ISO 8835-7-2011 Inhalational anaesthesia systems - Part 7 Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic g.pdf

1、Inhalational anaesthesia systems Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases Systmes danesthsie par inhalation Partie 7: Systmes danesthsie pour utilisation dans des zones avec quipement logistique limit en lectricit et en gaz an

2、esthsiques ISO 2011 Reference number ISO 8835-7:2011(E) First edition 2011-11-01 ISO 8835-7 INTERNATIONAL STANDARDISO 8835-7:2011(E)COPYRIGHT PROTECTED DOCUMENT ISO 2011 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any m

3、eans, 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 the 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 cop

4、yrightiso.org Web www.iso.org Published in Switzerland ii ISO 2011 All rights reservedISO 8835-7:2011(E) ISO 2011 All rights reserved iii Contents Page Foreword . v * Introduction .vi 1 * Scope . 1 2 Normative references . 1 3 Terms and definitions . 1 4 General requirements . 2 4.1 Electrical safet

5、y . 2 4.2 Mechanical hazards 2 4.3 Risk management 2 5 * Essential functions . 2 6 Oxygen concentrators . 3 7 Performance requirements . 3 7.1 Electrical supply 3 7.2 Gas supply 3 7.3 Flammable anaesthetic agents 3 8 Construction requirements . 3 8.1 Servicing 3 8.2 Materials . 3 9 Environmental con

6、ditions . 3 10 Marking . 4 11 Information to be provided by the manufacturer 4 Annex A (informative) Rationale . 5 A.1 General . 5 A.2 Introduction and Clause 5 . 5 A.3 Clause 1 . 5 Annex B (informative) Reference to the essential principles . 6 Bibliography . 7Foreword ISO (the International Organi

7、zation 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 establishe

8、d 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.

9、International 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. Pub

10、lication 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

11、 rights. ISO 8835-7 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 1, Breathing attachments and anaesthetic machines. ISO 8835 consists of the following parts, under the general title Inhalational anaesthesia systems: Part 7: Anaesthetic system

12、s for use in areas with limited logistical supplies of electricity and anaesthetic gases The following parts are withdrawn and replaced by ISO 80601-2-13: Part 2: Anaesthetic breathing systems Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems Part 4: Anaesthetic vap

13、our delivery devices Part 5: Anaesthetic ventilators Draw-over vaporizers are described in ISO/TS 18835. ISO 8835-7:2011(E)iv ISO 2011 All rights reserved* Introduction The World Health Organisation (WHO) and the World Federation of Societies of Anaesthesiologists (WFSA) are concerned about the prov

14、ision of safe anaesthesia, using appropriately designed anaesthetic equipment, in the large numbers of countries in the world where economics or infrastructure lead to a situation where complex technology is unlikely to function well, if at all, and might introduce hazards of its own. A total of 152

15、 countries have been identified where the infrastructure or economic restrictions prevent the use of complex equipment, creating a need for an appropriate standard. Equipment designed for use in these countries should meet the following minimum criteria: a) ability to function in the absence of a re

16、gular supply of compressed medical gases; b) ability to continue to function safely when the supply of medical gases fails; c) ability to function if mains electrical supplies are interrupted, or are subject to unpredictable increases or decreases in voltage; d) ability to function in a challenging

17、environment, including high temperatures, humidity, shocks, vibration, and dust. This part of ISO 8835 allows for the construction of an anaesthetic system, using the components identified in this part of ISO 8835, to suit the specific economic and environmental issues of each country. Throughout th

18、is part of ISO 8835, text for which a rationale is provided in Annex A is indicated by an asterisk (*). ISO 8835-7:2011(E) ISO 2011 All rights reserved vINTERNATIONAL STANDARD ISO 8835-7:2011(E) Inhalational anaesthesia systems Part 7: Anaesthetic systems for use in areas with limited logistical sup

19、plies of electricity and anaesthetic gases 1 * Scope This part of ISO 8835 specifies safety and performance requirements for anaesthetic systems and components that: a) can function in the absence of a supply of compressed medical gases or mains electricity; b) can withstand a challenging environmen

20、t, including high temperatures, humidity, shocks and vibration, and dust; c) allow local servicing and maintenance; d) may be suitable for use with flammable anaesthetic agents. 2 Normative references The following referenced documents are indispensable for the application of this document. For date

21、d references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 4135, Anaesthetic and respiratory equipment Vocabulary ISO 8359, Oxygen concentrators for medical use Safety requirements ISO 10083, Oxygen conc

22、entrator supply systems for use with medical gas pipeline systems ISO 14971, Medical devices Application of risk management to medical devices ISO 80601-2-13, Medical electrical equipment Part 213: Particular requirements for basic safety and essential performance of an anaesthetic workstation ISO/T

23、S 18835, Inhalational anaesthesia systems Drawover vaporizers and associated equipment IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance 3 Terms and definitions For the purposes of this document, the terms and definitions given in

24、ISO 4135 and the following apply. 3.1 anaesthetic system device for administering anaesthetic gases that may use, but is not reliant on, compressed gas or mains electrical supply for safe use ISO 2011 All rights reserved 14 General requirements 4.1 Electrical safety Anaesthetic systems or their comp

25、onents that are classed as medical electrical equipment in accordance with IEC 60601-1 shall, in addition to the requirements in this part of ISO 8835, meet the relevant requirements in IEC 60601-1. Check compliance by testing in accordance with IEC 60601-1. 4.2 Mechanical hazards Anaesthetic system

26、s or their components shall comply with IEC 60601-1:2005, Clause 9. Check compliance by testing in accordance with IEC 60601-1. 4.3 Risk management The manufacturer of an anaesthetic system, or parts intended for use in an anaesthetic system, shall follow a risk management process in accordance with

27、 ISO 14971. Any unacceptable risk shall be mitigated by, in this order: a) design features which prevent the hazard; b) inclusion of a means of protection; c) inclusion of a monitoring and/or alarm system; d) safety and handling advice by way of marking or labelling. If the inclusion of such risk mi

28、tigation measures is not feasible, the instructions for use shall contain: a statement recommending that such risk mitigation measures be added prior to the use of the anaesthetic system; sufficient specification of such risk mitigation measures. Check compliance by inspection of the risk management

29、 file and, if applicable, the instructions for use. 5 * Essential functions The anaesthetic system shall include the following: a) means of gas delivery; b) a draw-over vaporizer complying with ISO/TS 18835; c) means for the manual ventilation of the patient; NOTE 1 This may be an operatorpowered re

30、suscitator complying with ISO 10651-4, or an inflating bellows. NOTE 2 Additionally, an anaesthetic ventilator complying with ISO 80601-2-13 may be supplied. d) means for delivering gas to the patient by either a continuous flow breathing system complying with ISO 80601-2-13 or a draw-over breathing

31、 system complying with ISO/TS 18835; NOTE 3 Circle breathing systems are considered unsafe for use with these anaesthetic systems. e) means to prevent hypoxic gas mixtures of oxygen and nitrous oxide if nitrous oxide can be delivered by the anaesthetic system. ISO 8835-7:2011(E)2 ISO 2011 All rights

32、 reserved6 Oxygen concentrators If an oxygen concentrator is used as a means to supply an increased concentration of oxygen in the anaesthetic gas mixture delivered to the patient, it shall comply with either ISO 8359 or ISO 10083. 7 Performance requirements 7.1 Electrical supply Anaesthetic systems

33、 shall continue to function and allow the delivery of anaesthetic gases as specified by the manufacturer if the mains electricity supply fails, or the voltage increases or decreases. Check compliance by functional testing. Any change from mains to battery supply shall be indicated to the operator. T

34、he anaesthetic system shall be provided with suitable protection against excessively high voltage, surges, and spikes. NOTE See IEC 61000-4-5. 7.2 Gas supply 7.2.1 If a gas supply is available, the anaesthetic system shall be able to provide a minimum of 6 l/min of fresh gas flow. 7.2.2 Anaesthetic

35、systems shall continue to function and allow the delivery of anaesthetic gases as specified by the manufacturer if the pressure within the medical gas supply fails, increases or decreases. Any change in the gas supply status should be indicated to the operator. 7.3 Flammable anaesthetic agents If th

36、e anaesthetic system is designed to be used with flammable anaesthetic agents, such as diethyl ether, it shall comply with the requirements of IEC 60601-1:2005, Annex G. 8 Construction requirements 8.1 Servicing Anaesthetic systems shall be designed to take account of available communication, logist

37、ic supply and the electrical and mechanical skills available at the site of use. Check compliance by inspection of the service manual. 8.2 Materials The materials selected for manufacture shall not cause risk to the patient when in normal use and shall withstand the cleaning, disinfecting and steril

38、ization procedures which are recommended by the manufacturer or available locally. Check compliance by examination of the technical file. 9 Environmental conditions Anaesthetic systems shall function normally under the following environmental conditions: ISO 8835-7:2011(E) ISO 2011 All rights reserv

39、ed 3 temperature 5 C to 40 C relative humidity 15 % to 95 % pressure 70,0 kPa to 106,0 kPa The manufacturer of the anaesthetic system shall declare, in the instructions for use, how the anaesthetic system will respond if the environmental conditions are extended outside the range specified in the in

40、structions for use. 10 Marking Anaesthetic systems or their components shall be marked with the following: a) name and address of the manufacturer/supplier; b) lot, batch or serial number; c) if a flow-sensitive component can be assembled incorrectly, an arrow indicating the direction of flow; d) if

41、 applicable, an indication that the anaesthetic system or component thereof is suitable for use with flammable anaesthetic agents. 11 Information to be provided by the manufacturer Manufacturers of anaesthetic systems shall provide the following information where applicable: a) the method of assembl

42、y; b) a pre-use checklist; c) instructions for use, maintenance and servicing; d) instructions for cleaning, disinfecting and sterilization; e) any special warnings or instructions regarding suitability of use with flammable anaesthetic agents; f) the intended purpose and any restrictions on its use

43、; g) a list of spare parts to maintain the equipment for a minimum of 5 years; h) if applicable, contact details for a rapid response help-line; i) if applicable, a statement recommending risk mitigation measures prior to the use of the anaesthetic system and sufficient specification of such risk mi

44、tigation measures (see 4.3). ISO 8835-7:2011(E)4 ISO 2011 All rights reservedAnnex A (informative) Rationale A.1 General This annex provides rationale for certain requirements of this part of ISO 8835 and is intended for those who are familiar with the subject of this part of ISO 8835 but who have n

45、ot participated in its development. An understanding of the reasons for these requirements is considered to be essential for their proper application and is provided to aid in the application of this part of ISO 8835. Furthermore, as clinical practice and technology change, it is believed that a rat

46、ionale will facilitate any revision of this part of ISO 8835 that is necessitated by those developments. A.2 Introduction and Clause 5 Monitoring is recognised as a very emotive subject. A conscious decision was made not to mandate the use of any monitor as it is generally accepted that the patient

47、is constantly attended by the person administering the anaesthetic. The economic pressures and logistical problems with supply of spare and consumable parts in these countries are also factors. Pressure monitoring was considered to be most important when an anaesthetic ventilator is part of the syst

48、em. This is covered by compliance with ISO 80601-2-13. Oxygen monitoring was also considered but it was thought that if a choice had to be made a pulse oximeter may be preferred to an oxygen monitor as air is often the main fresh gas. A pulse oximeter is generally considered to be a patient monitor,

49、 not an equipment monitor, and is therefore not included in this part of ISO 8835. However, monitoring the concentration of oxygen in the inspired mixture is strongly encouraged, if feasible, especially if pulse oximetry is not available. Carbon dioxide and anaesthetic agent monitoring were considered not to be essential for the type of anaesthetic system covered by this part of ISO 8835. A.3 Clause 1 Anaesthetic systems will need to withstand adverse environmental conditions, especially temperature and hu