{"id":450754,"date":"2024-10-20T09:13:58","date_gmt":"2024-10-20T09:13:58","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iec-60601-2-352021a12024\/"},"modified":"2024-10-26T17:11:52","modified_gmt":"2024-10-26T17:11:52","slug":"bs-en-iec-60601-2-352021a12024","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iec-60601-2-352021a12024\/","title":{"rendered":"BS EN IEC 60601-2-35:2021+A1:2024"},"content":{"rendered":"
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
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2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
5<\/td>\n | Blank Page <\/td>\n<\/tr>\n | ||||||
6<\/td>\n | Annex ZA(normative)Normative references to international publicationswith their corresponding European publications <\/td>\n<\/tr>\n | ||||||
7<\/td>\n | English CONTENTS <\/td>\n<\/tr>\n | ||||||
9<\/td>\n | FOREWORD <\/td>\n<\/tr>\n | ||||||
12<\/td>\n | INTRODUCTION <\/td>\n<\/tr>\n | ||||||
13<\/td>\n | 201.1 Scope, object and related standards <\/td>\n<\/tr>\n | ||||||
15<\/td>\n | 201.2 Normative references 201.3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
16<\/td>\n | Figures Figure 201.101 \u2013 Positioning of temperature sensors on the contact surfaceof the heated area of a heating device(see 201.12.4.101 and 201.12.4.105) <\/td>\n<\/tr>\n | ||||||
17<\/td>\n | Figure 201.102 \u2013 Example of the positioning of temperature sensorson the contact surface of the heated areas of a heating device havingmore than one separately heated area <\/td>\n<\/tr>\n | ||||||
18<\/td>\n | 201.4 General requirements <\/td>\n<\/tr>\n | ||||||
19<\/td>\n | 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 \u2013 * Additional essential performance requirements <\/td>\n<\/tr>\n | ||||||
23<\/td>\n | 201.8 Protection against electrical hazards from me equipment <\/td>\n<\/tr>\n | ||||||
27<\/td>\n | Figure 201.103 \u2013 Apparatus for the spark ignition test <\/td>\n<\/tr>\n | ||||||
29<\/td>\n | 201.9 Protection against mechanical hazards of me equipment and me systems Figure 201.104 \u2013 Ramp for the impact test on pads <\/td>\n<\/tr>\n | ||||||
31<\/td>\n | 201.10 Protection against unwanted and excessive radiation hazards 201.11 Protection against excessive temperatures and other hazards Figure 201.105 \u2013 Partial covering conditions <\/td>\n<\/tr>\n | ||||||
33<\/td>\n | 201.12 Accuracy of controls and instruments and protection against hazardous outputs <\/td>\n<\/tr>\n | ||||||
38<\/td>\n | 201.13 Hazardous situations and fault conditions for me equipment <\/td>\n<\/tr>\n | ||||||
40<\/td>\n | Figure 201.106 \u2013 Method of folding blankets <\/td>\n<\/tr>\n | ||||||
42<\/td>\n | Figure 201.107 \u2013 Examples of folds <\/td>\n<\/tr>\n | ||||||
43<\/td>\n | 201.14 Programmable electrical medical systems (pems) 201.15 Construction of me equipment <\/td>\n<\/tr>\n | ||||||
44<\/td>\n | Table 201.102 \u2013 Temperature limits in dependency to time <\/td>\n<\/tr>\n | ||||||
47<\/td>\n | 201.16 Me systems 201.17 Electromagnetic compatibility of me equipment and me systems Figure 201.108 \u2013 Positions of a blanket for the ruck-resistance test <\/td>\n<\/tr>\n | ||||||
48<\/td>\n | 202 Electromagnetic disturbances \u2013 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 <\/td>\n<\/tr>\n | ||||||
49<\/td>\n | Annexes Annex D(informative)Symbols on marking <\/td>\n<\/tr>\n | ||||||
50<\/td>\n | Annex AA (informative)Particular guidance and rationale Figure AA.1 \u2013 Illustration of the main requirements of this document <\/td>\n<\/tr>\n | ||||||
62<\/td>\n | Annex BB (normative)Determination of the lagging material <\/td>\n<\/tr>\n | ||||||
63<\/td>\n | Annex CC (normative)* Determination of heat transfer towards the patient <\/td>\n<\/tr>\n | ||||||
65<\/td>\n | Annex DD (normative)* Determination of heat transfer away from the patient <\/td>\n<\/tr>\n | ||||||
66<\/td>\n | Annex EE (normative)Conditions of adequate heat discharge <\/td>\n<\/tr>\n | ||||||
67<\/td>\n | Annex FF (normative)Test procedure for maximum contact surface temperature for forced air devices <\/td>\n<\/tr>\n | ||||||
69<\/td>\n | Annex GG (normative)Test procedure for maximum contact surface temperaturefor forced air devices under single fault condition <\/td>\n<\/tr>\n | ||||||
70<\/td>\n | Annex HH (normative)Safety test procedure for average contact surfacetemperature for forced air devices <\/td>\n<\/tr>\n | ||||||
71<\/td>\n | Figure HH.1 \u2013 Sensor locations \u2013 Average contact surface temperature <\/td>\n<\/tr>\n | ||||||
72<\/td>\n | Bibliography <\/td>\n<\/tr>\n | ||||||
74<\/td>\n | Index of defined terms used in this document <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Medical electrical equipment – Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use<\/b><\/p>\n |