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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 865 : 1997 BS 5724
2、: Section 2.201 : 1997 The European Standard EN 865 : 1997 has the status of a British Standard ICS 11.040.50 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Pulse oximeters Particular requirements BS EN 865 : 1997 This British Standard, having been prepared under the directio
3、n of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 July 1997 BSI 1997 The following BSI references relate to the work on this standard: Committee reference CH/46 Draft for comment 92/57781 DC ISBN 0 580 27907 3 Amendment
4、s issued since publication Amd. No.DateText affected Committees responsible for this British Standard The 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 Anaesthe
5、tists of Great Britain and Ireland Association of British Health-care Industries Association of Paediatric Anaesthetists British Anaesthetic and Respiratory Equipment Manufacturers Association Department of Health Electro Medical Trade Association Limited Institution of Mechanical Engineers Institut
6、ion of Physics and Engineering in Medicine and Biology Intensive Care Society Royal College of Paediatrics and Child Health Safety Equipment Association BS EN 865 : 1997 BSI 1997i Contents Page Committees responsibleInside front cover National forewordii Foreword2 Text of EN 8653 ii BSI 1997 BS EN 8
7、65 : 1997 National foreword This British Standard has been prepared by Technical Committee CH/46 and is the English language version of EN 865 Pulse oximeters Particular requirements published by the European Committee for Standardization (CEN). Cross-references Publication referred toCorresponding
8、British Standard EN 475BS EN 475 : 1995 Medical devices. Electrically-generated alarm signals EN 60601-1 : 1990BS 5724 Medical electrical equipment Part 1 : 1989 General requirements for safety EN 60601-1-2 BS EN 60601 Medical electrical equipment Part 1 General requirements for safety Section 1.2 :
9、 1993 Collateral standard. Electromagnetic compatibility Requirements and tests IEC 801-2BS EN 60801 Electromagnetic compatibility for industrial-process measurement and control equipment Part 2 : 1993 Electrostatic discharge requirements The Technical Committee has reviewed the provisions of IEC 79
10、-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 pages This document comprises a front cover, an inside front cover,
11、 pages i and ii, the EN title page, pages 2 to 16, an inside back cover and a back cover. w w w . b z f x w . c o m CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1997 Copyright
12、reserved to CEN members Ref. No. EN 865 : 1997 E EUROPEAN STANDARDEN 865 NORME EUROPE ENNE EUROPA ISCHE NORM April 1997 ICS 11.040.50 Descriptors: Electromedical equipment, pulse oximeters, safety requirements, accident prevention, detail specifications, protection against electric shocks, protectio
13、n against mechanical hazards, radiation protection, explosion protection, fire protection, performance evaluation, tests, markings English version Pulse oximeters Particular requirements Oxyme tres de pouls Prescriptions particulie res Pulsoximeter Besondere Anforderungen This European Standard was
14、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
15、 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 notifi
16、ed 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.
17、 w w w . b z f x w . c o m Page 2 EN 865 : 1997 BSI 1997 Foreword This European Standard has been prepared by Technical Committee 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
18、 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 Associatio
19、n, 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 organi
20、zations of the following countries 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. Contents Page Foreword2 Introduction4
21、Section one. General 1Scope5 2Normative references5 3Terminology and definitions5 4General requirements and general requirements for test6 5Classification6 6Identification marking and documents6 7Power input7 Section two. Environmental conditions 8Basic safety categories7 9Removable protective means
22、7 10Environmental conditions7 11Not used7 12Not used7 Section three. Protection against electric shock hazards 13General7 14Requirements related to classification7 15Limitation of voltage and/or energy7 16Enclosures and protective covers7 17Separation7 18Protective earthing, functional earthing and
23、potential equilization8 19Continuous leakage currents and patient auxiliary currents8 20Dielectric strength8 Section four. Protection against mechanical hazards 21Mechanical strength8 22Moving parts8 23Surfaces, corners and edges8 24Stability in normal use8 25Expelled parts8 26Vibration8 27Pneumatic
24、 and hydraulic power8 28Suspended masses8 Section five. Protection against hazards from unwanted or excessive radiation 29X-radiation8 w w w . b z f x w . c o m Page 3 EN 865 : 1997 BSI 1997 Page 30Alpha, beta, gamma, neutron radiation and other particle radiation8 31Microwave radiation8 32Light rad
25、iation (including lasers)8 33Infra-red radiation8 34Ultra-violet radiation8 35Acoustical energy (including ultrasonics)8 36Electromagnetic compatibility8 Section six. Protection against hazards of ignition of flammable anaesthetic mixtures 37Locations and basic requirements9 38Marking, accompanying
26、documents9 39Common requirements for category AP and category APG equipment9 40Requirements and tests for category AP equipment, parts and components thereof9 41Requirements and tests for category APG equipment, parts and components thereof9 Section seven. Protection against excessive temperatures a
27、nd other safety hazards 42Excessive temperature9 43Fire prevention9 44Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility9 45Pressure vessels and parts subject to pressure9 46Human errors9 47Electrostatic charges9 48Biocompatibility9 49I
28、nterruption of the power suppy9 Section eight. Accuracy of operating data and protection against hazardous output 50Accuracy of operating data10 51Protection against hazardous output10 Section nine. Abnormal operation and fault conditions; environmental tests 52Abnormal operation and fault condition
29、s11 53Environmental tests11 Section ten. Constructional requirements 54General11 Page 55Enclosures and covers11 56Components and general assembly11 57Mains parts, components and layout11 58Protective earthing Terminals and connections11 59Construction and layout11 Section eleven. Additional requirem
30、ents specific to pulse oximeters 101 Pulse amplitude11 Annex AA (informative) Rationale12 Annex BB (informative) Guidance on pulse signals13 Annex CC (informative) Bibliography13 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Dire
31、ctives14 w w w . b z f x w . c o m Page 4 EN 865 : 1997 BSI 1997 Introduction This European Standard is one of a series based on European 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 requi
32、rements of this European Standard take precedence over those of EN 60601-1 : 1990. Clauses and subclauses additional to those in EN 60601-1 : 1990 are numbered beginning 101. Additional annexes are lettered beginning AA. Additional items in lettered lists are lettered beginning aa). The approximate
33、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
34、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
35、. Clauses and subclauses marked with R after their number have corresponding rationales contained in annex AA. w w w . b z f x w . c o m Page 5 EN 865 : 1997 BSI 1997 Section one. General 1 Scope Clause 1 of EN 60601-1 : 1990 applies except that 1.1 is replaced by the following: 1.1 This European St
36、andard 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) ad
37、ult 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 laboratory research applications and bench type oximeters that require a blood sample from the patient are
38、 outside the scope of this standard. 2 Normative references This 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 reference
39、s, subsequent amendments to or revisions of any of these publications apply to this European Standard only when 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 additio
40、ns: EN 475Medical devices Electrically-generated alarm signals EN 60601-1 : 1990Medical electrical equipment Part 1: General requirements for safety (IEC 601-1:1988) EN 60601-1-2Medical electrical equipment Part 1: General requirements for safety Collateral standard: Electromagnetic compatibility Re
41、quirements and tests (IEC 601-1-2:1993) IEC 79-4Electrical apparatus for explosive gas atmospheres Part 4: Method of test for ignition temperature IEC 801-2Electromagnetic compatibility for industrial-process measurement and control equipment Part 2: Electrostatic discharge requirements 3 Terminolog
42、y and definitions For the purposes of this standard, clause 2 of EN 60601-1 : 1990 applies with the following additions. 3.1 alarm Signal that is activated when a monitored variable equals or crosses the alarm limit. 3.2 alarm set point Setting of the adjustment control or display value which indica
43、tes the SpO2reading, 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 system Those parts of the pulse oximeter which: a) establish the alarm set point(s); b) activate an alarm wh
44、en the SpO2is 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 range Range over which SpO2values have been calibrated and validated by appropriate in vivo or in vitro methods. 3.5 default setting; default limits Parameters first a
45、ctive on power up of the device. 3.6 display range Range of SpO2values indicated by the pulse oximeter. 3.7 display update period Intervals between updates of the displayed values. 3.8 fractional saturation That saturation given by the oxyhaemoglobin (O2Hb) divided by the total haemoglobin (Hbtotal)
46、, represented mathematically as: O2Hb Hbtotal 3.9 functional saturation That saturation given by the oxyhaemoglobin divided by the sum of the oxyhaemoglobin and the deoxyhaemoglobin (HHb), represented mathematically as: O2Hb (02Hb + HHb) 3.10 probe Part of the pulse oximeter intended to sense the si
47、gnal from the patient from which the SpO2is derived. 3.11 probe fault Condition including, but not limited to a probe component failure or the disconnection of the probe from either the pulse oximeter, or from the patient. w w w . b z f x w . c o m Page 6 EN 865 : 1997 BSI 1997 3.12 pulse oximeter D
48、evice for determination of saturation of haemoglobin non-invasively from light signals of at least two wavelengths transmitted through or reflected from tissues. NOTE. The measurement principle depends on a changing signal caused by the pulsatile nature of blood flow. 3.13 Sa02 Percent haemoglobin s
49、aturation with oxygen in systemic arteries. 3.14 SpO2 Percent haemoglobin saturation with oxygen, either fractional or functional, as measured by a pulse oximeter and displayed as a percentage. 3.15 Total haemoglobin; Hbtotal Sum of all haemoglobin species including, but not limited to, oxyhaemoglobin, methaemoglobin (Met Hb), deoxyhaemoglobin and carboxyhaemoglobin (COHb). 4 General requirements and general requirements for test 4.1 Modifications to clause 3 of EN 60601-1 : 1990 Clause 3 of EN 60601-1 : 1990 applies with the foll