This document applies to the basic safety and essential performance of ventilatory high-flow therapy equipment, as defined in 201.3.204, hereafter also referred to as ME equipment, in combination with its accessories: – intended for use in the home healthcare environment; – intended for use in professional healthcare facilities; – intended for use by a lay operator or a healthcare professional operator; – intended for use with patients who can breathe spontaneously; – intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, including a patient whose upper airway is bypassed; and EXAMPLE 1 Patients with Type 1 Respiratory Failure, which exhibits a reduction in arterial blood oxygenation or patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high. – not intended for patients who are dependent on artificial ventilation for their life support. NOTE 1 In the home healthcare environment, the supply mains is often not reliable. Ventilatory high-flow therapy equipment is typically composed of four parts: 1) gas sources, – air, and – if needed, oxygen; NOTE 2 Gas sources include medical gas pipeline systems, gas cylinders, oxygen concentrators and ambient air. 2) humidifier; NOTE 3 When dry gas is utilized, a humidifier is typically needed. 3) breathing tube; 4) a patient interface, which is used to deliver gas to the patient; and 5) a flow controller, which is used to select and deliver the desired flow. NOTE 4 The flow controller can be at a fixed rate. NOTE 5 The flowrate range is dependent upon the intended patient population (e.g., neonatal, paediatric and adult patients can require different flowrates). These parts can be combined (e.g., the gas source and humidifier can be combined). Ventilatory highflow therapy equipment interfaces with the patient whose upper airway is intact via a nasal cannula or mask as well as a patient whose upper airway is bypassed via an endotracheal tube, oropharyngeal mask, or tracheostomy. Ventilatory high-flow therapy equipment can be transit-operable. This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilatory high-flow therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory high-flow therapy equipment. EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system. This document does not specify the requirements for: – ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601 2 12; – ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601 2 13; – ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601 2 84; – ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601 2 72; – ventilatory support equipment or accessories intended for ventilatory impairment, which are given in ISO 80601 2 79; – ventilatory support equipment or accessories intended for ventilatory insufficiency, which are given in ISO 80601 2 80; – sleep apnoea therapy ME equipment, which are given in ISO 80601 2 70; – continuous positive airway pressure (CPAP) ME equipment; – high-frequency jet ventilators (HFJVs); – high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601 2 87; and – cuirass or “iron-lung” ventilation equipment. NOTE 4 Ventilatory high-flow therapy equipment can be incorporated into any of the above equipment, in which case those standards would be applicable for those ventilation-modes. This docum…..<\/p>\n
| 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 | Contents <\/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 | ||||||
| 15<\/td>\n | 201. 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 20<\/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 | ||||||
| 21<\/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 | ||||||
| 22<\/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 Respiratory high-flow therapy equipment test conditions 201.5.101.2 * Gas flowrate specifications 201.5.101.3 * Respiratory high-flow therapy equipment testing errors <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 201. 6 Classification of ME equipment and ME systems 201. 7 ME equipment identification, marking and documents 201.7.1.101 Information to be supplied by the manufacturer 201.7.2.4.101 Additional requirements for accessories <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 201. 7.2.18 External gas source 201. 7.4.3 Units of measurement <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 201.7.9.2.1 General 201.7.9.2.1.101 Additional general requirements 201.7.9.2.2.101 * Additional requirements for warnings and safety notices <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 201.7.9.2.8.101 * Additional requirements for start-up procedure 201.7.9.2.9.101 Additional requirements for operating instructions 201.7.9.2.9.101.1 Lay operator operating instructions <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 201.7.9.2.9.101.2 Healthcare professional operator operating instructions 201.7.9.2.12 Cleaning, disinfection and sterilization <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 201.7.9.2.13.101 Additional requirements for maintenance 201.7.9.2.14.101 Additional requirements for accessories, supplementary equipment, used material 201.7.9.3.1.101 * Additional general requirements <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 201.7.9.3.101 Additional requirements for the technical description 201. 8 Protection against electrical hazards from ME equipment 201. 9 Protection against mechanical hazards of ME equipment and ME systems 201.9.4.3.101 Additional requirements for instability from unwanted lateral movement 201.9.4.4 Grips and other handling devices <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 201.9.6.2.1.101 Additional requirements for audible acoustic energy 201. 10 Protection against unwanted and excessive radiation hazards <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | 201. 11 Protection against excessive temperatures and other hazards 201.11.1.2.2 * Applied parts not intended to supply heat to a patient 201.11.2.2.1 Risk of fire in an oxygen rich environment <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | 201.11.6.6 * Cleaning and disinfection of ME equipment or ME system 201.11.6.7 Sterilization of ME equipment or ME system 201. 11.7 Biocompatibility of ME equipment and ME systems <\/td>\n<\/tr>\n | ||||||
| 34<\/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 | ||||||
| 35<\/td>\n | 201.11.8.101.2 Alternative power supply\/supply mains <\/td>\n<\/tr>\n | ||||||
| 36<\/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 Continuous flow breathing-therapy mode 201.12.1.101.1 Flowrate accuracy <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | 201.12.1.101.2 Accuracy of delivered oxygen concentration <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | 201.12.2.101 Usability of ME equipment 201. 12.4 Protection against hazardous output 201.12.4.101 Oxygen monitor <\/td>\n<\/tr>\n | ||||||
| 41<\/td>\n | 201.12.4.102 * Maximum limited pressure protection device 201.12.4.103 Flowrate monitoring <\/td>\n<\/tr>\n | ||||||
| 42<\/td>\n | 201.12.4.104 Obstruction alarm condition <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | 201. 12.101 * Protection against accidental adjustments 201. 13 Hazardous situations and fault conditions for ME equipment 201.13.2.101 * Additional specific single fault conditions 201.13.2.102 * Independence of delivery control function and related risk control measures <\/td>\n<\/tr>\n | ||||||
| 44<\/td>\n | 201.13.2.103 * Failure of one gas supply to respiratory high-flow therapy equipment 201. 14 Programmable electrical medical systems (PEMS) 201. 15 Construction of ME equipment 201. 15.101 Mode of operation <\/td>\n<\/tr>\n | ||||||
| 45<\/td>\n | 201. 15.102 Pre-use check 201. 15.103 Delivered oxygen concentration 201. 16 ME systems <\/td>\n<\/tr>\n | ||||||
| 46<\/td>\n | 201.16.1.101 Additional general requirements for ME systems 201. 16.2 * Accompanying documents of an ME system 201. 17 Electromagnetic compatibility of ME equipment and ME systems 201.101 Gas connections 201. 101.1 Breathing system connectors 201.101.1.1 * General <\/td>\n<\/tr>\n | ||||||
| 47<\/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 Accessory port 201.101.1.2.4 Monitoring probe port <\/td>\n<\/tr>\n | ||||||
| 48<\/td>\n | 201.101.1.2.5 Low-pressure oxygen inlet 201.101.1.2.6 Flow-direction-sensitive components 201.101.1.2.7 Nebulization port 201. 101.2 High-pressure oxygen inlet connector <\/td>\n<\/tr>\n | ||||||
| 49<\/td>\n | 201. 101.3 Gas intake port 201.102 Requirements for the breathing system and accessories 201. 102.1 * General 201. 102.2 Labelling 201. 102.3 Breathing sets <\/td>\n<\/tr>\n | ||||||
| 50<\/td>\n | 201. 102.4 * Humidification system 201. 102.5 Breathing system filter (BSF) 201. 102.6 Airway devices 201.103 * Indication of duration of operation <\/td>\n<\/tr>\n | ||||||
| 51<\/td>\n | 201.104 Functional connection 201. 104.1 General 201. 104.2 * Connection to an electronic health record 201. 104.3 * Connection to a distributed alarm system 201. 104.4 Connection for remote control 201.105 Power supply cords <\/td>\n<\/tr>\n | ||||||
| 52<\/td>\n | 201. 1.3 Collateral standards 201. 1.4 Particular standards <\/td>\n<\/tr>\n | ||||||
| 53<\/td>\n | 206 Usability <\/td>\n<\/tr>\n | ||||||
| 54<\/td>\n | 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems <\/td>\n<\/tr>\n | ||||||
| 55<\/td>\n | 208.6.5.4.2 Selection of default alarm preset 208.6.12.2 * Operator alarm system logging <\/td>\n<\/tr>\n | ||||||
| 56<\/td>\n | 211 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment 211.7.4.7 Additional requirements for cleaning, disinfection and sterilization <\/td>\n<\/tr>\n | ||||||
| 57<\/td>\n | 211.10.1.1 General requirements for mechanical strength Annexes <\/td>\n<\/tr>\n | ||||||
| 58<\/td>\n | 201. 1.3 Collateral standards 201. 1.4 Particular standards <\/td>\n<\/tr>\n | ||||||
| 64<\/td>\n | Annex D (informative) Symbols on marking <\/td>\n<\/tr>\n | ||||||
| 65<\/td>\n | Annex AA (informative) Particular guidance and rationale AA.1 General guidance AA.2 Rationale for particular clauses and subclauses <\/td>\n<\/tr>\n | ||||||
| 79<\/td>\n | Annex BB (informative) Data interface requirements BB.1 Background and purpose <\/td>\n<\/tr>\n | ||||||
| 80<\/td>\n | BB.2 Data definition <\/td>\n<\/tr>\n | ||||||
| 83<\/td>\n | Annex CC (informative) Reference to the IMDRF essential principles and labelling guidances <\/td>\n<\/tr>\n | ||||||
| 86<\/td>\n | Annex DD (informative) Reference to the essential principles <\/td>\n<\/tr>\n | ||||||
| 89<\/td>\n | Annex EE (informative) Reference to the general safety and performance requirements <\/td>\n<\/tr>\n | ||||||
| 92<\/td>\n | Annex FF (informative) Terminology \u2014 Alphabetized index of defined terms <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Medical electrical equipment – Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment<\/b><\/p>\n |