IEC 60601-1-2:2001/AMD1:2004
(Amendment)Amendment 1 - Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
Amendment 1 - Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
Amendement 1 - Appareils électromédicaux - Partie 1-2: Règles générales de sécurité - Norme collatérale: Compatibilité électromagnétique - Exigences et essais
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INTERNATIONAL IEC
STANDARD 60601-1-2
AMENDMENT 1
2004-09
Amendment 1
Medical electrical equipment –
Part 1-2:
General requirements for safety –
Collateral standard:
Electromagnetic compatibility –
Requirements and tests
IEC 2004 Droits de reproduction réservés Copyright - all rights reserved
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: +41 22 919 02 11 Telefax: +41 22 919 03 00 E-mail: inmail@iec.ch Web: www.iec.ch
PRICE CODE
Commission Electrotechnique Internationale S
International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
For price, see current catalogue
– 2 – 60601-1-2 Amend. 1 IEC:2004(E)
FOREWORD
This amendment has been prepared by subcommittee 62A: Common aspects of electrical
equipment used in medical practice, 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
62A/462/FDIS 62A/469/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 this amendment and the base publication will
remain unchanged until the maintenance result date indicated on the IEC web site under
"http://webstore.iec.ch" in the data related to the specific publication. At this date, the
publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
___________
INTRODUCTION
This amendment contains a first series of revisions to IEC 60601-1-2 (second edition, 2001):
Medical electrical equipment – Part 1-2: General requirements for safety – Collateral
standard: Electromagnetic compatibility – Requirements and tests.
This amendment deals primarily with requirements for EQUIPMENT and SYSTEMS that:
• comply with CISPR 11 Group 2 Class B except for the third harmonic of the fundamental
frequency;
• are for use by healthcare professionals;
• are not intended for sale to the general public; and
• are intended for use in domestic establishments or connected to the PUBLIC MAINS
NETWORK.
However, this amendment also includes several other corrections and additions to IEC
60601-1-2:2001.
To meet needs for change that were identified by users of this Collateral Standard, it was
necessary to amend the standard before the previously approved maintenance cycle date.
Page 6
INTRODUCTION
Delete, on page 7, the paragraph beginning “This second edition allows a risk analysis…”
60601-1-2 Amend. 1 IEC:2004(E) – 3 –
Page 8
2 Terminology and definitions
Replace the existing first paragraph with the following:
For the purposes of this Collateral Standard, the terms and definitions given in
IEC 60601-1:1988, IEC 60601-1-1:2000, IEC 60601-1-8:2003 and ISO 14971:2000 and the
following apply:
Delete definition 2.210 and change all occurrences of “ESSENTIAL PERFORMANCE” throughout
the document to normal font.
Replace the existing definition 2.212 with the following:
*2.212
FUNCTION (of an EQUIPMENT or SYSTEM)
clinically significant operation that the EQUIPMENT or SYSTEM is intended to perform in the
diagnosis, treatment or monitoring of a PATIENT
Add the following new definitions:
*2.227
PROFESSIONAL EQUIPMENT or SYSTEM
EQUIPMENT or SYSTEM for use by healthcare professionals and that is not intended for sale to
the general public
[IEV 161-05-05, modified]
2.228
TYPE A PROFESSIONAL EQUIPMENT or SYSTEM
PROFESSIONAL EQUIPMENT or SYSTEM that complies with CISPR 11 Group 2 Class B except for
the third harmonic of the fundamental frequency of the EQUIPMENT or SYSTEM, in which case
the third harmonic complies with the Group 2 Class A electromagnetic radiation disturbance
limit
NOTE See 36.201.1 a) 6).
Page 11
3 General requirements
3.201.2 Essential performance
Replace the existing text of this subclause with the following:
Either the essential performance of the EQUIPMENT or SYSTEM shall be identified (see Annex
GGG for guidance on identifying the essential performance) or the performance of all
FUNCTIONS of the EQUIPMENT or SYSTEM shall be considered essential performance for the
purpose of IMMUNITY testing (see 36.202.1 j)). The essential performance shall be disclosed in
the ACCOMPANYING DOCUMENTS.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS or, if this identification
is not performed, by inspection of the documents to verify that the performance of all
FUNCTIONS of the EQUIPMENT or SYSTEM has been tested in accordance with 36.202.
– 4 – 60601-1-2 Amend. 1 IEC:2004(E)
Page 12
3.201.4 Non-medical electrical equipment
Remove the asterisk from the title and replace the existing text of this subclause with the
following:
Non-medical electrical equipment that is supplied as part of a SYSTEM is exempt from the EMC
testing requirements of this standard, provided all of the following conditions are met (see
also Annex HHH):
a) the non-medical electrical equipment complies with applicable international EMC
standards;
b) both the EMISSIONS and IMMUNITY of the non-medical electrical equipment have been
determined not to adversely affect the essential performance or safety of the SYSTEM;
c) the EMISSIONS of the non-medical electrical equipment have been determined not to cause
the EMISSIONS of the SYSTEM to exceed applicable limits.
Compliance is checked by inspection of the documents for this determination and other
appropriate documents or certificates or, if this determination is not performed, by inspection
of the documents to verify that the non-medical electrical equipment has been tested in
accordance with this standard.
Add the following new subclause:
*3.201.5 General test conditions
For EMC testing, the SINGLE FAULT CONDITION requirements of the General Standard do not
apply.
Page 13
6.8.201 ACCOMPANYING DOCUMENTS
Renumber this subclause as follows:
6.8 ACCOMPANYING DOCUMENTS
6.8.2.201 Instructions for use
Add the following item:
*d) Requirements applicable to TYPE A PROFESSIONAL EQUIPMENT and SYSTEMS
If a TYPE A PROFESSIONAL EQUIPMENT or SYSTEM is intended for use in domestic
establishments or connection to the PUBLIC MAINS NETWORK (see 36.201.1 a) 6)), the
instructions for use shall include the following warning or equivalent:
Warning
This equipment/system is intended for use by healthcare professionals only. This
equipment/system may cause radio interference or may disrupt the operation of
nearby equipment. It may be necessary to take mitigation measures, such as re-
orienting or relocating the [EQUIPMENT or SYSTEM] or shielding the location.
where “[EQUIPMENT or SYSTEM]” shall be replaced with the MODEL or TYPE REFERENCE of the
EQUIPMENT or SYSTEM.
60601-1-2 Amend. 1 IEC:2004(E) – 5 –
6.8.3.201 Technical description
a) Requirements applicable to all EQUIPMENT and SYSTEMS
Replace, on page 14, the existing item a) 3) with the following:
,
3) 4)
*3) Table 201, with the modifications specified below. The flowchart in Figure 201 is
the requirement in step-by-step graphical form for completion of Table 201 for
CISPR 11 EQUIPMENT and SYSTEMS. The flowchart in Figure 202 is the requirement in
step-by-step graphical form for completion of Table 201 for CISPR 14 and CISPR 15
EQUIPMENT.
– For CISPR 11 EQUIPMENT and SYSTEMS, “[EQUIPMENT or SYSTEM]” shall be replaced
with the MODEL OR TYPE REFERENCE of the EQUIPMENT or SYSTEM.
– For CISPR 14 and CISPR 15 EQUIPMENT, “[EQUIPMENT]” shall be replaced with the
MODEL OR TYPE REFERENCE of the EQUIPMENT.
– For CISPR 11 Group 1 EQUIPMENT and SYSTEMS, rows 5, 12 and 13 shall be
deleted.
– For CISPR 11 Group 2 EQUIPMENT and SYSTEMS, rows 4, 12 and 13 shall be
deleted.
– For EQUIPMENT that complies with CISPR 14-1, rows 4 through 6 and row 13 shall
be deleted
– For EQUIPMENT that complies with CISPR 15, rows 4 through 6 and row 12 shall be
deleted.
– For CISPR 11 EQUIPMENT and SYSTEMS that comply with Class A, including TYPE A
PROFESSIONAL EQUIPMENT and SYSTEMS, “[A or B]” in column 2 of row 6 shall be
replaced with “A.” For CISPR 11 EQUIPMENT and SYSTEMS that comply with Class B,
“[A or B]” shall be replaced with “B.”
– For EQUIPMENT and SYSTEMS that comply with IEC 61000-3-2, “[Class A, B, C, D, or
Not applicable]” in column 2 of row 7 shall be replaced with the class of the
EQUIPMENT or SYSTEM according to IEC 61000-3-2. For EQUIPMENT and SYSTEMS
that comply with IEC 61000-3-3, “[Complies or Not applicable]” in column 2 of row
8 shall be replaced with “Complies.” For EQUIPMENT and SYSTEMS for which IEC
61000-3-2 and IEC 61000-3-3 are not applicable, “[Class A, B, C, D, or Not
applicable]” and “[Complies or Not applicable]” shall each be replaced with “Not
applicable.”
– For CISPR 11 EQUIPMENT and SYSTEMS, column 3 of rows 6, 7 and 8 shall be
merged into one cell. For CISPR 11 EQUIPMENT and SYSTEMS that comply with
Class B and with IEC 61000-3-2 and IEC 61000-3-3, the text in column 3 of row 9
shall be moved into the merged cell. For TYPE A PROFESSIONAL EQUIPMENT and
SYSTEMS for which use in a domestic establishment or connection to the PUBLIC
MAINS NETWORK is intended and justified (see 6.8.3.201 j) and 36.201.1 a) 6)) and
that comply with IEC 61000-3-2 and IEC 61000-3-3, the text in column 3 of row 10
shall be moved into the merged cell. For CISPR 11 EQUIPMENT and SYSTEMS for
which IEC 61000-3-2 and IEC 61000-3-3 are not applicable or that comply with
Class A but do not meet the requirements for TYPE A PROFESSIONAL EQUIPMENT and
SYSTEMS specified in 36.201.1 a) 6), the text in column 3 of row 11 shall be moved
into the merged cell.
– For CISPR 14 or CISPR 15 EQUIPMENT, column 3 of rows 7 and 8 shall be merged
into one cell. For CISPR 14 or CISPR 15 EQUIPMENT that comply with IEC
61000-3-2 and with IEC 61000-3-3, the text in column 3 of row 9 shall be moved
into the merged cell. For CISPR 14 or CISPR 15 EQUIPMENT for which IEC
61000-3-2 and IEC 61000-3-3 are not applicable, the text in column 3 of row 11
shall be moved into the merged cell.
———————
3)
See Annex BBB for examples. These modifications should be performed in the order in which they appear.
4)
Row numbers refer to those in Table 201 before modifications are made.
– 6 – 60601-1-2 Amend. 1 IEC:2004(E)
– For EQUIPMENT and SYSTEMS specified for use only in a shielded location and for
which the electromagnetic radiation disturbance allowance or the mains terminal
disturbance voltage allowance in 36.201.1 a) 4) is used, the text specified by
6.8.3.201 c) 2) shall be added.
– Rows 9, 10 and 11 shall be deleted.
– The row numbers shall be deleted.
Add, on page 15, the following new item a) 7):
7) The performance of the EQUIPMENT or SYSTEM that was determined to be essential
performance.
Page 18
h) Requirements applicable to LARGE, PERMANENTLY-INSTALLED EQUIPMENT and SYSTEMS
Replace the first paragraph of this item with the following:
For LARGE, PERMANENTLY-INSTALLED EQUIPMENT and SYSTEMS for which the exemption
specified in 36.202.3 b) 9) is used, the ACCOMPANYING DOCUMENTS shall include the
following information:
i) Requirements applicable to EQUIPMENT and SYSTEMS found by a risk analysis to have no
essential performance
In the title of item i) and in 1) and 2), delete “by a risk analysis”.
Page 19
Add the following new item:
*j) Requirements applicable to TYPE A PROFESSIONAL EQUIPMENT and SYSTEMS
For TYPE A PROFESSIONAL EQUIPMENT and SYSTEMS intended for use in domestic
establishments or connection to the PUBLIC MAINS NETWORK (see 36.201.1 a) 6)), the
ACCOMPANYING DOCUMENTS shall include a justification for not complying with the
CISPR 11 Group 2 Class B electromagnetic radiation disturbance limit at the third
harmonic of the fundamental frequency of the EQUIPMENT or SYSTEM. This justification shall
be based on significant physical, technological or physiological limitations that prevent
compliance. The ACCOMPANYING DOCUMENTS shall also include a justification why the
EQUIPMENT or SYSTEM needs to be used in domestic establishments or connected to the
PUBLIC MAINS NETWORK.
Compliance is checked by inspection.
60601-1-2 Amend. 1 IEC:2004(E) – 7 –
Page 19
Replace the existing Table 201 with the following:
Table 201 – Guidance and manufacturer’s declaration – electromagnetic emissions –
for all EQUIPMENT and SYTEMS (see 6.8.3.201 a) 3))
Row
Guidance and manufacturer’s declaration – electromagnetic emissions
The [EQUIPMENT or SYSTEM] is intended for use in the electromagnetic environment specified below. The
customer or the user of the [EQUIPMENT or SYSTEM] should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
The [EQUIPMENT or SYSTEM] uses RF energy only for
RF emissions
its internal function. Therefore, its RF emissions are
Group 1
very low and are not likely to cause any interference
CISPR 11
in nearby electronic equipment.
The [EQUIPMENT or SYSTEM] must emit electro-
RF emissions
magnetic energy in order to perform its intended
Group 2
function. Nearby electronic equipment may be
CISPR 11
affected.
RF emissions
6 Class [A or B]
CISPR 11
Harmonic emissions
[Class A, B, C, D,
or Not applicable]
IEC 61000-3-2
Voltage fluctuations/
[Complies or Not
flicker emissions
applicable]
IEC 61000-3-3
The [EQUIPMENT or SYSTEM] is suitable for use in all
establishments, including domestic establishments
[See 6.8.3.201 a)
9 and those directly connected to the public low-voltage
3) and Figure 201]
power supply network that supplies buildings used for
domestic purposes.
The [EQUIPMENT or SYSTEM] is suitable for use in all
establishments other than domestic, and may be used
in domestic establishments and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes, provided the following warning is heeded:
[See 6.8.3.201 a)
Warning: This equipment/system is intended for
3) and Figure 201]
use by healthcare professionals only. This
equipment/ system may cause radio interference or
may disrupt the opera
...
NORME CEI
INTERNATIONALE
IEC
60601-1-2
INTERNATIONAL
STANDARD
AMENDEMENT 1
AMENDMENT 1
2004-09
Amendement 1
Appareils électromédicaux –
Partie 1-2:
Règles générales de sécurité –
Norme collatérale:
Compatibilité électromagnétique –
Exigences et essais
Amendment 1
Medical electrical equipment –
Part 1-2:
General requirements for safety –
Collateral standard:
Electromagnetic compatibility –
Requirements and tests
IEC 2005 Droits de reproduction réservés Copyright - all rights reserved
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: +41 22 919 02 11 Telefax: +41 22 919 03 00 E-mail: inmail@iec.ch Web: www.iec.ch
CODE PRIX
S
Commission Electrotechnique Internationale
PRICE CODE
International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
Pour prix, voir catalogue en vigueur
For price, see current catalogue
– 2 – 60601-1-2 Amend. 1 CEI:2005
AVANT-PROPOS
Cet amendement a été préparé par le sous-comité 62A: Aspects généraux des équipements
électriques utilisés en pratique médicale, du Comité d'Études 62 de la CEI: Équipements
électriques dans la pratique médicale.
Cette version bilingue (2005-09) remplace la version monolingue anglaise.
Le texte anglais de cet amendement est basé sur les documents 62A/462/FDIS et
62A/469/RVD. Le rapport de vote 62A/469/RVD donne toute information sur le vote ayant
abouti à l’approbation de cet amendement.
La version française de cet amendement n’a pas été soumise au vote.
Le comité a décidé que le contenu de cet amendement ainsi que celui de la publication de
base resteront inchangés jusqu'à la date de maintenance indiquée sur le site web de la CEI à
l'adresse http://webstore.iec.ch par les informations spécifiques relatives à la publication. A
cette date, la publication sera
• reconduite;
• supprimée;
• remplacée par une édition révisée, ou
• amendée.
_____________
INTRODUCTION
Cet amendement contient une première série de révisions de la CEI 60601-1-2 (deuxième
édition, 2001): Appareils électromédicaux – Partie 1-2: Règles générales de sécurité – Norme
collatérale: Compatibilité électromagnétique – Prescriptions et essais.
Cet amendement traite principalement des exigences relatives aux APPAREILS et aux
SYSTEMES qui:
– sont conformes à la Classe B, Groupe 2, du CISPR 11 sauf pour le troisième harmonique
de la fréquence fondamentale;
– sont utilisés par des professionnels de la santé;
– ne sont pas prévus pour être vendus au grand public; mais
– sont prévus pour être utilisés dans des locaux domestiques ou reliés au RESEAU
ELECTRIQUE PUBLIC.
Toutefois, cet amendement inclut également plusieurs autres corrections et adjonctions à la
CEI 60601-1-2:2001.
Afin de répondre aux besoins d'évolution identifiés par les utilisateurs de cette norme
collatérale, il a été nécessaire d'amender la norme avant la date initialement approuvée pour
sa maintenance.
60601-1-2 Amend. 1 IEC:2005 – 3 –
FOREWORD
This amendment has been prepared by subcommittee 62A: Common aspects of electrical
equipment used in medical practice, of IEC technical committee 62: Electrical equipment in
medical practice.
This bilingual version (2005-09) replaces the English version.
The text of this amendment is based on the following documents:
FDIS Report on voting
62A/462/FDIS 62A/469/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 French version of this amendment fas not been voted upon.
The committee has decided that the contents of this amendment and the base publication will
remain unchanged until the maintenance result date indicated on the IEC web site under
"http://webstore.iec.ch" in the data related to the specific publication. At this date, the
publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
___________
INTRODUCTION
This amendment contains a first series of revisions to IEC 60601-1-2 (second edition, 2001):
Medical electrical equipment – Part 1-2: General requirements for safety – Collateral
standard: Electromagnetic compatibility – Requirements and tests.
This amendment deals primarily with requirements for EQUIPMENT and SYSTEMS that:
• comply with CISPR 11 Group 2 Class B except for the third harmonic of the fundamental
frequency;
• are for use by healthcare professionals;
• are not intended for sale to the general public; and
• are intended for use in domestic establishments or connected to the PUBLIC MAINS
.
NETWORK
However, this amendment also includes several other corrections and additions to IEC
60601-1-2:2001.
To meet needs for change that were identified by users of this Collateral Standard, it was
necessary to amend the standard before the previously approved maintenance cycle date.
– 4 – 60601-1-2 Amend. 1 CEI:2005
Page 12
INTRODUCTION
Supprimer, à la page 14, l'alinéa, commençant par "Cette deuxième édition permet de mettre
en oeuvre une analyse des risques.".
Page 16
2 Terminologie et définitions
Remplacer le premier alinéa existant par ce qui suit:
Pour les besoins de la présente norme collatérale, les termes et définitions donnés dans la
CEI 60601-1:1988, la CEI 60601-1-1:2001, la CEI 60601-1-8:2003 et dans l’ISO 14971:2000,
ainsi que les définitions suivantes s'appliquent.
Supprimer la définition 2.210 et changer toutes les occurrences de "PERFORMANCE
ESSENTIELLE" en police normale.
Remplacer la définition 2.212 existante par la suivante:
*2.212
FONCTION (d'un APPAREIL ou d'un SYSTEME )
opération cliniquement significative pour laquelle un APPAREIL ou un SYSTEME est prévu à des
fins de diagnostic, de traitement ou de surveillance d'un PATIENT
Ajouter les nouvelles définitions suivantes:
*2.227
APPAREIL ou SYSTEME PROFESSIONNEL
APPAREIL ou SYSTEME utilisé par les professionnels de santé et qui n'est pas destiné à être vendu au
grand public
[VEI 161-05-05, modifié]
*2.228
APPAREIL ou SYSTEME PROFESSIONNEL de TYPE A
APPAREIL PROFESSIONNEL ou SYSTEME qui est conforme à la CISPR 11, groupe 2, classe B, sauf pour
le troisième harmonique de la fréquence fondamentale de l'APPAREIL ou du SYSTEME, lequel troisième
harmonique respecte les limites pour les perturbations électromagnétiques rayonnées du groupe 2,
classe A
NOTE Voir 36.201.1 a) 6).
60601-1-2 Amend. 1 IEC:2005 – 5 –
Page 13
INTRODUCTION
Delete, on page 15, the paragraph beginning “This second edition allows a risk analysis…”
Page 17
2 Terminology and definitions
Replace the existing first paragraph with the following:
For the purposes of this Collateral Standard, the terms and definitions given in
IEC 60601-1:1988, IEC 60601-1-1:2000, IEC 60601-1-8:2003 and ISO 14971:2000 and the
following apply:
Delete definition 2.210 and change all occurrences of “ESSENTIAL PERFORMANCE” throughout
the document to normal font.
Replace the existing definition 2.212 with the following:
*2.212
FUNCTION (of an EQUIPMENT or SYSTEM)
clinically significant operation that the EQUIPMENT or SYSTEM is intended to perform in the
diagnosis, treatment or monitoring of a PATIENT
Add the following new definitions:
*2.227
PROFESSIONAL EQUIPMENT or SYSTEM
EQUIPMENT or SYSTEM for use by healthcare professionals and that is not intended for sale to
the general public
[IEV 161-05-05, modified]
2.228
TYPE A PROFESSIONAL EQUIPMENT or SYSTEM
PROFESSIONAL EQUIPMENT or SYSTEM that complies with CISPR 11 Group 2 Class B except for
the third harmonic of the fundamental frequency of the EQUIPMENT or SYSTEM, in which case
the third harmonic complies with the Group 2 Class A electromagnetic radiation disturbance
limit
NOTE See 36.201.1 a) 6).
– 6 – 60601-1-2 Amend. 1 CEI:2005
Page 24
3 Exigences générales
3.201.2 Performance essentielle
Remplacer le texte existant de ce paragraphe par ce qui suit:
Les performances essentielles des APPAREILS et des SYSTEMES doivent être identifiées (voir
l'Annexe GGG qui donne des recommandations concernant la façon d'identifier les
performances essentielles). Cependant, si les performances essentielles ne sont pas
identifiées, toutes les caractéristiques de performances de toutes les FONCTIONS de l'APPAREIL
ou du SYSTEME doivent être considérées comme des performances essentielles pour les
essais d'IMMUNITE (voir 36.202.1 j)). Les caractéristiques identifiées comme étant des
performances essentielles doivent être listées dans les DOCUMENTS D'ACCOMPAGNEMENT.
La conformité est vérifiée par l'inspection des DOCUMENTS D'ACCOMPAGNEMENT ou, si cette
identification n'est pas effectuée, par l'inspection de tout document permettant de vérifier que
toutes les caractéristiques de performances de toutes les FONCTIONS de l'APPAREIL ou du
SYSTEME ont été testées selon 36.202.
3.201.4 Appareil non électromédical
Supprimer l’astérisque du titre et remplacer le texte existant de ce paragraphe par le suivant:
SYSTEME est dispensé des
Un appareil non électromédical fourni en tant qu'élément d'un
exigences d'essais CEM de cette norme, si toutes les conditions suivantes sont satisfaites
(voir également l'Annexe HHH):
a) l'appareil non électromédical est conforme aux normes internationales CEM applicables;
b) il a été déterminé que ni les EMISSIONS ni l'IMMUNITE de l'appareil non électromédical ne
compromettaient les performances essentielles ou la sécurité de base du SYSTEME;
c) il a été déterminé que les EMISSIONS de l'appareil non électromédical n'entraînaient pas le
dépassement des limites applicables pour les EMISSIONS du SYSTEME.
La conformité est vérifiée par l'inspection des documents nécessaires à cette détermination et
d'autres documents ou certificats appropriés ou, si cette détermination n'est pas effectuée
ainsi, par l'inspection des documents destinés à vérifier que l'appareil non électromédical a
été testé selon cette norme.
Ajouter le nouveau paragraphe suivant:
*3.201.5 Conditions générales d'essai
Les exigences de la norme générale relatives aux CONDITIONS DE PREMIER DEFAUT ne
s'appliquent pas aux essais CEM.
60601-1-2 Amend. 1 IEC:2005 – 7 –
Page 25
3 General requirements
3.201.2 Essential performance
Replace the existing text of this subclause with the following:
Either the essential performance of the EQUIPMENT or SYSTEM shall be identified (see Annex
GGG for guidance on identifying the essential performance) or the performance of all
FUNCTIONS of the EQUIPMENT or SYSTEM shall be considered essential performance for the
purpose of IMMUNITY testing (see 36.202.1 j)). The essential performance shall be disclosed in
the ACCOMPANYING DOCUMENTS.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS or, if this identification
is not performed, by inspection of the documents to verify that the performance of all
FUNCTIONS of the EQUIPMENT or SYSTEM has been tested in accordance with 36.202.
3.201.4 Non-medical electrical equipment
Remove the asterisk from the title and replace the existing text of this subclause with the
following:
SYSTEM is exempt from the EMC
Non-medical electrical equipment that is supplied as part of a
testing requirements of this standard, provided all of the following conditions are met (see
also Annex HHH):
a) the non-medical electrical equipment complies with applicable international EMC
standards;
b) both the EMISSIONS and IMMUNITY of the non-medical electrical equipment have been
determined not to adversely affect the essential performance or safety of the SYSTEM;
c) the EMISSIONS of the non-medical electrical equipment have been determined not to cause
EMISSIONS of the SYSTEM to exceed applicable limits.
the
Compliance is checked by inspection of the documents for this determination and other
appropriate documents or certificates or, if this determination is not performed, by inspection
of the documents to verify that the non-medical electrical equipment has been tested in
accordance with this standard.
Add the following new subclause:
*3.201.5 General test conditions
For EMC testing, the SINGLE FAULT CONDITION requirements of the General Standard do not
apply.
– 8 – 60601-1-2 Amend. 1 CEI:2005
Page 26
6.8.201 DOCUMENTS D'ACCOMPAGNEMENT
Renuméroter ce paragraphe comme suit :
6.8 DOCUMENTS D'ACCOMPAGNEMENT
6.8.2.201 Instructions d'utilisation
Ajouter le point suivant:
*d) Exigences applicables aux APPAREILS ou SYSTEMES PROFESSIONNELS de TYPE A
Lorsque des APPAREILS et des SYSTEMES PROFESSIONNELS sont prévus pour être utilisés
dans des locaux domestiques ou raccordés au RESEAU ELECTRIQUE PUBLIC (voir 36.201.1 a)
6)), les instructions d'utilisation doivent inclure l'avertissement suivant ou équivalent:
Attention
Cet appareil/système est réservé uniquement à l'usage des professionnels de la
santé. C'est un appareil/système médical de la Classe A, Groupe 2, du CISPR 11. Cet
appareil/système peut provoquer des interférences radio ou peut perturber le
fonctionnement des appareils situés à proximité. Il peut être nécessaire de prendre
des mesures palliatives adéquates, comme réorienter ou repositionner [l'APPAREIL ou
le SYSTEME] ou bien encore de blinder la pièce.
Le terme "[APPAREIL ou SYSTEME]" doit être remplacé par la REFERENCE DU MODELE ou
DU TYPE de l'APPAREIL ou du SYSTEME.
6.8.3.201 Description technique
a) Exigences applicables à tous les APPAREILS et SYSTEMES
Remplacer page 28, le point a) 3) existant de ce paragraphe par ce qui suit:
1 2
*3) Le Tableau 201, avec les modifications spécifiées ci-dessous. L'organigramme de
la Figure 201 est l’exigence étape par étape, sous forme graphique, relative à la mise
en oeuvre du Tableau 201, concernant les APPAREILS et les SYSTEMES du CISPR 11.
L'organigramme de la Figure 202 est l’exigence étape par étape, sous forme
graphique, relative à la mise en oeuvre du Tableau 201, concernant les APPAREILS des
CISPR 14 et CISPR 15.
– Pour les APPAREILS et les SYSTEMES du CISPR 11, "[l'APPAREIL ou le SYSTEME]" doit
être remplacé par la REFERENCE DU MODELE ou DU TYPE de l'APPAREIL ou du
SYSTEME.
– Pour les APPA
...
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