{"id":439479,"date":"2024-10-20T08:09:18","date_gmt":"2024-10-20T08:09:18","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-80601-2-722023-tc\/"},"modified":"2024-10-26T15:16:35","modified_gmt":"2024-10-26T15:16:35","slug":"bs-en-iso-80601-2-722023-tc","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-80601-2-722023-tc\/","title":{"rendered":"BS EN ISO 80601-2-72:2023 – TC"},"content":{"rendered":"

This document applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as ME equipment: \u2014    intended for use in the home healthcare environment; \u2014    intended for use by a lay operator; and \u2014    intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients. 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.<\/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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\n30477240 <\/td>\n<\/tr>\n
235<\/td>\nA-30441458 <\/td>\n<\/tr>\n
236<\/td>\nundefined <\/td>\n<\/tr>\n
238<\/td>\nEuropean foreword
Endorsement notice <\/td>\n<\/tr>\n
243<\/td>\nForeword <\/td>\n<\/tr>\n
245<\/td>\nIntroduction <\/td>\n<\/tr>\n
247<\/td>\n201.1 Scope, object, and related standards
201.1.1 Scope <\/td>\n<\/tr>\n
248<\/td>\n201.1.2 Object
201.1.3 Collateral standards <\/td>\n<\/tr>\n
249<\/td>\n201.1.4 Particular standards
201.2 Normative references <\/td>\n<\/tr>\n
251<\/td>\n201.3 Terms and definitions <\/td>\n<\/tr>\n
267<\/td>\n201.4 General requirements <\/td>\n<\/tr>\n
268<\/td>\nTable 201.101 \u2014 Distributed essential performance requirements <\/td>\n<\/tr>\n
269<\/td>\n201. 4.4 Additional requirements for expected service life <\/td>\n<\/tr>\n
271<\/td>\n201.5 General requirements for testing of ME equipment <\/td>\n<\/tr>\n
272<\/td>\n201.6 Classification of ME equipment and ME systems
201.7 ME equipment identification, marking, and documents <\/td>\n<\/tr>\n
273<\/td>\n201. 7.2.18 Additional requirements for external gas source <\/td>\n<\/tr>\n
281<\/td>\n201.8 Protection against electrical hazards from ME equipment
201.9 Protection against mechanical hazards of ME equipment and ME systems <\/td>\n<\/tr>\n
283<\/td>\nTable 201.102 \u2014 Test conditions for acoustic tests
201.10 Protection against unwanted and excessive radiation hazards <\/td>\n<\/tr>\n
284<\/td>\n201.11 Protection against excessive temperatures and other hazards
Table 201.103 \u2014 Examples of permissible combinations of temperature and relative humidity <\/td>\n<\/tr>\n
286<\/td>\n201.12 Accuracy of controls and instruments and protection against hazardous outputs <\/td>\n<\/tr>\n
288<\/td>\nFigure 201.101 \u2014 Typical test setup for volume-control and pressure-control inflation-type accuracy <\/td>\n<\/tr>\n
289<\/td>\nTable 201.104 \u2014 Volume-control inflation-type settings <\/td>\n<\/tr>\n
291<\/td>\nTable 201.105 \u2014 Pressure-control inflation-type settings <\/td>\n<\/tr>\n
305<\/td>\n201.13 Hazardous situations and fault conditions <\/td>\n<\/tr>\n
307<\/td>\n201.14 Programmable electrical medical systems (PEMS)
201.15 Construction of ME equipment <\/td>\n<\/tr>\n
308<\/td>\n201.16 ME systems <\/td>\n<\/tr>\n
309<\/td>\n201.17 Electromagnetic compatibility of ME equipment and ME systems
201.101 Gas connections <\/td>\n<\/tr>\n
312<\/td>\n201. 101.2.2.8 Temperature sensor port
201.102 Requirements for the VBS and accessories <\/td>\n<\/tr>\n
313<\/td>\n201.103 Spontaneous breathing during loss of power supply <\/td>\n<\/tr>\n
314<\/td>\n201.104 Indication of duration of operation
201.105 Functional connection <\/td>\n<\/tr>\n
315<\/td>\n201.106 Display loops
201.107 Ventilator security <\/td>\n<\/tr>\n
316<\/td>\n201.108 Oxygen inlet port
202 Electromagnetic disturbances \u2014 Requirements and tests <\/td>\n<\/tr>\n
317<\/td>\n206 Usability <\/td>\n<\/tr>\n
319<\/td>\n208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems <\/td>\n<\/tr>\n
321<\/td>\n211 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment <\/td>\n<\/tr>\n
324<\/td>\nAnnex C (informative) Guide to marking and labelling requirements for ME equipment and ME systems
Table 201.C.101 \u2014 Marking on the outside of a ventilator, its parts or accessories <\/td>\n<\/tr>\n
325<\/td>\nTable 201.C.102 \u2014 Accompanying documents, general
Table 201.C.103 \u2014 Instructions for use <\/td>\n<\/tr>\n
330<\/td>\nTable 201.C.104 \u2014 Technical description <\/td>\n<\/tr>\n
331<\/td>\nAnnex D (informative) Symbols on marking
Table 201.D.2.101 \u2014 Additional symbols on marking <\/td>\n<\/tr>\n
333<\/td>\nAnnex AA (informative) Particular guidance and rationale <\/td>\n<\/tr>\n
359<\/td>\nAnnex BB (informative) Data interface requirements <\/td>\n<\/tr>\n
360<\/td>\nTable BB.101 \u2014 Parameters and units of measurement
Table BB.102 \u2014 Equipment identification <\/td>\n<\/tr>\n
361<\/td>\nTable BB.103 \u2014 Usage monitoring
Table BB.104 \u2014 Equipment settings <\/td>\n<\/tr>\n
364<\/td>\nTable BB.105 \u2014 Ventilation monitoring <\/td>\n<\/tr>\n
365<\/td>\nTable BB.106 \u2014 Ventilator alarm limits <\/td>\n<\/tr>\n
366<\/td>\nTable BB.107 \u2014 Event information
Table BB.108 \u2014Service monitoring <\/td>\n<\/tr>\n
367<\/td>\nAnnex CC (informative) Reference to the IMDRF essential principles and labelling guidances <\/td>\n<\/tr>\n
372<\/td>\nAnnex DD (informative) Reference to the essential principles
Table DD.1 \u2014 Correspondence between this document and the essential principles <\/td>\n<\/tr>\n
376<\/td>\nAnnex EE (informative) Reference to the general safety and performance requirements <\/td>\n<\/tr>\n
380<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Tracked Changes. Medical electrical equipment – Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients<\/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>\n390<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":439488,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[137,2641],"product_tag":[],"class_list":{"0":"post-439479","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\/439479","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\/439488"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=439479"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=439479"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=439479"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}