prEN IEC 60601-2-91:2023
(Main)Particular requirement for basic safety and essential performance of non-thermal plasma wound treatment equipment
Particular requirement for basic safety and essential performance of non-thermal plasma wound treatment equipment
Exigences particulières pour la sécurité de base et les performances essentielles des appareils de traitement des plaies par plasma non thermique
Posebne zahteve za osnovno varnost in bistveno delovanje opreme za zdravljenje ran z netermično plazmo
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2024
Posebne zahteve za osnovno varnost in bistveno delovanje opreme za zdravljenje
ran z netermično plazmo
Particular requirement for basic safety and essential performance of non-thermal plasma
wound treatment equipment
Exigences particulières pour la sécurité de base et les performances essentielles des
appareils de traitement des plaies par plasma non thermique
Ta slovenski standard je istoveten z: prEN IEC 60601-2-91:2023
ICS:
11.040.99 Druga medicinska oprema Other medical equipment
11.140 Oprema bolnišnic Hospital equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
62D/2091/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-91 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2023-11-24 2024-02-16
SUPERSEDES DOCUMENTS:
62D/2020/CD, 62D/2045A/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: PROPOSED HORIZONTAL STANDARD:
Other TC/SCs are requested to indicate their interest, if any, in
this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft for Vote
(CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.
This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
Recipients of this document are invited to submit, with their comments, notification of any relevant “In Some Countries” clau ses to
be included should this proposal proceed. Recipients are reminded that the CDV stage is the final stage for submitting ISC c lauses.
(SEE AC/22/2007 OR NEW GUIDANCE DOC).
TITLE:
Particular requirement for basic safety and essential performance of non-thermal plasma wound treatment
equipment
PROPOSED STABILITY DATE: 2029
NOTE FROM TC/SC OFFICERS:
file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions. You may not copy
or "mirror" the file or printed version of the document, or any part of it, for any other purpose without permission in writi ng from IEC.
IEC CDV 60601-2-91 © IEC:2023 – 2 – 62D/2091/CDV
1 201.1 Scope, object and related standards . 6
2 201.1.1 Scope . 6
3 201.1.2 Object . 6
4 201.1.3 Collateral standards . 6
5 201.1.4 Particular standards . 6
6 201.2 Normative references . 7
7 201.3 Terms and definitions . 7
8 201.4 General requirements . 8
9 201.5 General requirements for testing ME EQUIPMENT . 8
10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 8
11 201.7 ME EQUIPMENT identification, marking and documents . 8
12 201.8 Protection against electrical HAZARDS from ME EQUIPMENT and ME SYSTEMS . 8
13 201.9 Protection against mechanical HAZARDS from ME EQUIPMENT and ME SYSTEMS . 12
14 201.10 Protection against unwanted and excessive radiation HAZARDS . 12
15 201.11 Protection against excessive temperature and other HAZARDS . 12
16 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 14
17 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 14
18 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 14
19 201.15 Construction of ME EQUIPMENT . 15
20 201.16 ME SYSTEMS . 15
21 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 15
22 Annex AA (informative) Particular General guidance and rationale . 16
24 Figure 201.101 – Measurement of PATIENT LEAKAGE CURRENT . 9
25 Figure 201.102 – Measurement of cable high frequency LEAKAGE CURRENT . 11
26 Figure 201.103 – Measurement of maximum PATIENT tissue temperature . 13
27 Figure 201.104 – Measurement of REACTIVE SPECIES for equipment with a ground electrode . 14
28 Figure 201.105 – Measurement of REACTIVE SPECIES for equipment without a ground electrode14
IEC CDV 60601-2-91 © IEC:2023 – 3 – 62D/2091/CDV
32 INTERNATIONAL ELECTROTECHNICAL COMMISSION
33 ____________
35 MEDICAL ELECTRICAL EQUIPMENT
37 Part 2-91: Particular requirements for the basic safety and essential performance of
38 non-thermal plasma wound treatment equipment
41 FOREWORD
42 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national
43 electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions
44 concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publ ishes
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49 Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
50 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of
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65 reliance upon, this IEC Publication or any other IEC Publications.
66 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the
67 correct application of this publication.
68 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall
69 not be held responsible for identifying any or all such patent rights.
71 The text of this International Standard is based on the following documents:
Draft Report on voting
62D/1904/NP 62D/1933/RVN
73 Full information on the voting for its approval can be found in the report on voting indicated in the above table.
74 The language used for the development of this International Standard is English.
75 This document was drafted in accordance with the editorial rules of ISO/IEC Directives, Part 2, and developed
76 in accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available at
77 www.iec.ch/members_experts/refdocs. The main document types developed by IEC are described in greater
78 detail at www.iec.ch/standardsdev/publications.
79 The committee has decided that the contents of this document will remain unchanged until the stability date
80 indicated on the IEC website under "http://webstore.iec.ch" in the data related to the specific document. At
81 this date, the document will be
IEC CDV 60601-2-91 © IEC:2023 – 4 – 62D/2091/CDV
82 • reconfirmed,
83 • withdrawn,
84 • replaced by a revised edition, or
85 • amended.
IEC CDV 60601-2-91 © IEC:2023 – 5 – 62D/2091/CDV
87 INTRODUCTION
88 The minimum safety requirements specified in this particular standard are considered to provide for a practical
89 degree of safety in the operation of non-thermal plasma wound treatment equipment.
90 This particular standard amends and supplements IEC 60601-1: Medical electrical equipment – Part 1: General
91 requirements for basic safety and essential performance, hereinafter referred to as the general standard.
92 The requirements are followed by specifications for the relevant tests.
93 A "Particular guidance and rationale" section giving some explanatory notes, where appropriate, about the
94 more important requirements is included in annex AA.
95 Clauses or subclauses for which there are explanatory notes in annex AA are marked with an asterisk (*).
96 It is considered that a knowledge of the reasons for these requirements will not only facilitate the proper
97 application of the standard but will, in due course, expedite any revisi on necessitated by changes in clinical
98 practice or as a result of developments in technology. However, this annex does not form part of the
99 requirements of this standard.
IEC CDV 60601-2-91 © IEC:2023 – 6 – 62D/2091/CDV
102 MEDICAL ELECTRICAL EQUIPMENT
104 Part 2-91: Particular requirements for the basic safety and essential performance of
105 non-thermal plasma wound treatment equipment
107 201.1 Scope, object and related standards
1)
108 Clause 1 of the general standard applies, except as follows:
109 201.1.1 Scope
110 Replacement:
111 This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of NON-THERMAL PLASMA
112 WOUND TREATMENT EQUIPMENT hereafter referred to as ME EQUIPMENT.
113 NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT apples to chronic and acute wounds as well as diverse
114 skin and itching diseases
115 HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of
116 this document are not covered by specific requirements in this document except in 7.2.13 of the general
117 standard.
118 This document does not apply to:
119 - ME EQUIPMENT intended for the haemostasis in biological tissue by using ionized gas (see IEC 60601-2-76)
121 201.1.2 Object
122 Replacement:
123 The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE
124 requirements for NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT, as defined in 201.3.204.
125 201.1.3 Collateral standards
126 Addition:
127 IEC 60601-1-3, IEC 60601-1-10 and IEC 60601-1-11 do not apply. All other published collateral standards
128 listed in Clause 2 of IEC 60601-1 series and Clause 201.2 of this particular standard apply to this particular
129 standard.
130 201.1.4 Particular standards
131 Replacement:
132 In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the
133 general standard and collateral standards as appropriate for the particular ME EQUIPMENT under consideration,
134 and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements.
135 A requirement of a particular standard takes priority over the general standard. Collateral standards are referred
136 to by their document numbers.
137 The numbering of clauses and subclauses of this particular standard corresponds to that of the general standard with
138 the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of the general standard) or applicable
139 collateral st
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