BS EN ISO 80601-2-74:2021 – TC
$280.87
Tracked Changes. Medical electrical equipment – Particular requirements for basic safety and essential performance of respiratory humidifying equipment
| Published By | Publication Date | Number of Pages |
| BSI | 2021 | 232 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | 30447149 |
| 123 | A-30425917 |
| 124 | undefined |
| 126 | European foreword Endorsement notice |
| 129 | Foreword |
| 131 | Introduction |
| 133 | 201.1 Scope, object and related standards |
| 135 | 201.2 Normative references |
| 137 | 201.3 Terms and definitions |
| 140 | 201.4 General requirements |
| 143 | 201.5 General requirements for testing of ME equipment |
| 144 | 201.6 Classification of ME equipment and ME systems |
| 145 | 201.7 ME equipment identification, marking and documents |
| 152 | 201.8 Protection against electrical hazards form ME equipment 201.9 Protection against mechanical hazards of ME equipment and ME systems |
| 153 | 201.10 Protection against unwanted and excessive radiation hazards 201.11 Protection against excessive temperatures and other hazards |
| 156 | 201.12 Accuracy of controls and instruments and protection against hazardous outputs |
| 162 | 201.13 Hazardous situations and fault conditions for ME Equipment |
| 163 | 201.14 Programmable electrical medical systems (PEMS) |
| 164 | 201.15 Construction of ME equipment 201.16 ME systems 201. 16.2 Accompanying documents of an ME system 201.17 Electromagnetic compatibility of ME equipment and ME systems |
| 165 | 201.101 Breathing system connectors and ports |
| 167 | 201.102 Requirements for the breathing system and accessories |
| 168 | 201.103 Liquid container 201.104 Functional connection |
| 169 | 202 Electromagnetic disturbances — Requirements and tests |
| 170 | 206 Usability |
| 171 | 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems 211 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| 172 | Annex C (informative) Guide to marking and labelling requirements for ME equipment and ME systems |
| 177 | Annex D (informative) Symbols on marking |
| 179 | Annex AA (informative) Particular guidance and rationale |
| 196 | Annex BB (normative) * Determination of the accuracy of the displayed measured gas temperature |
| 198 | Annex CC (normative) * Determination of the humidification output |
| 203 | Annex DD (normative) * Specific enthalpy calculations |
| 205 | Annex EE (normative) Removable temperature sensors and mating ports |
| 209 | Annex FF (normative) * Reference temperature sensor |
| 212 | Annex GG (informative) Saturation vapour pressure |
| 213 | Annex HH (informative) Reference to the IMDRF essential principles and labelling guidances |
| 217 | Annex II (informative) Reference to the essential principles of safety and performance of medical devices in accordance with ISO 16142-1:2016 |
| 220 | Annex JJ (informative) Reference to the general safety and performance requirements |
| 223 | Annex KK (informative) Terminology — Alphabetized index of defined terms |
| 227 | Bibliography |
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BS EN IEC 60601-2-21:2021 – TC
Tracked Changes. Medical electrical equipment – Particular requirements for the basic safety and essential performance…
