{"id":277883,"date":"2024-10-19T18:43:10","date_gmt":"2024-10-19T18:43:10","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-80601-2-692014\/"},"modified":"2024-10-25T15:14:41","modified_gmt":"2024-10-25T15:14:41","slug":"bs-en-iso-80601-2-692014","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-80601-2-692014\/","title":{"rendered":"BS EN ISO 80601-2-69:2014"},"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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
4<\/td>\nForeword <\/td>\n<\/tr>\n
5<\/td>\nAnnex ZA (informative) Relationship between this Document and the Essential Requirements of EU Directive 93\/42\/EEC
Table ZA.1 \u2014 Correspondence between this Document and Directive 93\/42\/EEC <\/td>\n<\/tr>\n
7<\/td>\nTable ZA.2 \u2014 Relevant Essential Requirements from Directive 2006\/42\/EC on machinery that are addressed by this European Standard (according to article 3 of amended Directive 93\/42\/EEC) <\/td>\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
17<\/td>\n201.3 Terms and definitions <\/td>\n<\/tr>\n
18<\/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 <\/td>\n<\/tr>\n
19<\/td>\n201.5 General requirements for testing of me\u00a0equipment
201.5. 101 Additional requirements for general requirements for testing of me\u00a0equipment
201.5. 101.1 *\u00a0Me\u00a0equipment testing errors
201.6 Classification of me\u00a0equipment and me\u00a0systems
201.7 Me\u00a0equipment identification, marking and documents
201.7. 1.2 *\u00a0Legibility of markings
201.7. 2.4.101 Additional requirements for accessories
201.7. 2.13.101 Additional requirements for physiological effects <\/td>\n<\/tr>\n
20<\/td>\n201.7. 2.101 Additional requirements for marking on the outside of me\u00a0equipment or me\u00a0equipment parts <\/td>\n<\/tr>\n
25<\/td>\n201.8 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
26<\/td>\n201.10 Protection against unwanted and excessive radiation hazards
201.11 Protection against excessive temperatures and other hazards
201.11. 1 Maximum temperature during normal use
201.11. 1.2.2 Applied parts not intended to supply heat to a patient
201.11. 2.101 *\u00a0Additional requirements for fire prevention <\/td>\n<\/tr>\n
27<\/td>\n201.11. 6.4 Leakage
201.11. 6.6 *\u00a0Cleaning and disinfection of me\u00a0equipment or me\u00a0system <\/td>\n<\/tr>\n
28<\/td>\n201.11. 6.7 Sterilization of me\u00a0equipment or me\u00a0system
201.11. 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 <\/td>\n<\/tr>\n
29<\/td>\n201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.12. 1 Accuracy of controls and instruments
201.12. 1.101 Accuracy of continuous flowrate <\/td>\n<\/tr>\n
30<\/td>\n201.12. 1.102 Accuracy of triggered flowrate
201.12. 1.103 *\u00a0Accuracy of concentration <\/td>\n<\/tr>\n
32<\/td>\n201.12. 1.104 Outlet pressure
201.12. 4 Protection against hazardous output
201.12. 4.4.101 Additional requirements for incorrect output
201.12. 4.4.101.1 Flowrate control
201.12. 4.4.101.2 Indication of start-up period
201.12. 4.102 Low oxygen concentration alarm condition <\/td>\n<\/tr>\n
33<\/td>\n201.12. 4.103 Delivered gas filter
201.13 Hazardous situations and fault conditions
201.13. 2.101 Additional specific single fault conditions
201.14 Programmable electrical medical systems (pems)
201.15 Construction of me\u00a0equipment
201.16 Me\u00a0systems <\/td>\n<\/tr>\n
34<\/td>\n201.16. 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 Outlet connector
201.102 Requirements for parts and accessories
201.102. 1 *\u00a0General
201.102. 2 Labelling <\/td>\n<\/tr>\n
35<\/td>\n201.102. 3 *\u00a0Fire risk reduction in accessories
201.103 Signal input\/output part
201.103. 1 General
201.103. 2 *\u00a0Connection to a distributed alarm system <\/td>\n<\/tr>\n
36<\/td>\n201.103. 3 *\u00a0Connection for remote control
201.104 *\u00a0Indication of duration of operation
201.105 Integrated conserving equipment
202.6.2.1.10 *\u00a0Compliance criteria <\/td>\n<\/tr>\n
37<\/td>\n211.4.2.2 Environmental operating conditions <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Medical electrical equipment – Particular requirements for basic safety and essential performance of oxygen concentrator equipment<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2014<\/td>\n58<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":277887,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[137,2641],"product_tag":[],"class_list":{"0":"post-277883","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\/277883","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\/277887"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=277883"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=277883"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=277883"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}