DIN EN ISO 18778-2009 Respiratory equipment - Infant monitors - Particular requirements (ISO 18778 2005) English version of DIN EN ISO 18778 2009-08《呼吸设备 婴儿监视器 特殊要求(ISO 18778-2005).pdf

1、August 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; 97.190!$YAC“

2、1543032www.din.deDDIN EN ISO 18778Respiratory equipment Infant monitors Particular requirements (ISO 18778:2005)English version of DIN EN ISO 18778:2009-08Beatmungsgerte berwachungsgerte fr Kleinkinder Besondere Anforderungen (ISO 18778:2005)Englische Fassung DIN EN ISO 18778:2009-08SupersedesDIN EN

3、 ISO 18778:2005-06See start of validitywww.beuth.deDocument comprises 38 pagesDIN EN ISO 18778:2009-08 2 Start of validity This standard takes effect on 1 August 2009. DIN EN ISO 18778:2005-06 may be used in parallel until 21 March 2010. National foreword This standard has been prepared by Technical

4、 Committee ISO/TC 121 “Anaesthetic and respiratory equipment” (Secretariat: BSI, United Kingdom) in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” (Secretariat: BSI, United Kingdom). The responsible German body involved in its preparation was the Normenauss

5、chuss 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. The DIN Standards corres

6、ponding to the International Standards referred to in this document are as follows: ISO 4135 DIN EN ISO 4135 ISO 15001 DIN EN ISO 15001 IEC 60068-2-64 DIN EN 60068-2-64 IEC 60529 DIN EN 60529 (VDE 0470-1) IEC 60601-1 DIN EN 60601-1 (VDE 0750-1) IEC 60601-1-2 DIN EN 60601-1-2 (VDE 0750-2) IEC 60601-1

7、-8 DIN EN 60601-1-8 (VDE 0750-1-8) IEC 60601-2-23 DIN EN 60601-2-23 (VDE 0750-2-23) Amendments This standard differs from DIN EN ISO 18778:2005-06 as follows: a) Annex ZA (informative) concerning the relationship between this European Standard and the essential requirements of EU Directive 93/42/EEC

8、 on medical devices has been updated on the basis of EU Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directives 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices and 93/42/EEC on

9、medical devices and EU Directive 98/8/EC on the placing on the market of biocidal products. Previous editions DIN EN ISO 18778: 2005-06 3 National Annex NA (informative) Bibliography DIN EN ISO 4135, Anaesthetic and respiratory equipment Vocabulary DIN EN ISO 15001, Anaesthetic and respiratory equip

10、ment Compatibility with oxygen DIN EN 60068-2-64, Environmental testing Part 2-64: Tests Test Fh: Vibration, broadband random and guidance DIN EN 60529 (VDE 0470-1), Degrees of protection provided by enclosures (IP code) DIN EN 60601-1 (VDE 0750 Teil 1), Medical electrical equipment Part 1: General

11、requirements for basic safety and essential performance DIN EN 60601-1-2 (VDE 0750 Teil 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-

12、8), Medical electrical equipment Part 1-8: General requirements for basic safety and essential performance Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems DIN EN 60601-2-23 (VDE 0750-2-23), Medical electri

13、cal equipment Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment DIN EN ISO 18778:2008-08 DIN EN ISO 18778:2009-08 4 This page is intentionally blank EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 18778Ap

14、ril 2009ICS 11.040.10 Supersedes EN ISO 18778:2005 English VersionRespiratory equipment - Infant monitors - Particularrequirements (ISO 18778:2005)Matriel respiratoire - Moniteurs pour enfants - Exigencesparticulires (ISO 18778:2005)Beatmungsgerte - berwachungsgerte fr Kleinkinder -Besondere Anforde

15、rungen (ISO 18778:2005)This European Standard was approved by CEN on 21 March 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 alteration. Up-to-date lists and

16、bibliographical references concerning such nationalstandards 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 translationunder the responsibilit

17、y 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, Greece, Hungary, Iceland, Irel

18、and, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-

19、1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 18778:2009: EContents 2 DIN EN ISO 18778:2009-08 EN ISO 18778:2009 (E) Page Foreword .4 Introduction.5 1 * Scope .6 2 Normative references6 3 Terms and definition

20、s .7 4 General requirements and general requirements for tests.8 5 Classification .8 6 Identification, marking and documents 8 7 Power input 12 8 Basic safety categories 12 9 Removable protective means.13 10 Environmental conditions 13 11 Not used .13 12 Not used .13 13 General .13 14 Requirements r

21、elated to classification .14 15 Limitation of voltage and/or energy 14 16 Enclosures and protective covers.14 17 Separation 14 18 Protective earthing, functional earthing and potential equalization14 19 Continuous leakage currents and patient auxiliary currents .14 20 Dielectric strength.14 21 Mecha

22、nical strength14 22 Moving parts 15 23 Surfaces, corners and edges .15 24 Stability in normal use 15 25 Expelled parts15 26 Vibration and noise .15 27 Pneumatic and hydraulic power 15 28 Suspended masses.15 29 X-Radiation.16 30 Alpha, beta, gamma, neutron radiation and other particle radiation .16 3

23、1 Microwave radiation16 32 Light radiation (including lasers).16 33 Infrared radiation.16 3 EN ISO 18778:2009 (E) DIN EN ISO 18778:2009-08 34 Ultraviolet energy 16 35 Acoustical energy (including ultrasonics) .16 36 * Electromagnetic Compatibility 16 37 Locations and basic requirements . 16 38 Marki

24、ng and accompanying documents 16 39 Common requirements for category AP and category APG equipment . 17 40 Requirements and tests for category AP equipment, parts and components thereof 17 41 Requirements and tests for category APG equipment, parts and components thereof. 17 42 Excessive temperature

25、s. 17 43 * Fire prevention 17 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility. 18 45 Pressure vessels and parts subject to pressure. 18 46 Human errors 18 47 Electrostatic charges . 19 48 Biocompatibility 19 49 Interruption of the

26、 power supply. 19 50 Accuracy of operating data . 19 51 Protection against hazardous output . 19 52 Abnormal operation and fault conditions 19 53 Environmental tests . 20 54 General. 20 55 Enclosures and covers 20 56 Components and general assembly .20 57 Mains parts, components and layout . 20 58 P

27、rotective earthing Terminals and connections 20 59 Construction and layout 20 101 Additional requirements 21 Annex AA (informative) Rationale 25 Annex BB (informative) Environmental aspects . 28 Annex CC (informative) Index of defined terms 30 Bibliography. 31 Annex ZA (informative) Relationship bet

28、ween this European Standard and the Essential Requirements of EU Directive 93/42/EEC. 32 Foreword 4 DIN EN ISO 18778:2009-08 EN ISO 18778:2009 (E) The text of ISO 18778:2005 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization

29、for Standardization (ISO) and has been taken over as EN ISO 18778:2009 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 tex

30、t or by endorsement, at the latest by October 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 responsibl

31、e for identifying any or all such patent rights. This document supersedes EN ISO 18778:2005. 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 Directive. For relationship with EC

32、Directive, see informative Annex 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, Denma

33、rk, Estonia, Finland, France, 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 18778:2005 has been approve

34、d by CEN as EN ISO 18778:2009 without any modification. Introduction This International Standard specifies requirement for infant monitors (called in previous working documents “infant apnoea monitors” but with a too restrictive scope) which are used to recognize apparent life-threatening events in

35、an infant who is asleep. These devices are for domiciliary use only. This International standard is a Particular Standard 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 general medic

36、al and 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/for hazards and apply to all appli

37、cable equipment, such as medical 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 Definition of Collateral St

38、andard and Particular 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 Standard, for ease

39、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 completely by the te

40、xt of this Particular 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 modified by deleti

41、on 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: clauses, subclauses, tables and figures are numbered starting fr

42、om 101; additional list items are lettered aa), bb), etc. and additional Annexes are lettered AA, BB, etc. The term “this Standard” is used to make reference to the General Standard and this Standard taken together. Where there is no corresponding section, clause or subclause in this Standard, the s

43、ection, clause or subclause of the General Standard, although possibly not relevant, applies without modification, where it is intended that any part of the General Standard, although possibly relevant, is not to be applied, a statement to that effect is given in this Standard. Clauses and subclause

44、s to which there is a rationale are marked with an throughout this International Standard, text for which a rationale is provided in Annex AA is indicated by an asterisk (*). This rationale can be found in the informative Annex AA. 5 EN ISO 18778:2009 (E) DIN EN ISO 18778:2009-08 1 * Scope IEC 60601

45、-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 monitors used to detect apparent life-threatening events1)in sleeping or resting children under three years of age. This In

46、ternational Standard applies to devices used in home care applications. These monitors are generally used without continual professional supervision. This International Standard also applies to the accessories, e.g. probes and cables necessary to apply the monitor to the patient. This International

47、Standard does not apply to monitors intended for use in health care facilities/institutions. The requirements of this International Standard, which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995), are intended to take precedence over the corresponding

48、general requirements. 1.4 Addition: NOTE Planning and design of products complying with this Standard can have environmental impact during the product life cycle. Environmental aspects are addressed in Annex BB. Additional aspects of environmental impact are addressed in ISO 14971. 2 Normative refer

49、ences 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 referenced document (including any amendments) applies. EN 71-1:1998 + A1:2001, Safety of toys Part 1: Mechanical and physical properties EN 980:2003, Graphical symbols for use in the labelling of medical devices EN 1041:1998, Information supplied by the manufacturer with medical devices 1) Referred to as “monitor” througho