IEC 60601-2-27:2011/COR1:2012

Corrigendum 1 - Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

Corrigendum 1 - Appareils électromédicaux - Partie 2-27: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de surveillance d'électrocardiographie

General Information

• Status: Published
• Publication Date: 15-May-2012
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Current Stage: PPUB - Publication issued
• Start Date: 30-Apr-2012
• Completion Date: 16-May-2012

Relations

• Corrects: IEC 60601-2-27:2011 - Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-27
(Third edition – 2011)
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-27: Particular requirements for the basic safety and essential
performance of electrocardiographic monitoring equipment

CO RRI G E NDUM 1
Title
The correction applies to the French text only.

Figure 201.103 – Test of protection against the effects of defibrillation (common mode)
Replace the existing figure by the following new figure:
G
S
R
R 50 Ω
390 kΩ
R non-inductive
V
P 1 L (LA)
V
A B
S
S
EUT
R
5 kV d.c.
100Ω
L 500 µH
non-
R (RA)
R (d.c.) ≤ 10 Ω
L
inductive
F (LL)
C (V)
C 32 µF
N (RL)
P 2
F
IEC  833/12
May 2012
Components
G Sine wave generator 20 V peak-to-valley of 10 Hz
V
High voltage source 5 kV d.c.
Foil, simulating capacitance for CLASS II EQUIPMENT
Ⓕ
S
Switch; max. load 60 A, 5 kV
S
Switch connecting the signal source, 5 kV
S
Switch applying the signal source to LEAD WIRES
R
d.c. resistance of inductance L
L
R
Current limiting resistor
V
P1 Connecting point for EUT (includes PATIENT CABLES)
Connecting point for FUNCTIONAL EARTH TERMINAL and/or metal
P2
foil in contact with ENCLOSURE
Test to be conducted with MANUFACTURER’S recommended PATIENT CABLE and LEAD WIRES.
Figure 201.103 – Test of protection against the effects of defibrillation (common mode)
(see 201.8.5.5.1)
Figure 201.105 – General test circuit
Delete the symbol "F" between the lower part of the schematic and the legend beginning with
"Components".
201.12.1.101.15 * Heart rate range, accuracy, and QRS detection range
Replace the last sentence of the second paragraph with the following:
ECG input signals at rates above the upper limit of the specified display range, up to
300 1/min for adults and 350 1/min for neonatal and paediatric use shall not detect heart rates
lower than the specified upper limits.

_____________
May 2012
CEI 60601-2-27
(Troisième édition – 2011)
APPAREILS ÉLECTROMÉDICAUX –
Partie 2-27: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de surveillance d’électrocardiographie

CORRIGENDUM 1
Titre
Remplacer, sur la page de couvertu
...