{"id":450846,"date":"2024-10-20T09:14:33","date_gmt":"2024-10-20T09:14:33","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iec-80601-2-772021a12023\/"},"modified":"2024-10-26T17:13:03","modified_gmt":"2024-10-26T17:13:03","slug":"bs-en-iec-80601-2-772021a12023","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iec-80601-2-772021a12023\/","title":{"rendered":"BS EN IEC 80601-2-77:2021+A1:2023"},"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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nundefined <\/td>\n<\/tr>\n
5<\/td>\nBlank Page <\/td>\n<\/tr>\n
6<\/td>\nAnnex ZA(normative)Normative references to international publicationswith their corresponding European publications <\/td>\n<\/tr>\n
7<\/td>\nEnglish
CONTENTS <\/td>\n<\/tr>\n
9<\/td>\nFOREWORD <\/td>\n<\/tr>\n
12<\/td>\nINTRODUCTION <\/td>\n<\/tr>\n
13<\/td>\nINTRODUCTION to Amendment 1 <\/td>\n<\/tr>\n
14<\/td>\n201.1 Scope, object and related standards <\/td>\n<\/tr>\n
16<\/td>\n201.2 Normative references
201.3 Terms and definitions <\/td>\n<\/tr>\n
19<\/td>\n201.4 General requirements
Tables
Table 201.101 \u2013 List of essential performance requirements <\/td>\n<\/tr>\n
20<\/td>\n201.5 General requirements for testing of me equipment
201.6 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 <\/td>\n<\/tr>\n
21<\/td>\nFigure 201.102 \u2013 Graphic symbol for mass of mounted part <\/td>\n<\/tr>\n
22<\/td>\nTable 201.102 \u2013 Colours and meanings of indicator lights for rase and rass <\/td>\n<\/tr>\n
23<\/td>\n201.8 Protection against electrical hazards from me equipment <\/td>\n<\/tr>\n
24<\/td>\n201.9 * Protection against mechanical hazards of me equipment and me systems <\/td>\n<\/tr>\n
27<\/td>\n201.10 Protection against unwanted and excessive radiation hazards
201.11 Protection against excessive temperatures and other hazards <\/td>\n<\/tr>\n
28<\/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
29<\/td>\n201.14 Programmable electrical medical systems (pems)
201.15 Construction of me equipment
201.16 * Me systems <\/td>\n<\/tr>\n
30<\/td>\n201.17 * Electromagnetic compatibility of me equipment and me systems
202 Electromagnetic disturbances \u2013 Requirements and tests
206 * Usability <\/td>\n<\/tr>\n
32<\/td>\nAnnexes <\/td>\n<\/tr>\n
33<\/td>\nAnnex D (informative) Symbols on marking
Table 201.D.101 \u2013 Symbols for marking rase or its parts <\/td>\n<\/tr>\n
34<\/td>\nAnnex AA (informative) Particular guidance and rationale <\/td>\n<\/tr>\n
35<\/td>\nFigure 201.AA.101 \u2013 Examples of mechanical interface attachments <\/td>\n<\/tr>\n
37<\/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
39<\/td>\nFigure 201.AA.104 \u2013 Typical essential performance items of rase <\/td>\n<\/tr>\n
43<\/td>\nFigure 201.AA.105 \u2013 Example of risk assessment related to structural component <\/td>\n<\/tr>\n
46<\/td>\nAnnex BB (informative) Equations for the calculation of the overall system stopping performance and minimum distances <\/td>\n<\/tr>\n
47<\/td>\nFigure 201.BB.101 \u2013 Relationship between t1 and t2 <\/td>\n<\/tr>\n
48<\/td>\nAnnex CC (informative) Stopping functions of the rase
Table 201.CC.101 \u2013 Different stopping functions <\/td>\n<\/tr>\n
50<\/td>\nAnnex DD (informative) Alternative method to demonstrate structural integrity throughout the expected service life of the rase
Table 201.DD.101 \u2013 Alternative to safety factors: life testing <\/td>\n<\/tr>\n
53<\/td>\nAnnex EE (informative) Example of a testing method of the immunity test forhf surgical equipment emissions <\/td>\n<\/tr>\n
56<\/td>\nBibliography <\/td>\n<\/tr>\n
58<\/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>\n2024<\/td>\n62<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":450856,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[140,2641],"product_tag":[],"class_list":{"0":"post-450846","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-30","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\/450846","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\/450856"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=450846"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=450846"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=450846"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}