FprEN IEC 80601-2-58:2023
(Main)Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
IEC 80601-2-58:2024 is available as IEC 80601-2-58:2024 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 80601-2-58:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.209 and 201.3.217) and associated ACCESSORIES that can be connected to this MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 7.2.13 of IEC 60601-1:2005 and IEC 60601 1:2005/AMD2:2020 and 8.4.1 of IEC 60601-1:2005. IEC 80601-2-58:2024 cancels and replaces the second edition published in 2014 and its Amendment 1:2016. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) the alignment of this particular standard based on the amendment of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020; b) updating collateral, particular and IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 references to align with amendments to IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and other collateral standards; c) updated normative references; d) added new requirement for particulate matter from APPLIED PARTS in 201.9.5.101; e) adding the shadow light method in 201.12.1.101.7; f) clarify test conditions for EMC requirements in 202.7.1.2; g) updated Table D.4 references to include specific IEC references to the symbols and delete “Annex AA, 201.7.6.101”; h) include a new annex to address the relevant general safety and performance requirements of European regulation (EU) 2017/745 (Annex BB); i) remove all references of the LIQUEFACTION FRAGMENTATION LENS REMOVAL method.
Medizinische elektrische Geräte - Teil 2-58: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale für Geräte zur Linsenentfernung und Geräte zur Glaskörperentfernung in der Augenchirurgie
Appareils électromédicaux - Partie 2-58: Exigences particulières pour la sécurité de base et les performances essentielles des dispositifs de retrait du cristallin et des dispositifs de vitrectomie pour la chirurgie ophtalmique
IEC 80601-2-58:2024 est disponible sous forme de IEC 80601-2-58:2024 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.L'IEC 80601-2-58:2024 s’applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des DISPOSITIFS DE RETRAIT DU CRISTALLIN et des DISPOSITIFS DE VITRECTOMIE pour la chirurgie ophtalmique (comme cela est défini en 201.3.209 et 201.3.217) et des ACCESSOIRES liés qui peuvent être raccordés à ces APPAREILS ELECTROMEDICAUX, désignés ci-après comme APPAREILS EM. Lorsqu’un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux APPAREILS EM ou uniquement aux SYSTEMES EM, le titre et le contenu de cet article ou de ce paragraphe l’indiquent. Si ce n’est pas le cas, l’article ou le paragraphe s’applique à la fois aux APPAREILS EM et aux SYSTEMES EM, selon le cas. Les DANGERS inhérents à la fonction physiologique prévue des APPAREILS EM ou des SYSTEMES EM dans le cadre du domaine d’application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document, à l’exception du 7.2.13 de l’IEC 60601-1:2005 et l’IEC 60601-1:2005/AMD2:2020 et du 8.4.1 de l’IEC 60601-1:2005. L'IEC 80601-2-58:2024 le et remplace la deuxième édition parue en 2014 et son Amendement 1:2016. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: a) alignement de la présente norme particulière sur la base des amendements de l’IEC 60601-1:2005, l'IEC 60601-1:2005/AMD1:2012 et de l'IEC 60601-1:2005/AMD2:2020; b) mise à jour des références à l’IEC 60601-1:2005, l'IEC 60601-1:2005/AMD1:2012 et l'IEC 60601-1:2005/AMD2:2020 et aux normes particulières et collatérales pour les aligner sur les amendements de l’IEC 60601-1:2005, l'IEC 60601-1:2005/AMD1:2012 et l'IEC 60601-1:2005/AMD2:2020 et des autres normes collatérales; c) mise à jour des références normatives; d) ajout d’une nouvelle exigence relative aux corps solides qui proviennent des PARTIES APPLIQUEES dans le 201.9.5.101; e) ajout de la méthode de la lumière rasante dans le 201.12.1.101.7; f) clarification des conditions d’essai pour les exigences de CEM dans le 202.7.1.2; g) mise à jour des références du Tableau D.4 pour inclure les références IEC spécifiques aux symboles et supprimer le "201.7.6.101" existant de l’"Annexe AA"; h) inclusion d’une nouvelle annexe pour couvrir les exigences générales pertinentes en matière de sécurité et de performances du règlement européen (UE) 2017/745 (Annexe BB). i) suppression de toutes les références à la méthode de RETRAIT DU CRISTALLIN au moyen de la FRAGMENTATION PAR LIQUEFACTION.
Medicinska električna oprema - 2-58. del: Posebne zahteve za osnovno varnost in bistvene lastnosti naprav za odstranjevanje leč in naprav za vitrektomijo pri očesni kirurgiji
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Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN IEC 80601-2-58:2022
01-november-2022
Medicinska električna oprema - 2-58. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti naprav za odstranjevanje leč in naprav za vitrektomijo pri očesni
kirurgiji
Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and
essential performance of lens removal devices and vitrectomy devices for ophthalmic
surgery
Medizinische elektrische Geräte - Teil 2-58: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale für Geräte zur Linsenentfernung und
Geräte zur Glaskörperentfernung in der Augenchirurgie
Appareils électromédicaux - Partie 2-58: Exigences particulières pour la sécurité de base
et les performances essentielles des dispositifs de retrait du cristallin et des dispositifs de
vitrectomie pour la chirurgie ophtalmique
Ta slovenski standard je istoveten z: prEN IEC 80601-2-58:2022
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
oSIST prEN IEC 80601-2-58:2022 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN IEC 80601-2-58:2022
oSIST prEN IEC 80601-2-58:2022
62D/1969/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 80601-2-58 ED3
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-09-09 2022-12-02
SUPERSEDES DOCUMENTS:
62D/1914/CD, 62D/1936A/CC
IEC SC 62D : ELECTROMEDICAL EQUIPMENT
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.
TITLE:
Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential
performance of lens removal devices and vitrectomy devices for ophthalmic surgery
PROPOSED STABILITY DATE: 2028
NOTE FROM TC/SC OFFICERS:
electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions.
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 writing from IEC.
oSIST prEN IEC 80601-2-58:2022
62D/1969/CDV – 2 – IEC 80601-2-58:2022
© IEC 2022
1 CONTENTS
2 CONTENTS . 2
3 FOREWORD . 3
4 INTRODUCTION . 6
5 201.1 Scope, object and related standards . 8
6 201.2 Normative references . 10
7 201.3 Terms and definitions . 11
8 201.4 General requirements . 13
9 201.5 General requirements for testing of ME EQUIPMENT . 13
10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 13
11 201.7 ME EQUIPMENT identification, marking and documents . 13
12 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 15
13 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 15
14 201.10 Protection against unwanted and excessive radiation HAZARDS . 15
15 201.11 Protection against excessive temperatures and other HAZARDS . 15
16 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 16
17 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 27
18 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 27
19 201.15 Construction of ME EQUIPMENT . 27
20 201.16 * ME SYSTEMS. 27
21 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 28
22 202 Electromagnetic disturbances – Requirements and tests . 28
23 202.5.2.2.2 * Requirements applicable to ME EQUIPMENT and ME SYSTEMS specified
24 for use only in a shielded location SPECIAL ENVIRONMENT . 28
25 Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
26 and ME SYSTEMS . 30
27 201.C.5 ACCOMPANYING DOCUMENTS, instructions for use. 30
28 Annex D (informative) Symbols on marking (See Clause 7). 31
29 Annex AA (informative) Particular guidance and rationale . 32
30 A.A.1 General guidance. 32
31 A.A.2 Rationale for particular clauses and subclauses . 32
32 Annex BB (informative) Reference to the general safety and performance requirements . 39
33 Bibliography . 41
34 Index of defined terms . 42
36 Figure 201.101 – Test method for gravity fed IRRIGATION . 17
37 Figure 201.102 – Test method for pressurized IRRIGATION . 18
38 Figure 201.103 – Test method for ASPIRATION pressure measurement/display accuracy . 19
39 Figure 201.104 – Test method for ultrasonic velocity of tip accuracy . 23
41 Table 201.101 – Key of symbols for Figure 201.101 to Figure 201.103 . 19
42 Table 201.C.101 – ACCOMPANYING DOCUMENTS, instructions for use of LENS REMOVAL
43 DEVICES and VITRECTOMY DEVICES or their parts . 30
oSIST prEN IEC 80601-2-58:2022
IEC 80601-2-58:2022 – 3 – 6D/1969/CDV
© IEC 2022
45 INTERNATIONAL ELECTROTECHNICAL COMMISSION
46 ____________
48 MEDICAL ELECTRICAL EQUIPMENT –
50 Part 2-58: Particular requirements for the basic safety
51 and essential performance of lens removal devices
52 and vitrectomy devices for ophthalmic surgery
54 FOREWORD
55 1) The International Electrotechnical Commission (IEC) is a worldwide organization for stand ardization comprising
56 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
57 international co-operation on all questions concerning standardization in the electrical and electronic fields. To
58 this end and in addition to other activities, IEC publishes International Standards, Technical Specifi cations,
59 Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
60 Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
61 in the subject dealt with may participate in this preparatory work. International, governmental and non-
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63 with the International Organization for Standardization (ISO) in accordanc e with conditions determined by
64 agreement between the two organizations.
65 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
66 consensus of opinion on the relevant subjects since each technical committee has representation from all
67 interested IEC National Committees.
68 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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70 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
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72 4) In order to promote international uniformity, IEC National Committees undertake t o apply IEC Publications
73 transparently to the maximum extent possible in their national and regional publications. Any divergence
74 between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
75 the latter.
76 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
77 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
78 services carried out by independent certification bodies.
79 6) All users should ensure that they have the latest edition of this publication.
80 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
81 members of its technical committees and IEC National Committees for any personal injury, property damage or
82 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees ) and
83 expenses arising out of the publication, use of, or reliance upon, this IEC P ublication or any other IEC
84 Publications.
85 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
86 indispensable for the correct application of this publication.
87 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
88 patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
89 This version of IEC 80601-2-58 bears the edition number 3.0. It consists of the third
90 edition (202X-XX) [documents 62D/XXXX/FDIS and 62D/XXXX/RVD].
91 International standard IEC 80601-2-58 has been prepared by subcommittee 62D:
92 Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
93 practice, and subcommittee SC 7: Ophthalmic optics and instruments of ISO technical
94 committee 172: Optics and photonics.
95 It is published as a double logo standard.
96 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
oSIST prEN IEC 80601-2-58:2022
62D/1969/CDV – 4 – IEC 80601-2-58:2022
© IEC 2022
97 In this standard, the following print types are used:
98 – Requirements and definitions: roman type.
99 – Test specifications: italic type.
100 – Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
101 Normative text of tables is also in a smaller type.
102 – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
103 NOTED: SMALL CAPITALS.
104 In referring to the structure of this standard, the term
105 – “clause” means one of the seventeen numbered divisions within the table of contents,
106 inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
107 – “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
108 subclauses of Clause 7).
109 References to clauses within this standard are preceded by the term “Clause” followed by the
110 clause number. References to subclauses within this particular standard are by number only.
111 In this standard, the conjunctive “or” is used as an “inclusive or” , so a statement is true if any
112 combination of the conditions is true.
113 The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
114 Directives, Part 2. For the purposes of this standard, the auxiliary verb:
115 – “shall” means that compliance with a requirement or a test is mandatory for compliance
116 with this standard;
117 – “should” means that compliance with a requirement or a test is recommended but is not
118 mandatory for compliance with this standard;
119 – “may” is used to describe a permissible way to achieve compliance with a requirement or
120 test.
121 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
122 indicates that there is guidance or rationale related to that item in Annex AA.
123 A list of all parts of the IEC 60601 series, published under the general title Medical electrical
124 equipment, can be found on the IEC website.
oSIST prEN IEC 80601-2-58:2022
IEC 80601-2-58:2022 – 5 – 6D/1969/CDV
© IEC 2022
126 The committee has decided that the contents of the base publication and its amendment will
127 remain unchanged until the stability date indicated on the IEC web site under
128 "http://webstore.iec.ch" in the data related to the specific publication. At this date, the
129 publication will be
130 • reconf
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