SIST HD 395.2.10 S1:1998
(Main)Medical electrical equipment -- Part 2: Particular requirements for the safety of nerve and muscle stimulators
Medical electrical equipment -- Part 2: Particular requirements for the safety of nerve and muscle stimulators
Specifies particular requirements for the safety of electrical stimulators of muscles and nerves in the specialized practice of physical medicine. It excludes stimulators used with implanted electrodes, brain stimulation, neurological research, cardiac pacemakers, defibrillators and other surgical procedures.
Medizinische elektrische Geräte -- Teil 2: Besondere Festlegungen für die Sicherheit von Geräten zur Stimulation von Nerven und Muskeln
Appareils électromédicaux -- Partie 2: Règles particulières de sécurité pour stimulateurs de nerfs et de muscles
Spécifie les règles particulières de sécurité des stimulateurs des nerfs et des muscles utilisés dans la pratique spécialisée de la médecine physique. (En sont exclus les stimulateurs utilisés avec des électrodes implantées, les stimulateurs du cerveau ou du coeur, la recherche neurologique, les implants, les défibrillateurs et autres procédés chirurgicaux.)
Medical electrical equipment - Part 2: Particular requirements for the safety of nerve and muscle stimulators (IEC 60601-2-10:1987)
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST HD 395.2.10 S1:1998
01-september-1998
Medical electrical equipment - Part 2: Particular requirements for the safety of
nerve and muscle stimulators (IEC 60601-2-10:1987)
Medical electrical equipment -- Part 2: Particular requirements for the safety of nerve and
muscle stimulators
Medizinische elektrische Geräte -- Teil 2: Besondere Festlegungen für die Sicherheit von
Geräten zur Stimulation von Nerven und Muskeln
Appareils électromédicaux -- Partie 2: Règles particulières de sécurité pour stimulateurs
de nerfs et de muscles
Ta slovenski standard je istoveten z: HD 395.2.10 S1:1989
ICS:
11.040.60 Terapevtska oprema Therapy equipment
SIST HD 395.2.10 S1:1998 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST HD 395.2.10 S1:1998
CEI
NORME
IEC
INTERNATIONALE
601-2-10
INTERNATIONAL
Première édition
STANDARD
First edition
1987
Appareils électromédicaux
Deuxième partie:
Règles particulières de sécurité
pour stimulateurs de nerfs et de muscles
Medical electrical equipment
Part 2:
Particular requirements for the safety
of nerve and muscle stimulators
Copyright — all rights reserved
© CEI 1987 Droits de reproduction réservés —
of this publication may be reproduced or utilized in
Aucune partie de cette publication ne peut être reproduite ni No part
any form or by any means, electronic or mechanical,
utilisée sous quelque forme que ce soit et par aucun pro-
including photocopying and microfilm, without permission
cédé, électronique ou mécanique, y compris la photocopie et
in writing from the publisher.
les microfilms, sans l'accord écrit de l'éditeur.
Genève, Suisse
Bureau Central de la Commission Electrotechnique Internationale 3, rue de Varembé
Commission Electrotechnique Internationale CODE PRIX
International Electrotechnical Commission
PRICE CODE
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IEC MewAyHapoiaHaa 3netcrpoTexH►wecKaa
voir catalogue en vigueur
Pour prix,
• •
For price, see current catalogue
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601-2-10 © IEC
1987 — 3
CONTENTS
Page
FOREWORD 5
PREFACE 5
SECTION ONE — GENERAL
Clause
1. Scope and object 7
2. Terminology and definitions 7
3. General requirements 9
4. General requirements for tests 9
5. Classification 9
6.
Identification, marking and documents 9
7. Power input 11
SECTION Two — SAFETY REQUIREMENTS
SECTION THREE — PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
13. General 13
14. Requirements related to classification 13
19.
Continuous LEAKAGE CURRENTS and PA'T'IENT AUXILIARY CURRENT 13
20.
Dielectric strength 13
SECTION FOUR — PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE — PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
36. Electromagnetic compatibility 15
SECTION SIX — PROTECTION AGAINST HAZARDS OF EXPLOSIONS IN MEDICALLY USED ROOMS
SECTION SEVEN — PROTECTION AGAINST EXCESSIVE TEMPERATURES, FIRE AND OTHER HAZARDS,
SUCH AS HUMAN ERRORS
42. Excessive temperatures 19
46. Human errors 19
SECTION EIGHT — ACCURACY OF OPERATING DATA AND PROTECTION AGAINST INCORRECT OUTPUT
50. Accuracy of operating data 21
51. Protection against incorrect output 21
SECTION NINE — FAULT CONDITIONS CAUSING OVERHEATING AND/OR MECHANICAL DAMAGE;
ENVIRONMENTAL TESTS
SECTION TEN — CONSTRUCTIONAL REQUIREMENTS
57.
MAINS PARTS, components and layout 23
FIGURES 24
APPENDIX B: Testing during manufacture and/or installation 29
APPENDIX
AA: Rationale 31
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INTERNATIONAL ELECTROTECHNICAL COMMISSION
MEDICAL ELECTRICAL EQUIPMENT
Part 2: Particular requirements for the safety of
nerve and muscle stimulators
FOREWORD
1) The formal decisions or agreements of the IEC on technical matters, prepared by Technical Committees on which all
the National Committees having a special interest therein are represented, express, as nearly as possible, an international
consensus of opinion on the subjects dealt with.
2) They have the form of recommendations for inte rnational use and they are accepted by the National Committees in that
sense.
In order to promote international unification, the IEC expresses the wish that all National Committees should adopt the
3)
text of the IEC recommendation for their national rules in so far as national conditions will permit. Any divergence
between the IEC recommendation and the corresponding national rules should, as far as possible, be clearly indicated
in the latter.
PREFACE
This Particular Standard has been prepared by Sub-Committee 62D: Electromedical equipment, of IEC Technical
Committee No. 62: Electrical equipment in medical practice.
The text of this standard is based upon the following documents:
Six Months' Rule Report on Voting
62D(CO)29 62D(CO)32
Further information can be found in the Report on Voting indicated in the table above.
This Particular Standard amends and supplements IEC Publication 601-1 (first edition 1977): Safety of medical electrical
equipment, Part 1: General Requirements, hereinafter referred to as the General Standard. The requirements of this
Particular Standard take priority over those of the General Standard. The title of the General Standard will be changed in
the next edition to read: Medical electrical equipment, Part 1: General requirements for safety. This change is anticipated
in the title of this Particular Standard.
The numbering of sections, clauses and sub-clauses of this Particular Standard corresponds with that of the General
Standard.
Sub-clauses or figures which are additional to those of the General Standard are numbered starting from 101; additional
appendices are lettered AA, BB, etc., and additional items aa), 6b), etc.
In this standard, the following print types are used:
requirements, compliance with which can be tested and definitions: in roman type;
explanations, advice, introductions, general statements, exceptions and references: in smaller type;
—
test specifications: in italic type;
TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR THIS PARTICULAR STANDARD: SMALL
CAPITALS.
The requirements are followed by specifications for the relevant tests.
Following the decision taken by Sub-Committee 62D at the meeting in Washington in 1979, a rationale for the more
important requirements, where appropriate, is given in Appendix AA.
It is considered that a knowledge of the reasons for these requirements will not only facilitate the proper application of
the standard but will, in due course, expedite any revision necessitated by changes in clinical practice or as a result
of the requirements of this standard.
of developments in technology. However, this appendix does not form pa rt
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MEDICAL ELECTRICAL EQUIPMENT
Part 2: Particular requirements for the safety of
nerve and muscle stimulators
SECTION ONE — GENERAL
1. Scope and object
This clause of the General Standard applies except as follows:
11 Scope
Addition:
NERVE AND MUSCLE
This Particular Standard specifies the requirements for the safety of
STIMULATORS, as defined in Sub-clause 2.1.101, for use in the practice of physical medicine,
hereinafter referred to as STIMULATOR(S).
The following EQUIPMENT is excluded:
EQUIPMENT intended to be implanted or to be connected to implanted electrodes,
EQUIPMENT intended for the stimulation of the brain (e.g. electroconvulsive therapy
EQUIPMENT),
EQUIPMENT intended for neurological research,
cardiac pacemakers,
body-worn EQUIPMENT,
STIMULATORS
intended for use during surgical procedures,
EQUIPMENT intended for averaged evoked potential diagnosis,
EQUIPMENT intended for electromyography,
EQUIPMENT
intended for cardiac defibrillation,
EQUIPMENT intended only as a transcutaneous nerve and muscle STIMULATOR for pain relief.
2. Terminology and definitions
This clause of the General Standard applies except as follows:
2.1.5
APPLIED PART
Addition:
The STIMULATOR electrodes and all parts conductively connected to them.
Additional definitions:
2.1.101 STIMULATOR
EQUIPMENT
for the application of electric currents via electrodes in direct contact with the
PATIENT for the diagnosis and/or therapy of neuromuscular disorders.
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2.1.102 PULSE DURATION
The duration of the output pulse waveform at 50% of the maximum amplitude.
2.1.103
WAVEFORM
The variations in magnitude of an electrical signal (in either voltage or current) as a function
of time appearing in the APPLIED PART.
3. General requirements
This clause of the General Standard applies.
4. General requirements for tests
This clause of the General Standard applies except as follows:
4.1 Item b)
Addition:
Additional routine tests: see Appendix B.
5.
Classification
This clause of the General Standard applies except as follows:
5.1 Amendment:
Delete CLASS III EQUIPMENT.
5.2 Amendment:
Delete TYPE B EQUIPMENT.
5.6 Amendment:
Delete all except CONTINUOUS OPERATION.
6. Identification, marking and documents
This clause of the General Standard applies except as follows:
6.1 Marking on the outside
j) Power input
Replacement of the fourth paragraph:
The RATED power input of MAINS OPERATED STIMULATORS shall be the maximum power input
averaged over any period of 5 s under the conditions set out in Item aa) of Sub-clause 7.3.
p) Output
Addition:
EQUIPMENT capable of delivering output values in excess of 10 mA r.m.s. or 10 V r.m.s.
averaged over any period of 5 s shall be marked near the electrode connections with the symbol
No. 14 (see Appendix D of the General Standard).
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6.7 Indicator lights and push-buttons
Addition:
See also Sub-clause 51.103.
6.8 ACCOMPANYING DOCUMENTS
6.8.2 Instructions for use
Additional item:
aa) The instructions for use shall contain additionally:
a) Information on the output WAVEFORM(S), including any d.c. component, PULSE DURA-
TIONS, pulse repetition frequencies, maximum amplitude of output voltage and/or
current, and the effect of load impedance on these parameters.
b)
Advice on the size of electrodes to be used and the method of application for each
particular type of treatment for which the is intended.
STIMULATOR
c) Advice on any necessary precautions to be taken when the output contains a d.c.
component.
d) Advice that a PATIENT with an implanted electronic device (for example a cardiac
pacemaker) should not be subjected to stimulation unless specialist medical opinion
has first been obtained.
e) A warning on the following potential hazards:
— Simultaneous connection of a PATIENT to a h.f. surgical EQUIPMENT may result
in burns at the site of the STIMULATOR electrodes and possible damage to the
STIMULATOR.
— Operation in close proximity (e.g. 1 m) to a shortwave or microwave therapy
EQUIPMENT may produce instability in the STIMULATOR output.
f) For EQUIPMENT capable of delivering output values in excess of 10 mA r.m.s. or 10 V
r.m.s.:
— Information on maximum output values allowed for the electrodes recommended
by the manufacturer for use with the STIMULATOR.
— Advice that current densities for any electrodes exceeding 2 mA r.m.s./cm 2 may
require the special attention of the USER.
6.8.3 Technical description
Additional item:
aa)
The technical description shall specify the parameters mentioned in a) of Item aa) of
Sub-clause 6.8.2. The range of load impedance for which these parameters are valid shall
be specified.
7. Power input
This clause of the General Standard applies except as follows:
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7.3 Additional item:
aa) The power input shall be measured with a load resistance having a value within the range
specked in the technical description (see Sub-clause 6.8.3) and with any accessible output
controls set to give maximum power input.
SECTION TWO — SAFETY REQUIREMENTS
Clauses 8 to 12 of the General Standard apply.
SECTION THREE — PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
13. General
This clause of the General Standard applies except as follows:
Addition:
In the case of combined EQUIPMENT (e.g. a STIMULATOR provided with a function or an
APPLIED PART for ultrasonic therapy), this additional part shall comply with the relevant
Particular Standard.
14. Requirements related to classification
This clause of the General Standard applies except as follows:
14.3
CLASS HI EQUIPMENT: Does not apply.
14.4 Item a)
Amendment:
Delete CLASS III EQUIPMENT.
14.6 Replacement:
STIMULATORS shall be TYPE BF Or CF EQUIPMENT.
Clauses 15 to 18 of the General Standard apply.
19. Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENT
This clause of the General Standard applies except as follows:
Amendment:
The requirements and tests of the General Standard concerning PATIENT AUXILIARY
CURRENT are not applicable to STIMULATORS, except that for combined EQUIPMENT (see
Clause 13 of this standard) PATIENT AUXILIARY CURRENT shall be measured between each
STIMULATOR electrode in turn and any other APPLIED PART.
20. Dielectric strength
This clause of the General Standard applies except as follows:
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20.2
Amendment:
B-b: Not applicable.
B-f: Addition:
The electrical insulation of parts B-f need not be investigated if the PATIENT LEAKAGE
CURRENT and ENCLOSURE LEAKAGE CURRENT are not higher than the allowable limit for NORMAL
CONDITION when a short circuit between the relevant parts of the STIMULATOR is made.
20.3 Values of test voltages
Amendment:
B-d: The test voltage shall be not less than 1 500 V even if the reference voltage U is less than
250 V (CLASS I AND CLASS II EQUIPMENT and EQUIPMENT with an INTERNAL ELECTRICAL
POWER SOURCE).
PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FOUR
Clauses 21 to 28 of the General Standard apply.
SECTION FIVE — PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
Clauses 29 to 35 of the General Standard apply.
36. Electromagnetic compatibility
This clause of the General Standard applies except as follows:
Addition:
The EQUIPMENT shall be capable of operating in a radio frequency electromagnetic field such
as that produced by the normal operation of a shortwave therapy unit.
When the EQUIPMENT is tested as described below the displayed WAVEFORM shall not deviate
from the original WAVEFORM in amplitude, pulse duration or repetition frequency by more than
10%. Indication of direct radio frequency break-through on the display shall be ignored.
Compliance shall be checked by Tests 1 to 3. The following test equipment may be used, as
shown in Figures 101, 102 and 103, pages 24 to 26:
— Radio Frequency oscillator covering the ISM frequency, 27.12 MHz without modulation.
— Power amplifier capable of not less than 2.5 W output at the above frequency.
— R.F. attenuator, of suitable rating.
— R.F. power meter and matching unit.
— R.F. transformer to match test equipment impedance to 800 Q.
— Load resistances and by-pass capacitors.
— Oscilloscope — Band width, d.c. to a.c. not more than 10 MHz.
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— Low frequency oscillator, to provide external triggering of the oscilloscope, to enable
measurement of any change in pulse repetition frequency.
The EQUIPMENT is operated in each output mode, the output amplitude control(s) being set
in turn at maximum, minimum and one intermediate setting during each phase of the tests.
Test 1
The STIMULATOR and test equipment are set up as shown in Figure 101, page 24. In the
case of CLASS H and INTERNALLY POWERED EQUIPMENT, the EQUIPMENT shall be placed on
an earthed metal plate the area of which is at least that of the base of the STIMULATOR. Any
ACCESSIBLE CONDUCTIVE PARTS and the metal plate are connected together.
The R.F. attenuator is adjusted until the power being applied to RI and the STIMULATOR
under test is 2.5 W ± 10% as shown by the wattmeter when the line impedance is matched
so that the reflected power is such that the VSWR is less than 1.3 (approximately 2% reflected
power) .
The connections AA (Figure 101) are first connected to each pair of output terminals in turn
and the above test is carried out.
Next the connections AA (Figure 101) are connected between the enclosure, or metal plate
(in the case of CLASS H and INTERNALLY POWERED EQUIPMENT), and each output terminal in
turn, and the above test is repeated.
Test 2
The STIMULATOR and test equipment are set up as shown in Figure 102, page 25. In the
case of CLASS II and INTERNALLY POWERED EQUIPMENT, the EQUIPMENT shall be placed on
an earthed metal plate the area of which is at least that of the base of the STIMULATOR. Any
ACCESSIBLE CONDUCTIVE PARTS and the metal plate are connected together. If the mains cable
supplied with the STIMULATOR is in excess of 400 mm in length, it shall be folded to form a bundle
not exceeding 400 mm in length.
The R.F. attenuator is adjusted until the power of 1 W ± 10% is applied to the test fil
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