ISO INTERNATIONAL STANDARD 18777 First edition 2005-02-15 Transportable liquid oxygen systems for medical use Particular requirements Systemes transportables d'oxygene liquide a usage medical - Exigences particulieres Reference number ISO 18777:2005(E) Copyright International Organization for Standardization @ ISO 2005 Not for Resale ISO 18777:2005(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In accepts no liability in this area. Adobe is a trademarkof AdobeSystems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by IsO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below ?ISO2005 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, IsO's 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 [email protected] Web www.iso.org Published in Switzerland yemainagazainandardizato @ISO2005-All rights reserved mittedwithoutlicense from IHS Not for Resale ISO 18777:2005(E) Contents Page Foreword Introduction 1 Scope 2 Normative references . 3 Terms and definitions 4 General requirements and general requirements for tests 5 Classification. 6 Identification,markinganddocuments 7 Powerinput.. 8 Basic safety categories .... 9 Removable protective means 10 Environmental conditions.. 11 Not used.. 12 Not used. 13 General... 14 Requirements related to classification 15 Limitation of voltage and/or energy.... 16 Enclosures and protective covers 17 Separation.. 10 18 Protective earthing, functional earthing and potential equalization 19 Continuous leakage currents and patient auxiliary currents 10 20 Dielectric strength.. 21 Mechanical strength 0 22 Moving parts. 23 Surfaces, corners and edges.. 10 24 Stability in normal use.. 10 25 Expelled parts 26 Vibration and noise 27 28 Suspended masses 29 X-Radiation 30 Alpha, beta, gamma, neutron radiation and other particle radiation.. 31 Microwaveradiation 11 32 Light radiation (including lasers) ... 33 Infrared radiatio 2 Copyright International Oorganization for standardizallon'ghts reserved ili from IHS Not for Resale ISO 18777:2005(E) 34 Ultraviolet energy 35 Acoustical energy (including ultrasonics). 36 Electromagnetic compatibility. 37 Locations and basic requirements 38 Marking and accompanying documents. 39 Common requirements for category AP and category ApG equipment ... 40 Requirements and tests for category Ap equipment, parts and components thereof....12 41 Requirements and tests for category ApG equipment, parts and components thereof .... ....12 42 Excessive temperatures . 43 Fire prevention... ..13 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfectionandcompatibility..... ..13 45 Pressure vessels and parts subject to pressure 46 Human errors ... 47 Electrostatic charges 48 Biocompatibility.... ..15 49 Interruption of the power supply .. 50 Accuracy of operating data .... 51 Protection against hazardous output.. 52 Abnormal operation and fault conditions... 53 Environmental tests 54 General 55 Enclosures and covers ... 56 Components and general assembly..... 57 Mains parts, components and layout.. 58 Protective earthing - Terminals and connections.. 59 Construction and layout .... 101 Additional requirements ... Annex AA (informative) Rationale. 19 Annex BB (informative) Environmental aspects.. Annex cc (informative) Index of defined term