ANSI AAMI 10079-3-1999 Medical Suction Equipment-Part 3 Suction Equipment Powered from a Vacuum or Pressure Source.pdf

1、ANSI/AAMI/ISO 10079-3:1999Medical Suction EquipmentPart 3: Suction Equipment Powered from a Vacuum or Pressure Source 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 mai

2、ntained, so there are some 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

3、 This publication is subject 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. I

4、t is illegal under federal 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 crimi

5、nal penalties, and damages 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

6、the United States of America ISBN 1570205434 ANS/ISO 10079-3 1999 Medical Suction Equipment Part 3: Suction Equipment Powered from a Vacuum or Pressure Source Approved as an American National Standard by: ASTM International These materials are subject to copyright claims of ISO, ANSI, and ASTM Inter

7、national. Not for resale without the prior written 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 10079-3: 1999 2 Normative refer

8、ences (Add the following) CGA Z168.11-94, Vacuum Devices Used for Suction and Drainage Rationale for ASTM deviation: CGA Z168.11-94 has requirements for intermittent and interrupted regulators that are not part of ISO 10079-3 5.2 Suction tubing (Add the following) Suction tubing supplied with the su

9、ction equipment shall have a minimum length of 1.3 m. Rationale for ASTM deviation: This minimum length is specified in ISO 10079-1and 10079-2 8 Performance requirements for vacuum and flow rate (Replace the following clauses and delete Subclauses 8.5 and 8.6) 8.2 Vacuum When tested in accordance wi

10、th A.12, suction equipment shall develop a vacuum of at least 40 kPa, unless either marked “low vacuum” or marked with the maximum vacuum that can be developed. 8.3 Free Air Flow When tested in accordance with A.14, the peak free air flow shall be at least 20 L/min unless marked “low flow” in which

11、case the peak air flow shall be less than 20 L/min. Equipment intended for thoracic drainage, wound drainage, and intermittent and interrupted suction shall be exempt from the requirements of this clause. Rationale for ASTM deviation: This simplifies performance categories and allows all combination

12、s of high and flow vacuum and flow but exempts application-specific apparatus such as thoracic suction equipment. 10 Regulators (Add the following) 10.3 Intermittent Regulators 10.3.1 Intermittent Regulator Function When tested in accordance with A.19, an intermittent regulator shall cycle through i

13、ts off-time according to the manufacturers published specifications. 10.3.2 Intermittent Regulator Venting When tested in accordance with A.20, an intermittent regulator shall return to atmospheric pressure (0-kPa gauge) for at least 3 s before commencing the next on-cycle. 10.4 Interrupted Regulato

14、rs 10.4.1 Interrupted Regulator Function When tested in accordance with A.21, an interrupted regulator shall cycle between the vacuum relief set point and that of a lower level according to the manufacturers published specification. 10.4.2 Interrupted Regulator Venting When tested in accordance with

15、 A.22, an interrupted regulator shall return to a lower vacuum level before returning to the vacuum relief set point. Rationale for ASTM deviations: Above requirements can be found in CGA Z16811-94 but not ISO 10079-3 12.2 Equipment on carrying case (Change title to the following) Equipment or carry

16、ing case Rationale for ASTM deviation: Typing error in ISO document. (Replace a) with the following) a) the performance category as indicated in Clause 8 or the vacuum and flow rate ranges for patient use, with the marking visible in the normal operating position; Rationale for ASTM deviation: To ma

17、ke the marking consistent with performance. 13 Information to be supplied by manufacturer (Add the following) k) whether or not the suction equipment is suitable for use in a magnetic resonance imaging (MRI) unit. Rationale for ASTM deviation: This knowledge is necessary for safe use. Annex A Test m

18、ethods A.14 Test for free air flowrate of low vacuum equipment (Change title and test as follows) A.14 Test for free air flow With the collection container(s) empty, switch on the suction equipment with the regulator adjusted to give the maximum vacuum. Open the inlet and attach a low resistance flo

19、wmeter to it. Note the mean free air flow when stable conditions are reached. Rationale for ASTM deviation: To make the test procedure consistent with performance modifications. Vacuum level is tested in A.12. Therefore A.14 only needs to test for free air flow. A.17 Test for vacuum regulator with v

20、ariable setting (Modify as follows) Commence with the vacuum source at 79 kPa below atmospheric pressure and reduce the vacuum to 53 kPa below atmospheric pressure adjust the vacuum source from 53 kPa to 80 kPa below atmospheric pressure Rationale for ASTM deviation: Source pressure of 53 kPa is nee

21、ded in order to set the regulator to 53 kPa as required in test procedure. CGA Z168.11-94 also uses a supply pressure of 53 kPa for this test. Annex A (Add the following) A.19 Test for intermittent function of intermittent regulators (See Figure A.10) Connect the regulator to a vacuum source as reco

22、mmended by the manufacturer. Set the regulator to the intermittent mode and occlude the tubing at the patient port. Set the occluded vacuum level to a point in the middle third of the gauge range during the on cycle. With the unit still occluded, record the on time and off time during five full cycl

23、es. A.20 Test for venting of intermittent regulators (See figure A.11) Connect the regulator to a vacuum source as recommended by the manufacturer. Connect the patient side of the regulator to the vacuum side of a 2-L collection container. Occlude the patient side of the regulator. Set the regulator

24、 to the intermittent mode, occlude the tubing between the regulator and the collection container, and adjust the regulator to a point in the middle third of the gauge range during the on cycle. Release the occlusion on the tubing, ensuring that the regulator is cycling normally, and record the amoun

25、t of time that the vacuum indicator is at 0-kPa gauge (atmospheric pressure) during the off cycle. A.21 Test for interrupted function of interrupted regulators (See figure A.12) A.21.1 Fixed vacuum relief valves Connect the regulator to a vacuum source as recommended by the manufacturer. Adjust the

26、regulator static set point to 2.7 0.2 kPa (20 mmHg) above the vacuum relief valve set point. Allow the vacuum relief valve to cycle and record the maximum vacuum obtained. A.21.2 Adjustable vacuum relief valves Connect the regulator to a vacuum source as recommended by the manufacturer. Adjust the r

27、egulator static set point to 2.7 0.2 kPa (20 mmHg) above the minimum vacuum, relief valve set point. Allow the vacuum relief valve to cycle and record the maximum vacuum obtained. Repeat for the maximum vacuum relief valve set point. A.22 Test for venting of interrupted regulators A.22.1 Fixed vacuu

28、m relief valves Connect the regulator to a vacuum source as recommended by the manufacturer. Connect the patient side of the interrupted regulator to the vacuum side of a 2-L collection container. Connect a vacuum indicator having a range similar to that of the regulator to the patient side of the c

29、ollection container. Adjust the regulator static set point to 2.7 0.2 kPa (20 mmHg) above the vacuum relief valve set point. Allow the vacuum relief valve to cycle for five full cycles and record the minimum vacuum level on the 2-L collection container. A.22.2 Adjustable vacuum relief valves Connect

30、 the regulator to a vacuum source as recommended by the manufacturer. Connect a vacuum indicator having a range similar to that of the regulator to the patient side of the collection container. The patient side of the collection container shall have a vacuum indicator having a range similar to that

31、of the regulator. Adjust the regulator static set point to 2.7 0.2 kPa (20 mmHg) above the minimum vacuum relief valve set point. Allow the regulator to cycle for five full cycles and record the minimum vacuum level on the 2-L collection container. Repeat for the maximum vacuum relief set point. Rat

32、ionale for ASTM deviation: The additional test methods are needed for additional requirements. Test procedures were taken from CGA Z168.11-94. AReference numberISO 10079-3:1999(E)INTERNATIONALSTANDARDISO10079-3Second edition1999-08-15Medical suction equipment Part 3:Suction equipment powered from a

33、vacuum orpressure sourceAppareils daspiration mdicale Partie 3: Appareils daspiration aliments par une source de vide ou depressionISO 10079-3:1999(E) ISO 1999All rights reserved. Unless otherwise specified, no part of this publication may be reproducedor utilized in any form or by any means, electr

34、onic or mechanical, including photocopying andmicrofilm, without permission in writing from the publisher.International Organization for StandardizationCase postale 56 CH-1211 Genve 20 SwitzerlandInternet isoiso.chPrinted in SwitzerlandiiContents1 Scope 12 Normative references 23 Terms and definitio

35、ns .34 Cleaning, disinfection and sterilization.35 Design requirements .36 Operational requirements .47 Physical requirements.78 Performance requirements for vacuum and flowrate 79 Gas supply810 Vacuum regulator 811 Resistance to environment.912 Marking .913 Information to be supplied by manufacture

36、r 10Annex A (normative) Test methods.11 ISOISO 10079-3:1999(E)iiiForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISOmember bodies). The work of preparing International Standards is normally carried out through ISO technicalcomm

37、ittees. Each member body interested in a subject for which a technical committee has been established hasthe right to be represented on that committee. International organizations, governmental and non-governmental, inliaison with ISO, also take part in the work. ISO collaborates closely with the In

38、ternational ElectrotechnicalCommission (IEC) on all matters of electrotechnical standardization.International Standards 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 bodi

39、es for voting.Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.International Standard ISO 10079-3 was prepared by Technical Committee ISO/TC 121, Anaesthetic andrespiratory equipment, Subcommittee SC 8, Suction devices for hospital and e

40、mergency care use.This second edition cancels and replaces the first edition (ISO 10079-3:1992), which has been technically revised.ISO 10079 consists of the following parts, under the general title Medical suction equipment: Part 1: Electrically powered suction equipment Safety requirements Part 2:

41、 Manually powered suction equipment Part 3: Suction equipment powered from a vacuum or pressure sourceAnnex A forms a normative part of this part of ISO 10079.INTERNATIONAL STANDARD ISO ISO 10079-3:1999(E)1Medical suction equipment Part 3:Suction equipment powered from a vacuum or pressure source1 S

42、copeThis part of ISO 10079 specifies safety and performance requirements for medical suction equipment powered froma vacuum or pressure source (see Figure 1). In particular it applies to connections for pipelines and Venturiattachments.Suction equipment with components controlled by electrical means

43、, e.g. electronic timing, may also need to complywith IEC 60601-1.This part of ISO 10079 does not apply to electrically powered suction equipment, whether mains electricity orbattery-powered, which is dealt with in ISO 10079-1, nor to manually powered suction equipment which is dealt within ISO 1007

44、9-2, nor to the following:a) central power supply (by vacuum/compressed air generation), piping systems of vehicles and buildings, andwall connectors;b) catheter tubes, drains, curettes and suction tips;c) syringes;d) dental suction equipment;e) waste gas scavenging systems;f) laboratory suction;g)

45、autotransfusion systems;h) passive urinary drainage;i) closed systems for wound drainage;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 tracheostom

46、y;n) ventouse (obstetric) equipment;o) neonatal mucous extractors;p) breast pumps;q) liposuction;r) uterine aspiration.ISO 10079-3:1999(E) ISO2Key1 Vacuum indicator2 Filter3 Collection container4 Vacuum regulatorNOTE 1 ISO 10079-1 applies to mains electricity and battery-powered suction equipment. I

47、SO 10079-2 applies to manuallypowered suction equipment. ISO 10079-3 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 co

48、nsist of other arrangements andcomponents not illustrated.Figure 1 Schematic drawing 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

49、amendments to, or revisions of, any of these publicationsdo not apply. 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 and IEC maintainregisters of currently valid International Standards.ISO 3744:1994, Acoustics Determination of sound power levels of noise sources Engineering methods forfree-field