{"id":278010,"date":"2024-10-19T18:43:50","date_gmt":"2024-10-19T18:43:50","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-iso-80601-2-802018\/"},"modified":"2024-10-25T15:15:37","modified_gmt":"2024-10-25T15:15:37","slug":"bs-iso-80601-2-802018","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-iso-80601-2-802018\/","title":{"rendered":"BS ISO 80601-2-80:2018"},"content":{"rendered":"
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
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2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
13<\/td>\n | 201.1 Scope, object and related standards 201.1.1 * Scope <\/td>\n<\/tr>\n | ||||||
14<\/td>\n | 201.1.2 Object 201.1.3 Collateral standards <\/td>\n<\/tr>\n | ||||||
15<\/td>\n | 201.1.4 Particular standards 201.2 Normative references <\/td>\n<\/tr>\n | ||||||
17<\/td>\n | 201.3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
19<\/td>\n | 201.4 General requirements 201.4.3 Essential performance 201.4.3.101 * Additional requirements for essential performance 201.4.6 * Me equipment or me system parts that contact the patient <\/td>\n<\/tr>\n | ||||||
20<\/td>\n | 201.4.11.101 * Additional requirements for pressurized gas input 201.4.11.101.1 Overpressure requirement 201.4.11.101.2 Compatibility requirement <\/td>\n<\/tr>\n | ||||||
21<\/td>\n | 201.5 General requirements for testing of me equipment 201.5.101 * Additional requirements for the general requirements for testing of me equipment 201.5.101.1 Ventilatory support equipment test conditions 201.5.101.2 * Gas flowrate and leakage specifications 201.5.101.3 * Ventilatory support equipment testing errors <\/td>\n<\/tr>\n | ||||||
22<\/td>\n | 201.6 Classification of me equipment and me systems 201.6.101 * Additional requirements for classification of me equipment and me systems 201.7 Me equipment identification, marking and documents <\/td>\n<\/tr>\n | ||||||
29<\/td>\n | 201.8 Protection against electrical hazards from me equipment 201.9 Protection against mechanical hazards of me equipment and me systems <\/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 <\/td>\n<\/tr>\n | ||||||
32<\/td>\n | 201.11.7 Biocompatiblity of me equipment and me systems <\/td>\n<\/tr>\n | ||||||
33<\/td>\n | 201.11.8 Interruption of the power supply\/supply mains to me equipment 201.11.8.101 Additional requirements for interruption of the power supply\/supply mains to me equipment alarm condition 201.11.8.101.1 Alarm conditions <\/td>\n<\/tr>\n | ||||||
34<\/td>\n | 201.11.8.101.2 Alternative power supply\/supply mains <\/td>\n<\/tr>\n | ||||||
35<\/td>\n | 201.12 Accuracy of controls and instruments and protection against hazardous outputs 201.12.1 Accuracy of controls and instruments 201.12.1.101 Volume-controlled breath type <\/td>\n<\/tr>\n | ||||||
38<\/td>\n | 201.12.1.102 Pressure-controlled breath type <\/td>\n<\/tr>\n | ||||||
40<\/td>\n | 201.12.1.103 Other breath types <\/td>\n<\/tr>\n | ||||||
41<\/td>\n | 201.12.2.101 Usability of me equipment 201.12.4 Protection against hazardous output 201.12.4.101 * Measurement of airway pressure 201.12.4.101.1 General 201.12.4.101.2 Low airway pressure alarm condition <\/td>\n<\/tr>\n | ||||||
42<\/td>\n | 201.12.4.101.3 * High-pressure alarm condition and protection device <\/td>\n<\/tr>\n | ||||||
43<\/td>\n | 201.12.4.102 Measurement of expired volume 201.12.4.103 * Maximum limited pressure protection device 201.12.4.104 Hypoventilation alarm condition 201.12.4.105 * High leakage alarm condition <\/td>\n<\/tr>\n | ||||||
44<\/td>\n | 201.12.4.106 * CO2 rebreathing 201.12.101 * Protection against accidental adjustments <\/td>\n<\/tr>\n | ||||||
45<\/td>\n | 201.13 Hazardous situations and fault conditions for me equipment <\/td>\n<\/tr>\n | ||||||
46<\/td>\n | 201.14 Programmable electrical medical systems (pems) 201.15 Construction of me equipment 201.15.101 Mode of operation 201.15.102 Pre-use check 201.16 Me systems <\/td>\n<\/tr>\n | ||||||
47<\/td>\n | 201.17 Electromagnetic compatibility of me equipment and me systems 201.101 Gas connections 201.101.1 Vbs connectors 201.101.1.1 * General 201.101.1.2 Other named ports 201.101.1.2.1 General 201.101.1.2.2 Patient-connection port 201.101.1.2.3 * Manual ventilation port <\/td>\n<\/tr>\n | ||||||
48<\/td>\n | 201.101.1.2.4 Accessory port 201.101.1.2.5 Monitoring probe port 201.101.1.2.6 Oxygen inlet port 201.101.1.2.7 Flow-direction-sensitive components 201.102 Requirements for the vbs and accessories 201.102.1 * General <\/td>\n<\/tr>\n | ||||||
49<\/td>\n | 201.102.2 Labelling 201.102.3 Breathing sets 201.102.4 * Humidification 201.102.4.1 Humidifier 201.102.4.2 Heat and moisture exchanger (hme) 201.102.5 Breathing system filters (bsf) 201.103 * Spontaneous breathing during loss of power supply <\/td>\n<\/tr>\n | ||||||
50<\/td>\n | 201.104 * Training 201.105 * Indication of duration of operation 201.106 Functional connection 201.106.1 General <\/td>\n<\/tr>\n | ||||||
51<\/td>\n | 201.106.2 * Connection to an electronic health record 201.106.3 * Connection to a distributed alarm system 201.106.4 Connection for remote control 201.107 Display loops 201.107.1 Pressure-volume loops 201.107.2 Flow-volume loops <\/td>\n<\/tr>\n | ||||||
52<\/td>\n | 201.108 Power supply cords 201.109 Ventilatory support equipment security 202 Electromagnetic disturbances \u2014 Requirements and tests <\/td>\n<\/tr>\n | ||||||
53<\/td>\n | 206 Usability <\/td>\n<\/tr>\n | ||||||
55<\/td>\n | 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems <\/td>\n<\/tr>\n | ||||||
56<\/td>\n | 211 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Medical electrical equipment – Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency<\/b><\/p>\n |