ANSI AAMI 10651-4-2002 Lung ventilators-Part 4 Particular requirements for operator-powered resuscitators.pdf

1、ANSI/AAMI/ISO 10651-4:2002Lung ventilatorsPart 4: Particular requirements for operator-powered resuscitators 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,

2、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 This pub

3、lication 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. It is ille

4、gal 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 criminal penal

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6、d States of America ISBN 1570205396 Approved as an American National Standard with deviations by ASTM International INTERNATIONAL ANSI/ISO STANDARD 10651-4 First edition 2002-03-01 Lung ventilators Part 4: Particular requirements for operator-powered resuscitators Ventilateurs pulmonaires Partie 4 :

7、 Exigences relatives aux ressuscitateurs puissance motrice manuelle ASTM International Approved as an American National Standard with deviations by ASTM International ANSI/ISO 10651-4 MOD in ANSI/ISO 10651-4 means that ASTM International has approved the standard as an American National Standard wit

8、h deviations. The U.S. deviations are appended to the end of ANSI/ISO 10651-4. These materials are subject to copyright claims of ASTM International. Not for resale without the prior written permission of ASTM International. No part of this publication may be reproduced in any form, including an ele

9、ctronic retrieval system, without the prior written permission of ASTM International. ii ASTM International Approved as an American National Standard with deviations by ASTM International ANSI/ISO 10651-4 Foreword ISO (the International Organization for Standardization) is a worldwide federation of

10、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 be represented on that committee. Inte

11、rnational 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 Standards are drafted in accordance with th

12、e rules given in the ISO/IEC Directives, Part 3. 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. Publication as an International Standard requires approval b

13、y at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this part of ISO 10651 may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 10651-4 was prepared by the Europea

14、n Committee for Standardization (CEN) in collaboration with Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). Throughout t

15、he text of this document, read “.this European Standard.“ to mean “.this International Standard.“. ISO 10651 consists of the following parts, under the general title Lung ventilators: Part 1: Requirements Part 2: Particular requirements for home care ventilators Part 3: Particular requirements for e

16、mergency and transport ventilators Part 4: Particular requirements for operator-powered resuscitators Annex A forms a normative part of this part of ISO 10651. Annex B is for information only. For the purposes of this part of ISO 10651, the CEN annex regarding fulfilment of European Council Directiv

17、es has been removed. ASTM International iii Approved as an American National Standard with deviations by ASTM International ANSI/ISO 10651-4 Contents Page Forewordv 1 Scope .1 2 Normative references .1 3 Terms and definitions.1 4 Connectors 3 5 Operational requirements 3 6 Ventilatory requirements4

18、7 Storage and operating conditions.6 8 Requirements for resuscitator, or parts, supplied sterile .6 9 Marking 6 10 Information to be provided by the manufacturer in operating and maintenance instructions .7 Annex A (normative) Test methods9 Annex B (informative) Rationale19 Bibliography22 iv ASTM In

19、ternational Approved as an American National Standard with deviations by ASTM International ANSI/ISO 10651-4Foreword This document (EN ISO 10651-4:2002) has been prepared by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment“, the secretariat of which is held by BSI, in collaborat

20、ion with Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment“. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2002, and conflicting national standards shall be withdra

21、wn at the latest by September 2002. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). Annex A is normative and form part of this European Standard. Annex B is for in

22、formation only. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard : Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta,

23、Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. ASTM International v Approved as an American National Standard with deviations by ASTM International Approved as an American National Standard with deviations by ASTM International ANSI/ISO 10651-4 1 Scope This Europea

24、n Standard specifies requirements for operator-powered resuscitators intended for use with all age groups and which are portable and intended to provide lung ventilation to individuals whose breathing is inadequate. Operator-powered resuscitators for infants and children are designated according to

25、body mass range and approximate age equivalent. Electrically-and gas-powered resuscitators are not covered by this European Standard. NOTE Annex B contains rationale statements for this Part of this European Standard. The clauses and subclauses which have corresponding rationale statements are marke

26、d with R) after their number. 2 Normative references This European Standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in text and the publications are listed hereafter. For dated references, subseque

27、nt amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies (including amendments). EN 148-1, Respiratory protective devices - Thread

28、s for facepieces Part 1: Standard thread connection. EN 556: 1994+A1:1998, Sterilization of medical devices - Requirements for terminally-sterilized medical devices to be labelled “STERILE”. EN 737-1, Medical gas pipeline systems - Part 1: Terminal units for compressed medical gases and vacuum. EN 8

29、68-1, Packaging materials and systems for medical devices which are to be sterilized - Part 1: General requirements and test methods . EN 1041, Information supplied by the manufacturer with medical devices. EN 1281-1, Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and soc

30、kets. prEN 13544-2:2000, Respiratory therapy equipment Part 2 : Specifications for tubing and connectors. EN ISO 4135:1996, Anaesthesiology Vocabulary (ISO 4135 :1995). 3 Terms and definitions For the purposes of this part of EN ISO 10651, the terms and definitions given in EN ISO 4135:1996 and the

31、following terms and definitions apply. NOTE Some of the definitions have been taken from EN ISO 4135, but they are included in this European Standard for convenience; other definitions, which are given in EN ISO 4135, for apparatus in general, have been modified slightly for the purposes of this Eur

32、opean Standard as they apply specifically to resuscitators. 3.1 reverse leakage volume of expired gas which does not pass through the expiratory port but returns to the resuscitator 3.2 bag inlet valve valve activated by the subatmospheric pressure in the compressible unit of the resuscitator to ref

33、ill the compressible unit with gas at ambient pressure 3.3 bag refill valve valve, with no manual trigger, activated by the sub-atmospheric pressure in the compressible unit of the resuscitator to refill the compressible unit from a pressurized gas source ASTM International 1 Approved as an American

34、 National Standard with deviations by ASTM International ANSI/ISO 10651-4 3.4compressible unit that part of an operator-powered resuscitator e.g. a bag or bellows that, when compressed by the operator, delivers a volume of gas 3.5delivered oxygen concentration average concentration of oxygen in the

35、gas delivered from the resuscitator 3.6delivered volume, Vdel volume of gas, expressed in millilitres, leaving the resuscitator through the patient connection port during the inspiratory phase 3.7forward leakage volume of gas produced by the resuscitator during the inspiratory phase which does not p

36、ass through the patient port to the patient but passes to the atmosphere 3.8minute volume, V volume of gas per minute entering or leaving the patients lungs 3.9operator-powered resuscitator resuscitation device in which ventilation of the lungs is produced by the operator compressing the compressibl

37、e unit of the device NOTE Hereinafter called “resuscitator“. 3.10 patient connection port that opening through which gas flows to and from the patient 3.11 patient connection port connector connector at the patient connection port which connects directly to a face mask or an appropriate mating airwa

38、y device 3.12 patient valve valve in the breathing system that directs gas into the lungs for the inspiratory phase and into the atmosphere during the expiratory phase 3.13 pressure limiting system means for limiting the maximum delivery pressure 3.14 resuscitator deadspace, VD,app that volume of pr

39、eviously exhaled gas which is delivered from the resuscitator in the succeeding inspiratory phase 3.15 tidal volume, VTvolume of gas, expressed in millilitres, entering or leaving the patient or the lung model during the inspiratory or expiratory phase 3.16 ventilatory cycle ventilation cycle compri

40、sing the inspiratory phase plus the expiratory phase of breathing 2 ASTM International Approved as an American National Standard with deviations by ASTM International ANSI/ISO 10651-4 4 Connectors 4.1 Patient connection port connector The patient connection port connector of the resuscitator shall b

41、e a 15 mm female and 22 mm male coaxial connector complying with EN 1281-1. 4.2 R) Expiratory port connector for breathing gases If an expiratory port connector is provided, it shall be one of the following : a) a 30 mm male conical connector complying with EN 1281-1 or ; b) a permanent connection o

42、r propriatory connector incompatible with EN 1281-1 and EN 737-1 ; and with a means to prevent connection with internal lumen to any breathing attachment. 4.3 Face mask connectors If provided with the resuscitator, face masks shall have either a 22 mm female connector or a 15 mm male connector which

43、 shall mate with the corresponding connectors specified in EN 1281-1. 4.4 R) Bag refill valve connectors If a conical connector is provided for attachment of a bag refill valve, it shall be a unique 32 mm female design. The dimensions of this connector, when submitted to the test gauge given in Figu

44、re A.1, shall fit within the tolerance steps. 4.5 Bag inlet valve connectors Bag inlet valve connectors shall not be compatible with connectors dimensioned in accordance with EN 1281-1. The bag inlet valve should be designed to minimize the risk of unintentional connection of breathing attachments w

45、hich might block the valve 4.6 Threaded gas filter connectors If the resuscitator is fitted with a threaded gas filter connection, it shall comply with EN 148-1. 4.7 Oxygen tube connector and pressure gauge connector The oxygen tube connector, if provided, shall comply with prEN 13544-2:2000. The pr

46、essure gauge connector (if provided) shall not be compatible with tubing fitting the oxygen tube connector. 5 Operational requirements 5.1 General All test performance requirements in this European Standard shall be satisfied when the resuscitator is operated by one person. 5.2 R) Dismantling and re

47、assembly A resuscitator intended to be dismantled by the user, e.g. for cleaning, etc. should be designed so as to minimize the risk of incorrect reassembly when all parts are mated. The manufacturer shall recommend a functional test of operation to be carried out after reassembly (see 10.2d). ASTM International 3Approved as an American National Standard with deviations by ASTM International ANSI/ISO 10651-4 5.3 R) Patient valve function after contamination with vomitus Af