EN 60601-2-25:1995/A1:1999

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

EN following parallel vote

Medizinische elektrische Geräte - Teil 2-25: Besondere Festlegungen für die Sicherheit von Elektrokardiographen

Appareils électromédicaux - Partie 2-25: Règles particulières de sécurité des électrocardiographes

Medicinska električna oprema - 2-25. del: Posebne varnostne zahteve za elektrokardiografe - Dopolnilo A1 (IEC 60601-2-25:1993/A1:1999)

General Information

• Status: Withdrawn
• Publication Date: 02-Jun-1999
• Withdrawal Date: 30-Apr-2002
• ICS: 11.040.99 - Other medical equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 15-Sep-2018
• Completion Date: 15-Sep-2018
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 60601-2-25:1998/A1:2002 - Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs (IEC 60601-2-25:1993/A1:1999)

Relations

• Replaced By: EN 60601-2-25:2015 - Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
• Effective Date: 28-Jan-2023
• Amends: EN 60601-2-25:1995 - Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs
• Effective Date: 29-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-25:1998/A1:2002
01-februar-2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]DKWHYH]D
HOHNWURNDUGLRJUDIH'RSROQLOR$,(&$
Medical electrical equipment - Part 2-25: Particular requirements for the safety of
electrocardiographs (IEC 60601-2-25:1993/A1:1999)
Medizinische elektrische Geräte - Teil 2-25: Besondere Festlegungen für die Sicherheit
von Elektrokardiographen (IEC 60601-2-25:1993/A1:1999)
Appareils électromédicaux - Partie 2-25: Règles particulières de sécurité des
électrocardiographes (CEI 60601-2-25:1993/A1:1999)
Ta slovenski standard je istoveten z: EN 60601-2-25:1995/A1:1999
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
SIST EN 60601-2-25:1998/A1:2002 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-25:1998/A1:2002

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SIST EN 60601-2-25:1998/A1:2002

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SIST EN 60601-2-25:1998/A1:2002

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SIST EN 60601-2-25:1998/A1:2002

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SIST EN 60601-2-25:1998/A1:2002

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SIST EN 60601-2-25:1998/A1:2002
INTERNATIONAL IEC
STANDARD
60601-2-25
1993
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

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SIST EN 60601-2-25:1998/A1:2002
– 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.

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SIST EN 60601-2-25:1998/A1:2002
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.

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SIST EN 60601-2-25:1998/A1:2002
– 4 – 60601-2-25 Amend. 1 © IEC:1999(E)
36.201.1.7
Replacement:
The EQU
...