{"id":386633,"date":"2024-10-20T03:36:19","date_gmt":"2024-10-20T03:36:19","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iec-80601-2-772021\/"},"modified":"2024-10-26T06:34:59","modified_gmt":"2024-10-26T06:34:59","slug":"bs-en-iec-80601-2-772021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iec-80601-2-772021\/","title":{"rendered":"BS EN IEC 80601-2-77:2021"},"content":{"rendered":"

Clause 1 of the general standard3<\/sup> applies, except as follows:<\/p>\n

201.1.1<\/b> Scope<\/p>\n

Replacement:<\/i><\/p>\n

This part of IEC 80601 applies to the basic safety<\/small> and essential performance<\/small> of robotically assisted surgical equipment<\/small> (rase<\/small>) and robotically assisted surgical systems<\/small> (rass<\/small>), hereafter referred to as me equipment<\/small> and me systems<\/small> together with their interaction conditions<\/small> and interface conditions<\/small>. If a clause or subclause is specifically intended to be applicable to me equipment<\/small> only, or to me systems<\/small> only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to me equipment<\/small> and to me systems<\/small>, as relevant.<\/p>\n

If rase<\/small> or rass<\/small>, or its accessories<\/small> fall within scope of another particular standard, then the particular standard applies in addition to this standard.<\/p>\n

\n

EXAMPLES IEC 60601\u20112\u20112 [3] for hf surgical equipment<\/small>; IEC 60601\u20112\u201118 [4] for endoscopic equipment<\/small>; IEC 60601\u20112\u201122 [5] for laser equipment; IEC 60601\u20112\u201137 [6] for ultrasound equipment; IEC 60601\u20112\u201146 [7] for operating tables, etc.<\/p>\n<\/blockquote>\n

201.1.2<\/b> Object<\/p>\n

Replacement:<\/i><\/p>\n

The object of this particular standard is to establish particular basic safety<\/small> and essential performance<\/small> requirements for robotically assisted surgical equipment<\/small> and robotically assisted surgical systems<\/small>.<\/p>\n

201.1.3<\/b> * Collateral standards<\/p>\n

Addition:<\/i><\/p>\n

This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard.<\/p>\n

IEC 60601\u20111\u20112:2014 and IEC 60601\u20111\u20116:2010 and IEC 60601\u20111\u20116:2010\/AMD1:2013 apply as modified in Clauses 202 and 206 respectively. IEC 60601\u20111\u20113:2008 and IEC 60601\u20111\u20113:2008\/AMD1:2013 [8], IEC 60601\u20111\u20119:2007 and IEC 60601\u20111\u20119:2007\/AMD1:2013 [9], and IEC 60601\u20111\u201111:2015 [10] do not apply.<\/p>\n

201.1.4<\/b> Particular standards<\/p>\n

Replacement:<\/i><\/p>\n

In the IEC 60601 series , particular standards may modify, replace or delete requirements contained in the general standard and collateral standards as appropriate for the particular me equipment<\/small> under consideration, and may add other basic safety<\/small> and essential performance<\/small> requirements.<\/p>\n

A requirement of a particular standard takes priority over the general standard.<\/p>\n

For brevity, IEC 60601\u20111:2005 and IEC 60601\u20111:2005\/AMD1:2012 are referred to in this particular standard as the general standard. Collateral standards are referred to by their document number.<\/p>\n

The numbering of clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix \u201c201\u201d (e.g. 201.1 in this document addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix \u201c20x\u201d, where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the IEC 60601\u20111\u20112 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the IEC 60601\u20111\u20113 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words:<\/p>\n

\u201cReplacement<\/i>\u201d means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this particular standard.<\/p>\n

\u201cAddition<\/i>\u201d means that the text of this particular standard is additional to the requirements of the general standard or applicable collateral standard.<\/p>\n

\u201cAmendment<\/i>\u201d means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this particular standard.<\/p>\n

Subclauses, figures or tables which are additional to those of the general standard are numbered starting from 201.101. However, due to the fact that definitions in the general standard are numbered 3.1 through 3.147, additional definitions in this document are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.<\/p>\n

Subclauses, figures or tables which are additional to those of a collateral standard are numbered starting from 20x, where \u201cx\u201d is the number of the collateral standard, e.g. 202 for IEC 60601\u20111\u20112, 203 for IEC 60601\u20111\u20113 , etc.<\/p>\n

The term \u201cthis document\u201d is used to make reference to the general standard, any applicable collateral standards and this particular standard taken together.<\/p>\n

Where there is no corresponding clause or subclause in this particular standard, the clause or subclause of the general standard or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.<\/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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nundefined <\/td>\n<\/tr>\n
5<\/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>\n201.1 Scope, object and related standards <\/td>\n<\/tr>\n
14<\/td>\n201.2 Normative references <\/td>\n<\/tr>\n
15<\/td>\n201.3 Terms and definitions <\/td>\n<\/tr>\n
18<\/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
19<\/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
21<\/td>\nTable 201.102 \u2013 Colours of indicator lights and their meaning for me equipment <\/td>\n<\/tr>\n
22<\/td>\n201.8 Protection against electrical hazards from me equipment <\/td>\n<\/tr>\n
23<\/td>\n201.9 * Protection against mechanical hazards of me equipment and me systems <\/td>\n<\/tr>\n
26<\/td>\n201.10 Protection against unwanted and excessive radiation hazards
201.11 Protection against excessive temperatures and other hazards <\/td>\n<\/tr>\n
27<\/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
28<\/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
29<\/td>\n206 * Usability <\/td>\n<\/tr>\n
30<\/td>\nAnnexes <\/td>\n<\/tr>\n
31<\/td>\nAnnex D(informative)Symbols on marking
Table 201.D.101 \u2013 Symbols for marking rase or its parts <\/td>\n<\/tr>\n
32<\/td>\nAnnex AA(informative)Particular guidance and rationale <\/td>\n<\/tr>\n
33<\/td>\nFigure 201.AA.101 \u2013 Examples of mechanical interface attachments <\/td>\n<\/tr>\n
35<\/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
37<\/td>\nFigure 201.AA.104 \u2013 Typical essential performance items of rase <\/td>\n<\/tr>\n
41<\/td>\nFigure 201.AA.105 \u2013 Example of risk assessment related to structural component <\/td>\n<\/tr>\n
44<\/td>\nAnnex BB(informative)Equations for the calculation of the overall system stoppingperformance and minimum distances <\/td>\n<\/tr>\n
45<\/td>\nFigure 201.BB.101 \u2013 Relationship between t1 and t2 <\/td>\n<\/tr>\n
46<\/td>\nAnnex CC(informative)Stopping functions of the rase
Table 201.CC.101 \u2013 Different stopping functions <\/td>\n<\/tr>\n
48<\/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
51<\/td>\nAnnex EE(informative)Example of a testing method of the immunity test forhf surgical equipment emissions <\/td>\n<\/tr>\n
54<\/td>\nBibliography <\/td>\n<\/tr>\n
56<\/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
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