{"id":445864,"date":"2024-10-20T08:43:54","date_gmt":"2024-10-20T08:43:54","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-80601-2-842023\/"},"modified":"2024-10-26T16:15:50","modified_gmt":"2024-10-26T16:15:50","slug":"bs-en-iso-80601-2-842023","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-80601-2-842023\/","title":{"rendered":"BS EN ISO 80601-2-84:2023"},"content":{"rendered":"

This document applies to the basic safety and essential performance of an EMS ventilator in combination with its accessories, hereafter also referred to as ME equipment: \u00be     intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients; \u00be     intended to be operated by a healthcare professional operator; \u00be     intended for use in the EMS environment; and \u00be     intended for invasive or non-invasive ventilation. NOTE 2     An EMS ventilator can also be used for transport within a professional healthcare facility. An EMS ventilator is not considered to use a physiologic closed loop-control system unless it uses a physiological patient variable to adjust the  artificial ventilation therapy settings. This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system, or to an EMS ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the EMS ventilator. NOTE 3     If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601?1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE 4     Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2. This document does not specify the requirements for the following: NOTE 5     See ISO\/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient.  \u00be     ventilators or accessories intended for ventilator-dependent patients in critical care applications, which are given in ISO 80601-2-12. \u00be     ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-2-72. \u00be     ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601?2?13. \u00be     ventilators or accessories intended for ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing patients), which are given in ISO 80601?2-79 and ISO 80601-2-80. \u00be     obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601?2?70. \u00be     user-powered resuscitators, which are given in ISO 10651?4. \u00be     gas-powered emergency resuscitators, which are given in ISO 10651?5. \u00be     continuous positive airway pressure (CPAP) ME equipment. \u00be     high?frequency jet ventilators (HFJVs), which are given in ISO 80601-2-87. \u00be     high?frequency oscillatory ventilators (HFOVs)[44], which are given in ISO 80601-2-87. NOTE 6      An EMS ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilation-modes. \u00be     respiratory high-flow therapy equipment, which are given in ISO 80601-2-90. NOTE 7      An EMS ventilator can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients. \u00be     oxygen therapy constant flow ME equipment. \u00be     cuirass or \u201ciron?lung\u201d ventilators.<\/p>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nundefined <\/td>\n<\/tr>\n
4<\/td>\nEuropean foreword
Endorsement notice <\/td>\n<\/tr>\n
8<\/td>\nForeword <\/td>\n<\/tr>\n
10<\/td>\nIntroduction <\/td>\n<\/tr>\n
11<\/td>\n201. 1 Scope, object and related standards
201. 1.1 Scope <\/td>\n<\/tr>\n
12<\/td>\n201. 1.2 Object
201. 1.3 Collateral standards <\/td>\n<\/tr>\n
13<\/td>\n201. 1.4 Particular standards <\/td>\n<\/tr>\n
14<\/td>\n201. 2 Normative references <\/td>\n<\/tr>\n
15<\/td>\n201. 3 Terms and definitions <\/td>\n<\/tr>\n
33<\/td>\n201. 4 General requirements
201. 4.3 Essential performance
201. 4.3.101 Additional requirements for essential performance
201. 4.3.102 System recovery <\/td>\n<\/tr>\n
34<\/td>\n201. 4.4 Additional requirements for expected service life <\/td>\n<\/tr>\n
35<\/td>\n201. 4.5 Alternative risk control measures or test methods for ME equipment or ME system
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 for medical gas pipeline systems <\/td>\n<\/tr>\n
36<\/td>\n201. 4.11.101.3 Compatibility requirements for pressure regulators
201. 5 General requirements for testing of ME equipment <\/td>\n<\/tr>\n
37<\/td>\n201. 5.101 Additional requirements for general requirements for testing of ME equipment
201. 5.101.1 EMS ventilator test conditions
201. 5.101.2 Gas flowrate and leakage specifications
201. 5.101.3 EMS ventilator testing errors
201. 6 Classification of ME equipment and ME systems <\/td>\n<\/tr>\n
38<\/td>\n201. 7 ME equipment identification, marking and documents
201. 7.1.101 Information to be supplied by the manufacturer
201. 7.2.3 Consult accompanying documents
201. 7.2.4.101 Additional requirements for accessories
201. 7.2.18 External gas source <\/td>\n<\/tr>\n
39<\/td>\n201. 7.2.101 Additional requirements for marking on the outside of ME equipment or ME equipment parts <\/td>\n<\/tr>\n
40<\/td>\n201. 7.4.2 Control devices
201. 7.4.3 Units of measurement
201. 7.4.101 Labelling of units of measurement
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
41<\/td>\n201. 7.9.2.8.101 Additional requirements for start-up procedure <\/td>\n<\/tr>\n
42<\/td>\n201. 7.9.2.9.101 Additional requirements for operating instructions <\/td>\n<\/tr>\n
43<\/td>\n201. 7.9.2.12 Cleaning, disinfection, and sterilization
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
44<\/td>\n201. 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 <\/td>\n<\/tr>\n
45<\/td>\n201. 9.4.4 Grips and other handling devices
201. 9.6.2.1.101 Additional requirements for audible acoustic energy <\/td>\n<\/tr>\n
46<\/td>\n201. 10 Protection against unwanted and excessive radiation hazards
201. 11 Protection against excessive temperatures and other hazards <\/td>\n<\/tr>\n
47<\/td>\n201. 11.1.2.2 Applied parts not intended to supply heat to a patient
201. 11.6.6 Cleaning and disinfection of ME equipment or ME system <\/td>\n<\/tr>\n
48<\/td>\n201. 11.6.7 Sterilization of ME equipment or ME system
201. 11.7 Biocompatibility of ME equipment and ME systems
201. 12 Accuracy of controls and instruments and protection against hazardous outputs
201. 12.1.101 Volume-control inflation-type <\/td>\n<\/tr>\n
52<\/td>\n201. 12.1.102 Pressure-control inflation-type <\/td>\n<\/tr>\n
55<\/td>\n201. 12.1.103 Other inflation-types
201. 12.1.104 Inspiratory volume monitoring equipment
201. 12.4 Protection against hazardous output
201. 12.4.101 Oxygen monitor <\/td>\n<\/tr>\n
56<\/td>\n201. 12.4.102 Measurement of airway pressure <\/td>\n<\/tr>\n
57<\/td>\n201. 12.4.103 Measurement of expired volume and low volume alarm conditions <\/td>\n<\/tr>\n
58<\/td>\n201. 12.4.104 Maximum limited pressure protection device
201. 12.4.105 High airway pressure alarm condition and protection device <\/td>\n<\/tr>\n
60<\/td>\n201. 12.4.106 Expiratory end-tidal CO2 monitoring equipment
201. 12.4.107 Protection against inadvertent setting of high airway pressure
201. 13 Hazardous situations and fault conditions for ME equipment
201. 13.2.101 Additional specific single fault conditions <\/td>\n<\/tr>\n
61<\/td>\n201. 13.102 Failure of one gas supply to an EMS ventilator
201. 13.103 Independence of ventilation control function and related risk control measures <\/td>\n<\/tr>\n
62<\/td>\n201. 14 Programmable electrical medical systems (PEMS)
201. 14.1 General
201. 14.101 Cybersecurity capabilities of EMS ventilators <\/td>\n<\/tr>\n
63<\/td>\n201. 15 Construction of ME equipment
201. 15.3.5.101 Additional requirements for rough handling
201. 15.4.1 Construction of connectors <\/td>\n<\/tr>\n
64<\/td>\n201. 15.101 Mode of operation
201. 15.102 Delivered oxygen concentration
201. 15.103 Accessory self-check
201. 16 ME systems
201. 16.1.101 Additional general requirements for ME systems <\/td>\n<\/tr>\n
65<\/td>\n201. 16.2.101 Additional requirements for power supply
201. 17 Electromagnetic compatibility of ME equipment and ME systems
201. 101 Gas connections
201. 101.1 Protection against reverse gas leakage <\/td>\n<\/tr>\n
66<\/td>\n201. 101.2 Connection to a high-pressure inlet
201. 101.2.1 Low-pressure hose assembly
201. 101.2.2 Filter
201. 101.3 VBS connectors
201. 101.3.1 General
201. 101.3.2 Other named ports
201. 101.3.2.1 Patient-connection port <\/td>\n<\/tr>\n
67<\/td>\n201. 101.3.2.2 Gas output port and gas return port
201. 101.3.2.3 Flow-direction-sensitive components
201. 101.3.2.4 Gas pathway connection port <\/td>\n<\/tr>\n
68<\/td>\n201. 101.3.2.5 Gas exhaust port
201. 101.3.2.6 Gas intake port
201. 102 Requirements for the VBS and accessories
201. 102.1 General
201. 102.2 Labelling <\/td>\n<\/tr>\n
69<\/td>\n201. 102.3 Breathing sets
201. 102.4 Water vapour management
201. 102.4.1 Humidification system
201. 102.4.2 Heat and moisture exchanger (HME)
201. 102.5 Breathing system filters
201. 102.6 Leakage from complete VBS <\/td>\n<\/tr>\n
70<\/td>\n201. 103 Spontaneous breathing during loss of ventilation
201. 104 Indication of duration of operation
201. 105 Functional connection
201. 105.1 General <\/td>\n<\/tr>\n
71<\/td>\n201. 105.2 Connection to an electronic health record
201. 105.3 Connection to a distributed alarm system
201. 106 Display loops
201. 106.1 Pressure-volume loops
201. 106.2 Flow-volume loops
201. 107 Timed ventilatory pause <\/td>\n<\/tr>\n
72<\/td>\n201. 107.1 Expiratory pause
201. 107.2 Inspiratory pause <\/td>\n<\/tr>\n
73<\/td>\n202 Electromagnetic disturbances \u2014 Requirements and tests
202.4.3.1 Compliance criteria
202.5.2.2.1 Requirements applicable to all ME equipment and ME systems
202.8.1.101 Additional general requirements <\/td>\n<\/tr>\n
74<\/td>\n206 Usability
206.101 Primary operating functions <\/td>\n<\/tr>\n
76<\/td>\n206.102 Training
208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
208.6.3.2.2.1 4 m (distant) visual alarm signals <\/td>\n<\/tr>\n
77<\/td>\n208.6.8.3.101 Additional requirements for global indefinite alarm signal inactivation states
208.6.8.4.101 Additional requirements for termination of alarm signal inactivation
208.6.12.3 Responsible organization alarm system logging <\/td>\n<\/tr>\n
78<\/td>\n212 Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
212.4.2.2.1 Continuous operating conditions
212.8.1.1 Ingress of water or particulate matter into ME equipment
212.8.2 Additional requirements for interruption of the power supply to ME equipment and ME system <\/td>\n<\/tr>\n
79<\/td>\n212.8.3 Additional requirements for internal electrical power source for ME equipment
212.10.1.2 Requirements for mechanical strength for fixed or permanently installed ME equipment intended for use in a road ambulance
212.10.1.3 Requirements for mechanical strength for transportable ME equipment <\/td>\n<\/tr>\n
80<\/td>\n212.10.1.4 Requirements for mechanical strength for ME equipment intended for airborne use <\/td>\n<\/tr>\n
81<\/td>\nAnnex C (informative) Guide to marking and labelling requirements for ME equipment and ME systems
201.C.1 Marking on the outside of ME equipment, ME systems or their parts <\/td>\n<\/tr>\n
82<\/td>\n201.C.2 Accompanying documents, general
201.C.3 Accompanying documents, instructions for use <\/td>\n<\/tr>\n
84<\/td>\n201.C.4 Accompanying documents, technical description <\/td>\n<\/tr>\n
86<\/td>\nAnnex D (informative) Symbols on marking <\/td>\n<\/tr>\n
88<\/td>\nAnnex AA (informative) Particular guidance and rationale
AA.1 General guidance
AA.2 Rationale for particular clauses and subclauses <\/td>\n<\/tr>\n
124<\/td>\nAnnex BB (informative) Data interfaces
BB.1 Background and purpose <\/td>\n<\/tr>\n
125<\/td>\nBB.2 Data definition <\/td>\n<\/tr>\n
132<\/td>\nAnnex CC (informative) Reference to the IMDRF essential principles and labelling guidances <\/td>\n<\/tr>\n
136<\/td>\nAnnex DD (informative) Reference to the essential principles <\/td>\n<\/tr>\n
139<\/td>\nBibliography <\/td>\n<\/tr>\n
143<\/td>\nTerminology \u2014 Alphabetized index of defined terms <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Medical electrical equipment – Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2023<\/td>\n150<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":445873,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2641],"product_tag":[],"class_list":{"0":"post-445864","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-bsi","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/445864","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/445873"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=445864"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=445864"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=445864"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}