{"id":445755,"date":"2024-10-20T08:43:22","date_gmt":"2024-10-20T08:43:22","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-80601-2-122023\/"},"modified":"2024-10-26T16:14:50","modified_gmt":"2024-10-26T16:14:50","slug":"bs-en-iso-80601-2-122023","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-80601-2-122023\/","title":{"rendered":"BS EN ISO 80601-2-12:2023"},"content":{"rendered":"

This document applies to the basic safety and essential performance of a critical care ventilator in combination with its accessories, hereafter referred to as ME equipment: \u00be     intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility; NOTE 2      For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining. NOTE 3      For the purposes of this document, such a critical care ventilator can provide ventilation during transport within a professional healthcare facility (i.e. be a transit-operable ventilator). NOTE 4      A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an emergency medical services environment ventilator. \u00be     intended to be operated by a healthcare professional operator; and \u00be     intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients. A critical care 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 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. NOTE 5     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 6     Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2. This document is not applicable to ME equipment or an ME system operating in a ventilator-operational mode solely intended for patients who are not dependent on artificial ventilation. NOTE 7     A critical care ventilator, when operating in such a ventilator-operational mode, is not considered life-sustaining. This document is not applicable to ME equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility. This document does not specify the requirements for: NOTE 8     See ISO\/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient. \u00be     ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601?2?13; \u00be     ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84; \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 home-care ventilatory support devices, which are given in ISO 80601-2-79 and ISO 80601-2-80; \u00be     obstructive sleep a<\/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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nundefined <\/td>\n<\/tr>\n
35<\/td>\n201. 4.3.101 Additional requirements for essential performance <\/td>\n<\/tr>\n
36<\/td>\n201. 4.3.102 System recovery <\/td>\n<\/tr>\n
37<\/td>\n201. 4.4 Additional requirements for expected service life
201. 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 <\/td>\n<\/tr>\n
38<\/td>\n201. 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
39<\/td>\n201. 5.101 Additional requirements for general requirements for testing of ME equipment
201. 5.101.1 Ventilator test conditions
201. 5.101.2 Gas flowrate and leakage specifications <\/td>\n<\/tr>\n
40<\/td>\n201. 5.101.3 Ventilator testing errors
201. 7.1.101 Information to be supplied by the manufacturer <\/td>\n<\/tr>\n
41<\/td>\n201. 7.2.3 Consult accompanying documents
201. 7.2.4.101 Additional requirements for accessories
201. 7.2.18 External gas source
201. 7.2.101 Additional requirements for marking on the outside of ME equipment or ME equipment parts <\/td>\n<\/tr>\n
42<\/td>\n201. 7.4.3 Units of measurement
201. 7.9.2.1 General <\/td>\n<\/tr>\n
43<\/td>\n201. 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
44<\/td>\n201. 7.9.2.8.101 Additional requirements for start-up procedure
201. 7.9.2.9.101 Additional requirements for operating instructions <\/td>\n<\/tr>\n
45<\/td>\n201. 7.9.2.12 Cleaning, disinfection, and sterilization <\/td>\n<\/tr>\n
46<\/td>\n201. 7.9.2.14.101 Additional requirements for accessories, supplementary equipment, used material
201. 7.9.2.16.101 Additional requirements for reference to the technical description
201. 7.9.3.1.101 Additional general requirements <\/td>\n<\/tr>\n
47<\/td>\n201. 7.9.3.101 Additional requirements for the technical description
201. 9.6.2.1.101 Additional requirements for audible acoustic energy <\/td>\n<\/tr>\n
49<\/td>\n201. 9.101 Additional requirements for suction procedures <\/td>\n<\/tr>\n
51<\/td>\n201. 11.1.2.2 Applied parts not intended to supply heat to a patient <\/td>\n<\/tr>\n
52<\/td>\n201. 11.6.5.101 Additional requirements for ingress of water or particulate matter into ME equipment or ME system
201. 11.6.6 Cleaning and disinfection of ME equipment or ME system <\/td>\n<\/tr>\n
53<\/td>\n201. 11.6.7 Sterilization of ME equipment or ME system
201. 11.7 Biocompatibility of ME equipment and ME systems
201. 11.8.101 Additional requirements for interruption of the power supply\/supply mains to ME equipment <\/td>\n<\/tr>\n
55<\/td>\n201. 12.1.101 Volume-control inflation-type <\/td>\n<\/tr>\n
59<\/td>\n201. 12.1.102 Pressure-control inflation-type <\/td>\n<\/tr>\n
62<\/td>\n201. 12.1.103 Other inflation-types <\/td>\n<\/tr>\n
63<\/td>\n201. 12.1.104 Inspiratory volume monitoring
201. 12.1.105 Response of the ventilator to an increase in set oxygen (O2) concentration <\/td>\n<\/tr>\n
65<\/td>\n201. 12.4 Protection against hazardous output
201. 12.4.101 Oxygen monitor <\/td>\n<\/tr>\n
66<\/td>\n201. 12.4.102 Measurement of airway pressure <\/td>\n<\/tr>\n
67<\/td>\n201. 12.4.103 Measurement of expired volume and low volume alarm conditions
201. 12.4.103.1 Ventilators intended to provide a tidal volume >50 ml <\/td>\n<\/tr>\n
68<\/td>\n201. 12.4.103.2 Ventilators intended to provide a tidal volume \u226450 ml <\/td>\n<\/tr>\n
69<\/td>\n201. 12.4.104 Expiratory end-tidal CO2 monitoring equipment <\/td>\n<\/tr>\n
70<\/td>\n201. 12.4.105 Maximum limited pressure protection device
201. 12.4.106 High airway pressure alarm condition and protection device <\/td>\n<\/tr>\n
71<\/td>\n201. 12.4.107 PEEP alarm conditions
201. 12.4.108 Obstruction alarm condition <\/td>\n<\/tr>\n
72<\/td>\n201. 12.4.109 Disconnection alarm condition <\/td>\n<\/tr>\n
73<\/td>\n201. 12.4.110 Protection against inadvertent setting of high airway pressure
201. 12.101 Protection against accidental or unintentional adjustments <\/td>\n<\/tr>\n
74<\/td>\n201. 13.2.101 Additional specific single fault conditions
201. 13.2.102 Failure of one gas supply to a ventilator
201. 13.2.103 Independence of ventilation control function and related risk control measures <\/td>\n<\/tr>\n
75<\/td>\n201. 13.2.104 Failure of functional connection to a ventilator control or monitoring means
201. 14.1 General <\/td>\n<\/tr>\n
76<\/td>\n201. 14.102 Cybersecurity capabilities of critical care ventilators
201. 15.3.5.101 Additional requirements for rough handling
201. 15.3.5.101.1 Shock and vibration (robustness) <\/td>\n<\/tr>\n
77<\/td>\n201. 15.3.5.101.2 Shock and vibration for a transit-operable ventilator during operation <\/td>\n<\/tr>\n
79<\/td>\n201. 15.4.1 Construction of connectors
201. 15.101 Mode of operation
201. 15.102 Delivered oxygen concentration
201. 15.103 Accessory self-check <\/td>\n<\/tr>\n
80<\/td>\n201. 16.1.101 Additional general requirements for ME systems
201. 16.2 Accompanying documents of an ME system
201. 101.1 Protection against reverse gas leakage <\/td>\n<\/tr>\n
81<\/td>\n201. 101.2 Connection to an inlet
201. 101.2.1 Low-pressure hose assembly
201. 101.2.2 Filter
201. 101.3 VBS connectors
201. 101.3.1 General <\/td>\n<\/tr>\n
82<\/td>\n201. 101.3.2 Other named ports
201. 101.3.2.1 Patient-connection port
201. 101.3.2.2 Gas output port and gas return port
201. 101.3.2.3 Emergency intake
201. 101.3.2.4 Flow-direction-sensitive components <\/td>\n<\/tr>\n
83<\/td>\n201. 101.3.2.5 Gas pathway connection port
201. 101.3.2.6 Gas exhaust port
201. 101.3.2.7 Temperature sensor port <\/td>\n<\/tr>\n
84<\/td>\n201. 101.3.2.8 Gas intake port
201. 102.1 General
201. 102.2 Labelling
201. 102.3 Breathing sets
201. 102.4 Water vapour management <\/td>\n<\/tr>\n
85<\/td>\n201. 102.4.1 Humidification system
201. 102.4.2 Heat and moisture exchanger (HME)
201. 102.6 Breathing system filters
201. 102.7 Ventilator breathing systems
201. 102.7.1 Leakage from complete VBS
201. 102.7.2 Non-invasive ventilation <\/td>\n<\/tr>\n
87<\/td>\n201. 105.1 General
201. 105.2 Connection to an electronic health record
201. 105.3 Connection to a distributed alarm system or distributed information system about alarm conditions
201. 105.4 Connection for remote control
201. 106.1 Pressure-volume loops <\/td>\n<\/tr>\n
88<\/td>\n201. 106.2 Flow-volume loops
201. 107.1 Expiratory pause <\/td>\n<\/tr>\n
89<\/td>\n201. 107.2 Inspiratory pause <\/td>\n<\/tr>\n
90<\/td>\n202.4.3.1 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
91<\/td>\n206.101 Primary operating functions <\/td>\n<\/tr>\n
93<\/td>\n206.102 Training
208.6.3.2.2.2.101 Additional requirements for 1 m (operator\u2019s position) visual alarm signals and information signals
208.6.8.3.101 Additional requirements for global indefinite alarm signal inactivation states
208.6.8.4.101 Additional requirements for termination of alarm signal inactivation <\/td>\n<\/tr>\n
94<\/td>\n208.6.12.2 Operator alarm system logging
208.6.12.3 Responsible organization alarm system logging <\/td>\n<\/tr>\n
96<\/td>\n201.C.101 Marking on the outside of ME equipment, ME systems or their parts
201.C.102 Accompanying documents, general <\/td>\n<\/tr>\n
97<\/td>\n201.C.103 Accompanying documents, instructions for use <\/td>\n<\/tr>\n
100<\/td>\n201.C.104 Accompanying documents, technical description <\/td>\n<\/tr>\n
104<\/td>\nAA.1 General guidance
AA.2 Rationale for particular clauses and subclauses <\/td>\n<\/tr>\n
144<\/td>\nBB.1 Background and purpose <\/td>\n<\/tr>\n
145<\/td>\nBB.2 Data definition <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Medical electrical equipment – Particular requirements for basic safety and essential performance of critical care ventilators<\/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>\n170<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":445765,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[137,2641],"product_tag":[],"class_list":{"0":"post-445755","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-10","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/445755","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\/445765"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=445755"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=445755"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=445755"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}