ANSI/AAMI/ IEC 80601-2- 77:2020 pdf download – Medical electrical equipment—Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment.
201.1 Scope, object and related standards 201.1.1 Scope Replacement: This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT ( RASE ) and ROBOTICALLY ASSISTED SURGICAL SYSTEMS ( RASS ), hereafter referred to as ME EQUIPMENT and ME SYSTEMS together with their INTERACTION CONDITIONS and INTERFACE CONDITIONS . If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS 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 and to ME SYSTEMS , as relevant. If RASE or RASS , or its ACCESSORIES fall within scope of another particular standard, then the particular standard applies in addition to this standard. EXAMPLES IEC 60601-2-2[3] for HF SURGICAL EQUIPMENT ; IEC 60601-2-18[4] for ENDOSCOPIC EQUIPMENT ; IEC 60601-2-22[5] for laser equipment; IEC 60601-2-37[6] for ultrasound equipment; IEC 60601-2-46[7] for operating tables, etc. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for ROBOTICALLY ASSISTED SURGICAL EQUIPMENT and ROBOTICALLY ASSISTED SURGICAL SYSTEMS . 201.1.3 * Collateral standards Addition: 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. IEC 60601-1-2:2014 and IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013 apply as modified in Clauses 202 and 206 respectively. IEC 60601-1-3:2008 and IEC 60601-1-3:2008/AMD1:2013[8], IEC 60601-1-9:2007 and IEC 60601-1-9:2007/AMD1:2013[9], and IEC 60601-1-11:2015[10] do not apply.
For brevity, IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 are referred to in this particular standard as the general standard. Collateral standards are referred to by their document number. The numbering of clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”, 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 60601-1-2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words: “Replacement” means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this particular standard. “Addition” means that the text of this particular standard is additional to the requirements of the general standard or applicable collateral standard. “Amendment” 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. 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. Subclauses, figures or tables which are additional to those of a collateral standard are numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
201.3 Terms and definitions For the purposes of this document, the terms and definitions given in IEC 60601-1:2005, and IEC 60601-1:2005/AMD1:2012 and the following apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses:  IEC Electropedia: available at http://www.electropedia.org/;  ISO Online browsing platform: available at http://www.iso.org/obp. NOTE An index of defined terms is found beginning on page 42. Addition: 201 .3.201 BODY ORIFICE natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma or permanent tracheostomy [SOURCE: GHTF/SG1/N77:2012[11]] 201 .3.202 * CAPACITIVELY COUPLED HF CURRENT unavoidable HIGH FREQUENCY current flowing due to capacitive coupling from the APPLIED PART of HF SURGICAL EQUIPMENT to an another part of the RASE or RASS [SOURCE: IEC 60601-2-18:2009, 201.3.201, modified – Replacement of ” from an ENERGIZED ENDOTHERAPY DEVICE that is the APPLIED PART of HF SURGICAL EQUIPMENT to the ENDOSCOPE ” by ” from the APPLIED PART of HF SURGICAL EQUIPMENT to an another part of the RASE or RASS “.] 201 .3.203 ENDOSCOPIC EQUIPMENT energized endoscope together with its supply unit( S ), as required for its INTENDED USE [SOURCE: IEC 60601-2-18:2009, 201.3.204] 201 .3.204 HIGH FREQUENCY HF frequencies less than 5 MHz and generally greater than 200 kHz [SOURCE: IEC 60601-2-2:2017, 201.3.220]