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CENELEC
EN 61010-2-040:2015

EN 61010-2-040:2015

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040 Particular requirements for sterilizers and washer-disinfectors used to treat medical materials

Superseded date

12-09-2021

Published date

09-11-2015

Publisher

European Committee for Standards - Electrical

FOREWORD
1 Scope and object
2 Normative references
3 Terms and definitions
4 Tests
5 Marking and documentation
6 Protection against electric shock
7 Protection against mechanical HAZARDS and
   against HAZARDS related to mechanical functions
8 Mechanical resistance to shock and impact
9 Protection against the spread of fire
10 Equipment temperature limits and resistance to heat
11 Protection against HAZARDS from fluids
12 Protection against radiation, including laser sources,
   and against sonic and ultrasonic pressure
13 Protection against liberated gases, substances, explosion
   and implosion
14 Components
15 Protection by interlocks
16 HAZARDS resulting from application
17 RISK assessment
Annexes
Annex G (informative) - Leakage and rupture from fluids
        under pressure
Annex L (informative) - Index of defined terms
Bibliography
Annex ZA (normative) - Normative references to
         international publications with their
          corresponding European publications

IEC 61010-2-040:2015 specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical, veterinary, pharmaceutical and laboratory fields, when used under the environmental conditions of 1.4. It has the status of a group safety publication, as specified in IEC Guide 104. This second edition cancels and replaces the first edition published in 2005. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:a) A new clause (4.3.2.101) has been added for non-electrical supplies and services.b) Additional requirements for marking and documentation (Clause 5) have been added.c) Additional requirements for protection against mechanical hazards (Clause 7) have been included.d) Additional requirements for protection against radiation, including laser sources, and against sonic and ultrasonic pressure (Clause 12) have been included.

Committee
CLC/TC 66X
DevelopmentNote
Supersedes EN 61010-2-041, EN 61010-2-042, EN 61010-2-043 & EN 61010-2-045. (08/2005)
DocumentType
Standard
PublisherName
European Committee for Standards - Electrical
Status
Superseded
SupersededBy
Supersedes

I.S. EN 15424:2007 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
12/30261215 DC : 0 BS EN 13060 - SMALL STEAM STERILIZERS
11/30252448 DC : 0 BS EN 1422 - STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
PREN 14180 : DRAFT 2012 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
PREN 285 : DRAFT 2013 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
PREN 13060 : DRAFT 2012 SMALL STEAM STERILIZERS
EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
DIN EN 1422:2014-08 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
BS EN 15424:2007 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
DIN EN 1422:1997-11 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
DIN EN 15424:2007-08 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
PREN 1422 : DRAFT 2011 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
12/30262894 DC : 0 BS EN 14180 - STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
DIN EN ISO 15883-7 E : 2016 WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-7:2016)
BS EN ISO 15883-7:2016 Washer-disinfectors Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
13/30278676 DC : 0 BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
ISO 25424:2009 Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices
I.S. EN 14180:2014 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
I.S. EN 1422:2014 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
DIN EN 14180:2003-10 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
12/30248648 DC : DRAFT AUG 2012 BS EN 16442 - CONTROLLED ENVIRONMENT STORAGE CABINET FOR DISINFECTED THERMOLABILE ENDOSCOPES
I.S. EN 285:2015 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
BS EN 60335-2-58 : 2005 HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 2-58: PARTICULAR REQUIREMENTS FOR COMMERCIAL ELECTRIC DISHWASHING MACHINES
UNI EN ISO 25424 : 2011 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
EN 13060:2014 Small steam sterilizers
I.S. EN ISO 25424:2011 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
I.S. EN 13060:2014 SMALL STEAM STERILIZERS
DIN EN 13060:2015-03 SMALL STEAM STERILIZERS
DIN EN 285:2016-05 Sterilization - Steam sterilizers - Large sterilizers
UNI EN 14180 : 2014 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
UNI EN 1422 : 2014 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
DIN EN ISO 25424:2011-09 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
PREN 17180 : DRAFT 2017 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE VAPORIZED HYDROGEN PEROXIDE STERILIZERS - REQUIREMENTS AND TESTING
DIN EN ISO 15883-7:2016-10 WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-7:2016)
ISO 15883-7:2016 Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
04/30081258 DC : DRAFT MARCH 2004 BS EN ISO 11737-1 - STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1 - DETERMINATION OF A POPULATION OF MICRO ORGANISMS ON PRODUCTS
I.S. EN ISO 15883-7:2016 WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-7:2016)
DIN EN 14180:2014-09 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
BS EN 13060 : 2014 SMALL STEAM STERILIZERS
BS EN 285:2015 Sterilization. Steam sterilizers. Large sterilizers
BS EN 14180:2014 Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing
EN 15424:2007 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
EN ISO 15883-7:2016 Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016)
EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
BS EN ISO 25424:2011 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
UNE-EN ISO 15883-7:2016 Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016)
UNE-EN 13060:2015 Small steam sterilizers
UNE-EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
BS EN 1422:2014 Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods
UNE-EN 285:2016 Sterilization - Steam sterilizers - Large sterilizers
EN 60335-2-58:2005/A12:2016 HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 2-58: PARTICULAR REQUIREMENTS FOR COMMERCIAL ELECTRIC DISHWASHING MACHINES (IEC 60335-2-58:2002, MODIFIED)

IEC 61672-2:2013+AMD1:2017 CSV Electroacoustics - Sound level meters - Part 2: Pattern evaluation tests
IEC 60335-2-11:2008+AMD1:2012+AMD2:2015 CSV Household and similar electrical appliances - Safety - Part 2-11:Particular requirements for tumble dryers
ISO 2903:2016 ISO metric trapezoidal screw threads — Tolerances
EN 60335-2-4:2010/A1:2015 HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 2-4: PARTICULAR REQUIREMENTS FOR SPIN EXTRACTORS (IEC 60335-2-4:2008/A1:2012, MODIFIED)
ISO 15223-2:2010 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
EN 60825-1:2014/AC:2017-06 SAFETY OF LASER PRODUCTS - PART 1: EQUIPMENT CLASSIFICATION AND REQUIREMENTS (IEC 60825-1:2014)
ISO 2904:1977 ISO metric trapezoidal screw threads — Basic dimensions
ISO 4126-1:2013 Safety devices for protection against excessive pressure — Part 1: Safety valves
IEC 60335-2-7 : 7.2 HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 2-7: PARTICULAR REQUIREMENTS FOR WASHING MACHINES
EN 61672-2:2013/A1:2017 ELECTROACOUSTICS - SOUND LEVEL METERS - PART 2: PATTERN EVALUATION TESTS (IEC 61672-2:2013/A1:2017)
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 3585:1998 Borosilicate glass 3.3 Properties
EN 1837:1999+A1:2009 Safety of machinery - Integral lighting of machines
IEC TR 62471-2:2009 Photobiological safety of lamps and lamp systems - Part 2: Guidance on manufacturing requirements relating to non-laser optical radiation safety
IEC 60335-2-7:2008+AMD1:2011+AMD2:2016 CSV Household and similar electrical appliances - Safety - Part 2-7:Particular requirements for washing machines
IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
EN 62304:2006/A1:2015 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015)
EN 61010-2-010:2014 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of Materials
ISO 12100:2010 Safety of machinery — General principles for design — Risk assessment and risk reduction
IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
EN 61672-1:2013 Electroacoustics - Sound level meters - Part 1: Specifications
ISO 4126-2:2003 Safety devices for protection against excessive pressure Part 2: Bursting disc safety devices
ISO 2902:2016 ISO metric trapezoidal screw threads General plan
EN 62061:2005/A2:2015 SAFETY OF MACHINERY - FUNCTIONAL SAFETY OF SAFETY-RELATED ELECTRICAL, ELECTRONIC AND PROGRAMMABLE ELECTRONIC CONTROL SYSTEMS (IEC 62061:2005/A2:2015)
ISO 13849-2:2012 Safety of machinery — Safety-related parts of control systems — Part 2: Validation
IEC 60335-2-5:2012 Household and similar electrical appliances - Safety - Part 2-5: Particular requirements for dishwashers
IEC 62471:2006 Photobiological safety of lamps and lamp systems
EN ISO 12100:2010 Safety of machinery - General principles for design - Risk assessment and risk reduction (ISO 12100:2010)
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
EN 60335-2-58:2005/A12:2016 HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 2-58: PARTICULAR REQUIREMENTS FOR COMMERCIAL ELECTRIC DISHWASHING MACHINES (IEC 60335-2-58:2002, MODIFIED)
EN ISO 13849-2:2012 Safety of machinery - Safety-related parts of control systems - Part 2: Validation (ISO 13849-2:2012)
EN 60335-2-7:2010/A11:2013 HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 2-7: PARTICULAR REQUIREMENTS FOR WASHING MACHINES
EN 14222:2003 Stainless steel shell boilers
IEC 61010-2-010:2014 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of materials
ISO 14971:2007 Medical devices Application of risk management to medical devices
IEC 62061:2005+AMD1:2012+AMD2:2015 CSV Safety of machinery - Functional safety of safety-related electrical, electronic and programmable electronic control systems
IEC 61770:2008+AMD1:2015 CSV Electric appliances connected to the water mains - Avoidance ofbacksiphonage and failure of hose-sets
ISO 2901:2016 ISO metric trapezoidal screw threads Basic and design profiles
IEC 60335-2-58:2002+AMD1:2008+AMD2:2015 CSV Household and similar electrical appliances - Safety - Part 2-58: Particular requirements for commercial electric dishwashing machines
EN 62471:2008 Photobiological safety of lamps and lamp systems
EN 60335-2-5:2015 Household and similar electrical appliances - Safety - Part 2-5: Particular requirements for dishwashers
EN ISO 4126-1:2013/A1:2016 SAFETY DEVICES FOR PROTECTION AGAINST EXCESSIVE PRESSURE - PART 1: SAFETY VALVES (ISO 4126-1:2013/AMD 1:2016)
EN ISO 4126-2:2003/AC:2006 SAFETY DEVICES FOR PROTECTION AGAINST EXCESSIVE PRESSURE - PART 2: BURSTING DISC SAFETY DEVICES

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