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CEI EN 60601-1-1 : 2003

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
Available format(s)

Hardcopy , PDF

Withdrawn date

13-06-2020

Language(s)

English - Italian

Published date

01-01-2003

SECTION 1 - GENERAL
1 SCOPE AND OBJECT
2 TERMINOLOGY AND DEFINITIONS
3 GENERAL REQUIREMENTS
6 IDENTIFICATION, MARKING AND
   DOCUMENTS
SECTION 2 - ENVIRONMENTAL CONDITIONS
10 ENVIRONMENTAL CONDITIONS
SECTION 3 - PROTECTION AGAINST
            ELECTRIC SHOCK HAZARDS
16 ENCLOSURES AND PROTECTIVE
   COVERS
17 SEPARATION
19 CONTINUOUS LEAKAGE CURRENTS
   AND PATIENT AUXILIARY CURRENTS
SECTION 4 - PROTECTION AGAINST
            MECHANICAL HAZARDS
22 MOVING PARTS
SECTION 5 - PROTECTION AGAINST
            HAZARDS FROM UNWANTED
            OR EXCESSIVE RADIATION
SECTION 6 - PROTECTION AGAINST
            HAZARDS OF IGNITION OF
            FLAMMABLE ANAESTHETIC
            MIXTURES
SECTION 7 - PROTECTION AGAINST
            EXCESSIVE TEMPERATURES
            AND OTHER SAFETY HAZARDS
44 OVERFLOW, SPILLAGE, LEAKAGE, HUMIDITY,
   INGRESS OF LIQUIDS, CLEANING,
   STERILIZATION, DISINFECTION
   AND COMPATIBILITY
49 INTERRUPTION OF THE POWER SUPPLY
SECTION 8 - ACCURACY OF OPERATING
            DATA AND PROTECTION
            AGAINST HAZARDOUS OUTPUT
SECTION 9 - ABNORMAL OPERATION AND
            FAULT CONDITIONS; ENVIRONMENTAL
            TESTS
52 ABNORMAL OPERATION AND FAULT
   CONDITIONS
SECTION 10 - CONSTRUCTIONAL
             REQUIREMENTS
56 COMPONENTS AND GENERAL
   ASSEMBLY
57 MAINS PARTS, COMPONENTS
   AND LAYOUT
58 PROTECTIVE EARTHING - TERMINALS
   AND CONNECTION
59 CONSTRUCTION AND LAYOUT
ANNEX AAA - GENERAL GUIDANCE
            AND RATIONALE
ANNEX BBB - EXAMPLES OF
            COMBINATIONS OF MEDICAL
            ELECTRICAL EQUIPMENT AND
            NON-MEDICAL ELECTRICAL
            EQUIPMENT
ANNEX ZA (normative) - Normative
         references to international
         publications with their
         corresponding European
         publications
Bibliography
ANNEX EEE - REQUIREMENTS FOR MULTIPLE
            PORTABLE SOCKET-OUTLETS
ANNEX FFF - EXAMPLES OF APPLICATION
            OF MULTIPLE PORTABLE
            SOCKET-OUTLETS

Describes the safety requirements necessary to provide protection for the PATIENT, the OPERATOR and surroundings.

Committee
CT 62
DevelopmentNote
Classificazione CEI 62-51 (09/2001)
DocumentType
Standard
Pages
38
PublisherName
Comitato Elettrotecnico Italiano
Status
Withdrawn

Standards Relationship
EN 60601-1-1:2001 Identical
IEC 60601-1-1:2000 Identical

EN 60825-1:2014/AC:2017-06 SAFETY OF LASER PRODUCTS - PART 1: EQUIPMENT CLASSIFICATION AND REQUIREMENTS (IEC 60825-1:2014)
EN 60065:2014/AC:2017-01 AUDIO, VIDEO AND SIMILAR ELECTRONIC APPARATUS - SAFETY REQUIREMENTS (IEC 60065:2014/COR2:2016)
IEC 60950:1999 Safety of information technology equipment
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60884-1:2002+AMD1:2006+AMD2:2013 CSV Plugs and socket-outlets for household and similar purposes - Part1: General requirements
ISO 8359:1996 Oxygen concentrators for medical use Safety requirements
EN 60950:2000/corrigendum:2002 SAFETY OF INFORMATION TECHNOLOGY EQUIPMENT
ISO 7767:1997 Oxygen monitors for monitoring patient breathing mixtures — Safety requirements
IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
CEI 76-2 : 1ED 1989 APPARECCHI LASER - SICUREZZA DALLE RADIAZIONI, CLASSIFICAZIONE DEI MATERIALI E PRESCRIZIONI
ISO 9918:1993 Capnometers for use with humans Requirements
ISO 10079-1:2015 Medical suction equipment Part 1: Electrically powered suction equipment
CEI 96-1 : 1ED 1998
ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
CEI 23-50 : 2007 PLUGS AND SOCKET-OUTLETS FOR HOUSEHOLD AND SIMILAR PURPOSES GENERAL REQUIREMENTS
IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
IEC 60989:1991 Separating transformers, autotransformers, variable transformersand reactors.
CEI 70-1 : 1980 COR 1993
EN 60335-1:2012/A13:2017 HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 1: GENERAL REQUIREMENTS (IEC 60335-1:2010, MODIFIED)
CEI 62-5 : 1ED 1980
EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
EN 60601-1-4:1996/A1:1999 MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
EN 60529:1991/AC:2016-12 DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) (IEC 60529 EDITION 2.2 CORRIGENDUM 2:2015)
EN ISO 8185:2009 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)
IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems

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