{"id":379448,"date":"2024-10-20T03:02:28","date_gmt":"2024-10-20T03:02:28","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-iec-80601-2-772019\/"},"modified":"2024-10-26T05:27:22","modified_gmt":"2024-10-26T05:27:22","slug":"bs-iec-80601-2-772019","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-iec-80601-2-772019\/","title":{"rendered":"BS IEC 80601-2-77:2019"},"content":{"rendered":"

IEC 80601-2-77:2019 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL SYSTEMS (RASS), referred to as ME EQUIPMENT and ME SYSTEMS together with their INTERACTION CONDITIONS and INTERFACE CONDITIONS.<\/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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nundefined <\/td>\n<\/tr>\n
4<\/td>\nEnglish
CONTENTS <\/td>\n<\/tr>\n
6<\/td>\nFOREWORD <\/td>\n<\/tr>\n
9<\/td>\nINTRODUCTION <\/td>\n<\/tr>\n
10<\/td>\n201.1 Scope, object and related standards <\/td>\n<\/tr>\n
11<\/td>\n201.2 Normative references <\/td>\n<\/tr>\n
12<\/td>\n201.3 Terms and definitions <\/td>\n<\/tr>\n
15<\/td>\n201.4 General requirements
201.5 General requirements for testing of me equipment
Tables
Table 201.101 \u2013 List of essential performance requirements <\/td>\n<\/tr>\n
16<\/td>\n201.6 Classification of me equipment and me systems
201.7 Me equipment identification, marking and documents
Figures
Figure 201.101 \u2013 Graphic symbol for maximum patient mass and safe working load
Figure 201.102 \u2013 Graphic symbol for mass of mounted part <\/td>\n<\/tr>\n
18<\/td>\nTable 201.102 \u2013 Colours of indicator lights and their meaning for me equipment <\/td>\n<\/tr>\n
19<\/td>\n201.8 Protection against electrical hazards from me equipment <\/td>\n<\/tr>\n
20<\/td>\n201.9 * Protection against mechanical hazards of me equipment and me systems <\/td>\n<\/tr>\n
23<\/td>\n201.10 Protection against unwanted and excessive radiation hazards
201.11 Protection against excessive temperatures and other hazards <\/td>\n<\/tr>\n
24<\/td>\n201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.13 Hazardous situations and fault conditions for me equipment <\/td>\n<\/tr>\n
25<\/td>\n201.14 Programmable electrical medical systems (pems)
201.15 Construction of me equipment
201.16 * Me systems
201.17 * Electromagnetic compatibility of me equipment and me systems
202 Electromagnetic disturbances \u2013 Requirements and tests <\/td>\n<\/tr>\n
26<\/td>\n206 * Usability <\/td>\n<\/tr>\n
27<\/td>\nAnnexes <\/td>\n<\/tr>\n
28<\/td>\nAnnex D(informative)Symbols on marking
Table 201.D.101 \u2013 Symbols for marking rase or its parts <\/td>\n<\/tr>\n
29<\/td>\nAnnex AA(informative)Particular guidance and rationale <\/td>\n<\/tr>\n
30<\/td>\nFigure 201.AA.101 \u2013 Examples of mechanical interface attachments <\/td>\n<\/tr>\n
32<\/td>\nFigure 201.AA.102 \u2013 Example 1 of robotic surgery configuration:a case of laparoscopic rass
Figure 201.AA.103 \u2013 Example 2 of robotic surgery configuration:a case of bone milling rase <\/td>\n<\/tr>\n
34<\/td>\nFigure 201.AA.104 \u2013 Typical essential performance items of rase <\/td>\n<\/tr>\n
38<\/td>\nFigure 201.AA.105 \u2013 Example of risk assessment related to structural component <\/td>\n<\/tr>\n
41<\/td>\nAnnex BB(informative)Equations for the calculation of the overall system stoppingperformance and minimum distances <\/td>\n<\/tr>\n
42<\/td>\nFigure 201.BB.101 \u2013 Relationship between t1 and t2 <\/td>\n<\/tr>\n
43<\/td>\nAnnex CC(informative)Stopping functions of the rase
Table 201.CC.101 \u2013 Different stopping functions <\/td>\n<\/tr>\n
45<\/td>\nAnnex DD(informative)Alternative method to demonstrate structural integrity throughoutthe expected service life of the rase
Table 201.DD.101 \u2013 Alternative to safety factors: life testing <\/td>\n<\/tr>\n
48<\/td>\nAnnex EE(informative)Example of a testing method of the immunity test forhf surgical equipment emissions <\/td>\n<\/tr>\n
51<\/td>\nBibliography <\/td>\n<\/tr>\n
53<\/td>\nIndex of defined terms used in this particular standard <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Medical electrical equipment – Particular requirements for the basic safety and essential performance of robotically assisted surgical 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>\n2021<\/td>\n56<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":379457,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[136,2641],"product_tag":[],"class_list":{"0":"post-379448","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-01","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\/379448","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\/379457"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=379448"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=379448"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=379448"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}