{"id":277696,"date":"2024-10-19T18:42:08","date_gmt":"2024-10-19T18:42:08","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-80601-2-122011\/"},"modified":"2024-10-25T15:13:14","modified_gmt":"2024-10-25T15:13:14","slug":"bs-en-iso-80601-2-122011","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-80601-2-122011\/","title":{"rendered":"BS EN ISO 80601-2-12:2011"},"content":{"rendered":"

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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
14<\/td>\n201.1 Scope, object and related standards
201.1. 1 Scope <\/td>\n<\/tr>\n
15<\/td>\n201.1. 2 Object
201.1. 3 Collateral standards
201.1. 4 Particular standards <\/td>\n<\/tr>\n
16<\/td>\n201.2 Normative references <\/td>\n<\/tr>\n
19<\/td>\n201.3 Terms and definitions <\/td>\n<\/tr>\n
22<\/td>\n201.4 General requirements
201.4. 3 Essential performance
201.4. 3.101 *\u00a0Additional requirements for essential performance
201.4. 6 *\u00a0Me\u00a0equipment or me\u00a0system parts that contact the patient
201.4. 11.101 *\u00a0Additional requirements for pressurized gas input
201.4. 11.101.1 Overpressure requirement <\/td>\n<\/tr>\n
23<\/td>\n201.4. 11.101.2 Compatibility requirement
201.5 General requirements for testing of me\u00a0equipment
201.5. 101 *\u00a0Additional requirements for general requirements for testing of me\u00a0equipment
201.5. 101.1 Ventilator test conditions <\/td>\n<\/tr>\n
24<\/td>\n201.5. 101.2 *\u00a0Gas flowrate and leakage specifications
201.5. 101.3 *\u00a0Ventilator testing errors
201.6 Classification of me\u00a0equipment and me\u00a0systems
201.7 me\u00a0equipment identification, marking and documents
201.7. 2.3 *\u00a0Consult accompanying documents
201.7. 2.101 Additional requirements for marking on the outside of me\u00a0equipment or me\u00a0equipment parts <\/td>\n<\/tr>\n
25<\/td>\n201.7. 2.4.101 Additional requirements for accessories
201.7. 2.13.101 Additional requirements for physiological effects <\/td>\n<\/tr>\n
26<\/td>\n201.7. 2.17.101 Additional requirements for protective packaging
201.7. 4.3 *\u00a0Unit of measure
201.7. 9.1 Additional general requirements <\/td>\n<\/tr>\n
27<\/td>\n201.7. 9.2.1.101 Additional general requirements
201.7. 9.2.2.101 *\u00a0Additional requirements for warnings and safety notices <\/td>\n<\/tr>\n
28<\/td>\n201.7. 9.2.8.101 *\u00a0Additional requirements for start-up procedure
201.7. 9.2.9.101 *\u00a0Additional requirements for operating instructions <\/td>\n<\/tr>\n
29<\/td>\n201.7. 9.2.12 Cleaning, disinfection, and sterilization
201.7. 9.2.14.101 *\u00a0Additional requirements for accessories, supplementary equipment, used material
201.7. 9.2.16.101 *\u00a0Additional requirements for reference to the technical description
201.7. 9.3.1.101 *\u00a0Additional general requirements <\/td>\n<\/tr>\n
30<\/td>\n201.7. 9.3.101 Additional requirements for the technical description
201.8 Protection against electrical hazards from me\u00a0equipment
201.9 Protection against mechanical hazards of me\u00a0equipment and me\u00a0systems
201.9. 6.2.1.101 Additional requirements for audible acoustic energy <\/td>\n<\/tr>\n
31<\/td>\n201.9. 101 *\u00a0Additional requirements for suction procedures <\/td>\n<\/tr>\n
33<\/td>\n201.10 Protection against unwanted and excessive radiation hazards
201.11 Protection against excessive temperatures and other hazards
201.11. 6.4 Leakage <\/td>\n<\/tr>\n
34<\/td>\n201.11. 6.5.101 *\u00a0Additional requirements for ingress of water or particulate matter into me\u00a0equipment or me\u00a0system
201.11. 6.6 *\u00a0Cleaning and disinfection of me\u00a0equipment or me\u00a0system
201.11. 6.7 Sterilization of me\u00a0equipment or me\u00a0system <\/td>\n<\/tr>\n
35<\/td>\n201.11. 8.101 Additional requirements for interruption of the power supply\/supply\u00a0mains to me\u00a0equipment
201.11. 8.101.1 Technical alarm condition for power supply failure
201.11. 8.101.2 Internal electrical power source or external reserve electrical power source <\/td>\n<\/tr>\n
36<\/td>\n201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.12. 1 *\u00a0Accuracy of controls and instruments
201.12. 1.101 Volume-controlled breath type <\/td>\n<\/tr>\n
39<\/td>\n201.12. 1.102 Pressure-controlled breath type <\/td>\n<\/tr>\n
42<\/td>\n201.12. 1.103 *\u00a0Delivered volume monitoring
201.12. 1.104 *\u00a0Response of the ventilator to an increase in O2 concentration <\/td>\n<\/tr>\n
44<\/td>\n201.12. 4 Protection against hazardous output
201.12. 4.101 Oxygen monitor
201.12. 4.102 *\u00a0Measurement of airway pressure <\/td>\n<\/tr>\n
45<\/td>\n201.12. 4.103 *\u00a0Measurement of expired volume and low-volume alarm conditions
201.12. 4.103.1 Ventilators intended to provide a delivered volume > 50\u00a0ml
201.12. 4.103.2 Ventilators intended to provide a delivered volume u\u00a050\u00a0ml <\/td>\n<\/tr>\n
46<\/td>\n201.12. 4.104 *\u00a0Maximum limited pressure protection device
201.12. 4.105 High-pressure alarm condition and protection device
201.12. 4.106 Peep alarm conditions
201.12. 4.107 *\u00a0Obstruction alarm condition <\/td>\n<\/tr>\n
47<\/td>\n201.12. 4.108 *\u00a0Partial-occlusion alarm condition
201.12. 101 *\u00a0Protection against accidental adjustments
201.13 Hazardous situations and fault conditions
201.13. 2.101 *\u00a0Additional specific single fault conditions <\/td>\n<\/tr>\n
48<\/td>\n201.13. 102 *\u00a0Failure of one gas supply to a ventilator
201.13. 103 *\u00a0Independence of ventilation control function and related risk control measures
201.14 Programmable electrical medical systems (pems)
201.14. 101 Software life cycle
201.15 Construction of me\u00a0equipment
201.15. 3.5.101 Additional requirements for rough handling
201.15. 3.5.101.1 *\u00a0Shock and vibration <\/td>\n<\/tr>\n
49<\/td>\n201.15. 3.5.101.2 *\u00a0Shock and vibration for a mobile ventilator <\/td>\n<\/tr>\n
50<\/td>\n201.15. 101 Mode of operation <\/td>\n<\/tr>\n
51<\/td>\n201.15. 102 Delivered oxygen concentration
201.15. 103 Accessory self-check
201.16 Me\u00a0systems
201.16. 1.101 Additional general requirements for me\u00a0systems
201.17 Electromagnetic compatibility of me\u00a0equipment and me\u00a0systems
201.17. 101 Additional requirements for electromagnetic compatibility of me\u00a0equipment and me\u00a0systems
201.101 Gas connections
201.101. 1 *\u00a0Protection against reverse gas leakage <\/td>\n<\/tr>\n
52<\/td>\n201.101. 2 Connection to the medical gas pipeline system
201.101. 3 Vbs connectors
201.101. 3.1 *\u00a0General
201.101. 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 Manual ventilation port <\/td>\n<\/tr>\n
53<\/td>\n201.101. 3.2.4 Emergency intake port
201.101. 3.2.5 Flow-direction-sensitive components
201.101. 3.2.6 Accessory port
201.101. 3.2.7 Monitoring probe port
201.101. 3.2.8 Gas exhaust port
201.102 Requirements for the vbs and accessories
201.102. 1 *\u00a0General
201.102. 2 Labelling <\/td>\n<\/tr>\n
54<\/td>\n201.102. 3 Breathing tubes
201.102. 4 *\u00a0Water management
201.102. 4.1 Humidification system
201.102. 4.2 Heat and moisture exchanger (hme)
201.102. 5 Gas mixers
201.102. 6 Breathing system filters
201.102. 7 Ventilator breathing systems
201.102. 7.1 Leakage from complete vbs <\/td>\n<\/tr>\n
55<\/td>\n201.102. 7.2 *\u00a0Non-invasive ventilation
201.103 *\u00a0Spontaneous breathing during loss of power supply <\/td>\n<\/tr>\n
56<\/td>\n201.104 *\u00a0Training
201.105 *\u00a0Indication of duration of operation
201.106 Signal input\/output part
201.106. 1 General
201.106. 2 *\u00a0Connection to an electronic health record
201.106. 3 *\u00a0Connection to a distributed alarm system
201.106. 4 *\u00a0Connection for remote control
201.107 Display loops
201.107. 1 Pressure-volume loops <\/td>\n<\/tr>\n
57<\/td>\n201.107. 2 Flow-volume loops
201.108 *\u00a0Timed ventilatory pause
201.108. 1 Expiratory pause
201.108. 2 Inspiratory pause <\/td>\n<\/tr>\n
58<\/td>\n202\u00a0 Medical electrical equipment \u2013 Part 1-2: General requirements for basic safety and essential performance \u2013 Collateral standard: Electromagnetic compatibility \u2013 Requirements and tests
202.6.2.1.10 *\u00a0Compliance criteria <\/td>\n<\/tr>\n
59<\/td>\n206\u00a0 Medical electrical equipment \u2013 Part 1-6: General requirements for basic safety and essential performance \u2013 Collateral Standard: Usability <\/td>\n<\/tr>\n
60<\/td>\n208\u00a0 Medical electrical equipment \u2013 Part 1-8: General requirements for basic safety and essential performance \u2013 Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
208.6.3.3.2.101 *\u00a0Additional requirements for characteristics of alarm condition logging
208.6.8.3.101 Additional requirements for global indefinite alarm signal inactivation states
208.6.8.4.101 *\u00a0Additional requirements for termination of alarm signal inactivation <\/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>\n2013<\/td>\n94<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":277698,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[137,2641],"product_tag":[],"class_list":{"0":"post-277696","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\/277696","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\/277698"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=277696"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=277696"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=277696"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}