1、July 2009DEUTSCHE NORM English price group 16No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.10!$XV/“1535112www
2、.din.deDDIN EN ISO 18777Transportable liquid oxygen systems for medical use Particular requirements (ISO 18777:2005)English version of DIN EN ISO 18777:2009-07Flssigsauerstoffsysteme fr medizinische Anwendungen Besondere Anforderungen (ISO 18777:2005)Englische Fassung DIN EN ISO 18777:2009-07Superse
3、desDIN EN ISO 18777:2005-06www.beuth.deDocument comprises pages37DIN EN ISO 18777:2009-07 Start of validity This standard takes effect on 1 July 2009. DIN EN ISO 18777:2005-06 may be used in parallel until 21 March 2010. National foreword This standard includes safety requirements. This standard has
4、 been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” (Secretariat: BSI, United Kingdom) in cooperation with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” (Secretariat: BSI, United Kingdom). The responsible German body involved in its prepa
5、ration was the Normenausschuss Rettungsdienst und Krankenhaus (Rescue Services and Hospital Standards Committee), Technical Committee NA 053-03-01 AA Ansthesie und Beatmung. This standard contains specifications meeting the essential requirements set out in EU Directive 93/42/EEC on medical devices.
6、 The DIN Standards corresponding to the International Standards (ISO and IEC) referred to in clause 2 and in the Bibliography of the EN are as follows: ISO 4135 DIN EN ISO 4135 ISO 15001 DIN EN ISO 15001 ISO 18779 DIN EN ISO 18779 IEC 60529 DIN EN 60529 IEC 60601-1 DIN EN 60601-1 (VDE 0750-1) IEC 60
7、601-1-2 DIN EN 60601-1-2 (VDE 0750-1-2) IEC 60601-1-8 DIN EN 60601-1-8 (VDE 0750-1-8) Amendments This standard differs from DIN EN ISO 18777:2005-06 as follows: a) The informative Annex ZA “Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC“ has been
8、 updated on the basis of Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical d
9、evices and Directive 98/8/EC concerning the placing of biocidal products on the market. Previous editions DIN EN ISO 18777: 2005-06 2 DIN EN ISO 18777:2009-07 National Annex NA (informative) Bibliography DIN EN ISO 4135, Anaesthetic and respiratory equipment Vocabulary DIN EN ISO 15001, Anaesthetic
10、and respiratory equipment Compatibility with oxygen DIN EN ISO 18779, Medical devices for conserving oxygen and oxygen mixtures Particular requirements DIN EN 60601-1 (VDE 0750-1), Medical electrical equipment Part 1: General requirements for basic safety and essential performance DIN EN 60601-1-2 (
11、VDE 0750-1-2), Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and tests DIN EN 60601-1-8 (VDE 0750-1-8), Medical electrical equipment Part 1-8: General requirements for basic safet
12、y and essential performance Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems 3 DIN EN ISO 18777:2009-07 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 18777 Marc
13、h 2009 ICS 11.040.99 Supersedes EN ISO 18777:2005English Version Transportable liquid oxygen systems for medical use Particular requirements (ISO 18777:2005) Systmes transportables doxygne liquide usage mdical Exigences particulires (ISO 18777:2005) Flssigsauerstoffsysteme fr medizinische Anwendunge
14、n Besondere Anforderungen (ISO 18777:2005) This European Standard was approved by CEN on 24 February 2009. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteratio
15、n. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translat
16、ionunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Gr
17、eece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Managem
18、ent Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 18777:2009: EContents Page Foreword. 4 Introduction 5 1 Scope 6 2 Normative references . 6 3 Terms and definitions. 7 4 General
19、requirements and general requirements for tests 8 5 Classification. 8 6 Identification, marking and documents 8 7 Power input 13 8 Basic safety categories 13 9 Removable protective means 13 10 Environmental conditions 13 11 Not used. 14 12 Not used. 14 13 General. 14 14 Requirements related to class
20、ification . 14 15 Limitation of voltage and/or energy 14 16 Enclosures and protective covers 14 17 Separation 15 18 Protective earthing, functional earthing and potential equalization . 15 19 Continuous leakage currents and patient auxiliary currents . 15 20 Dielectric strength. 15 21 Mechanical str
21、ength . 15 22 Moving parts 15 23 Surfaces, corners and edges. 15 24 Stability in normal use 15 25 Expelled parts 16 26 Vibration and noise. 16 27 Pneumatic and hydraulic power 16 28 Suspended masses. 16 29 X-Radiation 16 30 Alpha, beta, gamma, neutron radiation and other particle radiation. 16 31 Mi
22、crowave radiation 16 32 Light radiation (including lasers) 16 33 Infrared radiation. 17 DIN EN ISO 18777:2009-07 EN ISO 18777:2009 (E) 234 Ultraviolet energy 17 35 Acoustical energy (including ultrasonics)17 36 Electromagnetic compatibility .17 37 Locations and basic requirements17 38 Marking and ac
23、companying documents.17 39 Common requirements for category AP and category APG equipment 17 40 Requirements and tests for category AP equipment, parts and components thereof17 41 Requirements and tests for category APG equipment, parts and components thereof .17 42 Excessive temperatures .17 43 Fir
24、e prevention.18 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility18 45 Pressure vessels and parts subject to pressure .19 46 Human errors .19 47 Electrostatic charges 20 48 Biocompatibility.20 49 Interruption of the power supply .20
25、 50 Accuracy of operating data 20 51 Protection against hazardous output20 52 Abnormal operation and fault conditions.20 53 Environmental tests 20 54 General .20 55 Enclosures and covers .20 56 Components and general assembly16 57 Mains parts, components and layout21 58 Protective earthing Terminals
26、 and connections .21 59 Construction and layout .21 101 Additional requirements .21 Annex AA (informative) Rationale .24 Annex BB (informative) Environmental aspects27 Annex CC (informative) Index of defined terms.29 Bibliography 33DIN EN ISO 18777:2009-07 EN ISO 18777:2009 (E) 3Annex ZA (informativ
27、e) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC30 Foreword The text of ISO 18777:2005 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO) and ha
28、s been taken over as EN ISO 18777:2009 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the secretariat of which is held by BSI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the late
29、st by September 2009, and conflicting national standards shall be withdrawn at the latest by March 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all s
30、uch patent rights. This document supersedes EN ISO 18777:2005. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EC Directives. For relationship with EC Directives, see informative A
31、nnex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France
32、, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 18777:2005 has been approved by CEN as a EN ISO 18777:2
33、009 without any modification. DIN EN ISO 18777:2009-07 EN ISO 18777:2009 (E) 4Introduction This International Standard specifies requirements for liquid oxygen systems which are used as a source of supply for oxygen therapy. Annex AA contains a rationale for some of the requirements. It is included
34、to provide additional insight into the committees reasoning that led to a requirement and identifying the hazards that the requirement addresses. Clauses and subclauses marked with * after their number have corresponding rationale contained in Annex AA. This International Standard is a Particular St
35、andard based on IEC 60601-1:1988, including Amendments 1 (1991) and 2 (1995), hereafter referred to as the General Standard. The General Standard is the basic standard for the safety of all medical electrical equipment used by or under the supervision of qualified personnel in the general medical an
36、d patient environment; it also contains certain requirements for reliable operation to ensure safety. The General Standard has associated Collateral Standards and Particular Standards. The Collateral Standards include requirements for specific technologies and/or hazards and apply to all applicable
37、equipment, such as medical electrical systems, EMC, radiation protection in diagnostic X-ray equipment, software, etc. The Particular Standards apply to specific equipment types, such as medical electron accelerators, high frequency surgical equipment, hospital beds, etc. NOTE Definitions of Collate
38、ral Standard and Particular Standard can be found in IEC 60601-1:1988, 1.5 and A.2, respectively. To facilitate the use of this International Standard, the following drafting conventions have been applied. This International Standard uses the same main clause titles and numbering as the General Stan
39、dard, for ease of cross-referencing of the requirements. The changes to the text of the General Standard, as supplemented by the Collateral Standards, are specified by the use of the following words. “Replacement” means that the indicated clause or subclause of the General Standard is replaced compl
40、etely by the text of this International Standard. “Addition” means that the relevant text of this Particular Standard is a new element (e.g. subclause, list item, note, table, figure) additional to the General Standard. “Amendment” means that an existing element of the General Standard is partially
41、modified by deletion and/or addition as indicated by the text of this Particular Standard. To avoid confusion with any amendments to the General Standard itself, a particular numbering has been employed for elements added by this International Standard: subclauses, tables and figures are numbered st
42、arting from 101; additional list items are lettered aa), bb), etc. and additional annexes are lettered AA, BB, etc. In this International Standard, the following print types are used: requirements, compliance with which can be verified, and definitions: roman type; notes and examples: smaller roman
43、type; description of type of document change and test methods: italic type; terms defined in the General Standard IEC 60601-1:1988, Clause 2, or in this Particular Standard: bold type. Throughout this International Standard, text for which a rationale is provided in Annex AA is indicated by an aster
44、isk (*). DIN EN ISO 18777:2009-07 EN ISO 18777:2009 (E) 51 Scope IEC 60601-1:1988, Clause 1, applies except as follows: Amendments (add at end of 1.1): 1.1 This International Standard specifies requirements for the safety and essential performance of transportable liquid oxygen systems which are use
45、d as a supply source for oxygen therapy. These devices usually consist of a portable unit to be carried by or with the patient whilst in use and the vessel used to refill the portable unit. These devices are mostly used in home care applications and in health care facilities/institutions. These devi
46、ces are often used without professional supervision. Liquid oxygen vessels used as a supply source for oxygen pipeline systems are excluded from this International Standard. The requirements of this International Standard which replace or modify the requirements of IEC 60601-1:1998 and its Amendment
47、s 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements. 1.4 Addition: NOTE Planning and design of products complying with this Internatinal Standard can have environmental impact during the product life cycle. Environmental aspects are addressed in Annex
48、BB. Additional aspects of environmental impact are addressed in ISO 14971. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referen
49、ced document (including any amendments) applies. EN 980:2003, Graphical symbols for use in the labelling of medical devices EN 1041:1998, Information supplied by the manufacturer with medical devices EN 1251-1:2000, Cryogenic vessels Transportable vacuum insulated vessels of not more than 1 000 litres volume Part 1: Fundamental requirements EN 1251-2:2000, Cryogenic vessels Transportable vacuum insulated vessels of not more than 1 000 litres volume Part 2: Design, fabrication, inspection and testing EN 1251-3:2000,
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