1、 Collection of SANS standards in electronic format (PDF) 1. Copyright This standard is available to staff members of companies that have subscribed to the complete collection of SANS standards in accordance with a formal copyright agreement. This document may reside on a CENTRAL FILE SERVER or INTRA
2、NET SYSTEM only. Unless specific permission has been granted, this document MAY NOT be sent or given to staff members from other companies or organizations. Doing so would constitute a VIOLATION of SABS copyright rules. 2. Indemnity The South African Bureau of Standards accepts no liability for any
3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. ISBN 978-0-626-21897-3 SANS 7396-2:2008Edition 1ISO 7396-2:2007Edition 2SOUTH AFRICAN NATIONAL STANDARD Medical gas pipeline systems Part 2: Anaesthetic
4、gas scavenging disposal systems This national standard is the identical implementation of ISO 7396-2:2007 and is adopted with the permission of the International Organization for Standardization. Published by SABS Standards Division 1 Dr Lategan Road Groenkloof Private Bag X191 Pretoria 0001Tel: +27
5、 12 428 7911 Fax: +27 12 344 1568 www.sabs.co.za SABS SANS 7396-2:2008 Edition 1 ISO 7396-2:2007 Edition 2 Table of changes Change No. Date Scope National foreword This South African standard was approved by National Committee SABS TC 58, Vessels and systems under pressure, in accordance with proced
6、ures of the SABS Standards Division, in compliance with annex 3 of the WTO/TBT agreement. This SANS document was published in December 2008. Reference numberISO 7396-2:2007(E)ISO 2007INTERNATIONAL STANDARD ISO7396-2Second edition2007-04-01Medical gas pipeline systems Part 2: Anaesthetic gas scavengi
7、ng disposal systems Rseaux de distribution de gaz mdicaux Partie 2: Rseaux dvacuation de gaz danesthsie non rutilisables SANS 7396-2:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 7396-2:2007(E) PDF disclaimer This PDF file may conta
8、in embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibil
9、ity of not infringing Adobes licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation para
10、meters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2007 All ri
11、ghts 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 either ISO at the address below or ISOs member body in the country of t
12、he requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2007 All rights reservedSANS 7396-2:2008This s tandard may only be used and printed by approved subscription and f
13、reemailing clients of the SABS .ISO 7396-2:2007(E) ISO 2007 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 2 4 General requirements. 6 4.1 Safety . 6 4.2 Alternative construction 6 4.3 Materials 6 4.4 Continuity of oper
14、ation 7 5 Power device . 7 6 Indicating systems 8 7 Pipelines, connecting assemblies and disposal hoses 8 8 Disposal system characteristics and test methods for pressure and flow 9 8.1 Requirements 9 8.2 Test methods for pressure and flow. 10 8.3 Means to prevent backflow 12 9 Terminal units . 12 10
15、 Marking and colour coding 12 10.1 Marking 12 10.2 Colour coding 13 10.3 Test for durability 13 11 Pipeline installation 13 12 Testing, commissioning and certification 15 12.1 General. 15 12.2 General requirements for tests . 15 12.3 Tests, inspections and checks 15 12.4 Requirements for tests, insp
16、ections and checks listed in 12.3 . 15 12.5 Certification of the system. 16 12.6 Extensions or modifications 17 13 Information to be supplied by the manufacturer. 17 13.1 General. 17 13.2 Instructions for use 17 13.3 Operational management information 18 13.4 “As-installed” drawings . 18 13.5 Electr
17、ical diagrams. 18 Annex A (informative) Guidelines for power devices consisting of fans, blowers or dedicated vacuum pumps 19 Annex B (informative) Example of procedure for testing and commissioning 20 Annex C (informative) Typical forms for certification of AGS disposal systems 23 Annex D (informat
18、ive) Risk management checklist 36 Annex E (informative) Rationale . 44 Bibliography . 45 SANS 7396-2:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 7396-2:2007(E) iv ISO 2007 All rights reservedForeword ISO (the International Organiz
19、ation for Standardization) 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
20、 has the right to 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. I
21、nternational Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publ
22、ication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent
23、rights. ISO 7396-2 was prepared by the European Committee for Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in collaboration with Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 6, Medical gas systems, in accordanc
24、e with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). This second edition cancels and replaces the first edition (ISO 7396-2:2000), which has been technically revised. ISO 7396 consists of the following parts, under the general title Medical gas pipeline systems: Part
25、 1: Pipeline systems for compressed medical gases and vacuum Part 2: Anaesthetic gas scavenging disposal systems SANS 7396-2:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 7396-2:2007(E) ISO 2007 All rights reserved vIntroduction Ana
26、esthetic gas scavenging systems (AGSS) are used to reduce occupational exposure to anaesthetic gases and vapours. The anaesthetic gas scavenging system comprises three main parts: a transfer system, a receiving system, and a disposal system. A schematic diagram of typical anaesthetic gas scavenging
27、systems is shown in Figure 1. Requirements for receiving systems and transfer systems are specified in ISO 8835-3. Type-specific connections for terminal units are specified in ISO 9170-2. In this part of ISO 7396, specifications and test procedures are given to ensure compatibility between the comp
28、onents of the system. This part of ISO 7396 specifies requirements for pipelines for anaesthetic gas scavenging systems for anaesthetic gases and vapours. It is intended for use by those persons involved in the design, construction, inspection and operation of healthcare facilities treating human be
29、ings. It is advisable that those persons involved in the design, manufacture and testing of equipment intended to be connected to pipeline systems also be aware of the contents of this part of ISO 7396. Specific components are used for scavenging terminal units and for other connectors which are int
30、ended to be used by the operator. In addition, the system is tested and certified to operate at safe flows and without leakage. It is also intended to address issues of patient safety. The objectives of this part of ISO 7396 are to ensure the following: a) avoidance of cross connections between diff
31、erent pipeline systems; b) continuity of function of the system; c) use of suitable materials; d) cleanliness of components; e) correct installation; f) provision of indicating system(s); g) correct marking of the pipeline system and components; h) testing, commissioning and certification; i) correc
32、t operational management. Annex E contains rationale statements for some of the requirements of this part of ISO 7396. It is included to provide additional insight into the reasoning that led to the requirements and recommendations that have been incorporated in this part of ISO 7396. The clauses an
33、d subclauses marked with (*) after their number have corresponding rationale contained in Annex E. SANS 7396-2:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .SANS 7396-2:2008This s tandard may only be used and printed by approved subscri
34、ption and freemailing clients of the SABS .INTERNATIONAL STANDARD ISO 7396-2:2007(E) ISO 2007 All rights reserved 1Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems 1 Scope This part of ISO 7396 specifies requirements for the design, installation, function, performance
35、, documentation, testing and commissioning of anaesthetic gas scavenging disposal systems to ensure patient safety and to minimize exposure of the operator and other persons to anaesthetic gases and vapours. It includes requirements for the power device, pipeline system, performance, non-interchange
36、ability between key components and avoidance of cross connections between anaesthetic gas scavenging (AGS) disposal systems and medical gas and vacuum pipeline systems. NOTE In this part of ISO 7396, the term “pipeline” refers exclusively to pipelines that are part of a dedicated anaesthetic gas sca
37、venging system (AGSS). This part of ISO 7396 is applicable only to those disposal systems intended to be connected via AGSS terminal units conforming to ISO 9170-2 and to AGSS receiving systems conforming to ISO 8835-3. This part of ISO 7396 also applies to: extensions of existing AGSS disposal syst
38、ems; modifications of existing AGSS disposal systems; modifications or replacement of power devices. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the lat
39、est edition of the referenced document (including any amendments) applies. ISO 5359, Low-pressure hose assemblies for use with medical gases ISO 7396-1:2007, Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum ISO 8835-3:1), Inhalational anaesthesia systems
40、Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems ISO 9170-2, Terminal units for medical gas pipeline systems Part 2: Terminal units for anaesthetic gas scavenging systems 1) To be published. (Revision of ISO 8835-3:1997.) SANS 7396-2:2008This s tandard may only be
41、used and printed by approved subscription and freemailing clients of the SABS .ISO 7396-2:2007(E) 2 ISO 2007 All rights reservedISO 14971, Medical devices Application of risk management to medical devices ISO 15001, Anaesthetic and respiratory equipment Compatibility with oxygen EN 1041, Information
42、 supplied by the manufacturer with medical devices EN 13348, Copper and copper alloys Seamless, round copper tubes for medical gases or vacuum 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 AGSS socket female part of a terminal unit which is
43、 either integral or attached to the base block by a type-specific interface, and which contains the type-specific connection point 3.2 AGSS terminal unit inlet assembly in an AGSS at which the operator makes connections and disconnections 3.3 AGSS terminal unit base block part of an AGSS terminal un
44、it which is attached to the pipeline disposal system 3.4 AGSS type 1 terminal unit connection point between the receiving system and the disposal system at which an operator makes connections and disconnections See Figure 1. 3.5 AGSS type 1H terminal units AGSS type 1 terminal unit to be used in hig
45、h-flow disposal systems 3.6 AGSS type 1L terminal units AGSS type 1 terminal unit to be used in low-flow disposal systems 3.7 AGSS type 2 terminal unit connection point between the power device or the disposal hose and the remainder of the disposal system at which an operator makes connections and d
46、isconnections See Figure 1. 3.8 AGSS type-specific having characteristics which prevent interchangeability and thereby allow assignment to one AGSS type only 3.9 AGSS type-specific connection point part of the AGSS socket which is the receptor for an AGSS type-specific probe SANS 7396-2:2008This s t
47、andard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 7396-2:2007(E) ISO 2007 All rights reserved 33.10 air compressor system source of supply with compressor(s) designed to provide medical air and/or air for driving surgical tools and/or air for AGSS
48、NOTE Different names or symbols are used for air for driving surgical tools, such as: instrument air, surgical air, air motor, air - 700 and air - 800. 3.11 anaesthetic gas scavenging system AGSS complete system which is connected to the exhaust port(s) of a breathing system or other equipment for t
49、he purpose of conveying expired and/or excess anaesthetic gases and vapours to an appropriate point of discharge NOTE Functionally, an AGSS comprises three different parts: a transfer system, a receiving system and a disposal system. These three functionally discrete parts can be either separate or sequentially combined in part or in total. In addition, one or more parts of an AGSS can be combined with a breathing system or other equipment (e.g. an anaesthetic ventilator) to include the transfer system, or trans
