IEC 60601-2-25:1993/AMD1:1999

Amendment 1 - Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs

General Information

• Status: Published
• Publication Date: 06-May-1999
• ICS: 11.040.99 - Other medical equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 19-Oct-2011

Relations

• Revised: IEC 60601-2-25:2011 - Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL IEC
STANDARD
60601-2-25
AMENDMENT 1
1999-05
Amendment 1
Medical electrical equipment –
Part 2-25:
Particular requirements for the safety
of electrocardiographs
Amendement 1
Appareils électromédicaux –
Partie 2-25:
Règles particulières de sécurité
pour les électrocardiographes
 IEC 1999  Copyright - all rights reserved
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: [phone] e-mail: [e-mail] IEC web site http://www.iec.ch
Commission Electrotechnique Internationale
PRICE CODE
M
International Electrotechnical Commission
For price, see current catalogue

– 2 – 60601-2-25 Amend. 1 © IEC:1999(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/309/FDIS 62D/314/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.
___________
Page 3
CONTENTS
Replacement:
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,
disinfection and compatibility . 25
SECTION ONE – GENERAL
Page 11
1.3 Particular Standards
Replace the first paragraph of the Addition by the following:
This Particular Standard refers to IEC 60601-1 (1988): Medical electrical equipment – Part 1:
General requirements for safety as amended by its amendment 1 (1991) and amendment 2
(1995). The General Standard takes into account IEC 60601-1-2 (1993), Medical electrical
equipment – Part 1 General requirements for safety – 2. Collateral Standard: Electromagnetic
compatibility – Requirements and tests.
Page 17
6 Identification, marking and documents
This clause of the Particular Standard applies except as follows:
6.1 Marking on the outside
Replace the existing title by the following:
Marking on the outside of EQUIPMENT or EQUIPMENT parts
Delete 6.1 l) and text.
60601-2-25 Amend. 1 © IEC:1999(E) – 3 –
6.8.2 Instructions for use
aa) Advice shall be given on the following:
In 1) replace the defined term TYPE B ELECTROCARDIOGRAPHS by TYPE B APPLIED PARTS.
In 3) replace the defined term TYPE BF OR CF ELECTROCARDIOGRAPHS by TYPE BF OR CF APPLIED
PARTS.
Page 19
Addition:
13) Where relevant, a statement that the EQUIPMENT is protected against malfunction caused
by electrosurgery.
17 Separation
Replacement:
This clause of the Particular Standard applies, except as follows:
17 h) second dash of the General Standard does not apply because it is covered by 51.101
and 51.102
Delete 17.101 and text.
Page 21
19.3 Allowable values
Delete 19.3 Item a), Additional item: 1) and Table 101, as they are covered by the General
Standard.
Page 23
SECTION FIVE – PROTECTION AGAINST HAZARD
FROM UNWANTED OR EXCESSIVE RADIATION
36 Electromagnetic compatibility
Replacement:
IEC 60601-1-2 applies, except as follows:
36.201.1.1
Replacement:
The EQUIPMENT shall comply with the requirements of CISPR 11, group 1, class A or B
depending on the environment of intended use.

– 4 – 60601-2-25 Amend. 1 © IEC:1999(E)
36.201.1.7
Replacement:
The EQUIPMENT shall be tested with the PATIENT cables, leads and electrodes attached to the
EQUIPMENT and terminated in a load simulating the PATIENT (see figure 108).
During the conductive emission test, the midpoint of the metal plate shall be connected to
ground via 220 pF in series with 510 Ω (see figure 108).
Signal input/output cables (if applicable) shall be attached to the EQUIPMENT during the test
(see 36.202.2.2 a).
36.202 IMMUNITY
Addition to paragraph 4:
Examples of SAFETY HAZARDS include failures involving changes in operating state,
irrecoverable loss or change of stored data, errors in control software such as unintended
changes in output or failure to meet the manufacturer’s specification.
36.202.1 Electrostatic discharge
Replacement:
A level of 6 kV shall apply for contact discharge to conductive ACCESSIBLE PARTS and coupling
planes.
Addition:
The EQUIPMENT shall return to the previous operating mode within 10 s without loss of any
stored data.
36.202.2 Radiated radio-frequency electromagnetic fields
36.202.1 a)
Replacement:
The EQUIPMENT shall be tested in accordance with IEC 61000-4-3.
36.202.2.1 d)
Replacement:
The EQUIPMENT shall operate within the limits specified in this standard. (The field strength of
3 V/m applies.)
36.202.2.2 a)
Replacement:
The EQUIPMENT shall be exposed to an r.f. field amplitude modulated at 80 % with a modulation
frequency of 10 Hz.
Any SIGNAL INPUT PART, SIGNAL OUTPUT PART cable and mains cable shall be arranged generally
as in figure 109.
60601-2-25 Amend. 1 © IEC:1999(E) – 5 –
36.202.2.2 d)
Replacement:
See 36.201.1.7.
36.202.3 Transients
Addition:
The EQUIPMENT shall return to the previous operating mode within 10 s without loss of any
stored data.
36.202.3.1 b)
Addition:
The patient cable shall be excluded from the test.
Compliance with the requirements is checked by verifying that the EQUIPMENT returns to the
previous operating mode within 10 s.
36.202.5 Conducted disturbances, induced by radio-frequency fields above 9 kHz
Addition:
When exposed to a conducted radio-frequency voltage, via the POWER SUPPLY CORD, the
EQUIPMENT shall operate within normal specifications.
The test methods and instruments shall be as described in IEC 61000-4-6.
The noise voltage that is injected into the mains power input shall be 3 V r.m.s. over the
frequency range of 150 kHz to 80 MHz. It shall be amplitude modulated at 80 % with a
modulation frequency of 10 Hz.
36.202.6 Magnetic fields
Addition:
The EQUIPMENT shall be exposed to an a.c. magnetic field at a frequency equal to the power
line frequency. The EQUIPMENT shall operate within the NORMAL limits of this standard when
exposed to this field.
Magnetic field intensity: 3 A/m
Frequency: SUPPLY MAINS
The test methods used shall be those of IEC 61000-4-8.
The ECG lead connector shall be shorted at the ECG unit. The ECG cable shall not be used.
Addition:
*36.202.101 Electrosurgery interference
Where means are provided for protection against malfunction caused by electrosurgery, the
test below, using any accessories or settings recommended by the manufacturer, applies.

– 6 – 60601-2-25 Amend. 1 © IEC:1999(E)
When the EQUIPMENT has been used together with HIGH FREQUENCY SURGICAL EQUIPMENT it shall
return to previous operating mode within 10 s after exposure to the field produced by the HIGH
FREQUENCY SURGICAL EQUIPMENT, without loss of any stored data.
Compliance shall be tested according to figures 110 and 111.
HIGH FREQUENCY SURGICAL EQUIPMENT
The which is used shall comply with IEC 60601-2-2, shall
have a minimum power cut mode capability of 300 W, a minimum coag mode of 100 W and
working frequency of 450 kHz ± 100 kHz.
a) Test in cut mode:
Set the output power of the HIGH FREQUENCY SURGICAL EQUIPMENT to the 300 W position.
Touch the metal contact/block in the test set-up (see figures 110 and 111) with the active
electrode and remove the electrode slowly to get an arc.
Repeat the procedure five times.
b) Test in coag mode:
Repeat the test in item a) except with a maximum output power of 100 W.
Test of the spray co
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