IEC IEC60601-2-23 Edition 3.0 2011-02 BB INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment- Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment Appareilsélectromedicaux Partie2-23:Exigences particulierespourlasecurite de base et lesperformances essentielles des appareils de surveillance de lapressionpartielle transcutanee IEC 60601-2-23:2011 material IEC IEC 60601-2-23 lice nsed Edition3.02011-02 BR Demo by Thomson Reuters ( INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment- Part 2-23:Particular requirements for the basic safety and essential performance of transcutaneouspartial pressuremonitoringequipment Appareilsélectromedicaux- on Partie2-23:Exigences particulierespourlasecuritede baseet lesperformances essentiellesdesappareils desurveillancedelapressionpartielletranscutanee No further INTERNATIONAL ELECTROTECHNICAL COMMISSION ion COMMISSION ELECTROTECHNIQUE INTERNATIONALE PRICECODE X CODEPRIX 1 is permitted. ICS 11.040.55 ISBN 978-2-88912-370-4 Uncontrolled @ Registered trademark of the International Electrotechnical Commission Marque deposee de la Commission Electrotechnique Internationale 60601-2-23@IEC:2011 -2 CONTENTS FOREWORD. BR INTRODUCTION. 201.1 Scope, object and related standards. by 201.2 Normative references.. 10 201.3 Terms and definitions... ..10 201.4 General requirements .11 201.5 General requirements fortesting of ME EQUIPMENT 201.6 Classification of ME EQUIPMENTand MESYSTEMS. 12 201.7 ME EQUiPMENT identification, marking and documents 201.8 Protection against electrical HAZARDs from ME EQUIPMENT. 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS. ..14 nc 201.10 Protection against unwanted and excessive radiation HAZARDs. .14 201.11 Protection against excessive temperatures and other HAzARDs. 201.12 Accuracy of controls and instruments and protection against hazardous outputs.... ..18 201.13 HAZARDOUS SITUATIONS and fault conditions. 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .23 201.15 Construction of ME EQUIPMENT. ...23 201.16 ME SYSTEMS.. 201.17 Electromagnetic compatibilityofMEEQUIPMENTandMESYSTEMS.. ...24 202 Electromagnetic compatibility-Requirements andtests .. .24 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. ...28 ...34 Annexes Annex AA(informative)Particular guidance and rationale ...35 AnnexBB(informative)AlarmdiagramsofClause208/lEC60601-1-8:2006 ....43 Index of defined terms used in this particular standard.. .46 Figure201.101-TRANSDUCER cablestrain relief test.. 14 Figure201.102-Foam block test (see 201.11.1.2.2.104 and 201.11.1.2.2.105). further Figure 201.103 - Linearity and hysteresis test set-up - Gas mix chamber, assembled.......20 Figure 201.104 -Linearity and hysteresis test set-up -Gas mix chamber, manufacturingdimensions... 21 Figure201.105-Linearity and hysteresis test set-up-Gas mix chamber,dimensions of hose connector.... Figure 202.101-Set-up for radiated and conducted EMissioNs testing according to 202.6.1.1.2 a)........ .25 Figure 202.102 - Set-up for radiated immunity test according to 202.6.2.3.2 Figure BB.1 - NoN-LATCHING ALARM SIGNALS without ALARM RESET .43 Figure BB.2 - NON-LATCHING ALARM SIGNALS with ALARM RESET .43 Figure BB.3 - LATCHING ALARM SIGNALS with ALARM RESET 44 Figure BB.4 -Two ALARM CONDITIONS with ALARM RESE