SAE AIR 6190-2012 Provisions of Medical Oxygen for Aircraft Occupants《飞机乘客用医用氧气供应》.pdf

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1、_ SAE Technical Standards Board Rules provide that: “This report is published by SAE to advance the state of technical and engineering sciences. The use of this report is entirely voluntary, and its applicability and suitability for any particular use, including any patent infringement arising there

2、from, is the sole responsibility of the user.” SAE reviews each technical report at least every five years at which time it may be revised, reaffirmed, stabilized, or cancelled. SAE invites your written comments and suggestions. Copyright 2017 SAE International All rights reserved. No part of this p

3、ublication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of SAE. TO PLACE A DOCUMENT ORDER: Tel: 877-606-7323 (inside USA and Canada)Tel: +1 724-776-4970

4、 (outside USA)Fax: 724-776-0790 Email: CustomerServicesae.org SAE WEB ADDRESS: http:/www.sae.org SAE values your input. To provide feedback on this Technical Report, please visit http:/standards.sae.org/AIR6190 AEROSPACEINFORMATION REPORTAIR6190 Issued 2012-06 Reaffirmed 2017-11 Provisions of Medica

5、l Oxygen for Aircraft Occupants RATIONALE AIR6190 has been reaffirmed to comply with the SAE Five-Year Review policy. TABLE OF CONTENTS 1. SCOPE 2 2. REFERENCES 2 2.1 Applicable Documents 2 2.1.1 SAE Publications . 2 2.1.2 Other Publications . 2 2.2 Definitions . 2 3. GENERAL DISCUSSION OF OXYGEN SU

6、PPLY EVENTS ON AIRCRAFT . 3 4. REQUIREMENTS . 4 4.1 Regulatory Requirements . 4 4.2 Limitations for Use of Medical Oxygen Equipment on Aircraft . 4 4.3 Physiological Requirements 5 4.4 Oxygen Use in Clinical Practice 5 5. EQUIPMENT FOR MEDICAL OXYGEN SUPPLY . 5 5.1 Oxygen Delivery Methods/Interfaces

7、 5 5.2 Administration and Monitoring of Oxygen . 5 6. NOTES 6 1. SCOPE This document provides information on provisions for passengers with disabilities on board commercial aircraft. In this context the term “provision of medical oxygen“ shall be understood as application of oxygen on board an aircr

8、aft not linked to (post) decompression in the sense of Airworthiness Requirements FAR/CS 25 and Operational Regulations of FAR 121/135. Information about available equipment and physiological treatment in clinical practice will be provided in this document. It covers the use of oxygen concentrators

9、according to guidance of FAR Advisory Circular AC120-95. 2. REFERENCES 2.1 Applicable Documents The following publications form a part of this document to the extent specified herein. The latest issue of SAE publications shall apply. The applicable issue of other publications shall be the issue in e

10、ffect on the date of the purchase order. In the event of conflict between the text of this document and references cited herein, the text of this document takes precedence. Nothing in this document, however, supersedes applicable laws and regulations unless a specific exemption has been obtained. 2.

11、1.1 SAE Publications Available from SAE International, 400 Commonwealth Drive, Warrendale, PA 15096-0001, Tel: 877-606-7323 (inside USA and Canada) or 724-776-4970 (outside USA), www.sae.org. AIR171 Glossary of Technical and Physiological Terms Related to Aerospace Oxygen Systems AS8010 Aviators Bre

12、athing Oxygen Purity Standard AS8025 Passenger Oxygen Mask AS8059 Carry-On Portable Oxygen Concentrators 2.1.2 Other Publications Guideline for Emergency Oxygen Use in Adult Patients Thorax / AN INTERNATIONAL JOURNAL OF RESPIRATORY MEDICINE: Thorax 2008;63 (Suppl. VI), vi1-vi68. Doi:10.1136/thx.2008

13、.102947 MIL-PRF -27210 Oxygen, Aviators Breathing, Liquid and Gas 2.2 Definitions CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD): Is the co-occurrence of chronic bronchitis and emphysema, a pair of commonly co-existing diseases of the lungs in which the airways become narrowed. DISPENSING DEVICE: Any

14、device approved for use, and installation or approved as carry-on aboard aircraft that will deliver breathing oxygen to an individual at the flow required by a physician or airworthiness requirements. EQUIVALENT SAFETY FINDING: Equivalent levels of safety (ELOS) findings are made when literal compli

15、ance with a certification regulation cannot be shown and compensating factors exist that can be shown to provide an equivalent level of safety. FIRST AID OXYGEN: An oxygen supply used for physiological treatment following cabin decompression and the entire time that cabin pressure altitudes exceed 1

16、0 000 ft, but also may be used in case of any medical emergency. SAE INTERNATIONAL AIR6190 Page 2 of 6_ MEDICAL OXYGEN: An oxygen supply, made available prior to and during flight, specifically for a passenger needing an enriched oxygen supply during the course of the entire flight. Oxygen quantity

17、and usage or flow is specified by prescription from the passengers physician. OXIMETER: A device based on photometric red and near infrared measurement of the oxygen saturation by determining the ratio of the reduced hemoglobin to oxyhemoglobin in the arterial or venous blood. OXYGEN SATURATION OF T

18、HE BLOOD: Fraction of total hemoglobin which is in the form of oxyhemoglobin PORTABLE OXYGEN CONCENTRATOR: A medical device that supplies concentrated oxygen gas generated through the pressure swing adsorption process that does not store oxygen gas, for supplemental gas use by an individual under pr

19、escription from a physician. PULSE OXIMETER: The pulse oxymetry is based in the recognition of the systolic/diastolic phase of the blood flow (e.g., in the finger). A mathematical algorithm allows it to identify the permanent signal in the detection, versus the blood signal. The photometry of the he

20、moglobin is made on the result, and gives “arterial” oxymetry (SaO2). SUPPLEMENTAL OXYGEN: An oxygen supply primarily for use when cabin altitude exceeds 10 000 ft, for physiological reasons during emergency cabin decompressions. THERAPEUTIC OXYGEN: This term is sometimes used in specific customer r

21、equest, but for all practical purposes is synonymous with the definition of the MEDICAL OXYGEN. 3. GENERAL DISCUSSION OF OXYGEN SUPPLY EVENTS ON AIRCRAFT In general oxygen supply on aircraft is closely defined by regulations contained in: Airworthiness requirements FAR/CS 25.1441 25.1453 specifying

22、the performance of the equipment with regards to minimum mass flow of supplemental oxygen for any kind of application. Operational requirements FAR 121.331/333 and 135.91 specifying the conditions and duration of oxygen administration. The purpose of these regulations are to provide physiological pr

23、otection in case of cabin pressure loss and enable so called “first-aid” treatment post decompression. In addition FAR 121.574 covers the operational requirements of “medical oxygen” (4 LPM STPD) on board of commercial aircraft. All current regulations require the administration of constant flow gas

24、eous oxygen. Several novel technologies are available which in general do not deliver a constant flow of 4 LPM STPD medical/aviators breathing oxygen. New oxygen delivery technologies have to show compliance to airworthiness requirements by EQUIVALENT LEVELS OF SAFETY (ELOS). Portable Oxygen Concent

25、rators Portable oxygen concentrators provide a demand flow equivalent to 0 to 5 LPM, as defined by the manufacturer of equipment. In addition several portable oxygen concentrators can provide a constant flow up to 2 LPM. The portable oxygen concentrators provide an oxygen purity of 90% 3%. Specific

26、models are allowed aboard aircraft by part CFR 11 and 121 (Docket No. FAA-2004-18596;SFAR#106). See also AS8059. SAE INTERNATIONAL AIR6190 Page 3 of 6_ Oxygen Conserving Systems Oxygen conserving systems deliver on demand a fixed oxygen dose per breath from a high pressure gaseous oxygen source (Med

27、ical oxygen or aviators breathing oxygen purity) to the user of the equipment. This kind of equipment, introduced on new aircraft type(s), does not directly comply with airworthiness requirements of FAR/CS 25.1443(d). With regards to delivery of oxygen compliance has to be demonstrated by “equivalen

28、t safety finding” showing that the equipment provides the same or better benefit to an individual using first aid oxygen by a comparative test to an existing, compliant constant flow first aid oxygen mask being delivered 4 LPM STPD oxygen. The underlying need of airworthiness requirements and associ

29、ated oxygen supply is to ensure an adequate blood saturation for physiological protection in foreseeable aircraft environment, either during emergency or normal cabin altitude. From regulation point of view passenger oxygen supply events on aircraft may be summarized as following: Supplemental oxyge

30、n during decompression at aircraft altitudes from 10 000 ft up to specified maximum flight altitude of aircraft. First aid oxygen treatment subsequent to decompression until cabin altitude is at 8000 ft. “Medical oxygen” at normal cabin altitudes according to specific operational requirements (FAR 1

31、21). Conclusion: Fixed installations of supplemental oxygen equipment usually provided with automatically presented drop down masks for decompression are not considered as provision for medical oxygen. Portable oxygen walk around cylinders may be combined for multiple use for cabin attendant supplem

32、ental oxygen, for first aid and for medical oxygen, if performance and compliance with regulations are met, such as flow and capacity requirements. 4. REQUIREMENTS 4.1 Regulatory Requirements From regulatory point of view medical oxygen is considered in operational regulations of FAR 121.574. In sen

33、se of regulatory requirements provisions of medical oxygen should be reviewed with regards to: Physiological performance and interface to human subjects. Compatibility of equipment with environment, interfaces and operational requirements of an aircraft. 4.2 Limitations for Use of Medical Oxygen Equ

34、ipment on Aircraft It is recommended to use oxygen dispensing equipment, like passenger masks and supplies from gaseous oxygen sources, usually available on commercial aircraft approved by appropriate standards, airworthiness requirements or special federal aviation regulation. If an aircraft occupa

35、nt requires oxygen due to a disability according to a prescription of his or her physician, medical oxygen equipment should be used at normal cabin pressure altitude only. SAE INTERNATIONAL AIR6190 Page 4 of 6_ 4.3 Physiological Requirements The aim of any kind of medical oxygen treatment, independe

36、nt of available equipment, should be to enable people, who do have a sufficient blood oxygen saturation at sea level, but may reach with increasing cabin altitude (under normal flight conditions and no decompression) a certain critical blood oxygen saturation limit, which should not be below 85% as

37、recommended in clinical practice. 4.4 Oxygen Use in Clinical Practice Clinical oxygen application, reference publication of 2.1.2, is based in principle on following criteria: Critical illnesses in adults requiring HIGH levels of supplemental oxygen. Serious illnesses in adults requiring MODERATE le

38、vels of supplemental oxygen if hypoxaemic. COPD and other conditions in adults requiring CONTROLLED OR LOW DOSE supplemental oxygen. Dependent on medical diagnosis the blood oxygen target saturation, ranging from 85 to 98% and oxygen flow varying from 2 to 15 LPM. 5. EQUIPMENT FOR MEDICAL OXYGEN SUP

39、PLY In general for medical oxygen supply to aircraft occupants the same equipment could be used as available on the aircraft for supplemental and first aid oxygen according to airworthiness requirements of CS/FAR 25.1443. 5.1 Oxygen Delivery Methods/Interfaces Oxygen may be delivered from different

40、sources, provided the breathing gas quality is equal to AS8010 standards (impurities do not exceed the levels specified in the standard), which could be: Continuous oxygen flow of a portable oxygen cylinder. Continuous oxygen flow from a chemical oxygen generator. Pulsed or demand flow generated by

41、a portable oxygen concentrator Pulsed or demand flow by a portable oxygen cylinder. Source(s) should be with regards to performance compatible with dispensing devices like masks. The user should request his or her physician to determine which dispensing device would be the most effective to provide

42、the oxygen from the source. 5.2 Administration and Monitoring of Oxygen Administration of supplemental oxygen may be provided by TSO approved masks as available on portable oxygen equipment. Nasal cannula. Patients own mask/dispensing device if used in conjunction with his/her carry on oxygen equipm

43、ent like POC. It is recommended to monitor the effect of oxygen administration by pulse oximetry and to document the usage. SAE INTERNATIONAL AIR6190 Page 5 of 6_ 6. NOTES 6.1 If medical oxygen supply is needed by a passenger, the airline should be contacted prior to flight and insure that their pol

44、icies will meet the passengers needs. The passenger should inform the airline (e.g., about the kind of equipment and its expected time of use during flight). Each airline may have different requirements. It is recommended that the passenger who desires travel with medical oxygen, either their own ox

45、ygen system or oxygen provided by the airline, must contact their airline at least 48 h in advance of their travel, and anticipate that the airline may require authorization from their physician. There may be a charge for the use of medical oxygen provided by the airline. Equipment provided by the p

46、assenger must meet the standards of the airline respectively of AS8059 and must be used/stowed on board the airplane in accordance with airline policies. 6.2 A change bar (l) located in the left margin is for the convenience of the user in locating areas where technical revisions, not editorial chan

47、ges, have been made to the previous issue of this document. An (R) symbol to the left of the document title indicates a complete revision of the document, including technical revisions. Change bars and (R) are not used in original publications, nor in documents that contain editorial changes only. PREPARED BY SAE COMMITTEE A-10, AIRCRAFT OXYGEN EQUIPMENT SAE INTERNATIONAL AIR6190 Page 6 of 6_