oSIST prEN IEC 80601-2-77:2026

Medizinische elektrische Geräte - Teil 2-77: Besondere Festlegungen an die Sicherheit, einschließlich der wesentlichen Leistungsmerkmale von durch Roboter unterstützte Chirurgiegeräte

Appareils électromédicaux - Partie 2-77: Exigences particulières pour la sécurité de base et les performances essentielles des appareils chirurgicaux robotiquement assistés

Medicinska električna oprema - 2-77. del: Posebne zahteve za osnovno varnost in bistvene lastnosti robotsko podprte kirurške opreme

General Information

• Status: Not Published
• Public Enquiry End Date: 31-Jul-2026
• ICS: 11.040.01 - Medical equipment in general
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 09-Jun-2026
• Due Date: 27-Oct-2026
• Ref Project: prEN IEC 80601-2-77:2026 - Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

Relations

• Revises: SIST EN IEC 80601-2-77:2021/A1:2024 - Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment (IEC 80601-2-77:2019/AMD1:2023)
• Effective Date: 06-Aug-2024
• Revises: SIST EN IEC 80601-2-77:2021 - Medical Electrical Equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment (IEC 80601-2-77:2019)
• Effective Date: 06-Aug-2024

Overview

oSIST prEN IEC 80601-2-77:2026 sets out particular requirements for the basic safety and essential performance of robotically assisted surgical equipment (RASE) and robotically assisted surgical systems (RASS). This international standard, developed by the Slovenian Institute for Standardization (SIST) in alignment with IEC and ISO committees, focuses exclusively on medical electrical equipment designed to assist in surgical procedures through robotic technology. Its aim is to address the unique safety, integrity, and performance considerations of robotic surgical devices, reflecting the rapid evolution of the medical robotics field.

Key Topics

• Basic Safety and Essential Performance
  Guidelines ensure RASE and RASS operate safely and perform according to their intended clinical purpose, minimizing risks to patients and users.

• Definitions and System Boundaries
  Provides precise terms for robotic surgical equipment, surgical instruments, interaction and interface conditions, and mechanical interfaces.

• Risk Management & Fault Conditions
  Emphasizes a risk-based approach to identifying and reducing residual hazards, including single fault conditions and test protocols adapted for robotic systems.

• Marking and Documentation
  Details requirements for clear identification, operator documentation, and safety markings. Includes graphic symbols for aspects such as patient mass, safe load, and mechanical parts.

• Compatibility and Integration
  Addresses the interaction of RASE and RASS with accessories, other medical devices, and supporting systems, ensuring system safety even when interconnected.

• Testing and Verification
  Sets procedures for verifying safety through functional and environmental testing, including humidity preconditioning and marking of IP classification relevant for drapes and covers.

• Usability and Controls
  Integrates usability engineering principles to enhance clinical effectiveness through intuitive interfaces and clear, actionable information for surgeons and staff.

• Annexes and Guidance
  Includes informative annexes on symbols, classification, risk assessment, testing methods, image-guided robotic systems, and structural integrity demonstration.

Applications

Robotically assisted surgical equipment covered by this standard is used in a variety of minimally invasive and open surgeries, offering precision and stability beyond manual techniques. Practical applications include:

• Laparoscopic and endoscopic procedures improved by remotely manipulated instruments.
• Orthopedic surgery using robotic milling or placement for enhanced accuracy.
• Image-guided surgical interventions, where RASE supports complex navigation tasks.
• Operating room integration, with RASS interfacing to imaging, patient tables, and ancillary devices.

By conforming to this standard, manufacturers, healthcare organizations, and regulatory authorities benefit from:

• Improved patient safety through harmonized requirements for electrical, mechanical, and radiation hazards.
• Streamlined market approval by aligning product development with international benchmarks.
• Enhanced clinician trust in system reliability, accuracy, and fail-safe operations.
• Facilitated training and maintenance thanks to standardized documentation and marking.

Related Standards

oSIST prEN IEC 80601-2-77:2026 works in conjunction with several general and collateral standards, including:

• IEC 60601-1: General requirements for basic safety and essential performance of medical electrical equipment.
• IEC 60601-1-2: Electromagnetic compatibility requirements.
• IEC 60601-1-6: Usability engineering for medical devices.
• IEC 60601-2-2, IEC 60601-2-18, IEC 60601-2-22, IEC 60601-2-37, IEC 60601-2-46: Standards covering specific device categories such as HF surgical, endoscopic, laser, ultrasound equipment, and surgical tables.
• IEC 62366-1: Application of usability engineering to medical devices.

Integrating these standards ensures that RASE and RASS products are developed with a comprehensive approach to safety, usability, and system integration, supporting innovation in surgical robotics while keeping patient welfare at the forefront.

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2026
Medicinska električna oprema - 2-77. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti robotsko podprte kirurške opreme
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and
essential performance of robotically assisted surgical equipment
Medizinische elektrische Geräte - Teil 2-77: Besondere Festlegungen an die Sicherheit,
einschließlich der wesentlichen Leistungsmerkmale von durch Roboter unterstützte
Chirurgiegeräte
Appareils électromédicaux - Partie 2-77: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils chirurgicaux robotiquement assistés
Ta slovenski standard je istoveten z: prEN IEC 80601-2-77:2026
ICS:
11.040.30 Operacijski instrumenti in Surgical instruments and
materiali materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

62D/2299/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 80601-2-77 ED2
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2026-06-05 2026-08-28
SUPERSEDES DOCUMENTS:
62D/2277/CD, 62D/2289A/CC
IEC SC 62D : PARTICULAR MEDICAL EQUIPMENT, SOFTWARE, AND SYSTEMS
SECRETARIAT: SECRETARY:
United States of America Ms Ladan Bulookbashi
OF INTEREST TO THE FOLLOWING COMMITTEES: HORIZONTAL FUNCTION(S):

ASPECTS CONCERNED:
SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
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to be included should this proposal proceed. Recipients are reminded that the CDV stage is the final stage for submitting ISC
clauses. (SEE AC/22/2007 OR NEW GUIDANCE DOC).

TITLE:
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential
performance of robotically assisted surgical equipment

PROPOSED STABILITY DATE: 2030
NOTE FROM TC/SC OFFICERS:
electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions.
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IEC CDV 80601-2-77 © IEC 2026
1 CONTENTS
3 FOREWORD . 3
4 INTRODUCTION to Edition 1 . 6
5 INTRODUCTION to Edition 2 . 7
6 201.1 Scope, object and related standards . 8
7 201.2 Normative references . 10
8 201.3 Terms and definitions . 10
9 201.4 General requirements . 13
10 201.5 General requirements for testing of ME EQUIPMENT . 13
11 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 14
12 201.7 ME EQUIPMENT identification, marking and documents . 14
13 201.8 Protection against electrical HAZARDS from ME EQUIPMENT. 17
14 201.9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 18
15 201.10 Protection against unwanted and excessive radiation HAZARDS . 21
16 201.11 Protection against excessive temperatures and other HAZARDS . 21
17 201.12 Accuracy of controls and instruments and protection against hazardous
18 outputs . 22
19 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 22
20 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 23
21 201.15 Construction of ME EQUIPMENT . 23
22 201.16 * ME SYSTEMS . 24
23 201.17 * ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 24
24 202 ELECTROMAGNETIC DISTURBANCES – Requirements and tests . 24
25 206 * USABILITY . 24
26 Annexes . 25
27 Annex D (informative) Symbols on marking . 26
28 Annex AA (informative) Particular guidance and rationale . 27
29 Annex BB (informative) Equations for the calculation of the overall system stopping
30 performance and minimum distances . 41
31 Annex CC (informative) Stopping functions of the RASE . 43
32 Annex DD (informative) Alternative method to demonstrate structural integrity
33 throughout the EXPECTED SERVICE LIFE of the RASE . 45
34 Annex EE (informative) Example of a testing method of the IMMUNITY test for HF
35 SURGICAL EQUIPMENT emissions . 48
36 Annex FF (informative) Image-guided RASE . 51
37 Bibliography . 55
38 Index of defined terms used in this particular standard . 57
40 Figure 201.101 – Graphic symbol for maximum PATIENT mass and SAFE WORKING LOAD . 14
41 Figure 201.102 – Graphic symbol for mass of MOUNTED PART . 14
42 Figure 201.AA.101 – Examples of MECHANICAL INTERFACE attachments . 28
43 Figure 201.AA.102 – Example 1 of ROBOTIC SURGERY CONFIGURATION: a case of
44 laparoscopic RASS . 30
IEC CDV 80601-2-77 © IEC 2026
45 Figure 201.AA.103 – Example 2 of ROBOTIC SURGERY CONFIGURATION: a case of bone
46 milling RASE . 30
47 Figure 201.AA.104 – Typical ESSENTIAL PERFORMANCE items of RASE . 32
48 Figure 201.AA.105 – Example of RISK ASSESSMENT related to structural component . 37
49 Figure 201.BB.101 – Relationship between t1 and t2 . 42
51 Table 201.101 – List of ESSENTIAL PERFORMANCE requirements. 13
52 Table 201.102 – Colours and meanings of indicator lights for RASE and RASS . 16
53 Table 201.D.101 – Symbols for marking RASE or its parts . 26
54 Table 201.AA.101 – Surgical instruments classification for invasive and non-invasive
55 use . 31
56 Table 201.CC.101 – Different stopping functions . 43
57 Table 201.DD.101 – Alternative to safety factors: life testing . 45
IEC CDV 80601-2-77 © IEC 2026
59 INTERNATIONAL ELECTROTECHNICAL COMMISSION
60 ____________
62 MEDICAL ELECTRICAL EQUIPMENT –
64 Part 2-77: Particular requirements for the BASIC SAFETY and essential
65 performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT
67 FOREWORD
68 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
69 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
70 co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
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76 Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
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IEC CDV 80601-2-77 © IEC 2026
103 International Standard IEC 80601-2-77 has been prepared by subcommittee 62D: Particular
104 medical equipment, software, and systems, of IEC technical committee 62: Medical equipment,
105 software, and systems, and ISO technical committee 299: Robotics.
106 This publication is published as a double logo standard.
107 This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
108 In this document, the following print types are used:
109 – requirements and definitions: roman type;
110 – test specifications: italic type;
111 – informative material appearing outside of tables, such as notes, examples and references: in smaller type.
112 Normative text of tables is also in a smaller type;
113 – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
114 NOTED: SMALL CAPITALS.
115 In referring to the structure of this document, the term
116 – "clause" means one of the nineteen numbered divisions within the table of contents,
117 inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
118 – "subclause" means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
119 subclauses of Clause 7).
120 References to clauses within this document are preceded by the term "Clause" followed by the
121 clause number. References to subclauses within this particular standard are by number only.
122 In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any
123 combination of the conditions is true.
124 The verbal forms used in this document conform to usage described in Clause 7 of the
125 ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb:
126 – "shall" means that compliance with a requirement or a test is mandatory for compliance with
127 this document;
128 – "should" means that compliance with a requirement or a test is recommended but is not
129 mandatory for compliance with this document;
130 – "may" is used to describe a permissible way to achieve compliance with a requirement or
131 test.
132 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
133 indicates that there is guidance or rationale related to that item in Annex AA.
134 A list of all parts of the IEC 60601 and IEC 80601 International Standard, published under the
135 general title Medical electrical equipment, can be found on the IEC website.
IEC CDV 80601-2-77 © IEC 2026
137 The committee has decided that the contents of this document and its amendment will remain
138 unchanged until the stability date indicated on the IEC website under webstore.iec.ch in the
139 data related to the specific document. At this date, the document will be
140 • reconfirmed,
141 • withdrawn,
142 • replaced by a revised edition, or
143 • amended.
145 NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing
146 organizations may need a transitional period following publication of a new, amended or revised IEC publication in
147 which to make products in accordance with the new requirements and to equip themselves for conducting new or
148 revised tests. It is the recommendation of the committees that the content of this publication be adopted for
149 implementation nationally not earlier than 3 years from the date of publication.
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IEC CDV 80601-2-77 © IEC 2026
153 INTRODUCTION to Edition 1
154 This part of IEC 80601 is written at a time when technical evolution of medical robots is in rapid
155 progress and the scientific foundation of safe use is still being expanded.
156 This document is the result of work that began in ISO/TC 184/SC 2/WG 7 in October 2006 on
157 personal care robots, to address an emerging type of medical robot that was used outside of
1 2
158 an industrial environment . That group was working on a new standard, ISO 13482[1] , which
159 was published as an International Standard (IS) in 2014. While initially focused on non -medical
160 applications, WG 7 recognized that work was likely to be needed on medical devices utilizing
161 robotic technology. In October 2009, ISO/TC 184/SC 2 established a WG 7, Study Group (SG)
162 on Medical care robots, comprised of experts from Canada, France, Germany, Japan, Korea,
163 Romania, Switzerland, UK and USA.
164 The work of ISO/TC 184/SC 2/WG 7 SG cumulated in a proposal to form a Joint Working Group
165 (JWG 9) with IEC/TC 62/SC 62A focusing on MEDICAL ELECTRICAL EQUIPMENT using robotic
166 technology. This JWG began developing a technical report (IEC TR 60601-4-1:2017[2]) dealing
167 with degree of autonomy. While developing this document, a particular standard was proposed
168 for robotic equipment used in surgical applications. This led to the creation of a Joint Working
169 Group 35 in April 2015 within IEC/TC 62/SC 62D to develop particular requirements of safety
170 of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS that utilize robotic
171 technology. The work would include medical robots for SURGERY. This proposal was approved,
172 resulting in the formation of Joint Working Group (JWG 35).
173 During IEC/TC 62/SC 62D discussion, there was a strong opinion that some types of MEDICAL
174 ELECTRICAL EQUIPMENT could be a medical robot, but not all MEDICAL ELECTRICAL EQUIPMENT were
175 medical robots. According to this opinion, JWG 35 discussed and agreed that the majority of
176 existing MEDICAL ELECTRICAL EQUIPMENT, including those used for surgical PROCEDURES, were
177 not considered medical robots, so it would be better to capture this type of ME EQUIPMENT
178 through a different definition – ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE).
179 JWG 9 defined medical robots as ME EQUIPMENT with a degree of autonomy
180 (IEC TR 60601-4-1:2017). JWG 35 found that some RASE have zero autonomy. Therefore, by
181 definition, RASE could not be equivalent to a medical robot. Regulatory agencies objected to
182 employ the term robot as defined in IEC TR 60601-4-1 and felt that it implied that the RASE were
183 performing the surgical PROCEDURE rather than the surgeon. The consensus in JWG 35 was
184 that the RASE only assists the surgeon. The surgeon maintains some level of control or
185 supervision of the RASE.
186 The minimum safety requirements specified in this particular standard for ROBOTICALLY ASSISTED
187 SURGICAL EQUIPMENT are presumed to establish that the RESIDUAL RISKS have been reduced to
188 acceptable levels unless there is OBJECTIVE EVIDENCE to the contrary.
189 The requirements are followed by particular specifications for the relevant tests.
___________
ISO TC 184/SC 2 was reorganized as ISO TC 299 in 2016.
Numbers in square brackets refer to the Bibliography.
IEC CDV 80601-2-77 © IEC 2026
191 INTRODUCTION to Edition 2
192 During the September 21, 2023, meeting of IEC SC 62D Plenary in Seoul, Republic of Korea,
193 the subcommittee discussed the need to proceed with a new edition of IEC 80601-2-77. The
194 need for a new edition was to include/modify the standard based on the latest ROBOTICALLY
195 ASSISTED SURGICAL EQUIPMENT (RASE).
196 A resolution was taken to proceed towards the 2nd edition of the IEC 80601-2-77.
197 The review report for the new edition can be found in the IEC document 62D/2157/RR.
198 This 2nd edition of the IEC 80601-2-77 supersedes the IEC 80601-2-77 edition 1.1 standard.
199 Major changes in this edition are;
200 – Extend the scope of this document by extending the definition of ROBOTIC SURGICAL
201 INSTRUMENT,
202 – Clarify the definition of SURGERY in the Annex AA,
203 – Add guidance on image-guided RASE in the Annex FF.
IEC CDV 80601-2-77 © IEC 2026
205 MEDICAL ELECTRICAL EQUIPMENT –
207 Part 2-77: Particular requirements for the BASIC SAFETY and essential
208 performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT
211 201.1 Scope, object and related standards
212 Clause 1 of the general standard applies, except as follows:
213 201.1.1 Scope
214 Replacement:
215 This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ROBOTICALLY
216 ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL SYSTEMS (RASS),
217 hereafter referred to as ME EQUIPMENT and ME SYSTEMS together with their INTERACTION
218 CONDITIONS and INTERFACE CONDITIONS. If a clause or subclause is specifically intended to be
219 applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or
220 subclause will say so. If that is not the case, the clause or subclause applies both to ME
221 EQUIPMENT and to ME SYSTEMS, as relevant.
222 If RASE or RASS, or its ACCESSORIES fall within scope of another particular standard, then the
223 particular standard applies in addition to this standard.
224 EXAMPLES IEC 60601-2-2[3] for HF SURGICAL EQUIPMENT; IEC 60601-2-18[4] for ENDOSCOPIC EQUIPMENT;
225 IEC 60601-2-22[5] for laser equipment; IEC 60601-2-37[6] for ultrasound equipment; IEC 60601-2-46[7] for operating
226 tables, etc.
227 Note: ME EQUIPMENT can be used with RASS for intraoperative surgical planning and visualization.
228 ME EQUIPMENT and ME SYSTEMS intended to be used for radiotherapy, nuclear medicine and
229 radiation dosimetry (example: IEC 60601-2-68[8]) are excluded from the scope of this document.
230 201.1.2 Object
231 Replacement:
232 The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
233 PERFORMANCE requirements for ROBOTICALLY ASSISTED SURGICAL EQUIPMENT and ROBOTICALLY
234 ASSISTED SURGICAL SYSTEMS.
235 201.1.3 * Collateral standards
236 Addition:
237 This particular standard refers to those applicable collateral standards that are listed in Clause
238 2 of the general standard and Clause 201.2 of this particular standard.
239 IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:2010,
240 IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020 apply as modified in
241 Clauses 202 and 206 respectively.
___________
The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
IEC CDV 80601-2-77 © IEC 2026
242 IEC 60601-1-3:2008, IEC 60601-1-3:2008/AMD1:2013 and IEC 60601-1-3:2008/AMD2:2021
243 [9], IEC 60601-1-9:2007, IEC 60601-1-9:2007/AMD1:2013 and
244 IEC 60601-1-9:2007/AMD2:2020 [10], and IEC 60601-1-11:2015 and
245 IEC 60601-1-11:2015/AMD1:2020 [11] do not apply.
246 201.1.4 Particular standards
247 Replacement:
248 In the IEC 60601 series, particular standards may modify, replace or delete requirements
249 contained in the general standard and collateral standards as appropriate for the particular ME
250 EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE
251 requirements.
252 A requirement of a particular standard takes priority over the general standard.
253 For brevity, IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
254 IEC 60601-1:2005/AMD2:2020 are referred to in this particular standard as the general
255 standard. Collateral standards are referred to by their document number.
256 The numbering of clauses and subclauses of this particular standard corresponds to that of the
257 general standard with the prefix "201" (e.g. 201.1 in this document addresses the content of
258 Clause 1 of the general standard) or applicable collateral standard with the prefix "20x", where
259 x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular
260 standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral standard, 203.4 in
261 this particular standard addresses the content of Clause 4 of the IEC 60601-1-3 collateral
262 standard, etc.). The changes to the text of the general standard are specified by the use of the
263 following words:
264 "Replacement" means that the clause or subclause of the general standard or applicable
265 collateral standard is replaced completely by the text of this particular standard.
266 "Addition" means that the text of this particular standard is additional to the requirements of the
267 general standard or applicable collateral standard.
268 "Amendment" means that the clause or subclause of the general standard or applicable
269 collateral standard is amended as indicated by the text of this particular standard.
270 Subclauses, figures or tables which are additional to those of the general standard are
271 numbered starting from 201.101. However, due to the fact that definitions in the general
272 standard are numbered 3.1 through 3.154, additional definitions in this document are numbered
273 beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items
274 aa), bb), etc.
275 Subclauses, figures or tables which are additional to those of a collateral standard are
276 numbered starting from 20x, where "x" is the number of the collateral standard, e.g. 202 for
277 IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
278 The term "this document" is used to make reference to the general standard, any applicable
279 collateral standards and this particular standard taken together.
280 Where there is no corresponding clause or subclause in this particular standard, the clause or
281 subclause of the general standard or applicable collateral standard, although possibly not
282 relevant, applies without modification; where it is intended that any part of the general standard
283 or applicable collateral standard, although possibly relevant, is not to be applied, a statement
284 to that effect is given in this particular standard.
IEC CDV 80601-2-77 © IEC 2026
285 201.2 Normative references
286 NOTE Informative references are listed in the Bibliography.
287 Clause 2 of the general standard applies, except as follows:
288 Replacement:
289 IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
290 safety and essential performance – Collateral Standard: Electromagnetic disturbances –
291 Requirements and tests
292 IEC 60601-1-2:2014/AMD1:2020
293 IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic
294 safety and essential performance – Collateral standard: Usability
295 IEC 60601-1-6:2010/AMD1:2013
296 IEC 60601-1-6:2010/AMD2:2020
297 IEC 62366-1:2015, Medical devices – Part 1: Application of usability engineering to medical
298 devices
299 IEC 62366-1:2015/AMD1:2020
300 Addition:
301 IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
302 and essential performance
303 IEC 60601-1:2005/AMD1:2012
304 IEC 60601-1:2005/AMD2:2020
305 201.3 Terms and definitions
306 For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
307 IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and the following apply.
308 ISO and IEC maintain terminological databases for use in standardization at the following
309 addresses:
310 • IEC Electropedia: available at http://www.electropedia.org/
311 • ISO Online browsing platform: available at http://www.iso.org/obp
312 NOTE An index of defined terms is found beginning on page 62.
313 Addition:
314 201.3.201
315 * CAPACITIVELY COUPLED HF LEAKAGE CURRENT
316 unavoidable HF LEAKAGE CURRENT flowing due to capacitive coupling from the APPLIED PART of
317 HF SURGICAL EQUIPMENT to another part of the RASE or RASS
318 [SOURCE: IEC 60601-2-18:2009, 201.3.201, modified – Replacement of " from an ENERGIZED
319 ENDOTHERAPY DEVICE that is the APPLIED PART of HF SURGICAL EQUIPMENT to the ENDOSCOPE" by
320 "from the APPLIED PART of HF SURGICAL EQUIPMENT to another part of the RASE or RASS", insertion
321 of “leakage”.]
322 201.3.202
323 ENDOSCOPIC EQUIPMENT
324 energized endoscope together with its supply unit(s), as required for its INTENDED USE
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325 [SOURCE: IEC 60601-2-18:2009, 201.3.204]
326 201.3.203
327 HIGH FREQUENCY
328 HF
329 frequencies less than 5 MHz and generally greater than 200 kHz
330 [SOURCE: IEC 60601-2-2:2017, 201.3.220]
331 201.3.204
332 HF SURGICAL ACCESSORY
333 ACCESSORY intended to conduct, supplement or monitor HF energy applied to the PATIENT from
334 HF SURGICAL EQUIPMENT
335 [SOURCE: IEC 60601-2-2:2017, 201.3.223, modified – The notes have been deleted.]
336 201.3.205
337 HF SURGICAL EQUIPMENT
338 MEDICAL ELECTRICAL EQUIPMENT which generates HIGH FREQUENCY currents intended for the
339 performance of surgical tasks, such as the cutting or coagulation of biological tissue by means
340 of these HIGH FREQUENCY currents
341 [SOURCE: IEC 60601-2-2:2017, 201.3.224, modified – The notes have been deleted.]
342 201.3.206
343 * INTERACTION CONDITIONS
344 conditions that shall be fulfilled to achieve BASIC SAFETY when RASE or RASS is used
345 simultaneously with multiple ROBOTIC SURGICAL INSTRUMENTS or with an APPLIED PARTS of other
346 ME EQUIPMENT, at least one APPLIED PART of which uses energy for providing its INTENDED USE,
347 e.g. HF current, ultrasound, or laser
348 201.3.207
349 * INTERFACE CONDITIONS
350 conditions that shall be fulfilled to achieve BASIC SAFETY for any FUNCTIONAL CONNECTION
351 between RASE or RASS and other ME EQUIPMENT or non-ME EQUIPMENT in the ROBOTIC SURGERY
352 CONFIGURATION
353 [SOURCE: IEC 60601-2-18:2009, 201.3.211, modified – Replacement of "endoscopic
354 EQUIPMENT" by "RASE or RASS", and of "configuration for ENDOSCOPIC EQUIPMENT" by "ROBOTIC
355 SURGERY CONFIGURATION".]
356 201.3.208
357 * MECHANICAL INTERFACE
358 mounting surface on RASE or RASS that allows for attachment of detachable ACCESSORIES,
359 components, or parts that are mechanically manipulated by the RASE or RASS
360 Note 1 to entry: A MECHANICAL INTERFACE can be used to attach items that are sterile.
361 Note 2 to entry: A MECHANICAL INTERFACE can provide insulation and other functions (e.g., sterile boundary) to
362 achieve BASIC SAFETY.
363 Note 3 to entry: RASE or RASS can have zero, one, or more MECHANICAL INTERFACE per each ROBOTIC SURGICAL
364 INSTRUMENT.
365 201.3.209
366 MOUNTED PART
367 any part of RASE or RASS, including ACCESSORIES intended to be mounted to an operating table
368 or on another supporting structure which is not part of the RASE or RASS
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369 201.3.210
370 RASE PROTECTIVE STOP
371 type of interruption of operation that allows a cessation of motion as a RISK CONTROL measure
372 and which retains the ability of PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) to facilitate
373 resumption of the operation of the RASE or RASS
374 Note 1 to entry: A RASE PROTECTIVE STOP can be manually initiated, or automatically initiated by means of PEMS.
375 Note 2 to entry: A RASE PROTECTIVE STOP can be coordinated with deactivation of energy of ROBOTIC SURGICAL
376 INSTRUMENT and ACCESSORIES if required as a RISK CONTROL measure.
377 Note 3 to entry: Annex CC tabulates differences between emergency stop and RASE PROTECTIVE STOP.
378 201.3.211
379 * ROBOTICALLY ASSISTED SURGICAL EQUIPMENT
380 RASE
381 MEDICAL ELECTRICAL EQUIPMENT that incorporates PEMS actuated mechanism intended to
382 facilitate the placement or manipulation of ROBOTIC SURGICAL INSTRUMENT(s)
383 Note 1 to entry: "Placement" includes INTENDED PURPOSE of positioning, maintaining, or holding of a ROBOTIC
384 SURGICAL INSTRUMENT.
385 Note 2 to entry: RASE can be referred to as surgical robots, robotically assisted surgical devices, computer-assisted
386 surgical systems, surgical manipulators, etc.
387 Note 3 to entry: A ROBOTIC SURGICAL INSTRUMENT is considered to be a part of the RASE or RASS in this document.
388 Note 4 to entry: This note applies to the French language only.
389 201.3.212
390 ROBOTICALLY ASSISTED SURGICAL SYSTEM
391 RASS
392 MEDICAL ELECTRICAL SYSTEM that incorporates PEMS actuated mechanism intended to facilitate
393 the placement or manipulation of ROBOTIC SURGICAL INSTRUMENT(s)
394 Note 1 to entry: This note applies to the French language only.
395 201.3.213
396 * ROBOTIC SURGERY CONFIGURATION
397 combination of RASE or RASS by means of INTERACTION CONDITIONS and INTERFACE CONDITIONS
398 with one or more of the following:
399 – ACCESSORIES;
400 – other RASE or RASS;
401 – other ME EQUIPMENT;
402 – non-ME EQUIPMENT; or
403 – ME SYSTEM
404 201.3.214
405 * ROBOTIC SURGICAL INSTRUMENT
406 device intended by the MANUFACTURER to be manipulated by the RASE or RASS to perform tasks
407 in SURGERY
408 Note 1 to entry: Tasks include visualization.
409 Note 2 to entry: A ROBOTIC SURGICAL INSTRUMENT can be detachable by means of a MECHANICAL INTERFACE. See
410 definition of MECHANICAL INTERFACE and Annex AA about the attachment of ROBOTIC SURGICAL INSTRUMENT to RASE.
411 Note 3 to entry: A ROBOTIC SURGICAL INSTRUMENT can be an ACCESSORY of RASE or RASS.
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412 201.3.215
413 * SURGERY
414 PROCEDURE involving the incision, excision, manipulation or suturing of tissue which usually
415 requires regional or general anaesthesia or profound sedation to control pain
416 [SOURCE: WHO/IER/PSP/2008.07[12], modified – The words "conducted in the operating
417 room" have been deleted.]
418 201.4 General requirements
419 Clause 4 of the general standard applies, except as follows:
420 201.4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS
421 Additional subclause:
422 201.4.1.101 * ROBOTIC SURGICAL INSTRUMENTS and other ME EQUIPMENT
423 Where requirements for ROBOTIC SURGICAL INSTRUMENTS and other ME EQUIPMENT given in other
424 applicable particular standards conflict with the requirements for INTERACTION CONDITIONS of this
425 particular standard, the requirements of this particular standard shall take precedence.
426 201.4.3 * ESSENTIAL PERFORMANCE
427 Addition:
428 Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in
429 Table 201.101.
430 Table 201.101 – List of ESSENTIAL PERFORMANCE requirements
Requirement Subclause
To ensure there is no unacceptable RISK if information essential to 201.13.1.101 Information essential to
perform SURGERY is degraded. perform SURGERY
To ensure there is no unacceptable RISK if motion control of the 201.13.1.102 Motion control of the ROBOTIC
ROBOTIC SURGICAL INSTRUMENT has performance degradation. SURGICAL INSTRUMENT
432 201.4.6 * ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT
433 Addition:
434 NOTE Additional information is provided in Annex AA.
435 201.4.7 SINGLE FAULT CONDITION for ME EQUIPMENT
436 Addition:
437 When applying 4.7, the INTERACTION CONDITIONS and INTERFACE CONDITIONS shall be taken into
438 account.
439 NOTE Given the complexity of testing of all possible combinations of INTERACTION CONDITIONS under SINGLE FAULT
440 CONDITIONS, a RISK-based approach supported by testing or objective evidence may be used to demonstrate
441 compliance.
442 201.5 General requirements for testing of ME EQUIPMENT
443 Clause 5 of the general standard applies, except as follows:
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444 201.5.4 Other conditions
445 Addition to a):
446 Before carrying out tests, RASE shall be prepared for operation as specified by the
447 MANUFACTURER.
448 201.5.7 Humidity preconditioning treatment
449 Addition:
450 Single-use equipment drapes are not subject to humidity preconditioning treatment.
451 201.6 Classification of ME EQUIPMENT and ME SYSTEMS
452 Clause 6 of the general standard applies.
453 201.7 ME EQUIPMENT identification, marking and documents
454 Clause 7 of the general standard applies, except as follows:
455 201.7.2.2 Identification
456 Additional subclauses:
457 201.7.2.2.101 Marking of maximum PATIENT mass and SAFE WORKING LOAD
458 If an operating table is a part of RASE, it shall be marked with the corresponding maximum
459 PATIENT mass and SAFE WORKING LOAD (for symbol, see Figure 201.101).
IEC
461 Figure 201.101 – Graphic symbol for maximum PATIENT mass and SAFE WORKING LOAD
462 201.7.2.2.102 Marking of the mass of MOUNTED PART
463 If RASE has one or more MOUNTED PARTS, each MOUNTED PART shall be marked with its maximum
464 mass unless the HAZARD related to the mass would not lead to an unacceptable RISK (for
465 example, when the mass is negligible) or the marking is not practicable (for symbol, see
466 Figure 201.102).
IEC
468 Figure 201.102 – Graphic symbol for mass of MOUNTED PART
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469 Mass of the MOUNTED PART should include the maximum mass of the attached instruments and
470 ACCESSORIES.
471 201.7.2.9 * IP classification
472 Addition:
473 If marking an IP classification is required for a RASE, and if a protective cover, for example, an
474 equipment drape, is required to meet the classification, the IP symbol marking shall be applied
475 to the protective cover. If the protective cover is single use, the IP classification may be affixed
476 to the individual packaging.
477 ROBOTIC SURGICAL INSTRUMENTS supplied with specific instructions detailing allowable
478 reprocessing methods and parameters are excluded from this requirement. No symbol is
479 required to identify the reprocessing PROCEDURE by this particular standard. See also 7.9.2.12
480 of the general standard.
481 201.7.2.10 APPLIED PARTS
482 Addition:
483 If marking of an APPLIED PART is not practicable and the APPLIED PART is single-use, the required
484 marking shall be on the individual packaging, or on the equipment adjacent to the connector for
485 the APPLIED PART.
486 Compliance is checked by inspection.
487 Additional subclause:
488 201.7.2.101 Alternative marking
489 Information which is accessible by the OPERATOR on an output device (e.g. display) of ME
490 EQUIPMENT is considered equivalent to marking on the equipment for requirements of 7.2 of the
491 general standard, as long as the marking is visible at the time the information is required.
492 Compliance is checked by inspection.
493 201.7.4.2 Control devices
494 Addition:
495 Alternative or no markings of control devices (for example, multi-function buttons) is acceptable
496 if the USABILITY ENGINEERING PROCESS demonstrates that this does not result in unacceptable
497 RISK.
498 NOTE Visual cues such as colour, tactile, location, shape can be used in lieu of markings.
499 Compliance is checked by inspecting the USABILITY ENGINEERING FILE.
500 201.7.8.1 * Colours of indicator lights
501 Add row 2 and 3 of Table 201.102 above the note of Table 2 of the general standard, and add
e f g
502 note , and of Table 201.102 to the note of Table 2 of the general standard:
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503 Table 201.102 – Colours and meanings of indicator lights for RASE and RASS
a
Name On when Alarm Accompanied OPERATOR
Indicator light
indicator light by sound requirement
e g
Cutting Yellow, flashing – –
Cutting mode Yes
f
activation
or not
g
Coagulation Coagulation Blue, flashing or – –
Yes
e f
activation
mode not
a
These indicator lights are INFORMATION SIGNALS, and IEC 60601-1-8 requires that they be perceived as different
than visual ALARM SIGNALS.
e
Applicable when RASE and RASS incorporate HF SURGICAL EQUIPMENT.
f
Yellow and blue indicator lights can also be used to indicate additional modes if multiple functions share the
same control device, provided the USABILITY ENGINEERING PROCESS demonstrates that this does not result in
unacceptable RISK.
g
As defined in 201.12.4.2.101 of IEC 60601-2-2:2017.
505 Addition at the end of subclause 201.7.8.1:
506 In addition to Table 2 of the general standard, red, yellow, and blue indicator colours may be
507 used as the following, provided the USABILITY ENGINEERING PROCESS demonstrates that this does
508 not result in unacceptable RISK.
509 • Red for situations where immediate response by the OPERATOR is required,
510 • Yellow for situations where prompt response by the OPERATOR is required,
511 • Blue for any situations other than those for red or yellow colours as indicated above.
512 201.7.9.2.2 Warning and safety notices
513 Addition:
514 In addition to requirements in other particular standards that can be relevant, the following
515 warning and safety notices shall be provided as applicable:
516 Warnings regarding INTERACTION CONDITIONS:
517 a) warning that, if the ROBOTIC SURGERY CONFIGURATION requires TYPE CF APPLIED PARTS,
518 the APPLIED PARTS of other ME EQUIPMENT used within the ROBOTIC SURGERY
519 CONFIGURATION shall be TYPE CF APPLIED PARTS;
520 b) warning that, if the ROBOTIC SURGERY CONFIGURATION requires TYPE BF APPLIED PARTS,
521 the APPLIED PARTS of other ME EQUIPMENT used within the ROBOTIC SURGERY
522 CONFIGURATION shall be F-TYPE APPLIED PARTS;
523 c) warning that, when other ME EQUIPMENT are used with ROBOTIC SURGICAL INSTRUMENTS,
524 PATIENT LEAKAGE CURRENTS can be additive;
525 d) warning that, when RASE or RASS is used with laser equipment, advice concerning their
526 safe use shall be given, including avoidance of potential injury, for example, wearing
527 suitable personal protective equipment, or by inserting a suitable filter for the ROBOTIC
528 SURGICAL INSTRUMENTS;
529 e) warning that, before each use, the compatibility of RASE or RASS with any ROBOTIC
530 SURGICAL INSTRUMENTS and other APPLIED PARTS including those of other ME EQUIPMENT
531 shall be checked according to any criteria for safe use defined in the instructions for
532 use;
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533 f) warning that, before each use, the outer surface of the portions of any ROBOTIC SURGICAL
534 INSTRUMENTS which are intended to be inserted into a PATIENT should be checked to
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