EN IEC 60601-2-91:2026
(Main)Medical electrical equipment - Part 2-91: Particular requirements for basic safety and essential performance of non-thermal plasma wound treatment equipment
- Abstract
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES.
NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES are not intended to supply heat to the PATIENT. They are used to treat chronic and acute wounds and biological tissue as well as diverse skin and itching diseases.
HAZARDS inherent in the intended physiological function of PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES within the scope of this document are covered by specific requirements in 7.2.13 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
This document does not apply to ME EQUIPMENT intended for the haemostasis of biological tissue (see IEC 60601-2-2[1]1 and IEC 60601-2-76[2]).
- Status
- Published
- Publication Date
- 13-Aug-2026
- Technical Committee
- CLC/TC 62 - Electrical equipment in medical practice
- Drafting Committee
- IEC/SC 62D - IEC_SC_62D
- Current Stage
- 6060 - Document made available - Publishing
- Start Date
- 14-Aug-2026
- Due Date
- 30-Sep-2024
- Completion Date
- 14-Aug-2026
EN IEC 60601-2-91:2026 is a CENELEC European Standard that adopts IEC 60601-2-91:2026 for non-thermal plasma wound treatment equipment. It specifies particular basic safety and essential performance requirements for equipment and accessories used to treat wounds and related skin and itching diseases without intending to supply heat to the patient. It is written for manufacturers, test laboratories, and technical teams that need to design, test, document, or assess these devices.
What does EN IEC 60601-2-91:2026 specify?
EN IEC 60601-2-91:2026 sets particular requirements for the basic safety and essential performance of non-thermal plasma wound treatment equipment and non-thermal plasma wound treatment accessories. It follows the IEC 60601-1 structure and adds device-specific requirements for the hazards created by plasma treatment, electrical output, insulation, temperature, and reactive species.
The document applies to equipment used for wound treatment and related biological tissue applications, and it states that the equipment and accessories are not intended to supply heat to the patient. It does not apply to equipment intended for haemostasis of biological tissue.
The body of the standard is organized as Clauses 201.1 to 201.17, covering scope, normative references, terms, general requirements, testing, classification, marking, electrical hazards, mechanical hazards, radiation hazards, temperature hazards, controls, hazardous situations, PEMS, construction, ME systems, and EMC.
| Annex | What it covers |
|---|---|
| Annex AA | Particular guidance and rationale for selected clauses and definitions |
| Annex BB | Guidance to the manufacturer on testing reactive species to inform the operator by measuring long-lived reactive species |
| Annex CC | Guidance to the manufacturer on testing reactive species to inform the operator by determining the production rate of reactive species |
| Annex ZA | Normative references to international publications with their corresponding European publications |
What are the key requirements of EN IEC 60601-2-91:2026?
EN IEC 60601-2-91:2026 mainly tightens the safety assessment for plasma-based wound treatment by adding device-specific test methods and information requirements. In practice, manufacturers have to show that the applied part, insulation, outputs, temperature rise, and reactive species risks are controlled for the intended use.
Device identity, marking, and instructions for use
Clause 201.7 requires warnings and safety notices, including a warning about direct eye contact for accessories unless the risk analysis shows that eye contact does not create unacceptable risk. The instructions for use must state the recommended distance between the distal end of the equipment and the patient, the maximum high frequency peak voltage, a list of compatible accessories, and any warnings and measures needed when long-lived reactive species may exceed safety thresholds.
This matters because the operator needs clear setup and use information, not only a device label. The distance, voltage, and compatibility list affect how the device is used safely in the clinic or treatment room.
Leakage current and electrical protection
Clause 201.8 adds a specific patient leakage current requirement for the non-thermal plasma output. The current is measured with the setup shown in Figure 201.101 and must stay within the limits for the declared applied part type in normal condition and single fault condition.
This matters because plasma systems can create electrical exposure at the treatment site. The standard therefore links compliance to the declared applied part and to a defined measurement setup.
Insulation of accessories and cords
Clause 201.8.8.3 requires insulation testing for non-thermal plasma wound treatment accessories and their cords. The insulation must be able to withstand high frequency dielectric stress and mains frequency or DC dielectric stress after saline preconditioning, and the tests are carried out in a specific order.
The standard also gives separate high frequency leakage and dielectric strength tests for accessories, including different arrangements for grounded and non-grounded electrode designs. This matters because the accessory is part of the patient-circuit interface and must remain safe after moisture, cleaning, disinfection, or sterilization cycles.
Temperature and burn risk
Clause 201.11 keeps the general temperature protection requirements and adds a measurement for maximum patient tissue temperature using a grounded copper plate and a thermocouple at the centre. The equipment is operated at maximum output for 5 minutes or the maximum operating time in the instructions for use, whichever is longer.
This matters because the device is not intended to supply heat, so temperature rise at the treatment site has to be checked under worst-case operating conditions.
Reactive species risk management
Clause 201.11.101 requires the manufacturer to identify risks associated with reactive species such as ozone, nitrogen monoxide, and nitrogen dioxide in the risk analysis, and to document the measures used to reduce those risks. Compliance is checked by review of the risk management file and, where relevant, the instructions for use.
This matters because the plasma process can generate chemically active species as well as electrical output. The standard therefore expects the manufacturer to treat gas exposure as a design and use issue, not only a laboratory measurement.
General IEC 60601-1 requirements still apply
Clauses 201.4, 201.5, 201.6, 201.9, 201.10, 201.12, 201.13, 201.14, 201.15, 201.16, and 201.17 state that the corresponding IEC 60601-1 clauses apply, with the particular modifications in this part. In practice, this means the device still has to meet the usual medical electrical equipment requirements for classification, testing, mechanical safety, radiation, controls, fault conditions, PEMS, construction, ME systems, and EMC.
What terms does EN IEC 60601-2-91:2026 define?
ACTIVE TREATED ZONE - The area of treated tissue during intended use.
NON-THERMAL PLASMA - A partially ionized gas with reactive species, electrons, ions, ambient molecules, and electromagnetic radiation that is not intended to supply heat to the patient.
NON-THERMAL PLASMA WOUND TREATMENT ACCESSORY - An accessory, which can be the applied part, intended to apply non-thermal plasma for wound treatment at the intended site.
NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT - Medical electrical equipment that treats wounds together with the related accessory using non-thermal plasma to promote wound recovery.
REACTIVE SPECIES - Reactive atoms or molecules generated in the non-thermal plasma with sufficient lifetime to reach the respiratory tract of the patient and operator.
WOUND TREATMENT - Treatment by non-thermal plasma applied to biological tissue in a wound or in diverse skin and itching diseases.
Who uses EN IEC 60601-2-91:2026?
EN IEC 60601-2-91:2026 is used by manufacturers of plasma-based wound treatment devices, accessory suppliers, test laboratories, and risk management teams. It is also relevant to technical reviewers who assess safety documentation, instructions for use, leakage current results, insulation testing, and reactive species risk controls.
In practice, manufacturers use it when designing the device, choosing compatible accessories, writing labeling and instructions, and preparing the risk management file. Test laboratories use it to set up leakage, dielectric strength, and temperature measurements in the specified configurations.
What changed in EN IEC 60601-2-91:2026 from the previous edition?
EN IEC 60601-2-91:2026 is identified as future edition 1 of IEC 60601-2-91 and was approved by CENELEC without modification. The European foreword gives the national implementation dates and states that the IEC text was adopted as EN IEC 60601-2-91:2026 without change.
Which standards are used with EN IEC 60601-2-91:2026?
The document uses IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, and IEC 60601-1:2005/AMD2:2020 as its general basis for medical electrical equipment safety and essential performance. It also names ISO 14971:2019 for risk management, which supports the risk analysis and risk management file used in the plasma-specific clauses.
The bibliography also names related standards and guidance that help place this part in context: IEC 60601-2-2:2017 and its amendment for high frequency surgical equipment, IEC 60601-2-76:2018 for low energy ionized gas haemostasis equipment, IEC 60601-1-3 and IEC 60601-1-10 as collateral standards, plus ozone and nitrogen oxide measurement standards used in Annex CC.
What does the EN IEC 60601-2-91:2026 document contain?
EN IEC 60601-2-91:2026 contains the clause-by-clause particular requirements, defined terms, test methods, and figure-based measurement setups needed for this device type. The figures show how to measure patient leakage current, high frequency leakage current, and maximum patient tissue temperature, so the reader can reproduce the intended test arrangements.
It also includes informative annexes with rationale and manufacturer guidance for reactive species assessment. Annex BB and Annex CC are especially useful for teams that need to design laboratory measurements and turn them into information for the operator and risk documentation.
Relations
- Effective Date
- 28-Jul-2026
- Effective Date
- 28-Jul-2026
- Effective Date
- 28-Jul-2026
- Effective Date
- 18-Aug-2026
- Effective Date
- 18-Aug-2026
- Effective Date
- 18-Aug-2026
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Frequently Asked Questions
EN IEC 60601-2-91:2026 is a standard published by CLC. Its full title is "Medical electrical equipment - Part 2-91: Particular requirements for basic safety and essential performance of non-thermal plasma wound treatment equipment". This standard covers: This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES. NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES are not intended to supply heat to the PATIENT. They are used to treat chronic and acute wounds and biological tissue as well as diverse skin and itching diseases. HAZARDS inherent in the intended physiological function of PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES within the scope of this document are covered by specific requirements in 7.2.13 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020. This document does not apply to ME EQUIPMENT intended for the haemostasis of biological tissue (see IEC 60601-2-2[1]1 and IEC 60601-2-76[2]).
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES. NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES are not intended to supply heat to the PATIENT. They are used to treat chronic and acute wounds and biological tissue as well as diverse skin and itching diseases. HAZARDS inherent in the intended physiological function of PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES within the scope of this document are covered by specific requirements in 7.2.13 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020. This document does not apply to ME EQUIPMENT intended for the haemostasis of biological tissue (see IEC 60601-2-2[1]1 and IEC 60601-2-76[2]).
EN IEC 60601-2-91:2026 is classified under the following ICS (International Classification for Standards) categories: 11.040.99 - Other medical equipment; 11.140 - Hospital equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN IEC 60601-2-91:2026 has the following relationships with other standards: It is inter standard links to EN 60601-1:2006, EN 60601-1:2006/A1:2013, EN 60601-1:2006/A2:2021, EN 1789:2007+A1:2010, EN 1789:2007+A2:2014, EN 13718-1:2008. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN IEC 60601-2-91:2026 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2026
Medicinska električna oprema - 2-91. del: Posebne zahteve za osnovno varnost in
bistveno delovanje opreme za zdravljenje ran z netermično plazmo (IEC 60601-2-
91:2026)
Medical electrical equipment - Part 2-91: Particular requirements for basic safety and
essential performance of non-thermal plasma wound treatment equipment (IEC 60601-2-
91:2026)
Besondere Festlegungen für die grundlegende Sicherheit und die wesentlichen
Leistungsmerkmale von Geräten zur nichtthermischen Plasmawundbehandlung (IEC
60601-2-91:2026)
Exigences particulières pour la sécurité de base et les performances essentielles des
appareils de traitement des plaies par plasma non thermique (IEC 60601-2-91:2026)
Ta slovenski standard je istoveten z: EN IEC 60601-2-91:2026
ICS:
11.040.99 Druga medicinska oprema Other medical equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN IEC 60601-2-91
NORME EUROPÉENNE
EUROPÄISCHE NORM August 2026
ICS 11.040.99; 11.140
English Version
Medical electrical equipment - Part 2-91: Particular requirements
for basic safety and essential performance of non-thermal
plasma wound treatment equipment
(IEC 60601-2-91:2026)
Appareils électromédicaux - Partie 2-91: Exigences Medizinische elektrische Geräte - Teil 2-91: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die grundlegende Sicherheit und die
essentielles des appareils de traitement des plaies par wesentlichen Leistungsmerkmale von Geräten zur
plasma non thermique nichtthermischen Plasmawundbehandlung
(IEC 60601-2-91:2026) (IEC 60601-2-91:2026)
This European Standard was approved by CENELEC on 2026-07-24. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60601-2-91:2026 E
European foreword
The text of document 62D/2297/FDIS, future edition 1 of IEC 60601-2-91, prepared by SC 62D
"Particular medical equipment, software, and systems" of IEC/TC 62 "Medical equipment, software,
and systems" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2027-08-31
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2029-08-31
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60601-2-91:2026 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standard indicated:
IEC 60601-2-2:2017 NOTE Approved as EN IEC 60601-2-2:2018 (not modified)
IEC 60601-2-2:2017/AMD1:2023 NOTE Approved as EN IEC 60601-2-2:2018/A1:2024 (not
modified)
IEC 60601-2-76:2018 NOTE Approved as EN IEC 60601-2-76:2019 (not modified)
IEC 60601-1-3 NOTE Approved as EN 60601-1-3
IEC 60601-1-10 NOTE Approved as EN 60601-1-10
ISO 14971:2019 NOTE Approved as EN ISO 14971:2019 (not modified)
+ A11:2021
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cencenelec.eu.
Publication Year Title EN/HD Year
IEC 60601-1 2005 Medical electrical equipment - Part 1: General EN 60601-1 2006
requirements for basic safety and essential
performance
- - + corrigendum Mar. 2010
+ A1 2012 + A1 2013
- - + A12 2014
+ A2 2020 + A2 2021
- - + A13 2024
IEC 60601-2-91 ®
Edition 1.0 2026-06
INTERNATIONAL
STANDARD
Medical electrical equipment -
Part 2-91: Particular requirements for basic safety and essential performance of
non-thermal plasma wound treatment equipment
ICS 11.040.99; 11.140 ISBN 978-2-8327-1327-3
IEC 60601-2-91:2026-06(en)
IEC 60601-2-91:2026 © IEC 2026
CONTENTS
FOREWORD . 2
INTRODUCTION . 4
201.1 Scope, object and related standards . 5
201.2 Normative references . 6
201.3 Terms and definitions . 7
201.4 General requirements. 8
201.5 General requirements for testing ME EQUIPMENT . 8
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 8
201.7 ME EQUIPMENT identification, marking and documents. 8
201.8 Protection against electrical HAZARDS from ME EQUIPMENT. 9
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS. 14
201.10 Protection against unwanted and excessive radiation HAZARDS . 14
201.11 Protection against excessive temperatures and other HAZARDS . 14
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 15
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 15
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 15
201.15 Construction of ME EQUIPMENT . 15
201.16 ME SYSTEMS . 16
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 16
Annex AA (informative) Particular guidance and rationale . 17
Annex BB (informative) Guidance to the MANUFACTURER on the REACTIVE SPECIES to be
tested to inform the OPERATOR (measurement of long-lived REACTIVE SPECIES) . 18
Annex CC (informative) Guidance to the MANUFACTURER on the REACTIVE SPECIES to be
tested to inform the OPERATOR (determining the production rate of REACTIVE SPECIES) . 20
Bibliography . 24
Index of defined terms . 26
Figure 201.101 – Measurement of PATIENT LEAKAGE CURRENT . 9
Figure 201.102 – Measurement of HIGH FREQUENCY leakage current. 12
Figure 201.103 – Measurement of maximum PATIENT tissue temperature . 15
Figure BB.1 – Experimental setup for measurement of REACTIVE SPECIES
concentrations for equipment not dependent on an additional grounded electrode for
operation . 18
Figure BB.2 – Experimental setup for measurement of REACTIVE SPECIES
concentrations for equipment dependent on an additional grounded electrode for
operation . 19
Figure CC.1 – Experimental setup for determining the production rate of REACTIVE
SPECIES . 21
IEC 60601-2-91:2026 © IEC 2026
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
Medical electrical equipment -
Part 2-91: Particular requirements for basic safety and essential
performance of non-thermal plasma wound treatment equipment
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC Publication(s)"). Their
preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
may participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence between
any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
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assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
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members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) IEC draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). IEC takes no position concerning the evidence, validity or applicability of any claimed patent rights in
respect thereof. As of the date of publication of this document, IEC had not received notice of (a) patent(s), which
may be required to implement this document. However, implementers are cautioned that this may not represent
the latest information, which may be obtained from the patent database available at https://patents.iec.ch. IEC
shall not be held responsible for identifying any or all such patent rights.
IEC 60601-2-91 has been prepared by subcommittee 62D: Particular medical equipment,
software, and systems, of IEC technical committee 62: Medical equipment, software, and
systems. It is an International Standard.
The text of this International Standard is based on the following documents:
Draft Report on voting
62D/2297/FDIS 62D/2314/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.
IEC 60601-2-91:2026 © IEC 2026
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/publications.
In this document, the following print types are used:
– requirements and definitions: roman type;
– test specifications: italic type;
– informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type;
– terms defined in Clause 3 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 AND
IEC 60601-1:2005/AMD2:2020, in this document or as noted: SMALL CAPITALS.
In referring to the structure of this document, the term
– "clause" means one of the eighteen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– "subclause" means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this document are preceded by the term "Clause" followed by the
clause number. References to subclauses within this document are by number only.
In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to usage described in Clause 7 of the ISO/IEC
Directives, Part 2. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance with
this document;
– "should" means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– "may" is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 series, published under the general title: Medical electrical
equipment, can be found on the IEC website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
– reconfirmed,
– withdrawn, or
– revised.
IEC 60601-2-91:2026 © IEC 2026
INTRODUCTION
The minimum safety requirements specified in this document are considered to provide for a
practical degree of safety in the operation of NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT.
This document amends and supplements 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.
The requirements are followed by specifications for the relevant tests.
This document is to define the safety of, and provides the test methods to evaluate the HAZARDS
of NON-THERMAL PLASMA WOUND TREATMENT ME. This would include the following potential
HAZARDS: plasma gas temperature, O level, nitrogen oxide level, electrical leakage, and
electrical insulation. This document will be limited to NON-THERMAL PLASMA WOUND TREATMENT
EQUIPMENT.
Conventional MEDICAL ELECTRICAL EQUIPMENT treats wounds individually using electrical
stimulation, heat, radiation, and light. Unlike conventional medical devices, plasma medical
devices treat wounds using a combination of REACTIVE SPECIES, electrons, ions, electromagnetic
fields, visible light and (v)UV radiation. There is no guidance on safety and the measurement
methods for NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT in comparison with other
conventional medical equipment. Therefore, a standard for NON-THERMAL PLASMA WOUND
TREATMENT EQUIPMENT can provide safety and ESSENTIAL PERFORMANCE.
IEC 60601-2-91:2026 © IEC 2026
201.1 Scope, object and related standards
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Clause 1, applies, except as follows:
201.1.1 Scope
Replacement:
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of NON-THERMAL
PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT
ACCESSORIES.
NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND
TREATMENT ACCESSORIES are not intended to supply heat to the PATIENT. They are used to treat
chronic and acute wounds and biological tissue as well as diverse skin and itching diseases.
HAZARDS inherent in the intended physiological function of PLASMA WOUND TREATMENT EQUIPMENT
and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES within the scope of this document
are covered by specific requirements in 7.2.13 of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
This document does not apply to ME EQUIPMENT intended for the haemostasis of biological tissue
(see IEC 60601-2-2[1] and IEC 60601-2-76[2]).
201.1.2 Object
Replacement:
The object of this document is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA
WOUND TREATMENT ACCESSORIES, as defined in 201.3.204 and 201.3.203.
201.1.3 Collateral standards
Addition:
This document refers to those applicable collateral standards that are listed in Clause 2 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and
Clause 201.2 of this document.
IEC 60601-1-3[3] and IEC 60601-1-10[4] do not apply. All other published collateral standards
in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Addition:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
___________
Numbers in square brackets refer to the Bibliography.
IEC 60601-2-91:2026 © IEC 2026
A requirement of a particular standard takes priority over IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
The numbering of clauses and subclauses of this document corresponds to that of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 with the
prefix "201" (e.g. 201.1 in this document addresses the content of Clause 1 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020) 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 document addresses the content of Clause 4 of
the IEC 60601-1-2 collateral standard, 203.4 in this document addresses the content of Clause
4 of the 60601-1-3 collateral standard, etc.). The changes to the text of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are specified by the use of
the following words:
"Replacement" means that the clause or subclause of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
standard is replaced completely by the text in this document.
"Addition" means that the text of this document is additional to the requirements of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or
applicable collateral standard.
"Amendment" means that the clause or subclause of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
standard is amended as indicated by the text of this document.
Subclauses, figures or tables which are additional to those of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered starting from
201.101. However, due to the fact that definitions in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered 3.1 through
3.154, 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.
Where there is no corresponding clause or subclause in this document, the clause or subclause
of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or
applicable collateral standard, although possibly not relevant, applies without modification;
where it is intended that any part of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 or applicable collateral standard, although possibly relevant, is
not to be applied, a statement to that effect is given in this document.
201.2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies.
For undated references, the latest edition of the referenced document (including any
amendments) applies.
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
IEC 60601-2-91:2026 © IEC 2026
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, 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 given after the Bibliography.
Addition:
201.3.201
ACTIVE TREATED ZONE
area of the treated tissue during INTENDED USE
201.3.202
*NON-THERMAL PLASMA
partially ionized gas consisting of REACTIVE SPECIES with electrons, ions, ambient molecules and
PATIENT according to the
electromagnetic radiation, that is not intended to supply heat to the
INTENDED USE
201.3.203
*NON-THERMAL PLASMA WOUND TREATMENT ACCESSORY
ACCESSORY, which can be the APPLIED PART of NON-THERMAL PLASMA WOUND TREATMENT
EQUIPMENT, intended for application of NON-THERMAL PLASMA to provide WOUND TREATMENT at the
PATIENT
intended site of the
Note 1 to entry: An APPLIED PART of the NON-THERMAL PLASMA WOUND TREATMENT is the part which necessarily comes
into contact with the PATIENT. Parts, that can accidentally come into contact with the PATIENT during application of
NON-THERMAL PLASMA are treated as APPLIED PART (see 4.6 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020).
Note 2 to entry: NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES can include cords and connectors for
attachment to NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT, as well as MEDICAL ELECTRICAL EQUIPMENT other
than NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT that can be electrically connected to the PATIENT circuit.
Note 3 to entry: Not all ACCESSORIES used with NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT are NON-
THERMAL PLASMA WOUND TREATMENT ACCESSORIES.
201.3.204
NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT
ME EQUIPMENT that treat wounds together with related NON-THERMAL PLASMA WOUND TREATMENT
ACCESSORY using NON-THERMAL PLASMA for the purpose of promoting wound recovery
201.3.205
REACTIVE SPECIES
reactive atoms or molecules generated in the NON-THERMAL PLASMA with sufficient lifetime to
reach the respiratory tract of PATIENT and OPERATOR
201.3.206
*WOUND TREATMENT
action of treatment by NON-THERMAL PLASMA to biological tissue in wound or diverse skin and
itching diseases
IEC 60601-2-91:2026 © IEC 2026
201.4 General requirements
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Clause 4, applies, except as follows:
201.4.6 ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT
Addition:
NOTE 1 A non-THERMAL PLASMA WOUND TREATMENT ACCESSORY is considered an APPLIED PART.
NOTE 2 The RISK ANALYSIS includes an assessment of whether parts that can come into contact with the PATIENT,
but fall outside the definition of APPLIED PARTS, is subject to the requirements for APPLIED PARTS.
201.5 General requirements for testing ME EQUIPMENT
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Clause 5, applies.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Clause 6, applies.
201.7 ME EQUIPMENT identification, marking and documents
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 applies,
Clause 7, except as follows:
201.7.9.2.2 Warnings and safety notices
Addition:
NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES to come in direct contact
Do not allow
with the PATIENTS' eyes, unless the RISK ANALYSIS determines that no unacceptable RISK exists
from contact with the eye.
Additional subclause:
201.7.9.2.2.101 Additional information in the instructions for use
The instructions for use shall include:
– The recommended distance according to the INTENDED USE between the distal end of the
NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT and the PATIENT.
– The maximum HIGH FREQUENCY peak voltage that can be output by the NON-THERMAL PLASMA
WOUND TREATMENT EQUIPMENT.
– A list of NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES that are compatible with the
NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT (see 201.8.8.3.103).
– When there is a RISK that safety thresholds of long-lived REACTIVE SPECIES (examples:
ozone, nitrogen monoxide, nitrogen dioxide [5], [6]) will be exceeded, appropriate warnings
and measures shall be listed.
IEC 60601-2-91:2026 © IEC 2026
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
Clause 8, applies, except as follows:
201.8.7.3 Allowable values
Additional subclause:
201.8.7.3.101 PATIENT LEAKAGE CURRENTS
In order to prevent electric shock, PATIENT LEAKAGE CURRENT from the NON-THERMAL PLASMA shall
not exceed the limits from Table 3 of IEC 60601-1:2005 for the declared APPLIED PART type in
NORMAL CONDITION and SINGLE FAULT CONDITION.
Compliance is checked as follows:
The PATIENT LEAKAGE CURRENT is measured according to Figure 201.101 using the measuring
device (MD) as defined in Figure 12 of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.
The area of the 1 mm thick copper plate shall be the greater of 120 % of the ACTIVE TREATED
ZONE or 100 mm × 100 mm whichever is greater at the INTENDED USE distance. The copper plate
surface shall be clean enough to measure the LEAKAGE CURRENT without additional impedance.
The height of the table is 1 m from the earthed conductive plane.
Key
1 Supply mains
2 Table, made of insulating material, at a height of 1 m above the conductive plane
3 Equipment
4 NON-THERMAL PLASMA WOUND TREATMENT ACCESSORY
5 Flat copper plate (120 % of the ACTIVE TREATED ZONE or 100 mm × 100 mm × 1 mm, whichever is greater)
6 Measuring Device (MD) from IEC 60601-1
7 Current meter
8 Earthed conductive plane
Figure 201.101 – Measurement of PATIENT LEAKAGE CURRENT
IEC 60601-2-91:2026 © IEC 2026
201.8.8.3 Dielectric strength
Amendment:
The requirements and tests for NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES are given
in 201.8.8.3.101.
Additional test conditions:
aa) If, during dielectric strength testing of solid insulation forming MEANS OF PATIENT
PROTECTION, a breakdown or flashover occurs through the atmosphere at the AIR
CLEARANCE specified in 8.9 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020, an insulating barrier can be placed to prevent this
breakdown so that the protective insulation can be tested.
bb) If, during dielectric strength testing of solid insulation forming MEANS OF PATIENT
PROTECTION, a breakdown or flashover occurs at the CREEPAGE DISTANCE specified in 8.9
of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020,
then the test shall be carried out on the components which provide MEANS OF
...