EN IEC 60601-2-83:2020/prA1:2022

Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment

2022-05-21-JO- to ensure continuity, HAS assessment should be prepared by Tony Wilkes

Medizinische elektrische Geräte - Teil 2-83: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Heim-Lichttherapiegeräten

Appareils électromédicaux - Partie 2-83: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de luminothérapie à domicile

Medicinska električna oprema - 2-83. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za svetlobno terapijo na domu - Dopolnilo A1

General Information

• Status: Not Published
• Publication Date: 22-Aug-2023
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 4060 - Enquiry results established and sent to TC, SR, BTTF - Enquiry
• Start Date: 22-Apr-2022
• Completion Date: 22-Apr-2022
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: SIST EN IEC 60601-2-83:2020/oprA1:2022 - Amendment 1 - Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment

Relations

• Amends: EN IEC 60601-2-83:2020 - Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
• Effective Date: 11-May-2021

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2022
Medicinska električna oprema - 2-83. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za svetlobno terapijo na domu - Dopolnilo A1
Amendment 1 - Medical electrical equipment - Part 2-83: Particular requirements for the
basic safety and essential performance of home light therapy equipment
Medizinische elektrische Geräte - Teil 2-83: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Heim-Lichttherapiegeräten
Appareils électromédicaux - Partie 2-83: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de luminothérapie à domicile
Ta slovenski standard je istoveten z: EN IEC 60601-2-83:2020/prA1:2022
ICS:
11.040.60 Terapevtska oprema Therapy equipment
SIST EN IEC 60601-2- en
83:2020/oprA1:2022
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

62D/1931/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-83/AMD1 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-01-28 2022-04-22
SUPERSEDES DOCUMENTS:
62D/1857/CD, 62D/1927/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:
Amendment 1 - Medical electrical equipment - Part 2-83: Particular requirements for the basic safety
and essential performance of home light therapy equipment

PROPOSED STABILITY DATE: 2027
NOTE FROM TC/SC OFFICERS:
This document is circulated as the Committee Draft for Vote (CDV). This standard is amended in order to align
with the published IEC 60601-1 series Amendment projects.
this 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.

62D/1931/CDV – 2 – IEC CDV 60601-2-83:2019/AMD1
© IEC:2022
1 FOREWORD
2 This amendment has been prepared by subcommittee 62D: Electromedical equipment, of IEC
3 technical committee 62: Electrical equipment in medical practice.
4 The text of this amendment is based on the following documents:
Draft Report on voting
62D/xxxx/FDIS 62D/xxxx/RVD
6 Full information on the voting for the approval of this amendment can be found in the report on
7 voting indicated in the above table.
8 The committee has decided that the contents of this amendment and the base publication will
9 remain unchanged until the stability date indicated on the IEC website under
10 “http://webstore.iec.ch” in the data related to the specific document. At this date, the document
11 will be
12 • reconfirmed,
13 • withdrawn,
14 • replaced by a revised edition, or
15 • amended.
17 NOTE The attention of users of this document is drawn to the fact that equipment manufacturers
18 and testing organizations may need a transitional period following publication of a new, amended or
19 revised IEC or ISO publication in which to make products in accordance with the new requirements and
20 to equip themselves for conducting new or revised tests. It is the recommendation of the committee that
21 the content of this publication be adopted for mandatory implementation nationally not earlier than 3
22 years from the date of publication.
23 _____________
25 INTRODUCTION TO AMENDMENT 1
26 The first edition of IEC 60601-2-83 was published in May 2019. Since the publication of IEC
27 60601-2-83:2019, the IEC Subcommittee (SC) 62A has published amendments to the general
28 and collateral standards, thus requiring amendments to the particular standards for alignment
29 as discussed at the IEC SC 62D meeting in Shanghai, China, in October 2019.
30 Because this is an amendment to IEC 60601-2-83:2019, the style in force at the time of
31 publication of IEC 60601-2-83 has been applied to this amendment. The style specified in
32 ISO/IEC Directives Part 2:2021 has only been applied when implementing the new style
33 guidance would not result in additional editorial changes.
34 Users of this document should note that when constructing the dated references to specific
35 elements in a standard, such as definitions, amendments are only referenced if they modified
36 the text being cited. For example, if a reference is made to a definition that has not been
37 modified by an amendment, then the reference to the amendment is not included in the dated
38 reference.
IEC/CDV 60601-2-83:2019 AMD1 – 3 – 62D/1931/CDV
© IEC:2022
40 INTRODUCTION
41 Replace the existing last paragraph with:
42 This document is aligned with:
43 ‒ IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020;
44 ‒ IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020;
45 ‒ IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020;
46 and
47 ‒ IEC 60601-1-11:2015 and IEC 60601-1-11:2015/AMD1:2020.
48 201.1 Scope
49 Replace the existing footnote 2 with:
50 2 The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
51 1:2005/AMD2:2020, Medical electrical equipment –Part 1: General requirements for basic
52 safety and essential performance.
53 201.1.3 Collateral standards
54 Replace the first sentence of the second paragraph with:
55 IEC 60601-1-2, IEC 60601-1-6 and IEC 60601-1-11 apply as modified in Clauses 202, 206 and
56 211, respectively.
57 201.1.4 Particular standards
58 Replace the first sentence of the third paragraph with:
59 For brevity, IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
60 1:2005/AMD2:2020 are referred to in this particular standards as the general standard.
61 201.2 Normative references
62 Replace the existing references to IEC 60601-1-2, IEC 60601-1-6 and ISO 15223-1 with the
63 following new references:
64 IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
65 safety and essential performance – Collateral Standard: Electromagnetic disturbances –
66 Requirements and tests
67 IEC 60601-1-2:2014/AMD1:2020
69 IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic
70 safety and essential performance – Collateral standard: Usability
71 IEC
...