ANSI AAMI 10079-2-1999 Medical Suction Equipment-Part 2 Manually Powered Suction Equipment.pdf

1、ANSI/AAMI/ISO 10079-2:1999Medical Suction EquipmentPart 2: Manually Powered Suction Equipment American National StandardThis document was approved and published when the U.S. TAG for TC 121 was held by ASTM, but it is now an AAMI standard. The original formatting has been maintained, so there are so

2、me variations from the typical AAMI style. Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2014 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is sub

3、ject to copyright claims of ISO, and AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, without the prior written permission of AAMI. All requests pertaining to this document should be submitted to AAMI. It is illegal under feder

4、al law (17 U.S.C. 101, et seq.) to make copies of all or any part of this document (whether internally or externally) without the prior written permission of the Association for the Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and damag

5、es of $100,000 per offense. For permission regarding the use of all or any part of this document, complete the reprint request form at www.aami.org or contact AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: 703-525-4890; Fax: 703-525-1067. Printed in the United States of Ame

6、rica ISBN 1570205388 ANS/ISO 10079-2 1999 Medical Suction Equipment Part 2: Manually Powered Suction Equipment Approved as an American National Standard by: ASTM International These materials are subject to copyright claims of ISO, ANSI, and ASTM International. Not for resale without the prior writt

7、en permission of ASTM International. No part of this publication may be reproduced in any form, including an electronic retrieval system, without the prior written permission of ASTM International. ASTM deviations to ISO 10079-2: 1999 5.2.1 General (Replace 5.2.1 with the following) Note: Suction pe

8、rformance may be markedly affected by the length diameter and degree of collapse of the suction tubing. 5.2.1.1 If supplied, suction tubing shall have an internal diameter of not less than 6 mm. 5.2.1.2 When tested in accordance with A.2, the degree of collapse of the suction tubing supplied with th

9、e equipment shall be less than 0.5 throughout its entire length. Rationale for ASTM deviation: Structured similar to ISO 10079 - 3 6 Operational requirements (Add the following) 6.8 The performance criteria in Clause 8 shall be met using a force of less than 350 N for foot-operated equipment and les

10、s than 45 N for hand-operated equipment. Rationale for ASTM deviation: These requirements are necessary so that equipment can be operated without excessive effort on the part of the operator. These requirements can be found in CGA Z168.11-94. 8.1 Vacuum (Replace with the following) When tested in ac

11、cordance with A.6, the suction equipment shall develop a vacuum of at least 40 kPa within 10 s, unless either marked as “low vacuum” or marked with the maximum vacuum that can be developed. Rationale for ASTM deviation: This allows for equipment other than high vacuum if appropriately labeled. This

12、modification is based on CGA Z168.11-94. 8.3 Free air flow (Replace with the following) When tested in accordance with A.7, the peak free air flow shall be at least 20 L/min unless marked “low flow.” Equipment intended for thoracic drainage, wound drainage, and intermittent and interrupted suction s

13、hall be exempt from the requirements of this clause. Rationale for ASTM deviation: This allows for equipment other than high flow if appropriately labeled and exempts application-specific equipment. This modification is based on CGA Z168.11-94. 10 Marking (Replace a) with the following) For equipmen

14、t not intended for field and/or transport use, the unit shall be marked appropriately based on the performance in Clause 8. Rationale for ASTM deviation: To make marking consistent with performance. 11 Information to be supplied by manufacturer (Add the following) p) whether or not the suction equip

15、ment is suitable for use in a magnetic resonance imaging (MRI) unit. Rationale for ASTM deviation: This knowledge is necessary for safe use. A.6 Test for vacuum (Replace with the following) Set up the suction equipment with the collection container in place and, using a short tube, fit a vacuum indi

16、cator to the container inlet, totally occluding the inlet. Operate the equipment at a frequency not exceeding 2 Hz. Record the reading of the vacuum indicator after 10 s. Rationale for ASTM deviation: It may not be possible to fit a vacuum indicator directly to the container inlet. AReference number

17、ISO 10079-2:1999(E)INTERNATIONALSTANDARDISO10079-2Second edition1999-08-15Medical suction equipment Part 2:Manually powered suction equipmentAppareils daspiration mdicale Partie 2: Appareils daspiration manuelleISO 10079-2:1999(E) ISO 1999All rights reserved. Unless otherwise specified, no part of t

18、his publication may be reproducedor utilized in any form or by any means, electronic or mechanical, including photocopying andmicrofilm, without permission in writing from the publisher.International Organization for StandardizationCase postale 56 CH-1211 Genve 20 SwitzerlandInternet isoiso.chPrinte

19、d in SwitzerlandiiContents1 Scope 12 Normative references 23 Terms and definitions .34 Cleaning and sterilization .35 Design requirements .36 Operational requirements .47 Physical requirements.58 Performance requirements for vacuum and flowrate 69 Resistance to environment.610 Marking .711 Informati

20、on to be supplied by manufacturer 7Annex A (normative) Test methods.8Annex B (informative) Table of typical ranges of volume for collection containers for specific uses.12Annex C (informative) Rationale statement13 ISOISO 10079-2:1999(E)iiiForewordISO (the International Organization for Standardizat

21、ion) is a worldwide federation of national standards bodies (ISOmember bodies). The work of preparing International Standards is normally carried out through ISO technicalcommittees. Each member body interested in a subject for which a technical committee has been established hasthe right to be repr

22、esented on that committee. International organizations, governmental and non-governmental, inliaison with ISO, also take part in the work. ISO collaborates closely with the International ElectrotechnicalCommission (IEC) on all matters of electrotechnical standardization.International Standards are d

23、rafted 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 casting a vote

24、.International Standard ISO 10079-2 was prepared by Technical Committee ISO/TC 121, Anaesthetic andrespiratory equipment, Subcommittee SC 8, Suction devices for hospital and emergency care use.This second edition cancels and replaces the first edition (ISO 10079-2:1992), which has been technically r

25、evised.ISO 10079 consists of the following parts, under the general title Medical suction equipment: Part 1: Electrically powered suction equipment Safety requirements Part 2: Manually powered suction equipment Part 3: Suction equipment powered from vacuum or pressure sourceAnnex A forms a normative

26、 part of this part of ISO 10079. Annexes B and C are for information only.INTERNATIONAL STANDARD ISO ISO 10079-2:1999(E)1Medical suction equipment Part 2:Manually powered suction equipment1 ScopeThis part of ISO 10079 specifies safety and performance requirements for manually powered medical suction

27、equipment intended for oro-pharyngeal suction. It covers equipment operated by foot or by hand or both (seeFigure 1). Non-electrical suction equipment which may be integrated with electrical equipment is included in thescope of this part of ISO 10079.This part of ISO 10079 does not apply to electric

28、ally powered suction equipment, whether mains electricity- orbattery-powered, which is dealt with in ISO 10079-1, nor to suction equipment powered from a vacuum or pressuresource which is dealt with in ISO 10079-3, nor to the following:a) central power supply (by vacuum/compressed air generation), p

29、iping systems of vehicles and buildings, andwall connectors;b) cathether tubes, drains, curettes and suction tips;c) syringes;d) dental suction equipment;e) waste gas scavenging systems;f) laboratory suction;g) autotransfusion systems;h) passive urinary drainage;i) closed systems for wound drainage;

30、j) gravity gastric drainage;k) orally operated mucous extractors;l) suction equipment where the collection container is downstream of the vacuum pump;m) equipment marked as suction unit for permanent tracheostomy;n) ventouse (obstetric) equipment;o) neonatal mucous extractors;p) breast pumps;q) lipo

31、suction;r) uterine aspiration;s) thoracic drainage.ISO 10079-2:1999(E) ISO2Key1 Vacuum indicator2 Filter3 Collection container4 Vacuum regulatorNOTE 1 ISO 10079-1 applies to mains electricity- and battery-powered suction equipment. ISO 10079-2 applies to manuallypowered suction equipment. ISO 10079-

32、3 applies to suction equipment powered from a vacuum or pressure source.NOTE 2 Components illustrated are not necessarily required by this part of ISO 10079.NOTE 3 Suction equipment shown is an example only, and actual systems may consist of other arrangements andcomponents which are not illustrated

33、.Figure 1 Examples of suction equipment2 Normative referencesThe following normative documents contain provisions which, through reference in this text, constitute provisions ofthis part of ISO 10079. For dated references, subsequent amendments to, or revisions of, any of these publicationsdo not ap

34、ply. However, parties to agreements based on this part of ISO 10079 are encouraged to investigate thepossibility of applying the most recent editions of the normative documents indicated below. For undatedreferences, the latest edition of the normative document referred to applies. Members of ISO an

35、d IEC maintainregisters of currently valid International Standards.ISO 5356-1:1996, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets.ISO 8836:1997, Suction catheters for use in the respiratory tract.ISO 10079-1:1999, Medical suction equipment Part 1: Electrically po

36、wered suction equipment Safetyrequirements. ISOISO 10079-2:1999(E)33 Terms and definitionsFor the purposes of this part of ISO 10079, the terms and definitions given in ISO 10079-1 and the following apply.3.1manually powered vacuummanually generated vacuumgeneration of vacuum by human effort with a

37、hand or foot or both3.2transportable equipmentequipment which is intended to be easily moved from one place to another, whether or not connected to the vacuumsupply, without an appreciable restriction of range4 Cleaning and sterilization4.1 The suction equipment shall meet the requirements given in

38、8.1 to 8.3 after those components which aresubject to contamination and which are intended for re-use have been submitted to 30 cycles of cleaning,disinfection and/or sterilization as recommended by the manufacturer.4.2 Any filters installed shall either be of the disposable type or be capable of be

39、ing cleaned, disinfected and/orsterilized for re-use in accordance with 4.1.4.3 Suction equipment incorporating a re-usable collection container assembly shall comply with the requirementsgiven in 8.1 to 8.3, as appropriate, before and after the collection container assembly has been subjected to 30

40、cycles of cleaning, disinfection and/or sterilization as recommended by the manufacturer.4.4 Suction tubing shall either be for single use or be capable of being cleaned, disinfected and/or sterilized asrecommended by the manufacturer.5 Design requirementsNOTE The constructional requirements may dev

41、iate from those detailed in this part of ISO 10079 if the equivalent level ofsafety is obtained.5.1 Connectors5.1.1 Collection container connectorsThe connectors for the suction tubing and the intermediate tubing to the vacuum source shall be designed tofacilitate correct assembly or marked to indic

42、ate correct assembly when all parts are mated. Compliance shall bechecked by inspection.The construction of the connections has frequently been a source of spillover into a vacuum pump. The use ofmechanical fittings so as to ensure correct attachment is highly desirable.5.1.2 Inside diameter of suct

43、ion tubing connectionThe inside diameter of the suction tubing connection (inlet port) shall be equal to or larger than the inside diameterof the largest tubing size recommended by the manufacturer.5.1.3 Exhaust openingIt shall not be possible to connect suction tubing to the exhaust opening.ISO 100

44、79-2:1999(E) ISO45.2 Suction tubing5.2.1 GeneralIf supplied, suction tubing shall have an inside diameter of not less than 6 mm.Suction performance may be markedly affected by the length, diameter and degree of collapse of the suction tubing.When tested in accordance with A.2, the degree of collapse

45、 of the suction tubing supplied with the equipment shallbe less than 0,5 throughout its entire length.5.2.2 Length of suction tubing for foot-operated suction equipmentWhen the foot-operated vacuum pump is on the floor in the operating position, the length of suction tubing, ifsupplied, shall be suc

46、h that the endpiece can be positioned at least 1,3 m above the floor.NOTE See also annex C for rationale.5.3 End-piecesSuction catheters, if supplied or recommended by the manufacturer, shall comply with ISO 8836.6 Operational requirements6.1 Ease of operationThe suction equipment shall be designed

47、to be operated by one person unaided.6.2 Dismantling and reassemblySuction equipment intended to be dismantled by the user (for example, for cleaning) shall be designed to facilitatecorrect assembly or marked to indicate correct reassembly when all parts are mated. After dismantling, reassemblyand t

48、esting in accordance with the manufacturers instructions, the suction equipment shall meet the requirementsgiven in 8.1 to 8.3, as appropriate.6.3 Mechanical shockAfter suction equipment intended for field or transport use or both has been drop-tested in accordance with A.3, itshall meet the require

49、ments given in 8.1 to 8.3, as appropriate.Field use of suction equipment is intended to cover use in situations outside the health care facility at the site ofaccidents or other emergencies. The use of suction equipment in these situations may expose the equipment towater (including rain), dirt, uneven support, mechanical shock and extremes of temperature.Transport use of suction equipment is intended to cover situations outside the health care facility such as inambulances, cars or airplanes. Use of suction equipment in these situations may exp