EN 61010-2-040:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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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
09-12-2021
11-09-2015
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)
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DocumentType |
Standard
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PublisherName |
European Committee for Standards - Electrical
|
Status |
Superseded
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SupersededBy | |
Supersedes |
Standards | Relationship |
UNE-EN 61010-2-040:2006 | Identical |
ONORM OVE EN 61010-2-040 : 2016 | Identical |
VDE 0411-2-040 : 2016 | Identical |
CEI EN 61010-2-040 : 2016 | Identical |
I.S. EN 61010-2-040:2015 | Identical |
IEC 61010-2-040:2015 | Identical |
SN EN 61010-2-040:2015 | Identical |
DIN EN 61010-2-040 : 2016 | Identical |
NF EN 61010 2-040 : 2015 | Identical |
BS EN 61010-2-040:2015 | Identical |
PN EN 61010-2-040 : 2015 | Identical |
NEN EN IEC 61010-2-040 : 2015 | Identical |
NBN EN 61010 2-040 : 2015 | Identical |
UNE-EN 61010-2-040:2015 | Identical |
PNE-FprEN 61010-2 -040 | Identical |
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 |
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 |
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