BS EN ISO 80601-2-72:2023 – TC
$280.87
Tracked Changes. Medical electrical equipment – Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
| Published By | Publication Date | Number of Pages |
| BSI | 2023 | 390 |
This document applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as ME equipment: — intended for use in the home healthcare environment; — intended for use by a lay operator; and — intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients. This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system or to a ventilator where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | 30477240 |
| 235 | A-30441458 |
| 236 | undefined |
| 238 | European foreword Endorsement notice |
| 243 | Foreword |
| 245 | Introduction |
| 247 | 201.1 Scope, object, and related standards 201.1.1 Scope |
| 248 | 201.1.2 Object 201.1.3 Collateral standards |
| 249 | 201.1.4 Particular standards 201.2 Normative references |
| 251 | 201.3 Terms and definitions |
| 267 | 201.4 General requirements |
| 268 | Table 201.101 — Distributed essential performance requirements |
| 269 | 201. 4.4 Additional requirements for expected service life |
| 271 | 201.5 General requirements for testing of ME equipment |
| 272 | 201.6 Classification of ME equipment and ME systems 201.7 ME equipment identification, marking, and documents |
| 273 | 201. 7.2.18 Additional requirements for external gas source |
| 281 | 201.8 Protection against electrical hazards from ME equipment 201.9 Protection against mechanical hazards of ME equipment and ME systems |
| 283 | Table 201.102 — Test conditions for acoustic tests 201.10 Protection against unwanted and excessive radiation hazards |
| 284 | 201.11 Protection against excessive temperatures and other hazards Table 201.103 — Examples of permissible combinations of temperature and relative humidity |
| 286 | 201.12 Accuracy of controls and instruments and protection against hazardous outputs |
| 288 | Figure 201.101 — Typical test setup for volume-control and pressure-control inflation-type accuracy |
| 289 | Table 201.104 — Volume-control inflation-type settings |
| 291 | Table 201.105 — Pressure-control inflation-type settings |
| 305 | 201.13 Hazardous situations and fault conditions |
| 307 | 201.14 Programmable electrical medical systems (PEMS) 201.15 Construction of ME equipment |
| 308 | 201.16 ME systems |
| 309 | 201.17 Electromagnetic compatibility of ME equipment and ME systems 201.101 Gas connections |
| 312 | 201. 101.2.2.8 Temperature sensor port 201.102 Requirements for the VBS and accessories |
| 313 | 201.103 Spontaneous breathing during loss of power supply |
| 314 | 201.104 Indication of duration of operation 201.105 Functional connection |
| 315 | 201.106 Display loops 201.107 Ventilator security |
| 316 | 201.108 Oxygen inlet port 202 Electromagnetic disturbances — Requirements and tests |
| 317 | 206 Usability |
| 319 | 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
| 321 | 211 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| 324 | Annex C (informative) Guide to marking and labelling requirements for ME equipment and ME systems Table 201.C.101 — Marking on the outside of a ventilator, its parts or accessories |
| 325 | Table 201.C.102 — Accompanying documents, general Table 201.C.103 — Instructions for use |
| 330 | Table 201.C.104 — Technical description |
| 331 | Annex D (informative) Symbols on marking Table 201.D.2.101 — Additional symbols on marking |
| 333 | Annex AA (informative) Particular guidance and rationale |
| 359 | Annex BB (informative) Data interface requirements |
| 360 | Table BB.101 — Parameters and units of measurement Table BB.102 — Equipment identification |
| 361 | Table BB.103 — Usage monitoring Table BB.104 — Equipment settings |
| 364 | Table BB.105 — Ventilation monitoring |
| 365 | Table BB.106 — Ventilator alarm limits |
| 366 | Table BB.107 — Event information Table BB.108 —Service monitoring |
| 367 | Annex CC (informative) Reference to the IMDRF essential principles and labelling guidances |
| 372 | Annex DD (informative) Reference to the essential principles Table DD.1 — Correspondence between this document and the essential principles |
| 376 | Annex EE (informative) Reference to the general safety and performance requirements |
| 380 | Bibliography |
Related products
-
BS EN ISO 27427:2023 – TC
Tracked Changes. Anaesthetic and respiratory equipment. Nebulizing systems and components Published By Publication Date Number…
-
BS EN ISO 80601-2-12:2023 – TC
Tracked Changes. Medical electrical equipment – Particular requirements for basic safety and essential performance of…
