SAE AS 8059-2012 Carry-On Portable Oxygen Concentrators《手提便携式氧气收集器》.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: +1 724-776-497

4、0 (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/AS8059 AEROSPACE STANDARD AS8059 Issued 2012-06 Reaffirmed 2017-11 Carry-On Portable Oxygen Con

5、centrators RATIONALE AS8059 has been reaffirmed to comply with the SAE Five-Year Review policy. TABLE OF CONTENTS 1. SCOPE 2 1.1 Background . 2 1.2 Purpose . 2 2. REFERENCES 2 2.1 Applicable Documents 2 2.1.1 SAE Publications . 2 2.2 Other Documents 2 2.3 Definitions . 3 3. GENERAL REQUIREMENTS . 3

6、3.1 Product Requirements 3 3.2 Hazardous Materials or Conditions . 4 3.3 Accompanying Documentation . 4 3.4 EMC Compatibility . 6 3.5 Design Requirements . 6 3.5.1 General . 6 3.5.2 Electrical 7 3.5.3 Environmental . 7 3.5.4 Labeling . 7 4. NOTES 7 1. SCOPE This SAE Aerospace Standard (AS) applies t

7、o a personal, portable oxygen concentrator (POC) to be supplied and used by a passenger requiring supplemental oxygen therapy while traveling on board civil, commercial, or personal aircraft. It covers a POC during both self-powered battery operation and while powered from an aircraft seats electric

8、al power through the use of an accessory adapter. The POC is not intended to be connected to the aircrafts oxygen systems or to be used by any aircraft personnel in any method of treatment or first aid of the general flying public. 1.1 Background In 2003 the FAA became aware of portable oxygen conce

9、ntrators (POC) being used by patients who had ambulatory oxygen needs. Historically, providing supplemental oxygen on board commercial aircraft for non-emergency use had been very difficult. It was a logistic problem for the airlines and the traveling public needing supplemental oxygen. Due to safet

10、y concerns, passengers were not permitted to bring on board their own high pressure oxygen cylinders or liquid oxygen dewars. POCs safely operate at low internal pressure and have virtually no oxygen storage, providing an opportunity to overcome the logistic and safety issues associated with passeng

11、ers bringing their own oxygen treatment on board. Thus in 2005, the FAA promulgated SFAR No. 106, which permitted certain POCs to be brought on board for personal use by passengers. The initial SFAR was meant as a temporary regulation until a more permanent standard could be issued for the approval

12、of a POC as safe for use on board aircraft. 1.2 Purpose The purpose of this standard is to provide guidance on the standards, procedures, rules, and processes needed to approve personal portable oxygen concentrators for safe use of onboard civil and commercial passenger aircraft. The approval proces

13、s will show air safety of a POC during use on board aircraft as a Medical-Personal Electronic Device (M-PED). 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 applicabl

14、e issue of other publications shall be the issue in effect 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 regulati

15、ons unless a specific exemption has been obtained. 2.1.1 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. AIR6190 Provisions of Medical Oxygen for Aircraft Occup

16、ants 2.2 Other Documents 2.2.1 21 CFR Parts 11 and 121 Docket No.” FAA-2004-18596; SFAR No. 106 Available at: www.gpoaccess.gov 2.2.2 RTCA DO160: Environmental Conditions and Test Procedures for Airborne Equipment Available at: www.rtca.org 2.2.3 IEC60601-1: Medical Electrical Equipment Part 1: Gene

17、ral Requirements for Basic Safety and Essential Requirements Available at: www.iec.ch SAE INTERNATIONAL AS8059 Page 2 of 7_ 2.2.4 IEC60601-1-2: Electromagnetic Compatibility Available at: www.iec.ch 2.2.5 UN Manual of Tests and Criteria: Class 9 in Subsection 38.3. Available at: www.enece.org 2.2.6

18、UL1642: Standard for Lithium Cells and Batteries Available at: 2.2.7 EC62133: Secondary Cells and Batteries Available at: www.iec.ch 2.2.8 Hazardous Materials Regulations (HMR; 49 CFR parts 100-180) Available at: www.gpoaccess.gov 2.2.9 93/42/EEC Medical Device Directive Available at: www.eur-lex.e

19、ruopa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:EN:PDF 2.3 Definitions 2.3.1 LITHIUM CELL OR BATTERY A family of cells and batteries that utilize lithium ions for moving charges between the negative and positive electrodes. 2.3.2 LITHIUM CONTENT For a secondary lithium cell, it is d

20、efined in grams of lithium equivalent content and for a battery made of lithium cells, the watt-hour rating. 2.3.3 PORTABLE OXYGEN CONCENTRATOR (POC) A portable medical device that generates, but does not store, non-life support or non-life sustaining concentrated oxygen therapy gas for supplemental

21、 use by an individual under prescription from a licensed medical practitioner. 2.3.4 SHORT CIRCUIT A direct connection between positive and negative terminals of a cell or battery that provides a virtual zero resistance path for current flow. 2.3.5 WATT-HOUR A unit of energy equivalent to 1 W of wor

22、k acting for 1 h of time calculated by multiplying the cells or batterys nominal voltage by its nominal ampere capacity times 1 h. 3. GENERAL REQUIREMENTS 3.1 Product Requirements The POC shall meet the following regulations and approvals for medical use of oxygen concentrators. 3.1.1 United States

23、(US) requirements shall be for Food and Drug Administration (FDA) approval for sale of the device class for oxygen concentrators. 3.1.2 European Community (CE) requirements shall be for Medical Device Directive (MDD) listing for class II products. SAE INTERNATIONAL AS8059 Page 3 of 7_ 3.1.3 The devi

24、ce shall be approved to supply a single user of medical oxygen in a non-life support or non-life sustaining situation under a licensed physicians care. 3.2 Hazardous Materials or Conditions 3.2.1 Any battery or self-contained power source must be shown to not present hazardous conditions. 3.2.1.1 An

25、y lithium cell or battery must meet the requirement of the United Nations (UN) Manual of Tests and Criteria for Class 9 in Subsection 38.3. 3.2.1.2 Any lithium cell or battery must meet the requirements of UL1642, The Standard for Lithium Batteries. 3.2.1.3 Any lithium cell or battery must meet the

26、requirements of IEC62133, Standard for Secondary Cells. 3.2.1.4 Any alternate cell or battery chemistry must meet the requirements for non-hazardous materials in effect for that substance or substances under the Hazardous Materials Regulations (HMR). 3.2.1.5 Any lithium cell must not contain more th

27、an 1.5 g of lithium equivalent content. 3.2.1.6 Any lithium battery must not contain more than 100 Wh of capacity. 3.2.2 The maximum pressure achieved within the POC during normal operation cannot exceed 43.8 psia. 3.2.3 All cells or batteries must be fully contained and packaged in a manner to prec

28、lude sparks or generation of a dangerous quantity of heat. 3.3 Accompanying Documentation 3.3.1 The accompanying documentation of a POC must contain the following items for safe use of the POC onboard an aircraft. 3.3.1.1 Information that states that there is to be no smoking or open flame within 10

29、 ft of any seat row where the person using the POC is located onboard the aircraft. 3.3.1.2 Information that states while the plane is on the ground, during taxi, takeoff, or landing: 3.3.1.2.1 The unit must be turned off and stowed under the seat in front of the user, or in another approved stowage

30、 location, as to not block the aisle way or the entryway into the row if the POC will be used during flight but not during these times 3.3.1.2.2 The user must be in a seat location that does not restrict any other passengers access to, or use of, any required emergency or regular exit, or the aisle(

31、s) in the passenger compartment of the aircraft if the POC is being used during all or part of these times. 3.3.1.3 Information that states that no person using a POC during any portion of the flight is permittted to be seated in an exit row. 3.3.1.4 Information stating that while operating at any t

32、ime the POC the air intake and exhaust ports must be free of blockage. 3.3.1.5 Information that states prior to air travel the POC user must discuss the following items with their physician: 3.3.1.5.1 The patients prescribed flow setting. SAE INTERNATIONAL AS8059 Page 4 of 7_ 3.3.1.5.2 How the treat

33、ment may be affected by the aircraft cabin pressure equivalent to an altitude of 8000 ft. 3.3.1.5.3 Whether or not the prescribed flow setting can be changed by the patient or traveling assistant if the patient feels discomfort during the flight. 3.3.1.5.4 What portions of the total time on the airc

34、raft (terminal, taxi-ing, takeoff, in air, landing) that the patient should be using the POC. 3.3.1.6 Information that states that if a POC is being used when decompression of the passenger cabin occurs and the cabin oxygen system deploys the following information is to be followed in order: 3.3.1.6

35、.1 The POC user is to remove any POC cannula or mask accessory and utilize the aircrafts supplemental oxygen delivery through the aircrafts individual oxygen supply mask. 3.3.1.6.2 The POC is to be switched off and stored safely away. 3.3.1.7 Information that states that the POC user must insure tha

36、t any spare batteries being carried onboard as carryon baggage to power the device during use must: 3.3.1.7.1 Be protected from short circuiting or accidental discharge through either 3.3.1.7.1.1 Recessed battery terminals or 3.3.1.7.1.2 Packaged so the battery terminals do not contact metallic or c

37、onductive surfaces. 3.3.1.8 Information stating that the user or their traveling assistant must make sure that all fittings, connections, tubing, or other materials in the external oxygen pathway are to be oxygen compatible and that only oxygen compatible lotions or salves may be used by any person

38、using or assisting with the connections for use of the POC. 3.3.1.9 Information stating that the user or traveling assistant shall inspect the POC to ensure it is in good condition and be free of damage or other signs of excessive wear or abuse. 3.3.1.10 Information stating that the user or travelin

39、g assistant fully understands the operation of the POC onboard an aircraft. 3.3.1.10.1 The user or traveling assistant must have the cognitive ability to be able to operate, and readjust the flow setting if required of, the POC under normal conditions while in the passenger cabin. 3.3.1.10.2 The use

40、r or traveling assistant must able to see or hear the devices audible and visual alarms. 3.3.1.10.3 The user or travelling assistant must have the cognitive ability to respond to the various caution and warning alarms, whether audible or visual, of the device during abnormal operation. 3.3.1.11 A st

41、atement identifying the modes of operation (i.e., flow setting, powered via internal/external battery or power source, powered by an adapter connected to aircraft seat power while running and/or charging the POC) for which the POC is approved for use onboard the aircraft. 3.3.1.12 Information that i

42、f the POC is not intended to be used during the flight. 3.3.1.12.1 Any removable POC lithium cells or battery cannot be stowed as checked baggage in the cargo compartment and must be carried on board the passenger section of the aircraft for stowage under the conditions of 3.3.1.7. 3.3.1.12.2 And if

43、 the battery pack of the POC is not removable, the POC must contain at least two effective protective features to prevent accidental operation and delivery of oxygen. SAE INTERNATIONAL AS8059 Page 5 of 7_ 3.3.1.12.3 The POC can be checked in baggage for stowage in the cargo compartment or can be car

44、ried on board the aircraft by the passenger. If not in use, it must be turned off, and stowed in an approved stowage location. 3.3.1.12.4 Advising the user to contact the airline, aircraft operator, and security agency for any updated information regarding POC and lithium cell or battery carriage on

45、 board an aircraft. 3.3.1.13 Information advising the patient about operational aspects of the flight. 3.3.1.13.1 Charts or tables regarding operating times at the various flow settings or conditions of the POC using any self-contained or any internal or external battery power source. 3.3.1.13.2 The

46、 patient or assistant must contact and inform the airline or aircraft operator that the patient will be using an approved POC while on board the flights aircraft and the following information is needed: 3.3.1.13.2.1 The total expected flight time. 3.3.1.13.2.2 Any available seat power and capacity f

47、or use by the POC in operation. 3.3.1.13.2.3 Space available for storing the POC under the seat in front of the user or assistant. 3.3.1.13.2.4 Seating locations and/or restrictions for the patient using a POC. 3.3.1.13.3 The user must determine the amount of spare battery power needed for the durat

48、ion of the flight along with any expected delays based on the total flight times and operational time of the POC on battery power. 3.3.1.13.4 The user is responsible for providing battery power to operate their POC over the expected operating time. 3.3.1.13.5 The airline or aircraft operator cannot guarantee nor should the user dep