BS-EN-864-1997 BS-5724-2.30-1997.pdf

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 864 : 1997 BS 5724 : Section 2.30 : 1997 The European Standard EN 864 : 1996 has the status of a British Standard ICS 11.040.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Medical electrical equipment Ð Capnometers for use with humans Ð Particular requirements Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 864 : 1997 This 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 on 15 May 1997 BSI 1997 The following BSI references relate to the work on this standard: Committee reference CH/46 Draft for comment 92/57780 DC ISBN 0 580 27093 9 Amendments 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 Anaesthetists of Great Britain and Ireland Association of British Health-care Industries Association of Paediatric Anaesthetists British Anaesthetic and Respiratory Equipment Manufacturers' Association British Paediatric Association Department of Health Electro Medical Trade Association Limited Institution of Mechanical Engineers Institution of Physics and Engineering in Medicine and Biology Intensive Care Society Safety Equipment Association Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 864 : 1997 BSI 1997i Contents Page Committees responsibleInside front cover National forewordii Foreword2 Text of EN 8643 Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii BSI 1997 BS EN 864 : 1997 National foreword This British Standard has been prepared by Technical Committee CH/46 and is the English language version of EN 864 Medical electrical equipment Ð Capnometers for use with humans Ð Particular requirements, published by the European Committee for Standardization (CEN). It supersedes BS 5724 : Section 2.30 : 1993, which is withdrawn. Cross-references Publication referred toCorresponding British Standard EN 475BS EN 475 : 1995 Medical devices Ð Electrically-generated alarm signals EN 1281-2BS EN 1281 Anaesthetic and respiratory equipment Ð Conical connectors Part 2 : 1996 Screw-threaded, weight-bearing connectors EN 60601-1 : 1990BS 5724 Medical electrical equipment Part 1 : 1989 General requirements for safety EN 60601-1-2BS EN 60601 Medical electrical equipment Part 1 General requirements for safety Section 1.2 : 1993 Collateral standard. Electromagnetic compatibility. Requirements and tests EN ISO 3744BS EN ISO 3744 : 1995 Acoustics Ð Determination of sound power level of noise sources using sound pressure Ð Engineering method in an essentially free field over a reflecting plane IEC 651BS EN 60651 : 1994 Specification for sound level meters IEC 801-2BS EN 60801 Electromagnetic compatibility for industrial-process measurement and control equipment Part 2 : 1993 Electrostatic discharge requirements 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, pages i and ii, the EN title page, pages 2 to 20, an inside back cover and a back cover. Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI CEN European Committee for Standardization Comite  Europe Âen de Normalisation Europa Èisches Komitee fu Èr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1996 Copyright reserved to CEN members Ref. No. EN 864 : 1996 E EUROPEAN STANDARDEN 864 NORME EUROPE ÂENNE EUROPA ÈISCHE NORM October 1996 ICS 11.040.10 Descriptors: electromedical equipment, capnometers, men, safety requirements, accident prevention, detail specifications, protection against electric shocks, protection against mechanical hazard, radiation protection, explosion proofing, fire protection, performance evaluation, tests, marking English version Medical electrical equipment Ð Capnometers for use with humans Ð Particular requirements Appareils e Âlectrome Âdicaux Ð Capnome Átres pour utilisation chez l'homme Ð Prescriptions particulie Áres Medizinische elektrische Gera Ète Ð Kapnometer fu Èr die Anwendung am Menschen Ð Besondere Anforderungen This European Standard was approved on CEN on 1996-09-14. 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. Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 2 EN 864 : 1996 BSI 1997 Foreword This European Standard has been prepared 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 latest by April 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 Directives, see informative annex ZA, which is an integral part of this standard. Annexes AA, BB and ZA are for information only. According to the CEN/CENELEC Internal Regulations, the national standards organizations 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 Introduction3 Section one. General 1Scope4 2Normative references4 3Terminology and definitions4 4General requirements and general requirements for tests6 5Classification6 6Identification, marking and documents6 7Power input7 Section two. Environmental conditions 8Basic safety categories8 9Removable protective means8 10Environmental conditions8 11Not used8 12Not used8 Section three. Protection against electric shock hazards 13General8 14Requirements related to classification8 15Limitation of voltage and/or energy8 Page 16Enclosures and protective covers8 17Separation8 18Protective earthing, functional earthing and potential equalization8 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 26Vibration and noise8 27Pneumatic and hydraulic power9 28Suspended masses9 Section five. Protection against hazards from unwanted or excessive radiation 29X-radiation9 30Alpha, beta, gamma, neutron radiation and other particle radiation9 31Microwave radiation9 32Light radiation (including lasers)9 33Infra-red radiation9 34Ultra-violet radiation9 35Acoustical energy (including ultrasonics)9 36Electromagnetic compatibility9 Section six. Protection against hazards of ignition of flammable anaesthetic mixtures 37Locations and basic requirements10 38Marking and accompanying documents10 39Common requirements for category AP and category APG equipment10 40Requirements and tests for category AP equipment, parts and components thereof10 41Requirements and tests for category APG equipment, parts and components thereof10 Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 3 EN 864 : 1996 BSI 1997 Page Section seven. Protection against excessive temperatures, and other safety hazards 42Excessive temperatures10 43Fire prevention10 44Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility10 45Pressure vessels and parts subject to pressure10 46Human errors10 47Electrostatic charges10 48Biocompatibility10 49Interruption of the power supply10 Section eight. Accuracy of operating data and protection against hazardous output 50Accuracy of operating data11 51Protection against hazardous output13 Section nine. Abnormal operations and fault conditions: Environmental tests 52Abnormal operations and fault conditions14 53Environmental tests14 Section ten. Constructional requirements 54General14 55Enclosures and covers14 56Components and general assembly14 57Mains parts, components and layout14 58Protective earthing Ð terminals and connections14 59Construction and layout14 Section eleven. Additional requirements specific to capnometers 101Determination of interfering gas and vapour effects other than water vapour14 102Sustained pressure14 103Gas leakage14 104Exhaust port14 105Breathing system connections15 Annexes Annex AA (informative) 2 Rationale15 Annex BB (informative) 2 Bibliography16 Annex ZA (informative) 2 Clauses of this European Standard addressing essential requirements or other provisions of EU Directives17 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 requirements 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 figures are numbered beginning 101' and additional tables are numbered beginning 101'. Additional items in lettered lists are lettered beginning aa)' . The measurement of carbon dioxide in a gaseous mixture 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. Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 EN 864 : 1996 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 Standard specifies requirements for the safety of capnometers as defined in 3.6 of this standard. It applies to capnometers used with adults, children, and neonates. It does not apply to devices intended for use as transcutaneous monitors. Capnometers intended for use in laboratory research applications are 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 references, 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. Appendix L of EN 60601-1 : 1990 applies with the following additions: EN 475Medical devices. Electrically-generated alarm signals prEN 737-3Medical gas pipeline systems Ð Part 3: Pipelines for compressed medical gases and vacuum Ð Basic requirements prEN 740 : 1992Medical electrical equipment Ð Anaesthetic workstations and their modules Ð Particular requirements prEN 1281-1Anaesthetic and respiratory equipment Ð Conical connectors Ð Part 1: Cones and sockets EN 1281-2Anaesthetic and respiratory equipment Ð Conical connectors Ð Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2 : 1987 modified) EN 60601-1 : 1990Medical electrical equipment Ð Part 1: General requirements for safety EN 60601-1-2Medical electrical equipment Ð Part 1: General requirements for safety Ð Collateral standard: Electromagnetic compatibility Ð Requirements and tests EN ISO 3744Acoustics Ð Determination of sound power levels of noise sources using sound pressure Ð Engineering method in an essentially freefield over a reflecting plane (ISO 3744 : 1994) IEC 79-4Electrical apparatus for explosive gas atmospheres Ð Part 4: Method of test for ignition temperature IEC 651Sound level meters IEC 801-2Electromagnetic compatibility for industrial-process measurement and control equipment Ð Part 2: Electrostatic discharge requirements 3 Terminology and definitions Clause 2 of EN 60601-1 : 1990 applies with the following additions: 3.1 accuracy Quality which characterizes the ability of a device to give indications approximating to the true value of the quantity measured. 3.2 alarm Signal that is activated when a monitored variable equals or crosses the alarm limit. 3.3 alarm limit Reading of a monitored variable at which the alarm is first activated. 3.4 alarm set point Setting of the adjustment control or display value which indicates the monitored variable's 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 described the same function. 3.5 alarm system Those parts of the capnometer which: a) establish the alarm limit(s); b) activate an alarm when the carbon dioxide reading is less than or equal to the low alarm set point, if provided, or is equal to or greater than the high alarm set point. 3.6 capn