{"id":278009,"date":"2024-10-19T18:43:50","date_gmt":"2024-10-19T18:43:50","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-iso-80601-2-792018\/"},"modified":"2024-10-25T15:15:36","modified_gmt":"2024-10-25T15:15:36","slug":"bs-iso-80601-2-792018","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-iso-80601-2-792018\/","title":{"rendered":"BS ISO 80601-2-79:2018"},"content":{"rendered":"
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
---|---|---|---|---|---|---|---|
2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
6<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
8<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
11<\/td>\n | 201.1 Scope, object and related standards 201.1.1 * Scope <\/td>\n<\/tr>\n | ||||||
12<\/td>\n | 201.1.2 Object <\/td>\n<\/tr>\n | ||||||
13<\/td>\n | 201.1.3 Collateral standards 201.1.4 Particular standards <\/td>\n<\/tr>\n | ||||||
14<\/td>\n | 201.2 Normative references <\/td>\n<\/tr>\n | ||||||
16<\/td>\n | 201.3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
17<\/td>\n | 201.4 General requirements 201.4.3 Essential performance <\/td>\n<\/tr>\n | ||||||
18<\/td>\n | 201.4.3.101 * Additional requirements for essential performance 201.4.6 * Me equipment or me system parts that contact the patient 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 | ||||||
19<\/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 | ||||||
20<\/td>\n | 201.6 Classification of me equipment and me systems 201.7 Me equipment identification, marking and documents <\/td>\n<\/tr>\n | ||||||
26<\/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 | ||||||
27<\/td>\n | 201.10 Protection against unwanted and excessive radiation hazards 201.11 Protection against excessive temperatures and other hazards <\/td>\n<\/tr>\n | ||||||
30<\/td>\n | 201.12 Accuracy of controls and instruments and protection against hazardous outputs 201.12.1 Accuracy of controls and instruments <\/td>\n<\/tr>\n | ||||||
31<\/td>\n | 201.12.1.101 Volume-controlled breath type <\/td>\n<\/tr>\n | ||||||
34<\/td>\n | 201.12.1.102 Pressure-controlled breath type <\/td>\n<\/tr>\n | ||||||
36<\/td>\n | 201.12.1.103 Other breath types <\/td>\n<\/tr>\n | ||||||
37<\/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 | ||||||
38<\/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 * CO2 rebreathing <\/td>\n<\/tr>\n | ||||||
39<\/td>\n | 201.12.101 Protection against accidental adjustments <\/td>\n<\/tr>\n | ||||||
40<\/td>\n | 201.13 Hazardous situations and fault conditions for me equipment 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 <\/td>\n<\/tr>\n | ||||||
41<\/td>\n | 201.16 Me systems 201.17 Electromagnetic compatibility of me equipment and me systems 201.101 Gas connections 201.101.1 Vbs connectors 201.101.1.1 * General <\/td>\n<\/tr>\n | ||||||
42<\/td>\n | 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 201.101.1.2.4 Accessory port 201.101.1.2.5 Monitoring probe port <\/td>\n<\/tr>\n | ||||||
43<\/td>\n | 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 201.102.2 Labelling 201.102.3 Breathing sets <\/td>\n<\/tr>\n | ||||||
44<\/td>\n | 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 * Training 201.104 * Indication of duration of operation <\/td>\n<\/tr>\n | ||||||
45<\/td>\n | 201.105 Functional connection 201.105.1 General 201.105.2 * Connection to an electronic health record 201.105.3 Connection for remote control 201.106 Display loops 201.106.1 Pressure-volume loops 201.106.2 Flow-volume loops <\/td>\n<\/tr>\n | ||||||
46<\/td>\n | 201.107 Spontaneous breathing during loss of ventilation 202 Electromagnetic disturbances \u2014 Requirements and tests <\/td>\n<\/tr>\n | ||||||
47<\/td>\n | 206 Usability <\/td>\n<\/tr>\n | ||||||
48<\/td>\n | 211 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment <\/td>\n<\/tr>\n | ||||||
50<\/td>\n | Annex C(informative)Guide to marking and labelling requirements for me equipment and me systems <\/td>\n<\/tr>\n | ||||||
56<\/td>\n | Annex D(informative)Symbols on marking <\/td>\n<\/tr>\n | ||||||
58<\/td>\n | Annex AA(informative)Particular guidance and rationale <\/td>\n<\/tr>\n | ||||||
71<\/td>\n | Annex BB(informative)Data interface requirements <\/td>\n<\/tr>\n | ||||||
77<\/td>\n | Annex CC(informative)Reference to the essential principles <\/td>\n<\/tr>\n | ||||||
81<\/td>\n | Annex DD(informative)Terminology \u2014 Alphabetized index of defined terms <\/td>\n<\/tr>\n | ||||||
85<\/td>\n | Bibliography <\/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 impairment<\/b><\/p>\n |