ANSI AAMI 4135-2001 Anaesthetic and Respiratory Equipment-Vocabulary.pdf

1、ANSI/AAMI/ISO 4135: 2001Anaesthetic and Respiratory EquipmentVocabulary 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 some variations from the

2、 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 subject to copyright clai

3、ms 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 federal law (17 U.S.C. 101,

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6、NS/ISO 4135 2001 Anaesthetic and Respiratory Equipment Vocabulary 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 written permission of ASTM International. No part

7、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 4135-2001 Anesthesia gas supply device, n assembly of components that controls and delivers all gas flows and agent concentr

8、ations in the fresh gas into the anesthesia breathing system. Note: it may include a flow adjustment control(s), a gas mixing system, and an anesthetic vapor delivery device(s). Anesthesia gas supply piping, n all pipe work, including unions, from the unidirectional valve(s) in the pipeline inlet(s)

9、, the piping connecting the high pressure supply to the gas pressure-reducing device/system, and from the gas pressure-reducing device/system, and from the gas pressure-reducing device/system outlet to the flow adjustment control(s) and auxiliary gas outlet. It includes piping leading to and from pn

10、eumatic alarm device(s), pressure indicator(s), oxygen flush, anesthetic vapor delivery device(s), and piping leading to the common gas outlet. Anesthetic-gas scavenging systems, n complete systems that collect and remove the excess gases released from equipment used in administering anesthesia or e

11、xhaled by the patient during anesthesia for the purpose of conveying these gases to an appropriate place of discharge. Auxiliary oxygen flowmeter, n self-contained oxygen flowmeter with its own flow adjustment control, flow indicator, and outlet that is not an integral part of the anesthesia gas sup

12、ply device. Computer network n connection between two or more computers for the purpose of transferring data. Control center, n information system component of an anesthesia workstation mediating the centralized alarm prioritization and management strategy(ies). Data backup, n retrievable copy of in

13、formation. Decision support system, n system that provides output information intended to facilitate decision making by the operator. Editing, v changing a recorded value, comment, annotation, event, or other information at any time after it has been made part of the record. Flow adjustment control,

14、 n device or assembly that controls the flow of gas(es) or gas mixtures. Note: a flow control valve is one type of flow adjustment control (even though the “flow adjustment control” is often called the “flow control valve”). Flow indicator, n device that indicates the volume of a specific gas or gas

15、 mixture passing through it in a unit of time. Note: a flow meter is one kind of flow indicator In popular usage, a flow indicator is sometimes called a flow meter. Gas pressure reducing device/system n single device or group of devices designed to provide a range of controlled delivered pressures o

16、ver a specific range of inlet pressures. Information system, n digital system collecting, displaying, or processing information from primary or secondary data sources of both. Note: examples include AARKs and decision support systems Infusion device n mechanical or electromechanical device regulatin

17、g the flow of liquids to the patient under positive pressure. Note: the positive pressure may be generated either by a pump or by gravitational force. Input device n device used to enter data or control the anesthesia information system manually. Examples include key words, mice trackballs, light pe

18、ns, barcode scanners, and microphones. Legible, adj discernible or identifiable to an operator with 6-6 (20/20) vision (corrected if necessary) from a distance of 1 m at a light level of 215 lux when viewing displayed qualitative information, values, functions, or markings perpendicular to and inclu

19、ding 15 degrees above, below, left, and right of the normal line of sight of the operator. Medium priority alarm n signal(s) indicating that prompt operator action is required. Nonvolatile memory, adj stored electronically in such a way that loss of all electrical power (normal and reserve) to the s

20、ystem or storage device will not alter the stored data. Operator n person handling the equipment. Operator input n data provided by interactions of the operator with the equipment. Primary data source n monitoring device, delivery device, or operator input providing function or measured data via dig

21、ital interfaces. Protection device n device that, without intervention of the operator, protects the patient from incorrect delivery of energy or substances. Note: such devices include the oxygen supply failure device and maximum pressure limitation device. Recorded data n captured data that is stor

22、ed by a computer. Reserve electrical power supply n that portion of equipment that temporarily supplies electrical power in the event of interruption of the normal electrical supply. Secondary data source n information system that retransmits data collected from primary data sources and other second

23、ary data sources. Note 1 a secondary data source may have modular primacy data sources as components. Note 2: digital data may be primary or secondary depending on whether it originates from within a multiport communication device of another digital source. Selector valve n device that permits the s

24、witching of the rout taken by a fluid. Selector valve n - in anesthesia breathing systems, device that is used to direct gases to an anesthesia reservoir bag or a ventilator intended for use during anesthesia. Transducer n device for converting energy from one form to another. In measurements applic

25、ations, a transducer senses energy related to a property of a substance and transforms it into a form that can be observed and interpreted as information about the substance, for example into an electrical signal for monitoring or recording. User n authority responsible for the use and maintenance o

26、f equipment. Reference numberNumro de rfrenceISO 4135:2001(E/F)ISO 2001INTERNATIONALSTANDARDNORMEINTERNATIONALEISO4135Third editionTroisime dition2001-08-01Anaesthetic and respiratory equipment VocabularyMatriel danesthsie et de ranimationrespiratoire VocabulaireISO 4135:2001(E/F)PDF disclaimerThis

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40、droits rservs iiiContents PageScope.11 Medical gas supply systems 22 Anaesthetic machines and workstations for use with humans103 Ventilators and resuscitators.124 Breathing systems.245 Humidifiers, nebulizers and moisture exchangers 316 Airways, tracheal tubes, tracheostomy tubes and intubation equ

41、ipment.377 Anaesthetic gas scavenging systems.428 Suction devices439 Monitoring 47Alphabetical index56ISO 4135:2001(E/F)iv ISO 2001 All rights reserved/Tous droits rservsSommaire PageDomaine dapplication11 Systmes de distribution de gaz mdicaux22 Appareils danesthsie et systme danesthsie pour utilis

42、ation chez lhomme .103 Ventilateurs et ressuscitateurs.124 Systmes respiratoires .245 Humidificateurs, nbuliseurs et changeurs dhumidit.316 Voies ariennes, sondes trachales, canules de trachotomie et matriel dintubation.377 Systmes dvacuation des gaz danesthsie428 Dispositifs daspiration .439 Monito

43、rage47Index alphabtique .59ISO 4135:2001(E/F) ISO 2001 All rights reserved/Tous droits rservs vForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISOmember bodies). The work of preparing International Standards is normally carried

44、 out through ISO technicalcommittees. 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 co

45、llaborates closely with the International 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

46、 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.Attention is drawn to the possibility that some of the elements of this International Standard may be the subject ofpatent rights. ISO shall not

47、 be held responsible for identifying any or all such patent rights.International Standard ISO 4135 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratoryequipment, Subcommittee SC 4, Anaesthesia terminology.This third edition cancels and replaces the second edition (ISO 4135:199

48、5), of which it constitutes a technicalrevision.ISO 4135:2001(E/F)vi ISO 2001 All rights reserved/Tous droits rservsAvant-proposLISO (Organisation internationale de normalisation) est une fdration mondiale dorganismes nationaux denormalisation (comits membres de lISO). Llaboration des Normes internationales est en gnral confie auxcomits techniques de lISO. Chaque comit membre intress par une tude a le droit de faire partie du comittechnique cr cet effet. Les organisations internationales, gouvernementales et non gouvernementales, enliaison avec lISO, partic