BS EN IEC 80601-2-77:2021

Clause 1 of the general standard³ applies, except as follows:

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.

201.1.4 Particular standards

Replacement:

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 under consideration, and may add other basic safety and essential performance requirements.

A requirement of a particular standard takes priority over the general standard.

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.

The term “this document” is used to make reference to the general standard, any applicable collateral standards and this particular standard taken together.

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.

PDF Catalog

PDF Pages	PDF Title
2	undefined
5	Annex ZA(normative)Normative references to international publicationswith their corresponding European publications
7	English CONTENTS
9	FOREWORD
12	INTRODUCTION
13	201.1 Scope, object and related standards
14	201.2 Normative references
15	201.3 Terms and definitions
18	201.4 General requirements 201.5 General requirements for testing of me equipment Tables Table 201.101 – List of essential performance requirements
19	201.6 Classification of me equipment and me systems 201.7 Me equipment identification, marking and documents Figures Figure 201.101 – Graphic symbol for maximum patient mass and safe working load Figure 201.102 – Graphic symbol for mass of mounted part
21	Table 201.102 – Colours of indicator lights and their meaning for me equipment
22	201.8 Protection against electrical hazards from me equipment
23	201.9 * Protection against mechanical hazards of me equipment and me systems
26	201.10 Protection against unwanted and excessive radiation hazards 201.11 Protection against excessive temperatures and other hazards
27	201.12 Accuracy of controls and instruments and protection against hazardous outputs 201.13 Hazardous situations and fault conditions for me equipment
28	201.14 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 – Requirements and tests
29	206 * Usability
30	Annexes
31	Annex D(informative)Symbols on marking Table 201.D.101 – Symbols for marking rase or its parts
32	Annex AA(informative)Particular guidance and rationale
33	Figure 201.AA.101 – Examples of mechanical interface attachments
35	Figure 201.AA.102 – Example 1 of robotic surgery configuration:a case of laparoscopic rass Figure 201.AA.103 – Example 2 of robotic surgery configuration:a case of bone milling rase
37	Figure 201.AA.104 – Typical essential performance items of rase
41	Figure 201.AA.105 – Example of risk assessment related to structural component
44	Annex BB(informative)Equations for the calculation of the overall system stoppingperformance and minimum distances
45	Figure 201.BB.101 – Relationship between t1 and t2
46	Annex CC(informative)Stopping functions of the rase Table 201.CC.101 – Different stopping functions
48	Annex DD(informative)Alternative method to demonstrate structural integrity throughoutthe expected service life of the rase Table 201.DD.101 – Alternative to safety factors: life testing
51	Annex EE(informative)Example of a testing method of the immunity test forhf surgical equipment emissions
54	Bibliography
56	Index of defined terms used in this particular standard

Status	Withdrawn
Title	Medical electrical equipment – Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
Corrects	BS IEC 80601-2-77:2019
Publisher	BSI
Committee	CH/62/4
Pages	58
Publication Date	2021-10-14
Withdrawn Date	2024-01-02
ISBN	978 0 539 19525 5
Standard Number	BS EN IEC 80601-2-77:2021
Identical National Standard Of	EN IEC 80601-2-77:2021, IEC 80601-2-77:2019
Descriptors	Surgical equipment, Medical equipment, Performance, Safety, Medical electrical equipment
ICS Codes	11.040.30 - Surgical instruments and materials