IEC 60601-2-10:1987/AMD1:2001
(Amendment)Amendment 1 - Medical electrical equipment. Part 2: Particular requirements for the safety of nerve and muscle stimulators
Amendment 1 - Medical electrical equipment. Part 2: Particular requirements for the safety of nerve and muscle stimulators
The contents of the corrigendum of January 2002 have been included in this copy.
General Information
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Standards Content (Sample)
INTERNATIONAL IEC
STANDARD
60601-2-10
AMENDMENT 1
2001-09
Amendment 1
Medical electrical equipment –
Part 2-10:
Particular requirements for the safety
of nerve and muscle stimulators
Amendement 1
Appareils électromédicaux –
Partie 2-10:
Règles particulières de sécurité
pour stimulateurs de nerfs et de muscles
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– 2 – 60601-2-10 Amend. 1 IEC:2001(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/413/FDIS 62D/420/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.
The committee has decided that the contents of the base publication and its amendments will
remain unchanged until 2004. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
The contents of the corrigendum of January 2002 have been included in this copy.
_____________
Page 5
PREFACE
Replace the final two paragraphs of the Preface with the following new text:
A rationale for the more important requirements, where appropriate, is given in annex AA. It is
considered that a knowledge of the reasons for these requirements will not only facilitate the
proper application of the Particular Standard but will, in due course, expedite any revision
necessitated by changes in clinical practice or as a result of developments in technology.
However this annex does not form part of the requirements of this standard.
The clauses and subclauses which have corresponding rationale statements are marked with
an asterisk (*) before their number.
The numbers of the following clauses should be preceded by an asterisk in the main body of
the text:
1.1, 5.2, 5.6, 6.1, 6.8.2 aa), 14.6, 19, 20.2, 46.101, 50.1, 50.2, 51.101, 51.102, 50.103, 51.104,
57.3
60601-2-10 Amend. 1 IEC:2001(E) – 3 –
SECTION ONE – GENERAL
Page 7
1 Scope and object
1.1 Scope
th
At the end of the 4 dashed item add: (partly covered by IEC 60601-2-31)
th
At the end of the 7 dashed item add: (covered by IEC 60601-2-40)
th
At the end of the 8 dashed item add: (covered by IEC 60601-2-40)
Add the following subclauses:
1.3 Particular Standards
Add the following new text:
This Particular Standard for NERVE AND MUSCLE STIMULATORS is to be read in conjunction with
the following standard:
IEC 60601-1:1988, Medical electrical equipment – Part 1: General requirements for safety
Amendment 1 (1991)
Amendment 2 (1995)
The requirements of this Particular Standard take priority over the above-mentioned standard
and its amendments, hereinafter referred to as the General Standard.
1.5 Collateral Standards
Add the following new text:
The following Collateral Standards apply:
IEC 60601-1-1:2000, Medical electrical equipment – Part 1-1: General requirements for safety
– 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
Amendment 1 (1999)
– 4 – 60601-2-10 Amend. 1 IEC:2001(E)
Page 9
2.1.102 Pulse duration
Replace “waveform” by “WAVEFORM”.
2.1.103 Waveform
Replace "the APPLIED PART" by "a PATIENT CIRCUIT".
4 General requirements for tests
4.1 Item b)
Delete 4.1, Item b.
Add the following new text:
4.6 Additional Item:
aa) Where reference is made in test specifications to electrode cables and/or electrodes,
those supplied or recommended by the manufacturer shall be used.
5 Classification
5.1 Amendment:
Delete subclause 5.1.
5.2 Amendment:
Replace "TYPE B EQUIPMENT" by "TYPE B APPLIED PART".
6 Identification, marking and documents
6.1 Marking on the outside
Replace the existing title with “Marking on the outside of EQUIPMENT or EQUIPMENT parts".
6.1 j) Power input
Replace "MAINS OPERATED" by "mains operated".
6.1 p) Output
Replace "Appendix D" by "Appendix D, Table DI".
60601-2-10 Amend. 1 IEC:2001(E) – 5 –
Page 11
6.8 Accompanying documents
6.8.2 Instructions for use
Item aa) e):
Add the following new dashed item:
– Application of electrodes near the thorax may increase the risk of cardiac fibrillation.
7 Power input
Replace, on page 13, first line, the numbering of subclause "7.3" by "7.1".
Page 13
SECTION TWO – SAFETY REQUIREMENTS
Change title to “SECTION TWO — ENVIRONMENTAL CONDITIONS”.
SECTION THREE – PROTECTION AGAINST ELECTRIC
SHOCK HAZARDS
14 Requirements related to classification
14.3 Class III equipment
Delete subclause 14.3.
14.4 Item a)
Delete subclause 14.4
14.6 Replacement:
In the text replace "STIMULATORS shall be TYPE BF or CF EQUIPMENT". by "THE APPL
...
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