prEN IEC 80601-2-78:2026

• Status: Not Published
• Publication Date: 02-Jan-2028
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Current Stage: 4060 - Enquiry results established and sent to TC, SR, BTTF - Enquiry
• Start Date: 28-Aug-2026
• Completion Date: 28-Aug-2026
• Ref Project: oSIST prEN IEC 80601-2-78:2026 - Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

• Revises: EN IEC 80601-2-78:2020/A1:2024 - Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
• Effective Date: 06-Aug-2024
• Revises: EN IEC 80601-2-78:2020 - Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
• Effective Date: 06-Aug-2024

Overview

prEN IEC 80601-2-78:2026 specifies particular requirements for the basic safety and essential performance of medical robots for rehabilitation, assessment, compensation, or alleviation. Developed by the International Electrotechnical Commission (IEC) and adopted by CLC, this standard addresses programmable medical robots that physically interact with patients to support or perform clinical tasks related to movement functions. The document aims to ensure that such advanced medical electrical equipment meets stringent safety and performance requirements in healthcare environments.

This standard focuses on devices known as RACA robots (robots for rehabilitation, assessment, compensation, or alleviation), recognizing their increasing role in patient care. It builds on the IEC 60601 series and updates key definitions, requirements for battery management systems, and provisions for extended reality (XR) devices.

Key Topics

The standard covers a comprehensive set of requirements and definitions, including:

• Scope and Definitions: Clarifies which medical robots are included, delineating RACA robots from other healthcare or assistive devices such as electric wheelchairs or prostheses.
• Basic Safety and Performance: Outlines requirements for preventing hazards, managing electrical and mechanical safety, and ensuring proper labelling, identification, and documentation.
• Mechanical and Electrical Hazards: Specific provisions for protection against mechanical injuries, excessive temperatures, and unwanted radiation.
• Programmable Electrical Medical Systems (PEMS): Requirements for systems’ software, autonomy levels, and user interaction.
• Usability and Risk Management: References collateral standards related to usability engineering and the application of risk management to medical devices (e.g., IEC 62366-1, ISO 14971).
• Battery Management and Extended Reality: Introduces requirements for devices with secondary batteries and those using head-mounted displays or XR devices in medical environments.
• Application Environment: Addresses requirements for various care settings, including home healthcare, and guides on alarm systems and physiologic closed-loop controls.

Applications

prEN IEC 80601-2-78:2026 is directly applicable to manufacturers, designers, and evaluators of:

• Medical exoskeletons and robotic orthoses for assessment, rehabilitation, alleviation, or compensation of movement impairments
• Robotic end-effectors and active balance control equipment
• Robotic body-weight support systems and walkers for clinical rehabilitation
• Devices for alleviating joint pain or spasticity through controlled movement
• Continuous Passive Motion (CPM) devices with autonomy features

Healthcare facilities, testing organizations, and regulators will utilize this standard when integrating, assessing, or certifying medical robots with direct patient interaction, particularly those used in rehabilitation medicine, neurology, and orthopedics. By ensuring compliance, stakeholders help safeguard patient wellbeing and support reliable device performance.

Related Standards

prEN IEC 80601-2-78:2026 references and builds upon internationally recognized standards, including:

• IEC 60601-1: General requirements for basic safety and essential performance of medical electrical equipment
• IEC 60601-1-2: Electromagnetic disturbances - requirements and tests
• IEC 60601-1-6: Collateral standard for usability
• IEC 60601-1-8: Alarm systems in medical electrical equipment
• IEC 60601-1-10: Development of physiologic closed-loop controllers
• IEC 60601-1-11: Requirements for equipment in home healthcare environments
• IEC 62366-1: Application of usability engineering to medical devices
• ISO 14971: Risk management for medical devices
• ISO 22523: Requirements and test methods for external limb prostheses
• ISO 7176: Standards for electric wheelchairs
• ISO 13482: Personal care robots (excluding direct rehabilitation functions)

These cross-references ensure harmonization within the broader framework of medical electrical safety and performance standards, supporting consistent quality and safety in medical robotics worldwide.

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Keywords: prEN IEC 80601-2-78:2026, medical robot safety, rehabilitation robots, essential performance, RACA robots, medical electrical equipment standard, CLC, IEC 60601 series, programmable medical systems, healthcare robotics compliance, usability, risk management.

SLOVENSKI STANDARD
01-julij-2026
Medicinska električna oprema - 2-78. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti medicinskih robotov za rehabilitacijo, ocenjevanje,
nadomestitev funkcij ali lajšanje simptomov
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and
essential performance of medical robots for rehabilitation, assessment, compensation or
alleviation
Medizinische elektrische Geräte - Teil 2-78: Besondere Festlegungen an die Sicherheit,
einschließlich der wesentlichen Leistungsmerkmale von medizinischen Robotern zur
Rehabilitation, Beurteilung, Kompensation oder Linderung
Appareils électromédicaux - Partie 2-78: Exigences particulières pour la sécurité de base
et les performances essentielles des robots médicaux dédiés à la rééducation,
l’évaluation, la compensation ou l'atténuation
Ta slovenski standard je istoveten z: prEN IEC 80601-2-78:2026
ICS:
11.040.60 Terapevtska oprema Therapy equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

62D/2304/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 80601-2-78 ED2
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2026-06-05 2026-08-28
SUPERSEDES DOCUMENTS:
62D/2278/CD, 62D/2290A/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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for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
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clauses 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 2-78: Particular requirements for basic safety and essential
performance of medical robots for rehabilitation, assessment, compensation or alleviation

PROPOSED STABILITY DATE: 2030
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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NOTE FROM TC/SC OFFICERS:
All comments in 62D/2290A/CC with resolutions stating “will be adopted by the central office for the CDV”
have been incorporated into this Committee Draft for Vote.
IEC CDV 80601-2-78 © IEC 2026
1 CONTENTS
2 CONTENTS . 2
3 FOREWORD . 4
4 201.1 Scope, object and related standards . 9
5 201.2 Normative references . 11
6 201.3 Terms and definitions . 12
7 201.4 General requirements . 16
8 201.5 General requirements for testing of ME EQUIPMENT . 18
9 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 18
10 201.7 ME EQUIPMENT identification, marking and documents . 18
11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT. 20
12 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 20
13 201.10 Protection against unwanted and excessive radiation HAZARDS . 27
14 201.11 Protection against excessive temperatures and other HAZARDS . 27
15 201.12 Accuracy of controls and instruments and protection against hazardous
16 outputs . 27
17 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 28
18 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 28
19 201.15 Construction of ME EQUIPMENT . 28
20 201.16 ME SYSTEMS . 30
21 201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 30
22 202 ELECTROMAGNETIC DISTURBANCES – Requirements and tests . 30
23 206 USABILITY . 30
24 208 * General requirements, tests and guidance for alarm systems in MEDICAL
25 ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS . 32
26 210 * Process requirements for the development of PHYSIOLOGIC CLOSED-LOOP
27 CONTROLLERS . 32
28 211 * Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL
29 SYSTEMS used in the HOME HEALTHCARE ENVIRONMENT . 32
30 Annexes . 34
31 Annex A (informative) General guidance and rationale . 34
32 Annex AA (informative) Particular guidance and rationale . 35
33 Annex BB (informative) Guidance and examples of SITUATION AWARENESS . 65
34 Annex CC (normative) RACA ROBOT containing SECONDARY BATTERIES and their
35 protection circuits . 79
36 Annex DD (informative) Guidance and rationale for Annex CC . 89
37 Bibliography . 91
38 Index of defined terms used in this particular standard . 94
40 Figure AA.1 – Relationship of the terms used to describe equipment, accessories or
41 equipment parts . 38
42 Figure AA.2 – Endsley's model of SITUATION AWARENESS (based on [10], drawn by Dr.
43 Peter Lankton, May 2007) . 42
44 Figure AA.3 – Model of user-medical device interaction . 43
IEC CDV 80601-2-78 © IEC 2026
45 Figure AA.4 – RACA ROBOT shared control system block diagram: control by PATIENT
46 and RACA ROBOT . 47
47 Figure AA.5 – RACA ROBOT shared control system block diagram: control by PATIENT,
48 OPERATOR and RACA ROBOT . 48
49 Figure AA.6 – RACA ROBOT shared control system block diagram: control by PATIENT
50 and RACA ROBOT, and control modulation by OPERATOR . 49
51 Figure AA.7 – WALKING RACA ROBOT using motion-related bio-signal input . 50
52 Figure AA.8 – System block diagram of a WALKING RACA ROBOT using a motion-related
53 bio-signal as input . 50
54 Figure AA.9 – RACA ROBOT that is an arm exoskeleton for REHABILITATION that applies a
55 PATIENT-cooperative shared control strategy . 51
56 Figure AA.10 – System block diagram of an arm exoskeleton for REHABILITATIOn that
57 applies a PATIENT-cooperative shared control strategy . 52
58 Figure AA.11 – Cane-type RACA ROBOT for REHABILITATION of walking . 53
59 Figure AA.12 – System block diagram of a cane-type RACA ROBOT . 54
60 Figure AA.13 – Example of ROBOT arm type RACA ROBOT for lower extremities . 55
61 Figure AA.14 – Example of ROBOT arm type RACA ROBOT for upper extremities . 56
62 Figure AA.15 – Example of exoskeleton type RACA ROBOT for upper extremities . 57
63 Figure AA.16 – Example of exoskeleton type RACA ROBOT for knee joint . 59
64 Figure AA.17 – Example of soft artificial muscle-type RACA ROBOT for knee joint . 60
65 Figure AA.18 – Example of exoskeleton-type WALKING RACA ROBOT . 61
66 Figure AA.19 – Example of RACA ROBOT for balance control . 62
67 Figure AA.20 – Example of a body-weight support-type RACA ROBOT with gait following
68 function . 63
69 Figure BB.1 – All the proximate causes of loss of SITUATION AWARENESS [19] . 68
70 Figure BB.2 – Relationship between SITUATION AWARENESS, the RISK MANAGEMENT
71 PROCESS (ISO 14971:2019) and the USABILITY ENGINEERING PROCESS (IEC 62366-
72 1:2015 and IEC 62366-1:2015/AMD1:2020) . 70
73 Figure BB.3 – Relationship between GDTA and RISK MANAGEMENT and USABILITY
74 ENGINEERING PROCESSES. 73
75 Figure BB.4 – WALKING exoskeleton RACA ROBOT . 79
76 Figure CC.1 – Schematic flowchart for testing the protection circuits of SECONDARY
77 BATTERIES. . 83
79 Table 201.101 – List of potential ESSENTIAL PERFORMANCEs . 20
80 Table 19 – MECHANICAL HAZARDS covered by this clause . 22
81 Table 201.102 – Overview of different stopping procedures . 23
82 Table 28 – Mechanical strength test applicability . 31
83 Table 1 – Mechanical strength test applicability, non-TRANSIT-OPERABLE . 35
84 Table 2 – Mechanical strength test applicability, TRANSIT-OPERABLE . 35
85 Table AA.1 – Correlation mapping between Figure AA.2 and Figure AA.3 . 44
86 Table BB.1 – Example of using GDTA in BB.5.2 . 75
87 Table BB.2 – Example of using GDTA in BB.5.3 . 76
88 Table BB.3 – Example of using GDTA in BB.5.4 . 78
89 Table BB.4 – Example of using GDTA in BB.5.5 . 80
90 Table DD.1 – Relationship between IEC 60601-1 subclause 15.4.3 and Annex CC . 92
IEC CDV 80601-2-78 © IEC 2026
91 Table DD.2 – Originating source for subclauses in Annex CC . 93
IEC CDV 80601-2-78 © IEC 2026
93 INTERNATIONAL ELECTROTECHNICAL COMMISSION
94 ____________
96 MEDICAL ELECTRICAL EQUIPMENT –
98 Part 2-78: Particular requirements for basic safety and essential
99 performance of medical robots for rehabilitation, assessment,
100 compensation or alleviation
102 FOREWORD
103 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
104 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
105 co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
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130 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
131 indispensable for the correct application of this publication.
132 9) IEC and ISO draw attention to the possibility that the implementation of this document may involve the use of (a)
133 patent(s). IEC and ISO take no position concerning the evidence, validity or applicability of any claimed patent
134 rights in respect thereof. As of the date of publication of this document, IEC and ISO had not received notice of
135 (a) patent(s), which may be required to implement this document. However, implementers are cautioned that this
136 may not represent the latest information, which may be obtained from the patent database available at
137 https://patents.iec.ch and www.iso.org/patents. IEC and ISO shall not be held responsible for identifying any or
138 all such patent rights.
139 International standard IEC 80601-2-78 has been prepared by IEC subcommittee 62D:
140 Particular medical equipment, software, and systems 62: Medical equipment, software, and
141 systems, and ISO Technical Committee 299: Robotics.
142 This publication is published as a double logo standard.
143 This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
144 In this document, the following print types are used:
145 – requirements and definitions: roman type;
146 – test specifications: italic type;
IEC CDV 80601-2-78 © IEC 2026
147 – informative material appearing outside of tables, such as notes, examples and references in smaller type.
148 Normative text of tables is also in a smaller type;
149 – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
150 NOTED: SMALL CAPITALS.
151 In referring to the structure of this document, the term
152 – "clause" means one of the seventeen numbered divisions within the table of contents,
153 inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
154 – "subclause" means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
155 subclauses of Clause 7).
156 References to clauses within this document are preceded by the term "Clause" followed by the
157 clause number. References to subclauses within this particular standard are by number only.
158 In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any
159 combination of the conditions is true.
160 The verbal forms used in this document conform to usage described in Clause 7 of the ISO/IEC
161 Directives, Part 2. For the purposes of this document, the auxiliary verb:
162 – "shall" means that compliance with a requirement or a test is mandatory for compliance with
163 this document;
164 – "should" means that compliance with a requirement or a test is recommended but is not
165 mandatory for compliance with this document;
166 – "may" is used to describe a permissible way to achieve compliance with a requirement or
167 test.
168 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
169 indicates that there is guidance or rationale related to that item in Annex AA.
170 A list of all parts of the IEC 80601 and IEC 60601 International Standard, published under the
171 general title Medical electrical equipment, can be found on the IEC website.
IEC CDV 80601-2-78 © IEC 2026
173 The committee has decided that the contents of this document and its amendment will remain
174 unchanged until the stability date indicated on the IEC website under webstore.iec.ch in the
175 data related to the specific document. At this date, the document will be
176 • reconfirmed,
177 • withdrawn, or
178 • revised.
179 NOTE
180 The attention of users of this document is drawn to the fact that equipment manufacturers and testing organizations
181 may need a transitional period following publication of a new, amended or revised IEC publication in which to make
182 products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is
183 the recommendation of the committees that the content of this publication be adopted for implementation nationally
184 not earlier than 3 years from the date of publication.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this document using a colour printer.
IEC CDV 80601-2-78 © IEC 2026
187 INTRODUCTION
189 During the September 21, 2023, meeting of IEC SC62D Plenary in Seoul, Republic of Korea,
190 the subcommittee discussed the need to proceed with a new edition of IEC 80601-2-78. The
191 need for a new edition was to include/modify the standard based on the latest medical robots
192 for rehabilitation, assessment, compensation or alleviation (RACA).
nd
194 A resolution was taken to proceed towards the 2 edition of the IEC 80601-2-78.
195 The review report for the new edition can be found in the IEC 62D/2158/RR document.
nd
196 This 2 edition of the IEC 80601-2-78 supersedes the IEC 80601-2-78 edition 1.1 standard.
198 In this second edition, compared to the first edition, the following significant points were
199 added or modified:
200 • revised the scope to clarify which product falls in the scope of this standard
201 • revised definitions, including RACA ROBOT, for clarity
202 • added new requirements for battery management systems of secondary batteries
203 • revised requirements for support systems for clarity
204 • added new requirements for use of Head Mounted Displays (HMD) or other extended
205 reality (XR) devices with RACA ROBOTS
206 The following flowchart provides guidance on whether an ME EQUIPMENT or ME SYSTEM is a
207 RACA ROBOT.
IEC CDV 80601-2-78 © IEC 2026
No Decision Description Further Information
1 Is the device a ME EQUIPMENT or ME Refer to definition:
No
SYSTEM? 1. IEC 60601-1 Clause 3.63 ME EQUIPMENT
2. IEC 60601-1 Clause 3.64 ME SYSTEM
Yes
2 Is the ME EQUIPMENT or ME SYSTEM a The listed devices are addressed in following standards:
Yes • external limb prosthetic devices • ISO 22523
• electric wheelchairs • ISO 7176 (all parts)
• diagnostic imaging equipment • e.g. MRI, IEC 60601-2-33
No
• personal care robots • ISO 13482
3 Is the INTENDED USE of ME EQUIPMENT or / Refer to definition:
No
1. IEC 80601-2-78 Clause 201.3.202 ALLEVIATION
ME SYSTEM related to REHABILITATION,
“Treatment to ease symptoms due to an IMPAIRMENT of a
ASSESSMENT, COMPENSATION or
PATIENT”
ALLEVIATION?
Yes
2. IEC 80601-2-78 Clause 201.3.203 ASSESSMENT
“Procedure to quantify or to aid in the qualification of the
level of IMPAIRMENT of a PATIENT”
3. IEC 80601-2-78 Clause 201.3.205 COMPENSATION
“Mitigation of IMPAIRMENT of a PATIENT through support of
body structures or through support or replacement of body
functions”
4. IEC 80601-2-78 Clause 201.3.211 * REHABILITATION
“Treatment to improve MOVEMENT FUNCTIONS related to an
IMPAIRMENT of a PATIENT”
4 Does the ME EQUIPMENT or / ME SYSTEM Refer to definition:
have an ACTUATED APPLIED PART? IEC 80601-2-78 Clause 201.3.201 ACTUATED APPLIED PART
No
“Intended to provide actively controlled physical interactions with
Yes
the PATIENT»
5 Is the ACTUATED APPLIED PART intended to Refer to definition:
No
physically interact with a PATIENT, 1. IEC 80601-2-78 Clause 201.3.209 MOVEMENT FUNCTIONS
related to PATIENT MOVEMENT FUNCTIONS, “Function consisting of one or more of sensory,
to perform a clinical function? neuromusculoskeletal or movement-related body functions
that comprise PATIENT motor control”
Yes
6 Does the ME EQUIPMENT or ME SYSTEM Refer to definition:
have a LEVEL OF AUTONOMY greater than 1. IEC 80601-2-78 Clause 201.3.214EVEL OF AUTONOMY
zero? extent to which functions or tasks under NORMAL USE are
No
performed without OPERATOR intervention”

7 The ME EQUIPMENT or / ME SYSTEM is a RACA
Yes
ROBOT
RACA
ROBOT
8 The device is not a RACA ROBOT

NO RACA
ROBOT
210 The defined terms can be found in:
211 1 IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety
212  and essential performance
213 IEC 80601-2-78 Medical electrical equipment – Part 2-78: Particular requirements for basic
214 safety and essential performance of medical robots for rehabilitation, assessment,
215 compensation or alleviation
216 or may also be listed in Electropedia; https://www.electropedia.org
220 MEDICAL ELECTRICAL EQUIPMENT –
IEC CDV 80601-2-78 © IEC 2026
222 Part 2-78: Particular requirements for basic safety and essential
223 performance of medical robots for rehabilitation, assessment,
224 compensation or alleviation
227 201.1 Scope, object and related standards
228 Clause 1 of the general standard applies, except as follows:
229 201.1.1 Scope
230 Replacement:
231 This part of IEC 80601 applies to the general requirements for BASIC SAFETY and ESSENTIAL
232 PERFORMANCE of medical robots that physically interact with a PATIENT with an IMPAIRMENT to
233 support or perform REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION related to the
234 PATIENT’S MOVEMENT FUNCTIONS, as intended by the MANUFACTURER.
235 Note: A MOVEMENT FUNCTION is a function consisting of one or more of sensory, neuromusculoskeletal or movement -
236 related body functions that comprise PATIENT motor control.
238 A RACA ROBOT is defined in this standard as a PROGRAMMABLE ELECTRICAL MEDICAL SYSTEM (PEMS)
239 with a LEVEL OF AUTONOMY greater than zero, comprising an ACTUATED APPLIED PART, intended
240 by its MANUFACTURER to perform REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION
241 Note 1: a LEVEL OF AUTONOMY of zero is defined as having no AUTONOMY in any of its functions
243 RACA ROBOTS covered by this particular standard include but are not limited to:
244 • Exoskeletons or robotic orthoses for upper and lower limbs for ASSESSMENT,
245 REHABILITATION, ALLEVIATION or COMPENSATION
246 • Robotic end-effectors for upper / lower extremities for ASSESSMENT or REHABILITATION
247 • Active balance control equipment for ASSESSMENT or REHABILITATION
248 • Overhead robotic body weight support systems
249 • Robotic walkers
250 • Robots intended to alleviate hemiplegic shoulder/ joint pain or spasticity through
251 movement
252 • Continuous Passive Motion devices with a LEVEL OF AUTONOMY
254 Note 2: Annex AA lists examples of RACA ROBOT.
255 Note 3: This particular standard is primarily focused on human beings but, may also be used for animal PATIENTS.
256 The RISK MANAGEMENT PROCESS may be necessary to address specific BASIC SAFETY and ESSENTIAL PERFORMANCE for
257 animal PATIENTS.
258 This particular standard does not apply to:
259 • Devices that support activities of daily living (including active assisted living),
260 but do not directly address PATIENT MOVEMENT FUNCTIONS, such as:
261 o electric wheelchairs (use ISO 7176 (all parts)),
262 o personal care / service robots (use ISO 13482: 2014), e.g. feeding robots,
263 robotic hoists, robotic bed
264 • Devices with a LEVEL OF AUTONOMY of zero
265 o E.g. Continuous Passive Motion devices with no AUTONOMY
266 • the following devices which are covered by other standards:
267 o external limb prosthetic devices (use ISO 22523: 2006),
268 o diagnostic imaging equipment (e.g. MRI, use IEC 60601-2-33: 2022),
____________
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 80601-2-78 © IEC 2026
269 o stationary training equipment (ISO 20957 series) e.g. treadmills
270 If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME
271 SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case,
272 the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
273 NOTE See also 4.2 of the general standard.
274 201.1.2 Object
275 Replacement:
276 The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
277 PERFORMANCE requirements for MEDICAL ROBOTS that physically interact with a PATIENT with an
278 IMPAIRMENT, to support or perform REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION
279 related to the PATIENT’S MOVEMENT FUNCTIONS.
280 201.1.3 Collateral standards
281 Addition:
282 This particular standard refers to those applicable collateral standards that are listed in Clause
283 2 of the general standard and Clause 201.2 of this particular standard.
284 IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:2010, IEC 60601-1-
285 6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020, IEC 60601-1-8:2006, IEC 60601-1-
286 8:2006/AMD1:2012 and IEC 60601-1-8:2006/AMD2:2020, IEC 60601-1-10:2007, IEC 60601-1-
287 10:2007/AMD1:2013 and IEC 60601-1-10:2007/AMD2:2020, and IEC 60601-1-11:2015 and
288 IEC 60601-1-11:2015/AMD1:2020 apply as modified in Clauses 202, 206, 208, 210 and 211
289 respectively. IEC 60601-1-3 and IEC 60601-1-12 do not apply. All other published collateral
290 standards in the IEC 60601-1 series apply as published.
291 201.1.4 Particular standards
292 Replacement:
293 In the IEC 60601 series, particular standards may modify, replace or delete requirements
294 contained in the general standard and collateral standards as appropriate for the particular
295 ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
296 PERFORMANCE requirements.
297 A requirement of a particular standard takes priority over the general standard.
298 For brevity, IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/
299 AMD2:2020 are referred to in this particular standard as the general standard. Collateral
300 standards are referred to by their document number.
301 The numbering of clauses and subclauses of this particular standard corresponds to that of the
302 general standard with the prefix "201" (e.g. 201.1 in this document addresses the content of
303 Clause 1 of the general standard) or applicable collateral standard with the prefix "20x" where
304 x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular
305 standard addresses the content of Clause 4 of the 60601-1-2 collateral standard, 203.4 in this
306 particular standard addresses the content of Clause 4 of the IEC 60601-1-3 collateral standard,
307 etc.). The changes to the text of the general standard are specified by the use of the following
308 words:
309 "Replacement" means that the clause or subclause of the general standard or applicable
310 collateral standard is replaced completely by the text of this particular standard.
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311 "Addition" means that the text of this particular standard is additional to the requirements of the
312 general standard or applicable collateral standard.
313 "Amendment" means that the clause or subclause of the general standard or applicable
314 collateral standard is amended as indicated by the text of this particular standard.
315 Subclauses, figures or tables which are additional to those of the general standard are
316 numbered starting from 201.101. However, due to the fact that definitions in the general
317 standard are numbered 3.1 through 3.147, additional definitions in this document are numbered
318 beginning from 201.3.201. Additional Annexes are lettered AA, BB, etc., and additional items
319 aa), bb), etc.
320 Subclauses, figures or tables which are additional to those of a collateral standard are
321 numbered starting from 20x, where "x" is the number of the collateral standard, e.g. 202 for
322 IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
323 The term "this document" is used to make reference to the general standard, any applicable
324 collateral standards and this particular standard taken together.
325 Where there is no corresponding clause or subclause in this particular standard, the clause or
326 subclause of the general standard or applicable collateral standard, although possibly not
327 relevant, applies without modification; where it is intended that any part of the general standard
328 or applicable collateral standard, although possibly relevant, is not to be applied, a statement
329 to that effect is given in this particular standard.
330 201.2 Normative references
331 NOTE Informative references are listed in the Bibliography.
332 Clause 2 of the general standard applies, except as follows:
333 Replacement:
334 IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
335 safety and essential performance – Collateral Standard: Electromagnetic disturbances –
336 Requirements and tests
337 IEC 60601-1-2:2014/AMD1:2020
338 IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic
339 safety and essential performance – Collateral standard: Usability
340 IEC 60601-1-6:2010/AMD1:2013
341 IEC 60601-1-6:2010/AMD2:2020
342 IEC 60601-1-8:2006, Medical electrical equipment – Part 1-8: General requirements for basic
343 safety and essential performance – Collateral Standard: General requirements, tests and
344 guidance for alarm systems in medical electrical equipment and medical electrical systems
345 IEC 60601-1-8:2006/AMD1:2012
346 IEC 60601-1-8:2006/AMD2:2020
347 ISO 14971:2019, Medical devices – Application of risk management to medical devices
348 Addition:
349 IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
350 and essential performance
351 IEC 60601-1:2005/AMD1:2012
352 IEC 60601-1:2005/AMD2:2020
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353 IEC 60601-1-10:2007, Medical electrical equipment – Part 1-10: General requirements for basic
354 safety and essential performance – Collateral Standard: Requirements for the development of
355 physiologic closed-loop controllers
356 IEC 60601-1-10:2007/AMD1:2013
357 IEC 60601-1-10:2007/AMD2:2020
358 IEC 60601-1-11:2015, Medical electrical equipment – Part 1-11: General requirements for basic
359 safety and essential performance – Collateral Standard: Requirements for medical electrical
360 equipment and medical electrical systems used in the home healthcare environment
361 IEC 60601-1-11:2015/AMD1:2020
362 IEC 62366-1:2015, Medical devices – Part 1: Application of usability engineering to medical
363 devices
364 IEC 62366-1:2015/AMD1:2020
365 ISO 22523:2006, External limb prostheses and external orthoses – Requirements and test
366 methods
367 201.3 Terms and definitions
368 For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
369 IEC 60601­1:2005/AMD1:2012 and IEC 60601-1:2005/AMD1:2020 apply.
370 ISO and IEC maintain terminological databases for use in standardization at the following
371 addresses:
372 • IEC Electropedia: available at http://www.electropedia.org/
373 • ISO Online browsing platform: available at http://www.iso.org/obp
374 NOTE An Index of defined terms is found beginning on page 76.
375 Amendment:
376 201.3.63
377 * MEDICAL ELECTRICAL EQUIPMENT
378 ME EQUIPMENT
379 Addition:
380 Note to entry: See Figure AA.1 which was specifically adapted for new types of RACA ROBOT classified as WALKING
381 201.3.65
382 MOBILE
383 Addition:
384 Note to entry: MOBILE also includes equipment intended to support the movement of a PATIENT from one location to
385 another.
386 201.3.144
387 Replacement:
388 *RACA BODY-WORN
389 term referring to PORTABLE equipment whose INTENDED USE includes operation while being worn
390 by a PATIENT or attached to a PATIENT’S clothing
391 Note to entry: RACA BODY-WORN is a subcategory of PORTABLE ME EQUIPMENT and ME SYSTEM, replacing BODY-WORN,
392 as shown in Figure AA.1
394 :
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395 201.3.201
396 *ACTUATED APPLIED PART
397 subcategory of APPLIED PART that is intended to provide actively controlled physical interactions
398 with the PATIENT that are related to the PATIENT’s MOVEMENT FUNCTIONS, to perform a clinical
399 function of a RACA ROBOT
400 Note 1 to entry: "Actively controlled" as used above is intended to mean controlled by the RACA ROBOT, including
401 shared control with the PATIENT or OPERATOR.
402 Note 2 to entry: Actively controlled physical interactions include position control, force control, impedance control,
403 admittance control, or any other controls that regulate the interaction between a RACA ROBOT and the PATIENT.
404 Note 3 to entry: Each ACTUATED APPLIED PART is part of an actuation system according to 9.8.1 of the general
405 standard.
406 201.3.202
407 ALLEVIATION
408 treatment to ease symptoms due to an IMPAIRMENT of a PATIENT
409 Note to entry: An example of ALLEVIATION is physical therapy performed by a RACA ROBOT to reduce pain or other
410 secondary effects of an IMPAIRMENT.
411 201.3.203
412 * ASSESSMENT
413 procedure to quantify or to aid in the qualification of the level of IMPAIRMENT of a PATIENT.
414 Note 1 to entry: The term "ASSESSMENT" should not be confused with the term "RISK ASSESSMENT’"
415 Note 2 to entry: Assessment in this definition focuses on the level of IMPAIRMENT of body functions and structures
416 and not of activity limitations or participation restrictions ([1]2, Chapter 4).
417 Note 3 to entry: ASSESSMENT can be distinguished from both measurement and diagnosis. Measurement typically
418 refers to the physiological parameter being measured (e.g. PATIENT hand position by a RACA ROBOT) and is typically
419 related to, or is the direct output of a transducer. Those measurements are then used to quantify an IMPAIRMENT (e.g.,
420 proprioception, planning of a movement, etc). Because IMPAIRMENTs are not the same as the underlying pathology,
421 but are the manifestations of an underlying pathology, an ASSESSMENT that quantifies the IMPAIRMENT can then be
422 used by a clinician to support a diagnosis that identifies the pathology, or to monitor the progression of a pathology
423 or recovery from an injury. See Annex AA for an example.
425 201.3.204
426 COMPENSATION
427 mitigation of IMPAIRMENT of a PATIENT through support of body structures or through support or
428 replacement of body functions
429 Note to entry: COMPENSATION could be provided by, for example, externally powered orthoses. COMPENSATION does
430 not include the improvement of MOVEMENT FUNCTIONS related to an IMPAIRMENT, which is defined as REHABILITATION.
431 201.3.205
432 EMERGENCY STOP
433 manually initiated interruption of operation intended to stop the RACA ROBOT to prevent HARM
434 Note 1 to entry: EMERGENCY STOP is meant as a last resort when no other means to reduce risk are available.
435 Note 2 to entry: EMERGENCY STOP does not allow an automatic restart, in contrast to a PROTECTIVE STOP.
436 Note 3 to entry: The activation of an EMERGENCY STOP does not necessarily shut down all the power in a RACA
437 ROBOT. Refer to 9.2.4 of the general standard for further clarification.
____________
Numbers in square brackets refer to the Bibliography.
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438 201.3.206
439 * IMPAIRMENT
440 problem in body function or structure, such as significant deviation or loss
441 Note 1 to entry: "Problems" here is used to refer to a (negative) deviation from generally accepted population
442 normality levels in the biomedical status of the body and its functions. Notification of the constituents of IMPAIRMENT
443 is undertaken primarily by those qualified to judge functioning according to the generally accepted normality levels.
444 An IMPAIRMENT usually follows a disease or accident, but also includes birth defects.
445 Note 2 to entry: This document only concerns ME EQUIPMENT or ME SYSTEM, meaning that it addresses IMPAIRMENT
446 of a PATIENT and not normal age-related IMPAIRMENTS.
447 [SOURCE: ISO 9999:2016, 2.11, modified – The term is here in singular instead of plural. The
448 notes to entry have been added.]
449 201.3.207
450 *MOVEMENT FUNCTION
451 function consisting of one or more of sensory, neuromusculoskeletal or movement -related body
452 functions that comprise PATIENT motor control.
453 Note to entry: ”Sensory”, "neuromusculoskeletal" and "movement-related" come from the body functions
454 classification presented in [1] [6] For example: Gait pattern functions are considered a MOVEMENT FUNCTION, whereas
455 walking is considered an activity [6].
456 201.3.208
457 * PROTECTIVE STOP
458 interruption of operation automatically initiated by the RACA ROBOT, that allows a cessation of
459 motion for BASIC SAFETY and ESSENTIAL PERFORMANCE purposes, which could allow the
460 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEM (PEMS)/PROGRAMMABLE ELECTRONIC SUBSYSTEM
461 (PESS) to facilitate a restart
462 Note 1 to entry: See also ISO 8373:2021, 6.24.
463 Note 2 to entry: A PROTECTIVE STOP is defined in contrast to an EMERGENCY STOP or a normal stop; clarification is
464 provided in Table 201.102.
465 Note 3 to entry: Automatically initiated” means that the RACA ROBOT is detecting a potentially HAZARDOUS SITUATION
466 and as a result of this detection the RACA ROBOT then initiates a stopping procedure
467 Note 4 to entry: The defined term is related to FALLBACK MODE defined in IEC 60601-1-10:2007, 3.11.
468 Note 5 to entry: Even during the cessation of motion, the actuators are not necessarily deactivated. In certain
469 conditions, the actuators may hold the PATIENT or PATIENT’S limbs in a stable position.
470 201.3.209
471 * REHABILITATION
472 treatment to improve MOVEMENT FUNCTIONS related to an IMPAIRMENT of a PATIENT
473 EXAMPLE: Relearning of motor control of the upper or lower extremities, restoration of muscle strength and
474 endurance.
475 Note 1 to entry: REHABILITATION can be carried out in situations where a PATIENT has an IMPAIRMENT due to an
476 accident or disease or congenital conditions (e.g. cerebral palsy) or can be used to slow down the expected loss of
477 body functions due to neurodegenerative diseases (e.g. Parkinson’s, Multiple Sclerosis).
478 Note 2 to entry: This definition differs from the World Health Organization (WHO) definition and covers only a subset
479 of that defi
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