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EN 60601-1-1:2001

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems

Superseded date

01-10-2006

Superseded by

EN 60601-1:2006/A12:2014

Published date

09-04-2001

FOREWORD
SECTION ONE - GENERAL
1 Scope and object
2 Terminology and definitions
3 General requirements
6 Identification, marking and documents
SECTION TWO - ENVIRONMENTAL CONDITIONS
10 Environmental conditions
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
16 ENCLOSURES and PROTECTIVE COVERS
17 Separation
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
22 Moving parts
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR
               EXCESSIVE RADIATION
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE
              ANAESTHETIC MIXTURES
SECTION SEVEN - 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 EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST
                HAZARDOUS OUTPUT
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS;
               ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly
57 MAINS PARTS, components and layout
58 Protective earthing - Terminals and connections
59 Construction and layout
Annex AAA (informative) General guidance and rationale
Annex BBB (informative) Examples of combinations of MEDICAL
          ELECTRICAL EQUIPMENT and non-medical electrical equipment
Annex CCC (normative) Normative references
Annex DDD (informative) Bibliography
Annex EEE (normative) Requirements for MULTIPLE PORTABLE
          SOCKET-OUTLETS
Annex FFF (informative) Examples of application of MULTIPLE PORTABLE
          SOCKET-OUTLETS
Annex ZA (normative) Normative references to international
         publications with their corresponding European publications
Annex ZB (informative) Bibliography

Applies to the safety of medical electrical systems, as defined as follows: combination of items of equipment, at least one of which must be medical electrical equipment and inter-connected by functional connection or use of a multiple portable socket-outlet. Describes the safety requirements necessary to provide protection for the patient, the operator and surroundings. Cancels and replaces the first edition published in 1992 and its amendment 1 (1995) and constitutes a technical revision.

Committee
CLC/TC 62
DocumentType
Standard
PublisherName
European Committee for Standards - Electrical
Status
Superseded
SupersededBy

IEEE 1073.4.1 : 2000 STANDARD FOR MEDICAL DEVICE COMMUNICATIONS - PHYSICAL LAYER INTERFACE - CABLE CONNECTED
DIN EN 60601-2-40 : 1998 MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROMYGRAPHS AND EVOKED RESPONSE EQUIPMENT
ISO/IEEE 11073-00103:2015 Health informatics — Personal health device communication — Part 00103: Overview
BS 5724-1.4(1997) : 1997 MEDICAL ELECTRICAL EQUIPMENT - PART 1-4: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD - GENERAL REQUIREMENTS FOR PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
BS EN 60601-2-38:1997 Medical electrical equipment. Particular requirements for safety Particular requirements for the safety of electrically operated hospital beds
BS 5724-2.40(1998) : 1998 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - PART 2-40: ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT
BS 5724-2.38(1997) : 1997 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS
BS 5724-2.204(1999) : 1999 ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS
BS EN 60601-2-40:1998 Medical electrical equipment. Particular requirements for safety Specification for electromyographs and evoked response equipment
CEI EN 60601-2-9 : 1998 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF PATIENT CONTACT DOSEMETERS USED IN RADIOTHERAPY WITH ELECTRICALLY CONNECTED RADIATION DETECTORS
BS EN 41003:2009 Particular safety requirements for equipment to be connected to telecommunication networks and/or a cable distribution system
EN 13976-1:2011 Rescue systems - Transportation of incubators - Part 1: Interface conditions
DIN EN 60601-2-35 : 1997 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF BLANKETS, PADS AND MATTRESSES, INTENDED FOR HEATING IN MEDICAL USE
CEI EN 60580 : 2001 MEDICAL ELECTRICAL EQUIPMENT DOSE AREA PRODUCT METERS
BS EN 60601-2-12:2006 Medical electrical equipment Particular requirements for the safety of lung ventilators. Critical care ventilators
09/30205924 DC : 0 BS EN 13976-1 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
03/317861 DC : DRAFT OCT 2003 EN ISO 22523 - EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS
BS EN 60601-1-4:1997 Medical electrical equipment. General requirements for safety Collateral standard. General requirements for programmable electrical medical systems
CEI EN 60601-2-12 : 2007 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
BS EN 13976-1:2011 Rescue systems. Transportation of incubators Interface conditions
VDE 0750-2-40 : 1998 MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT
EN 60601-2-40:1998 Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment
UNE-EN 13976-1:2011 Rescue systems - Transportation of incubators - Part 1: Interface conditions
EN 41003:2008 Particular safety requirements for equipment to be connected to telecommunication networks and/or a cable distribution system
I.S. EN ISO 11073-00103:2017 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015)
BS ISO/IEEE 11073-00103 : 2015 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW
02/564996 DC : DRAFT NOV 2002 BS EN ISO 16201 - TECHNICAL AIDS FOR DISABLED PERSONS - REMOTE CONTROL SYSTEMS
BS EN ISO 11073-00103:2017 Health informatics. Personal health device communication Overview
BS EN 60118-14:1998 Hearing aids Specification of a digital interface device
BS 5724-2.18(1997) : 1997 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR ENDOSCOPIC EQUIPMENT
I.S. EN 60601-2-40:1999 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT
16/30333928 DC : 0 BS EN 13976-1 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
UNI EN 13976-1 : 2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
I.S. EN 60580:2000 MEDICAL ELECTRICAL EQUIPMENT - DOSE AREA PRODUCT METERS
I.S. EN 60601-2-12:2006 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
I.S. EN 60601-2-38:1998 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS
EN 60580:2000 Medical electrical equipment - Dose area product meters
BS EN 740:1999 Anaesthetic workstations and their modules. Particular requirements
BS EN 12523:1999 External limb prostheses and external orthoses. Requirements and test methods
EN ISO 11073-00103:2017 Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015)
BS EN 60580:2000 Dose area product meters
IEEE 11073-00103-2012 Health informatics - Personal health device communication Part 00103: Overview
CEI EN 60601-2-40 : 1999 MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT
DIN EN 13976-1:2016-03 (Draft) RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
I.S. EN 13976-1:2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
I.S. EN 60601-2-9:1998 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF PATIENT CONTACT DOSEMETERS USED IN RADIOTHERAPY WITH ELECTRICALLY CONNECTED RADIATION DETECTORS
EN 60601-2-38:1996/A1:2000 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS
DIN EN 13976-1:2011-08 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
EN 12523 : 1999 EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS
EN 60601-2-9:1996/corrigendum:1996 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF PATIENT CONTACT DOSEMETERS USED IN RADIOTHERAPY WITH ELECTRICALLY CONNECTED RADIATION DETECTORS
EN 60601-2-12:2006 Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators

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
ISO 9918:1993 Capnometers for use with humans — Requirements
ISO 10079-1:2015 Medical suction equipment — Part 1: Electrically powered suction equipment
ISO 8185:2007 Respiratory tract humidifiers for medical use — Particular requirements for respiratory humidification systems
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.
EN 60335-1:2012/A13:2017 HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 1: GENERAL REQUIREMENTS (IEC 60335-1:2010, MODIFIED)
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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