IEC 60601-1-2:2007/ISH1:2010

Interpretation sheet 1 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

Feuille d'interprétation 1 - Appareils électromédicaux - Partie 1-2: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Compatibilité électromagnétique - Exigences et essais

General Information

• Status: Published
• Publication Date: 15-Mar-2010
• ICS: 11.040.01 - Medical equipment in general
• ICS: 33.100.10 - Emission
• ICS: 33.100.20 - Immunity
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 25-Feb-2014

Relations

• Revised: IEC 60601-1-2:2014 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-1-2:2007 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
• Effective Date: 05-Sep-2023

Standards Content (Sample)

– 1 –
SC 62A/Publication IEC 60601-1-2 (2007), Third edition/I-SH 01
MEDICAL ELECTRICAL EQUIPMENT –

Part 1-2: General requirements for
basic safety and essential performance –
Collateral standard: Electromagnetic compatibility –
Requirements and tests
INTERPRETATION SHEET
This interpretation sheet has been prepared by SC 62A: Common aspects of electrical
equipment used in medical practice.
The text of this interpretation sheet is based on the following documents:
ISH Report on voting
62A/685/ISH 62A/694/RVD
Full information on the voting for the approval of this interpretation sheet can be found in the
report on voting indicated in the above table.
___________
Subclause 6.2.2.2 e) (ESD IMMUNITY)
1)
(This is also applicable to Subclause 36.202.2 b) 5) in IEC 60601-1-2:2001 .)
This subclause states the following:
The test may be performed with the ME EQUIPMENT or ME SYSTEM powered at any one of its
NOMINAL input voltages and frequencies.
This is clarified by the following:
The test may be performed at any input power voltage and frequency within the ME
EQUIPMENT or ME SYSTEM RATED voltage and frequency range. If the ME EQUIPMENT or ME
SYSTEM is tested at one power input voltage and one power input frequency meeting this
specification, it is not necessary to re-test at additional voltages or frequencies.
Subclause 6.2.3.2 j) (Radiated RF IMMUNITY)
(This is also applicable to Subclause 36.202.3 b) 10) in IEC 60601-1-2:2001.)
This subclause states the following:
The test may be performed with the ME EQUIPMENT or ME SYSTEM powered at any one of its
NOMINAL input voltages and frequencies.
This is clarified by the following:
—————————
1)
A consolidated edition 2.1 exists (withdrawn) including IEC 60601-1-2:2001 and its Amendment 1 (2004).
March 2010 ICS 11.040.01; 33.100.10; 33.100.20 French text overleaf

– 2 –
The test may be performed at any power input voltage and frequency within the ME
EQUIPMENT or ME SYSTEM RATED voltage and frequency range. If the EQUIPMENT or SYSTEM is
tested at one power input voltage and one power input frequency meeting this
specification, it is not necessary to re-test at additional voltages or frequencies.
Subclause 6.2.4.2 e) (EFT/burst IMMUNITY)
(This is also applicable to Subclause 36.202.4 b) 5) in IEC 60601-1-2:2001.)
This subclause states the following:
For ME EQUIPMENT and ME SYSTEMS that have, for power input, multiple voltage settings or
autoranging voltage capability, the test is performed at the minimum and maximum RATED
input voltages. The test may be performed with the ME EQUIPMENT or ME SYSTEM powered at
any one of its NOMINAL power frequencies.
This is clarified by the following:
For ME EQUIPMENT and ME SYSTEMS that have, for power input, multiple voltage settings or
autoranging voltage capability, the test shall be performed at the minimum and maximum
ME EQUIPMENT or ME SYSTEM RATED power input voltages. The test may be performed at any
power input frequency within the ME EQUIPMENT or ME SYSTEM RATED range. If the ME
EQUIPMENT or ME SYSTEM is tested at power input voltages and a power input frequency
meeting these specifications, it is not necessary to re-test at additional voltages or
frequencies.
Subclause 6.2.5.2 f) (Surge IMMUNITY)
(This is also applicable to Subclause 36.202.5 b) 6) in IEC 60601-1-2:2001.)
This subclause states the following:
For ME EQUIPMENT and ME SYSTEMS that have, for power input, multiple voltage settings or
autoranging voltage capability, the test is performed at the minimum and maximum RATED
input voltages. The test may be performed with the ME EQUIPMENT or ME SYSTEM powered at
any one of its NOMINAL power frequencies.
This is clarified by the following:
For ME EQUIPMENT and ME SYSTEMS that have, for power input, multiple voltage settings or
autoranging voltage capability, the test shall be performed at the minimum and maximum
ME EQUIPMENT or ME SYSTEM RATED power input voltages. The test may be performed at any
power input frequency within the ME EQUIPMENT or ME SYSTEM RATED range. If the ME
EQUIPMENT or ME SYSTEM is tested at power input voltages and a power input frequency
meeting these specifications, it is not necessary to re-test at additional voltages or
frequencies.
Subclause 6.2.6.2 j) (Conducted RF IMMUNITY)
(This is also applicable to Subclause 36.202.6 b) 10) in IEC 60601-1-2:2001.)
This subclause states the following:
The test may be performed with the ME EQUIPMENT or ME SYSTEM powered at any one of its
NOMINAL input voltages and frequencies.
This is clarified by the following:
The test may be performed at any power input voltage and frequency within the ME
EQUIPMENT or ME SYSTEM RATED voltage and frequency range. If the EQUIPMENT or SYSTEM is
March 2010 ICS 11.040.01; 33.100.10; 33.100.20 French text overleaf

– 3 –
tested at one power input voltage and one power input frequency meeting this
specification, it is not necessary to re-test at additional voltages or frequencies.
Subclause 6.2.7.2 c) (Voltage dips and interruptions IMMUNITY)
(This is also applicable to Subclause 36.202.7 b) 4) in IEC 60601-1-2:2001.)
This subclause states the following:
For ME EQUIPMENT and ME SYSTEMS that have, for power input, multiple voltage settings or
autoranging voltage capability, the test is performed at the minimum and maximum RATED
input voltages. The test is performed at the minimum RATED power frequency.
This is clarified by the following:
For ME EQUIPMENT and ME SYSTEMS that have, for power input, multiple voltage settings or
autoranging voltage capability, the test shall be performed at the minimum and maximum
ME EQUIPMENT or ME SYSTEM RATED input voltages. The test shall be performed with the ME
EQUIPMENT or ME SYSTEM powered at the minimum RATED power frequency. If the ME
EQUIPMENT or ME SYSTEM is tested at power input voltages and a power input frequency
meeting these specifications, it is not necessary to re-test at additional voltages or
frequencies.
Subclause 6.2.8.1.2 (Power-frequency magnetic field IMMUNITY)
(This is also applicable to Subclause 36.202.8.1 b) in IEC 60601-1-2:2001.)
This subclause states the following:
a) (Item 1) in IEC 60601-1-2:2001)
Only the continuous field test shall be performed.
– The test is performed at both 50 Hz and 60 Hz, with the exception that ME
EQUIPMENT and ME SYSTEMS RATED for use only at one of these frequencies need
only be tested at that frequency. In either case, during the test, the ME EQUIPMENT or
ME SYSTEM is powered at the same frequency as the applied magnetic field.
– If the ME EQUIPMENT or ME SYSTEM is INTERNALLY POWERED or powered from an
external d.c. supply, the test is performed at both 50 Hz and 60 Hz, with the
exception that ME EQUIPMENT and ME SYSTEMS intended for use only in areas
supplied at one of these frequencies need be tested only at that frequency.
b) (Item 2) in IEC 60601-1-2:2001))
The test may be performed with the ME EQUIPMENT or ME SYSTEM powered at any one of
its NOMINAL power voltages.
Item b) is clarified by the following:
The test may be performed at any power input voltage within the ME EQUIPMENT or ME
SYSTEM RATED power input voltage range. If the EQUIPMENT or SYSTEM is tested at one
power input voltage, it is not necessary to re-test at additional voltages.
For EMISSIONS, IEC 60601-1-2 references CISPR 11. IEC 60601-1-2 does not add any
clarification regarding the power input voltage and frequency during EMISSIONS testing.
Subclause 7.5.3 of CISPR 11:2009 states the following:
Mains power at the nominal voltage shall be supplied.
This is clarified by the following:
March 2010 ICS 11.040.01; 33.100.10; 33.100.20 French text overleaf

– 4 –
The test may be performed at any input power voltage and frequency within the ME
EQUIPMENT or ME SYSTEM RATED voltage and frequency range. If the ME EQUIPMENT or ME
SYSTEM is tested at one power input voltage and one power input frequency meeting this
specification, it is not necessary to re-test at additional voltages or frequencies.
Subclause 9.1 of CISPR 11:2009 states the following:
Power at the nominal voltage shall be supplied.
This is clarified by the following:
The test may be performed at any input power voltage and frequency within the ME
EQUIPMENT or ME SYSTEM RATED voltage and frequency range. If the ME EQUIPMENT or ME
SYSTEM is tested at one power input voltage and one power input frequency meeting this
specification, it is not necessary to re-test at additional voltages or frequencies.
These clarifications will remain valid until a new version of IEC 60601-1-2 is published.

March 2010 ICS 11.040.01; 33.100.10; 33.100.20 French text overleaf

– 5 –
SC 62A/Publication CEI 60601-1-2 (2007), Troisième édition/I-SH 01
APPAREILS ÉLECTROMÉDICAUX –
Partie 1-2: Exigences générales pour la sécurité
de base et les performances essentielles –
Norme collatérale: Compatibilité électromagnétique –
Exigences et essais
FEUILLE D'INTERPRÉTATION
La présente feuille d'interprétation a été établie par le SC 62A: Aspects généraux des
équipements électriques utilisés en pratique médicale.
Le texte de cette feuille d’interprétation est issu des documents suivants:
ISH Rapport de vote
62A/685/ISH 62A/694/RVD
Le rapport de vote indiqué dans le tableau ci-dessus donne toute information sur le vote ayant
abouti à l'approbation de cette feuille d’interprétation.
___________
Paragraphe 6.2.2.2 e) (IMMUNIT
...