【BS英国标准】BS EN 8651997 pulse oximetersparticular requirements.doc

BRITISH STANDARDPulse oximeters Ð Particular requirementsThe European Standard EN 865 : 1997 has the status of aBritish StandardICS 11.040.50| BS EN865 : 1997| BS 5724 :| Section 2.201 :1997|NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN 865 : 1997Committees responsible for thisBritish StandardThe preparation of this British Standard was entrusted to Technical Committee CH/46, Lung ventilators and related equipment, upon which the following bodies were represented:Association of Anaesthetists of Great Britain and IrelandAssociation of British Health-care IndustriesAssociation of Paediatric AnaesthetistsBritish Anaesthetic and Respiratory Equipment Manufacturers' AssociationDepartment of HealthElectro Medical Trade Association LimitedInstitution of Mechanical EngineersInstitution of Physics and Engineering in Medicine and BiologyIntensive Care SocietyRoyal College of Paediatrics and Child HealthSafety Equipment AssociationThis British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on15 July 1997BSI 1997The following BSI references relate to the work on this standard:Committee reference CH/46Draft for comment 92/57781 DCISBN 0 580 27907 3Amd. No.DateText affectedAmendments issued since publicationBS EN 865 : 1997ContentsPage Committees responsible Inside front cover National foreword ii Foreword 2Text of EN 8653BSI 1997iBS EN 865 : 1997National forewordThis British Standard has been prepared by Technical Committee CH/46 and is the English language version of EN 865 Pulse oximeters Ð Particular requirements published by the European Committee for Standardization (CEN).Cross-referencesPublication referred to Corresponding British StandardEN 475BS EN 475 : 1995 Medical devices. Electrically-generated alarm signalsEN 60601-1 : 1990BS 5724 Medical electrical equipmentPart 1 : 1989 General requirements for safetyBS EN 60601 Medical electrical equipmentiiBSI 1997EN 60601-1-2Part 1 General requirements for safetySection 1.2 : 1993 Collateral standard. Electromagnetic compatibility Ð Requirements and testsIEC 801-2BS EN 60801 Electromagnetic compatibility for industrial-process measurement and control equipment Part 2 : 1993 Electrostatic discharge requirementsThe Technical Committee has reviewed the provisions of IEC 79-4, to which reference is made in the text, and has decided that they are acceptable for use in conjunction with this standard.Compliance with a British Standard does not of itself confer immunity from legal obligations.Summary of pagesThis document comprises a front cover, an inside front cover, pages i and ii, the ENtitle page, pages 2 to 16, an inside back cover and a back cover.EUROPEAN STANDARDEN 865NORME EUROPE ENNEEUROPAÈ ISCHE NORMApril 1997ICS 11.040.50Descriptors: Electromedical equipment, pulse oximeters, safety requirements, accident prevention, detail specifications, protection against electric shocks, protection against mechanical hazards, radiation protection, explosion protection, fire protection, performance evaluation, tests, markingsEnglish versionPulse oximeters Ð Particular requirementsOxymeÁ tres de pouls Ð Prescriptions particulieÁ resPulsoximeter Ð Besondere AnforderungenThis European Standard was approved by CEN on 1997-01-17. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.CENEuropean Committee for Standardization Comite Europe en de Normalisation EuropaÈ isches Komitee fuÈ r NormungCentral Secretariat: rue de Stassart 36, B-1050 Brussels1997 Copyright reserved to CEN membersRef. No. EN 865 : 1997 EPage 9EN 865 : 1997BSI 1997ForewordThis European Standard has been prepared byTechnical Committee TC 215, Respiratory andContentsPageanaesthetic 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 latest by August 1997, and conflicting national standards shall be withdrawn at the latest by June 1998.This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s).For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this standard.Annexes AA, BB, CC and ZA are for information only. According to the CEN/CENELEC Internal Regulations,the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.Foreword 2Introduction 4Section one. General1 Scope 52 Normative references 53 Terminology and definitions 54 General requirements and generalrequirements for test 65 Classification 66 Identification marking and documents 67 Power input 7Section two. Environmental conditions8 Basic safety categories 79 Removable protective means 710 Environmental conditions 711 Not used 712 Not used 7Section three. Protection against electric shock hazards13General714Requirements related to classification715Limitation of voltage and/or energy716Enclosures and protective covers717Separation718Protective earthing, functional earthing and potential equilization819Continuous leakage currents and patient auxiliary currents820Dielectric strength8Section four. Protection againstmechanical hazards21 Mechanical strength 822 Moving parts 823 Surfaces, corners and edges 824 Stability in normal use 825 Expelled parts 826 Vibration 827 Pneumatic and hydraulic power 828 Suspended masses 8Section five. Protection against hazards from unwanted or excessive radiation29 X-radiation 830 Alpha, beta, gamma, neutron radiationPagePage55 Enclosures and covers 11and other particle radiation 831 Microwave radiation 832 Light radiation (including lasers) 833 Infra-red radiation 834 Ultra-violet radiation 835 Acoustical energy (includingultrasonics) 836 Electromagnetic compatibility8Section six. Protection against hazards of ignition of flammable anaesthetic mixtures56Components and general assembly1157Mains parts, components and layout1158Protective earthing ± Terminals and connections1159Construction and layout11Section eleven. Additional requirements specific to pulse oximeters101 Pulse amplitude 11Annex AA (informative) Rationale 12Annex BB (informative) Guidance on pulse signals 13Annex CC (informative) Bibliography 13Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives 1437Locations and basic requirements938Marking, accompanying documents939Common requirements for categoryAP and category APG equipment940Requirements and tests for category AP equipment, parts and components thereof941Requirements and tests for category APG equipment, parts and components thereof9Section seven. Protection against excessive temperatures and other safety hazards42Excessive temperature943Fire prevention944Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility945Pressure vessels and parts subject to pressure946Human errors947Electrostatic charges948Biocompatibility949Interruption of the power suppy9Section eight. Accuracy of operating data andprotection against hazardous output50 Accuracy of operating data 1051 Protection against hazardous output 10Section nine. Abnormal operation and fault conditions; environmental tests52Abnormal operation and faultconditions1153Environmental tests11Section ten. Constructional requirements54 General 11IntroductionThis European Standard is one of a series based onEuropean Standard EN 60601-1 : 1990.In EN 60601-1 this type of European Standard is referred to as a Particular Standard'. As stated in 1.3 of EN 60601-1 : 1990, the requirements of this European Standard take precedence over those ofEN 60601-1 : 1990. Clauses and subclauses additional to those in EN 60601-1 : 1990 are numbered beginning101'. Additional annexes are lettered beginning AA'. Additional items in lettered lists are lettered beginningaa)'.The approximate measurement of haemoglobin saturation through the use of pulse oximetry has become an increasingly common practice in many areas of clinical medicine, such as anaesthesia,respiratory therapy, paediatrics, and intensive care. The minimum safety requirements given in this European Standard are based on parameters that are achievable within the limits of existing technology.Annex AA contains a rationale for the most important requirements. It is included to provide additional insight into the reasoning that led to the requirements and recommendations that have been incorporated in this standard. Clauses and subclauses marked with R after their number have corresponding rationales contained in annex AA.Section one. General1 ScopeClause 1 of EN 60601-1 : 1990 applies except that 1.1 is replaced by the following:1.1 This European Standard specifies requirements for the safety of pulse oximeters, as defined in 3.12 of this standard, intended for use in the approximate measurement of the saturation of human arterial haemoglobin, non-invasively.The field of application includes, but is not limited to:a) perioperative use;b) adult critical care application;c) paediatric and neonatal applications;d) general determination of saturation on hospitalized and non-hospitalized patients. Pulse oximeters intended for use in laboratoryresearch applications and bench' type oximeters thatrequire a blood sample from the patient are outside the scope of this standard.2 Normative referencesThis European Standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard onlywhen incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies:Annex L of EN 60601 : 1990 applies with the following additions:EN 475Medical devices Ð Electrically-generated alarm signalsEN 60601-1 : 1990 Medical electrical equipment Part 1: General requirements for safety (IEC 601-1:1988)EN 60601-1-2Medical electrical equipment Part 1: General requirements for safety Ð Collateral standard: Electromagnetic compatibility Ð Requirements and tests(IEC 601-1-2:1993)IEC 79-4Electrical apparatus for explosive gas atmospheres ÐPart 4: Method of test for ignition temperatureIEC 801-2Electromagnetic compatibility for industrial-process measurement and control equipment ÐPart 2: Electrostatic discharge requirements3 Terminology and definitionsFor the purposes of this standard, clause 2 ofEN 60601-1 : 1990 applies with the following additions.3.1 alarmSignal that is activated when a monitored variable equals or crosses the alarm limit.3.2 alarm set pointSetting of the adjustment control or display value which indicates the SpO2 reading, at or beyond which the alarm is intended to be activated.NOTE. Terms such as alarm limits' or alarm threshold' are frequently used to describe the same function.3.3 alarm systemThose parts of the pulse oximeter which:a) establish the alarm set point(s);b) activate an alarm when the SpO2 is less than or equal to the low alarm set point or is equal to or greater than the high alarm set point.3.4 calibration rangeRange over which SpO2 values have been calibrated and validated by appropriate in vivo or in vitro methods.3.5 default setting; default limitsParameters first active on power up of the device.3.6 display rangeRange of SpO2 values indicated by the pulse oximeter.3.7 display update periodIntervals between updates of the displayed values.3.8 fractional saturationThat saturation given by the oxyhaemoglobin (O2Hb) divided by the total haemoglobin (H