BS EN IEC 60601-2-35:2021 – TC
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Tracked Changes. Medical electrical equipment – Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
Published By | Publication Date | Number of Pages |
BSI | 2021 | 196 |
IEC 60601-2-35:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HEATING DEVICES using BLANKETS, PADS or MATTRESSES in medical use, also referred to as ME EQUIPMENT. HEATING DEVICES intended to prewarm a bed are included in the scope of this document. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. If a clause or subclause is specifically intended to be applicable to a specifically defined type of ME EQUIPMENT, as is the case with FORCED AIR DEVICES, then the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document, except in 7.2.13 and 8.4.1 of the general standard. IEC 60601-2-35:2020 does not apply to: – HEATING DEVICES intended for physiotherapy; – INFANT RADIANT WARMERS; for information, see IEC 60601-2-21; – INFANT INCUBATORS; for information, see IEC 60601-2-19; – INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20; – cooling devices. IEC 60601-2-35:2020 cancels and replaces IEC 80601-2-35 published in 2009 and Amendment 1:2016. This edition constitutes a technical revision. IEC 60601-2-35:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.
PDF Catalog
PDF Pages | PDF Title |
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1 | 30447130 |
121 | A-30385668 |
122 | undefined |
125 | Annex ZA(normative)Normative references to international publicationswith their corresponding European publications |
127 | CONTENTS |
129 | FOREWORD |
132 | INTRODUCTION |
133 | 201.1 Scope, object and related standards |
135 | 201.2 Normative references 201.3 Terms and definitions |
136 | Figure 201.101 – Positioning of temperature sensors on the contact surface of the heated area of a heating device(see 201.12.4.101 and 201.12.4.105) |
137 | Figures Figure 201.102 – Example of the positioning of temperature sensors on the contact surface of the heated areas of a heating device havingmore than one separately heated area |
138 | 201.4 General requirements |
139 | 201.5 General requirements for testing me equipment 201.6 Classification of me equipment and me systems 201.7 Me equipment identification, marking and documents Tables Table 201.101 – * Additional essential performance requirements |
143 | 201.8 Protection against electrical hazards from me equipment |
147 | Figure 201.103 – Apparatus for the spark ignition test |
149 | 201.9 Protection against mechanical hazards of me equipment and me systems Figure 201.104 – Ramp for the impact test on pads |
151 | 201.10 Protection against unwanted and excessive radiation hazards 201.11 Protection against excessive temperatures and other hazards Figure 201.105 – Partial covering conditions |
153 | 201.12 Accuracy of controls and instruments and protection against hazardous outputs |
158 | 201.13 Hazardous situations and fault conditions for me equipment |
160 | Figure 201.106 – Method of folding blankets |
162 | Figure 201.107 – Examples of folds |
163 | 201.14 Programmable electrical medical systems (pems) 201.15 Construction of me equipment |
164 | Table 201.102 – Temperature limits in dependency to time |
167 | 201.16 Me systems 201.17 Electromagnetic compatibility of me equipment and me systems Figure 201.108 – Positions of a blanket for the ruck-resistance test |
168 | 202 Electromagnetic disturbances – Requirements and tests 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems 210 * Requirements for the development of physiologic closed-loop controllers |
169 | Annexes Annex D (informative) Symbols on marking |
170 | Annex AA (informative) Particular guidance and rationale Figure AA.1 – Illustration of the main requirements of this document |
182 | Annex BB (normative) Determination of the lagging material |
183 | Annex CC (normative) * Determination of heat transfer towards the patient |
185 | Annex DD (normative) * Determination of heat transfer away from the patient |
186 | Annex EE (normative) Conditions of adequate heat discharge |
187 | Annex FF (normative) Test procedure for maximum contact surface temperature for forced air devices |
189 | Annex GG (normative) Test procedure for maximum contact surface temperature for forced air devices under single fault condition |
190 | Annex HH (normative) Safety test procedure for average contact surface temperature for forced air devices |
191 | Figure HH.1 – Sensor locations – Average contact surface temperature |
192 | Bibliography |
194 | Index of defined terms used in this document |