IEC 60601-2-3:1991/AMD1:1998
(Amendment)Amendment 1 - Medical electrical equipment - Part 2-3: Particular requirements for the safety of short-wave therapy equipment
Amendment 1 - Medical electrical equipment - Part 2-3: Particular requirements for the safety of short-wave therapy equipment
Contains a series of revisions to IEC 60601-2-3 (second edition, 1991) taking into account amendments 1 and 2 of the General Standard, which include reference to the collateral standards.
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Standards Content (Sample)
INTERNATIONAL IEC
STANDARD
60601-2-3
AMENDMENT 1
1998-09
Amendment 1
Medical electrical equipment –
Part 2:
Particular requirements for the safety
of short-wave therapy equipment
IEC 1998 Copyright - all rights reserved
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– 2 – 60601-2-3 Amend.1 © IEC:1998(E)
FOREWORD
This amendment has been prepared by subcommittee 62D: Electromedical equipment, of
IEC technical committee 62: Electrical equipment in medical practice.
The text of this amendment is based on the following documents:
FDIS Report on voting
62D/292/FDIS 62D/298/RVD
Full information on the voting for the approval of this amendment can be found in the report on
voting indicated in the above table.
–––––––––––
INTRODUCTION
This amendment contains a series of revisions to IEC 60601-2-3 (second edition, 1991) taking
into account amendments 1 and 2 of the General Standard, which include reference to the
collateral standards. The technical content remaining essentially unchanged.
NOTE – The page numbers referenced in this amendment are those in IEC 60601-2-3:1991.
Page 3
CONTENTS
Delete clauses 13 and 18 from the Contents.
Page 5
Replace "FIGURES 101 à 104" by "FIGURES 101 to 104"
Page 9
INTRODUCTION
Replace in the last sentence “.an * after.” by “.an asterisk (*) before.”.
Page 11
1 Scope and object
Add, after the introductory sentence of this clause, the following subclause heading:
1.1 Scope
Replace, in the existing text of the first paragraph of the Addition by
, "Sub-clause 2.1"
"subclause 2.1.101".
60601-2-3 Amend.1 © IEC:1998(E) – 3 –
Replace the second paragraph of the Addition by the following:
"LOW POWER EQUIPMENT as defined in subclause 2.2.101 is exempted from certain
requirements of this standard".
Add the following subclause to the Particular Standard:
1.5 Collateral Standards
Addition:
The following Collateral Standards apply:
IEC 60601-1-1:1992, Medical electrical equipment – Part 1: General requirements for safety –
1. Collateral Standard: Safety requirements for medical electrical systems
IEC 60601-1-2:1993, Medical electrical equipment – Part 1: General requirements for safety –
2. Collateral Standard: Electromagnetic compatibility – Requirements and tests
IEC 60601-1-4:1996, Medical electrical equipment – Part 1: General requirements for safety –
4. Collateral Standard: Programmable electrical medical systems
2 Terminology and definitions
Add, after 2.1.103, the following new definition:
L
2.2.101 OW POWER EQUIPMENT
EQUIPMENT having a RATED OUTPUT POWER not exceeding 10 W.
Page 13
4.11 Sequence
In the Amendment replace "temperature-rise test of Sub-clause 42.4" by "compliance test
which follows subclause 42.3".
*5.2 Amendment:
Replace "EQUIPMENT" by "APPLIED PART".
Page 15
6.1 Marking on the outside of EQUIPMENT
p) Output
In the text of the first dash of the Replacement, replace "power in watts" by "POWER in watts".
– 4 – 60601-2-3 Amend.1 © IEC:1998(E)
6.8.2 Instructions for
...
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