 9170-1 First edition 1999-12-15 Terminal units for medical gas pipeline systems Part 1: Terminal units for use with compressed medical gases and vacuum Prises murales pour rseaux de distribution de gaz mdicaux Partie 1: Prises murales p
2、our les gaz mdicaux comprims et le vide Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 00:34:45 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 917
3、0-1:1999(E) ISO 1999 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher. International Organization fo
4、r Standardization Case postale 56 CH-1211 Genve 20 Switzerland Internetisoiso.ch Printed in Switzerland ii Contents Page 1 Scope1 2 Normative references2 3 Terms and definitions .2 4 General requirements5 4.1 Safety.5 4.2 R Alternative construction.5 4.3 Materials 5 4.4 Design requirements5 4.5 Cons
5、tructional requirements.8 5 Test methods8 5.1 General.8 5.2 Test for endurance9 5.3 Test for pressure drop9 5.4 Test for connection force and torque.11 5.5 Test for disconnection force and torque12 5.6 Test for mechanical strength.12 5.7 Test for leakage.12 5.8 Test for gas-specificity.13 5.9 Test f
6、or effective connection of probes .13 5.10 Test for durability of markings and colour coding13 6 Marking, colour coding and packaging.13 6.1 Marking13 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not fo
7、r Resale, 04/19/2007 00:34:45 MDTNo reproduction or networking permitted without license from IHS -,-,- ISOISO 9170-1:1999(E) 6.2 Colour coding .13 6.3 Packaging14 7 Information to be supplied by the manufacturer14 Annex A (informative) Rationale15 Bibliography16 Copyright International Organization
8、 for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 00:34:45 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 9170-1:1999(E) ISO iv Foreword ISO (the International Organization for Standard
9、ization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to
10、be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Stand
11、ards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies ca
12、sting a vote. International Standard ISO 9170-1 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 6, Medical gas systems. This first edition, together with ISO 9170-2, cancels and replaces the first edition of ISO 9170 (ISO 9170:1994), which has b
13、een technically revised. ISO 9170 consists of the following parts, under the general title Terminal units for medical gas pipeline systems: Part 1: Terminal units for use with compressed medical gases and vacuum Part 2: Terminal units for anaesthetic gas scavenging systems Annex A of this part of IS
14、O 9170 is for information only. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 00:34:45 MDTNo reproduction or networking permitted without license from IHS -,-,- ISOISO 9170-1:1
15、999(E) Introduction Terminal units are the points on a medical gas pipeline system where the operator makes connections and disconnections for the supply of specified medical gases to anaesthetic machines, lung ventilators or other items of medical equipment. A wrong connection can create a hazard t
16、o the patient or operator. It is important that terminal units and their components are designed, manufactured, installed and maintained in such a way as to meet the basic requirements specified in this part of ISO 9170. This part of ISO 9170 pays particular attention to: suitability of materials; g
17、as-specificity; cleanliness; testing; identification; information supplied. This part of ISO 9170 specifies the provision of information for the installation and subsequent testing of terminal units prior to use. Testing of terminal units prior to use is critical to patient safety, and it is essenti
18、al that terminal units are not used until full testing in accordance with ISO 7396-1 has been completed. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 00:34:45 MDTNo reproducti
19、on or networking permitted without license from IHS -,-,- Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 00:34:45 MDTNo reproduction or networking permitted without license from
20、 IHS -,-,- INTERNATIONAL STANDARD ISOISO 9170-1:1999(E) 1 Terminal units for medical gas pipeline systems Part 1: Terminal units for use with compressed medical gases and vacuum 1 Scope This part of ISO 9170 specifies requirements for terminal units intended for use in medical gas pipeline systems i
21、n accordance with ISO 7396-1, for use with the following services: oxygen; nitrous oxide; air for breathing; carbon dioxide; oxygen/nitrous oxide mixture 50 %/50 % (by volume); air for driving surgical tools; nitrogen for driving surgical tools; vacuum. It is intended especially to ensure the gas-sp
22、ecific assembly of terminal units and to prevent their interchange between different gases. This part of ISO 9170 specifies requirements for terminal units for supply and disposal of nitrogen or air for driving surgical tools. This part of ISO 9170 specifies requirements for probes intended to be co
23、nnected to the gas-specific connection point which is part of the terminal unit. This part of ISO 9170 does not specify the dimensions of probes and of the gas-specific connection points of the terminal units. This part of ISO 9170 does not specify the dimensions of NIST connectors, which are define
24、d in ISO 5359. This part of ISO 9170 does not specify the requirements for terminal units for anaesthetic gas scavenging systems (AGSS), which are defined in ISO 9170-2. NOTE 1 The requirements of this part of ISO 9170 may be used as guidelines for terminal units for other medical gases. These medic
25、al gases will be considered for inclusion in this part of ISO 9170 when they come into general use. NOTE 2Throughout this part of ISO 9170, clauses for which a rationale is provided in annex A are indicated by a boldface capital R. Copyright International Organization for Standardization Provided by
26、 IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 00:34:45 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 9170-1:1999(E) ISO 2 2 Normative references The following normative documents contain provisions which, through
27、 reference in this text, constitute provisions of this part of ISO 9170. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part of ISO 9170 are encouraged to investigate the possibility of applying th
28、e most recent edition of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 32:1977, Gas cylinders for medical use Marking for ide
29、ntification of content. ISO 5359, Low-pressure hose assemblies for use with medical gases ISO 6506-1, Metallic materials Brinell hardness test Part 1: Test method. ISO 7396-1, Medical gas pipeline systems Part 1: Pipelines for compressed medical gases and vacuum. ISO 14971-1, Medical devices Risk ma
30、nagement Part 1: Application of risk analysis. ISO 15001, Anaesthetic and respiratory equipment Compatibility with oxygen. 3 Terms and definitions For the purposes of this part of ISO 9170, the following terms and definitions apply. A diagram of a typical terminal unit and probe, with an example of
31、terminology, is shown in Figure 1. 3.1 diameter-index safety system connector DISS connector range of male and female components intended to maintain gas-specificity by allocation of a set of different diameters to the mating connectors for each particular gas 3.2 gas-specific having characteristics
32、 which prevent interchangeability and thereby allow assignment to one gas or vacuum service only 3.3 gas-specific connection point that part of the socket which is the receptor for a gas-specific probe 3.4 gas-specific connectors connectors which are either NIST (non-interchangeable screw-threaded)
33、or DISS (diameter-index safety system) or non-interchangeable quick connectors of terminal units 3.5 low-pressure hose assembly assembly, consisting of a flexible hose with permanently attached gas-specific inlet and outlet connectors, which is designed to conduct a medical gas at pressures less tha
34、n 1 400 kPa 3.6 medical gas any gas or mixture of gases intended to be administered to patients for therapeutic, diagnostic or prophylactic purposes, or for surgical tool application(s) Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Tech
35、nical Standards 1/9972545001 Not for Resale, 04/19/2007 00:34:45 MDTNo reproduction or networking permitted without license from IHS -,-,- ISOISO 9170-1:1999(E) 3 3.7 medical gas pipeline system central supply system consisting of control equipment, a pipeline distribution system and terminal units
36、at the points where medical gases or vacuum may be required 3.8 medical gas supply system medical gas pipeline system or any other installation having no permanent pipeline system but employing a medical gas supply source complete with pressure regulators 3.9 nominal distribution pressure pressure w
37、hich the pipeline distribution system is designed to deliver at the terminal unit NOTE Unless otherwise specified, pressures in this part of ISO 9170 are expressed as gauge pressures (i.e. atmospheric pressure is defined as 0). 3.10 non-interchangeable screw-threaded connector NIST connector range o
38、f male and female components intended to maintain gas-specificity by the allocation of a set of different diameters and a left- or right-hand screw thread to the mating components for each particular gas 3.11 probe gas-specific male component designed for acceptance by and retention in the socket 3.
39、12 quick connector pair of non-threaded gas-specific components which can be easily and rapidly joined together by a single action of one or both hands without the use of tools 3.13 single-fault condition condition in which a single means for protection against a safety hazard in equipment is defect
40、ive or a single external abnormal condition is present 3.14 socket that 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 3.15 terminal unit outlet assembly (inlet for vacuum) in a me
41、dical gas supply system at which the operator makes connections and disconnections 3.16 terminal unit base block that part of a terminal unit which is attached to the pipeline distribution system 3.17 terminal unit check valve valve which remains closed until opened by insertion of an appropriate pr
42、obe and which then permits flow in either direction Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 00:34:45 MDTNo reproduction or networking permitted without license from IHS -
43、,-,- ISO 9170-1:1999(E) ISO 4 Key 1NIST or DISS body 2Hose insert 3Point for brazed connection 4Base block 5Maintenance valve 6Check valve 7Gas-specific interface 8Socket 9Gas-specific connection point 10Probe Figure 1 Diagram showing typical components of a terminal unit and probe Copyright Interna
44、tional Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 00:34:45 MDTNo reproduction or networking permitted without license from IHS -,-,- ISOISO 9170-1:1999(E) 5 3.18 terminal unit maintenance valve val
45、ve which permits maintenance of the terminal unit without shutting down the pipeline system to other terminal units 3.19 terminal unit for supply and disposal of nitrogen or air for driving surgical tools combination of an outlet assembly (for supply) and an inlet assembly (for disposal) which are c
46、onnected to a medical gas supply system and to an anaesthetic gas disposal system respectively and at which the operator makes connections and disconnections by means of a combined probe 4 General requirements 4.1 Safety Terminal units shall, when transported, stored, installed, operated in normal u
47、se and maintained according to the instructions of the manufacturer, cause no safety hazard which could be foreseen using risk analysis procedures in accordance with ISO 14971-1 and which is related to their intended application, in normal condition and in single- fault condition. 4.2 R Alternative
48、construction Terminal units and components, or parts thereof, which use materials or have forms of construction different from those detailed in clause 4 of this part of ISO 9170 shall be accepted if it can be demonstrated that an equivalent degree of safety is obtained. Such evidence shall be provided by the manufacturer. 4.3 Materials 4.3.1 The materials in contact wit