Safety & Compliance Forum

The limits and methods of measurement laid down in this International Standard apply to industrial, scientific and medical (ISM) equipment as defined in Clause 2, and to electrodischarge machining (EDM) and arc welding equipment.

NOTE The limits have been determined on a probabilistic basis taking into account the likelihood of interference. In cases of interference, additional provisions may be required.

Procedures are given for the measurement of radio-frequency disturbances and limits are laid down within the frequency range 9 kHz to 400 GHz.

Requirements for ISM lighting apparatus operating in the ISM frequency bands of 915 MHz (only allowed in region 2 as defined by the ITU Radio Regulations), 2,45 GHz and 5,8 GHz are contained in this standard.

Requirements for other types of lighting apparatus are covered in CISPR 15.

Scope
This part of IEC 61347 specifies particular safety requirements for electronic control gear for use on a.c. supplies at 50 Hz or 60 Hz up to 1000 V and/or d.c. supplies up to 1000 V at 50 Hz or 60 Hz with lamp operating frequencies deviating from the supply frequency, associated with fluorescent lamps as specified in IEC 60081 and IEC 60901, and other fluorescent lamps for high-frequency operation.
Performance requirements are the subject of IEC 60929.
Particular requirements for electronic control gear with means protection against overheating are given in Annex C.
For emergency lighting operation, particular requirements for control gear operated from a central supply are given in Annex J. Performance requirements appropriate to the safe operation of emergency lighting are also contained in Annex J.
Requirements for emergency lighting control gear operating from non-centralised power supplies are given in IEC 61347-2-7.
NOTE Performance requirements detailed by Annex J are those considered to be safety-related with respect to reliable emergency operation.

This part of CSA E61347 specifies particular safety requirements for electronic control gear designed to be installed on branch circuits not exceeding 600 V nominal between conductors, in accordance with CSA C22.1, Canadian Electrical Code, Part I, with lamp operating frequencies deviating from the supply frequency associated with fluorescent lamps as specified in IEC 60081 and IEC 60901, or ANSI C78.81 and ANSI C78.901, and other fluorescent lamps for high-frequency operation.
Performance requirements are the subject of IEC 60929 and ANSI C82.11.

The limits and methods of measurement laid down in this International Standard apply to industrial, scientific and medical (ISM) equipment as defined in Clause 2, and to electrodischarge machining (EDM) and arc welding equipment.

NOTE The limits have been determined on a probabilistic basis taking into account the likelihood of interference. In cases of interference, additional provisions may be required.

Procedures are given for the measurement of radio-frequency disturbances and limits are laid down within the frequency range 9 kHz to 400 GHz.

Requirements for ISM lighting apparatus operating in the ISM frequency bands of 915 MHz (only allowed in region 2 as defined by the ITU Radio Regulations), 2,45 GHz and 5,8 GHz are contained in this standard.

Requirements for other types of lighting apparatus are covered in CISPR 15.

This part of IEC 61010 specifies general safety requirements for the following types of electrical equipment and their accessories, wherever they are intended to be used.

a) Electrical test and measurement equipment

This is equipment which by electromagnetic means tests, measures, indicates or records one or more electrical or physical quantities, also non-measuring equipment such as signal generators, measurement standards, power supplies for laboratory use, transducers, transmitters, etc.

NOTE 1 This includes bench-top power supplies intended to aid a testing or measuring operation on another piece of equipment. Power supplies intended to power equipment are within the scope of IEC 61558 (see 1.1.2 h)).

This Standard also applies to test equipment integrated into manufacturing processes and intended for testing manufactured devices.

NOTE 2 Manufacturing test equipment is likely to be installed adjacent to and interconnected with industrial machinery in this application.

b) Electrical industrial process-control equipment

This is equipment which controls one or more output quantities to specific values, with each value determined by manual setting, by local or remote programming, or by one or more input variables.

c) Electrical laboratory equipment

This is equipment which measures, indicates, monitors, inspects or analyses materials, or is used to prepare materials, and includes in vitro diagnostic (IVD) equipment.

This equipment may also be used in areas other than laboratories; examples include self-test IVD equipment to be used in the home and inspection equipment to be used to check people or material during transportation.

1.1.2
Equipment excluded from scope

This Standard does not apply to equipment within the scope of:

a) IEC 60065 (Audio, video and similar electronic apparatus);
b) IEC 60204 (Safety of machinery - Electrical equipment of machines);
c) IEC 60335 (Household and similar electrical appliances);
d) IEC 60364 (Electrical installations of buildings);
e) IEC 60439 (Low-voltage switchgear and controlgear assemblies);
f) IEC 60601 (Medical electrical equipment);
g) IEC 60950 (Information technology equipment including electrical business equipment, except as specified in 1.1.3);
h) IEC 61558 (Power transformers, power supply units and similar);
i) IEC 61010-031 (Hand-held probe assemblies);
j) IEC 61243-3 (Live working - Voltage detectors - Part 3: Two-pole low-voltage type).

1.1.3
Computing equipment

This Standard applies only to computers, processors, etc. which form part of equipment within the scope of this standard or are designed for use exclusively with the equipment.

NOTE Computing devices and similar equipment within the scope of IEC 60950 and conforming to its requirements are considered to be suitable for use with equipment within the scope of this standard. However, some of the requirements of IEC 60950for resistance to moisture and liquids are less stringent than those in this standard (see 5.4.4 second paragraph)).

1.1.4
DV DR Addition of the following referencing the National Electrical Code and the Canadian Electrical Code:

This Standard applies to equipment:

a) To be employed in accordance with ANSI/NFPA 70, National Electrical Code® (NEC);
b) Designed to comply with the general requirements of CAN/CSA C22.2 No. 0 and to be installed in accordance with the Canadian Electrical Code (CEC), Part I, CSA C22.1; or
c) Both (a) and (b).

1.2
Object

1.2.1
Aspects included in scope

The purpose of the requirements of this standard is to ensure that HAZARDS to the OPERATOR and the surrounding area are reduced to a tolerable level. Requirements for protection against particular types of HAZARD are given in Clauses 6 to 13, as follows:

a) electric shock or burn (see Clause 6);
b) mechanical HAZARDS (see Clauses 7 and 8);
c) spread of fire from the equipment (see Clause 9);
d) excessive temperature (see Clause 10);
e) effects of fluids and fluid pressure (see Clause 11);
f) effects of radiation, including lasers sources, and sonic and ultrasonic pressure (see Clause 12);
g) liberated gases, explosion and implosion (see Clause 13).
Requirements for protection against HAZARDS arising from REASONABLY FORESEEABLE MISUSE and ergonomic factors are specified in Clause 16.

RISK assessment for HAZARDS or environments not fully covered above is specified in Clause 17.

NOTE Attention is drawn to the existence of additional requirements regarding the health and safety of labour forces.

1.2.2
Aspects excluded from scope

This Standard does not cover:

a) reliable function, performance, or other properties of the equipment not related to safety;
b) effectiveness of transport packaging;
c) EMC requirements (see the IEC 61326 series);
d) protective measures for explosive atmospheres (see the IEC 60079 series).

1.3
Verification

This Standard also specifies methods of verifying that the equipment meets the requirements of this standard, through inspection, TYPE TESTS, ROUTINE TESTS, and RISK assessment.

1.4
Environmental conditions

1.4.1
Normal environmental conditions

This Standard applies to equipment designed to be safe at least under the following conditions:

a) indoor use;
b) altitude up to 2 000 m;
c) temperature 5 °C to 40 °C;
d) maximum relative humidity 80 % for temperatures up to 31 °C decreasing linearly to 50 % relative humidity at 40 °C;
e) MAINS supply voltage fluctuations up to ±10 % of the nominal voltage;
f) TRANSIENT OVERVOLTAGES up to the levels of OVERVOLTAGE CATEGORY II;
NOTE 1 These levels of transient overvoltage are typical for equipment supplied from the building wiring.
g) TEMPORARY OVERVOLTAGES occurring on the MAINS supply.
h) applicable POLLUTION DEGREE of the intended environment (POLLUTION DEGREE 2 in most cases).

NOTE 2 Manufacturers may specify more restricted environmental conditions for operation; nevertheless the equipment must be safe within these normal environmental conditions.

1.4.2
Extended environmental conditions

This Standard applies to equipment designed to be safe not only in the environmental conditions specified in 1.4.1, but also in any of the following conditions as RATED by the manufacturer of the equipment:

a) outdoor use;
b) altitude above 2 000 m;
c) ambient temperatures below 5 °C or above 40 °C;
d) relative humidity above the levels specified in 1.4.1;
e) MAINS supply voltage fluctuations exceeding ±10 % of the nominal voltage;
f) WET LOCATION;
g) TRANSIENT OVERVOLTAGES up to the levels of OVERVOLTAGE CATEGORY III or IV (see Annex K).

This part of IEC 62368 is applicable to the safety of electrical and electronic equipment within the field of audio, video, information and communication technology, and business and office machines with a RATED VOLTAGE not exceeding 600 V. This standard does not include requirements for performance or functional characteristics of equipment.

NOTE 1 Examples of equipment within the scope of this standard are given in Annex A.

NOTE 2 A RATED VOLTAGE of 600 V is considered to include equipment rated 400/690 V.

This part of IEC 62368 is also applicable to:

- components and subassemblies intended for incorporation in this equipment. Such components and subassemblies need not comply with every requirement of the standard, provided that the complete equipment, incorporating such components and subassemblies, does comply;

- external power supply units intended to supply other equipment within the scope of this part of IEC 62368;

- accessories intended to be used with equipment within the scope of this part of IEC 62368.

This part of IEC 62368 does not apply to power supply systems which are not an integral part of the equipment, such as motor-generator sets, BATTERY backup systems and distribution transformers.

This part of IEC 62328 specifies SAFEGUARDS for ORDINARY PERSONS, INSTRUCTED PERSONS, and SKILLED PERSONS. Additional requirements may apply for equipment that is clearly designed or intended for use by children or specifically attractive to children.

NOTE 3 In Australia, the work conducted by an INSTRUCTED PERSON or a SKILLED PERSON may require formal licensing from regulatory authorities.

This standard assumes an altitude of 2 000 m unless specified otherwise by the manufacturer.

This part of IEC 62368 does not apply to equipment to be used in wet areas. Additional requirements may apply.

Additional requirements for equipment intended for outdoor installation are given in IEC 60950-22.

This part of IEC 62368 does not address:

- manufacturing processes except safety testing;

- injurious effects of gases released by thermal decomposition or combustion;

- disposal processes;

- effects of transport (other than as specified in this standard);

- effects of storage of materials, components, or the equipment itself;

- the likelihood of injury from particulate radiation such as alpha particles and beta particles;

- the likelihood of thermal injury due to radiated or convected thermal energy;

- the likelihood of injury due to flammable liquids;

- the use of the equipment in oxygen-enriched or EXPLOSIVE atmospheres;

- exposure to chemicals other than as specified in Clause 7;

- electrostatic discharge events;

- environmental aspects;

- requirements for functional safety.

NOTE 4 For specific functional and software safety requirements of electronic safety-related systems (for example, protective electronic circuits), see IEC 61508-1.

1DV.1 DC Modify Clause 1 by adding the following text after the third paragraph:

Battery backup systems that are not an integral part of stationary equipment, such as provided in separate cabinets, are subject to the appropriate standard for battery backup systems, such as UL 1973, Batteries for Use in Light Electric Rail (LER) Applications and Stationary Applications.

NOTE See Figures 1.1 and 1.2 of UL 1973 for more information on independent electric energy storage systems (EESS) covered by UL 1973, which can consist of both low voltage (class ES or ES2) and high voltage (class ES3) subsystems, battery management, thermal management, and related features and safeguards. When interconnected with AV, IT, and CT Equipment, and typically used in conjunction with an uninterruptible power supply (UPS), such EESS typically serve as a short-term substitution of the mains supply during power outages and similar disturbances.

1DV.2 DE Modify Clause 1 by replacing the seventh paragraph with the following:

Additional requirements for information and communication technology equipment intended for outdoor installation are given in CSA/UL 60950-22. Additional requirements for audio/video equipment intended for outdoor installation are given in the relevant requirements in CAN/CSA C22.2 No. 60065 or UL 60065.

1DV.3 DR Modify Clause 1 by adding the following text:

1DV.3.1 This standard also is applicable to equipment designed to be installed in accordance with the Canadian Electrical Code, Part I, CSA C22.1-12; Canadian Electrical Code, (CEC) Part II, General Requirements, CAN/CSA C22.2 No. 0-10; the National Electrical Code, NFPA 70-2014; and the National Electrical Safety Code, IEEE C2-2012.

1DV.3.2 The standard is also applicable to equipment, when identified by a marking or instruction [see Annex DVK (Annex DVA, Clause 1 entry)], designed to be installed in accordance with Article 645 of the National Electrical Code, NFPA 70-2014 and the Standard for the Protection of Information Technology Equipment, NFPA 75-2013.

1DV.3.3 See Annex DVA for requirements and references to regulatory requirements that apply to this equipment, as applicable.

1DV.4 D2 Modify Clause 1 by adding the following text:

1DV.4.1 This standard includes additional requirements for equipment used for entertainment purposes intended for installation in general patient care areas of health care facilities. See Annex DVB.

1DV.4.2 This standard includes additional requirements for equipment intended for mounting under kitchen cabinets. See Annex DVC.

1DV.4.3 This standard does not apply to equipment having Remote Feeding Telecommunication (RFT) circuits. Equipment having RFT circuits is covered by CSA/UL 60950-21.

1DV.4.4 Additional requirements may apply to large data storage equipment. Refer to CSA/UL 60950-23.

1DV.4.5 This standard does not cover Modular Data Centers (MDCs), only the information and communication technology equipment contained within.

NOTE: In the U.S., Modular Data Centers are covered by UL 2755, Modular Data Centers.

1DV.5 DC Modify Clause 1 by adding the following text:

1DV.5.1 Power Distribution Equipment and Sub-Assemblies

1DV.5.1.1 This standard also is applicable to power distribution subassemblies connected to a mains used to distribute power entirely within a system of equipment also covered by this standard, such as power distribution units (PDUs) in the form of cord-connected power strips and shelves with multiple power outlets (receptacles) and intended to be installed in system racks, cabinets, home entertainment centers, etc.

1DV.5.1.2 For equipment covered by this standard that incorporates components and sub-assemblies that perform a power distribution and control function covered by other standards, such as panelboards, load transfer equipment, or uninterruptible power systems utilized in power conditioners and computer power centers, this standard only may be used for investigation of safety for those aspects not covered by the other standards.

1DV.5.1.3 This standard also does not apply to stand-alone equipment used for distribution of mains power that is covered by individual power distribution equipment standards.

1DV.5.1.4 Based on the specific function, the following requirements are applicable to the stand-alone distribution equipment, or apply additionally to power distribution sub-assemblies and components of equipment covered by this standard, as described in 1DV.5.1.2 and 1DV.5.1.3:

- For Industrial Control Equipment, see CSA C22.2 No. 14 and UL 508.

- For Panelboards, see CSA C22.2 No. 29 and UL 67.

- For Switchboards, see CSA C22.2 No 244 and UL 891.

- For Transfer Switch Equipment, see CSA C22.2 No 178.1 and UL 1008.

- For Uninterruptible Power Systems, see CSA C22.2 No. 107.3 and UL 1778.

- For Power Distribution Centers for Communications Equipment, see UL 1801.

- For other forms of power distribution units for general applications, such as,

* Relocatable Power Taps, see CSA C22.2 No. 21, Cord Sets and Power Supply Cords, and UL 1363, Relocatable Power Taps.

* Cord connected Surge Protective Devices, see CSA Technical Information Letter No. A-24, Interim Certification Requirements for AC Line Connected Wiring Devices with Varistors, and UL 1449, Surge Protective Devices.

* Furniture Power Distribution Units, see CSA C22.2 No. 21, Cord Sets and Power Supply Cords, and UL 962A, Furniture Power Distribution Units.

NOTE 1 It is assumed that power distribution equipment covered by the scope of this Standard is interconnected to the "Outlet" of a "Branch Circuit" as defined in Section 0 of the CEC, Part I, and Article 100 of the NEC. In the case of cord-connected equipment, the Outlet is the Receptacle associated with the building wiring. In the case of permanently connected equipment, the Outlet is the interface between the Branch Circuit conductors associated with the building wiring and the input terminals, pressure connectors, or leads associated with the power distribution equipment covered in whole or part by this standard.

NOTE 2 The following are common definitions of the hardware with related functions that require additional investigation to the appropriate Canadian and U.S. standards.

Industrial Control Panel - An assembly of two or more components consisting of one of the following:

(1) Power circuit components only, such as motor controllers, overload relays, fused disconnect switches, and circuit breakers;

(2) Control circuit components only, such as pushbuttons, pilot lights, selector switches, timers, switches, control relays; or

(3) A combination of power and control circuit components.

These components, with associated wiring and terminals, are mounted on or contained within an enclosure or mounted on a subpanel. The industrial control panel does not include the controlled equipment.

Panelboard - A single panel or group of panel units designed for assembly in the form of a single panel, including buses and automatic overcurrent devices, and equipped with or without switches for the control of light, heat, or power circuits; designed to be placed in a cabinet or cutout box placed in or against a wall, partition, or other support; and accessible only from the front.

Switchboard - A large single panel, frame, or assembly of panels on which are mounted, on the face, back, or both, switches, overcurrent and other protective devices, buses, and usually instruments. Switchboards are generally accessible from the rear as well as from the front and are not intended to be installed in cabinets.

Transfer Switch - An automatic or nonautomatic device for transferring one or more load conductor connections from one power source to another.

Uninterruptible Power Supply - A power supply used to provide alternating current power to a load for some period of time in the event of a power failure.

This Code applies to all electrical work and electrical equipment operating or intended to operate at all voltages in electrical installations for buildings, structures, and premises, including factory-built relocatable and non-relocatable structures, and self-propelled marine vessels stationary for periods exceeding five months and connected to a shore supply of electricity continuously or from time to time, with the following exceptions:

a) installations or equipment employed by an electric, communication, or community antenna distribution system utility in the exercise of its function as a utility, as recognized by the regulatory authority having jurisdiction, and located outdoors or in buildings or sections of buildings used for that purpose;

b) equipment and facilities that are used in the operation of an electric railway and are supplied exclusively from circuits that supply the motive power;

c) installations or equipment used for railway signalling and railway communication purposes, and located outdoors or in buildings or sections of buildings used exclusively for such installations;

d) aircraft; and

e) electrical systems in ships that are regulated under Transport Canada.

For mines and quarry applications, see also CSA M421.

This Code and any standards referenced in it do not make or imply any assurance or guarantee by the authority adopting this Code with respect to life expectancy, durability, or operating performance of equipment and materials so referenced.

The limits and methods of measurement laid down in this International Standard apply to industrial, scientific and medical (ISM) equipment as defined in Clause 2, and to electrodischarge machining (EDM) and arc welding equipment.

NOTE The limits have been determined on a probabilistic basis taking into account the likelihood of interference. In cases of interference, additional provisions may be required.

Procedures are given for the measurement of radio-frequency disturbances and limits are laid down within the frequency range 9 kHz to 400 GHz.

Requirements for ISM lighting apparatus operating in the ISM frequency bands of 915 MHz (only allowed in region 2 as defined by the ITU Radio Regulations), 2,45 GHz and 5,8 GHz are contained in this standard.

Requirements for other types of lighting apparatus are covered in CISPR 15.

Scope

Replacement:

NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.

This document applies to the basic safety and essential performance of a critical care ventilator in combination with its accessories, hereafter referred to as ME equipment:

- intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility;

NOTE 2 For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining.

NOTE 3 For the purposes of this document, such a critical care ventilator can provide ventilation during transport within a professional healthcare facility (i.e. be a transit-operable ventilator).

NOTE 4 A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an emergency medical services environment ventilator.

- intended to be operated by a healthcare professional operator; and

- intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.

A critical care ventilator is not considered to use a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings.

This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator.

NOTE 5 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.

Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005 +AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.

NOTE 6 Additional information can be found in IEC 60601-1:2005+AMD1:2012 +AMD2:2020, 4.2.

This document is not applicable to ME equipment or an ME system operating in a ventilator-operational mode solely intended for patients who are not dependent on artificial ventilation.

NOTE 7 A critical care ventilator, when operating in such a ventilator-operational mode, is not considered life-sustaining.

This document is not applicable to ME equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility.

This document does not specify the requirements for:

NOTE 8 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient.

- ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13;

- ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84;

- ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-2-72;

- ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO 80601-2-79 and ISO 80601-2-80;

- obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601-2-70;

- continuous positive airway pressure (CPAP) ME equipment.

- high-frequency ventilators, which are given in ISO 80601-2-87;

NOTE 9 A critical care ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilator-operational modes.

- respiratory high-flow therapy equipment, which are given in ISO 80601-2-90;

NOTE 10 A critical care ventilator can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.

- oxygen therapy constant flow ME equipment; and

- cuirass or iron-lung ventilation equipment.

Scope

Replacement:

This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS intended to be used for projection RADIOGRAPHY and INDIRECT RADIOSCOPY. IEC 60601-2-43 applies to ME EQUIPMENT and ME SYSTEMS intended to be used for interventional applications and refers to applicable requirements in this document.

ME EQUIPMENT and ME SYSTEMS intended to be used for bone or tissue absorption densitometry, computed tomography, mammography or dental or radiotherapy applications are excluded from the scope of this document. The scope of this document also excludes radiotherapy simulators.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

Scope

Replacement:

This part of IEC 60601 specifies safety requirements for OPERATING TABLES, whether or not having electrical parts, including TRANSPORTERS, used for the transportation of the OPERATING TABLE top to or from the base or pedestal of an OPERATING TABLE with detachable OPERATING TABLE top.

NOTE See also IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, 4.2.

This particular standard does not apply to

– dental PATIENT chairs (see ISO 7494-1),

– examination chairs and couches,

– PATIENT-supporting systems of diagnostic, interventional and therapeutic equipment (see IEC 60601-2-54 or IEC 60601-2-43),

– OPERATING TABLE heating blankets (see IEC 60601-2-35),

– PATIENT transfer equipment,

– delivery tables and delivery beds,

– medical beds (see IEC 60601-2-52 and EN 50637), and

– field tables.

Scope

Replacement:

NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.

This document applies to the basic safety and essential performance of an EMS ventilator in combination with its accessories, hereafter also referred to as ME equipment:

- intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients;

- intended to be operated by a healthcare professional operator;

- intended for use in the EMS environment; and

- intended for invasive or non-invasive ventilation.

NOTE 2 An EMS ventilator can also be used for transport within a professional healthcare facility.

An EMS ventilator is not considered to use a physiologic closed loop-control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings.

This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system, or to an EMS ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the EMS ventilator.

NOTE 3 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.

Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005 +AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.

NOTE 4 Additional information can be found in IEC 60601-1:2005+AMD1:2012 +AMD2:2020, 4.2.

This document does not specify the requirements for the following:

NOTE 5 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient.

- ventilators or accessories intended for ventilator-dependent patients in critical care applications, which are given in ISO 80601-2-12.

- ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-2-72.

- ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13.

- ventilators or accessories intended for ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing patients), which are given in ISO 80601-2-79 and ISO 80601-2-80.

- obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601-2-70.

- user-powered resuscitators, which are given in ISO 10651-4.

- gas-powered emergency resuscitators, which are given in ISO 10651-5.

- continuous positive airway pressure (CPAP) ME equipment.

- high-frequency jet ventilators (HFJVs), which are given in ISO 80601-2-87.

- high-frequency oscillatory ventilators (HFOVs)[44], which are given in ISO 80601-2-87.

NOTE 6 An EMS ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilation-modes.

- respiratory high-flow therapy equipment, which are given in ISO 80601-2-90.

NOTE 7 An EMS ventilator can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.

- oxygen therapy constant flow ME equipment.

- cuirass or iron-lung ventilators.

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1.

NOTE: See also 4.2.

This standard can also be applied to equipment used for compensation or alleviation of disease, injury or disability.

In vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT is covered by the IEC 61010 series 2). This standard does not apply to the implantable parts of active implantable medical devices covered by ISO 14708-1 3).

1.2 Object

The object of this standard is to specify general requirements and to serve as the basis for particular standards.

1.3 * Collateral standards

In the IEC 60601 series, collateral standards specify general requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE applicable to:

- a subgroup of ME EQUIPMENT (e.g. radiological equipment);

- a specific characteristic of all ME EQUIPMENT not fully addressed in this standard.

Applicable collateral standards become normative at the date of their publication and shall apply together with this standard.

NOTE 1 When evaluating compliance with IEC 60601-1, it is permissible to independently assess compliance with the collateral standards.

NOTE 2 When declaring compliance with IEC 60601-1, the declarer should specifically list the collateral standards that have been applied. This allows the reader of the declaration to understand which collateral standards were part of the evaluation.

NOTE 3 Members of IEC maintain a register of valid International Standards. Users of this standard should consult this register to determine which collateral standards have been published.

If a collateral standard applies to ME EQUIPMENT for which a particular standard exists, then the particular standard takes priority over the collateral standard.

1.4 * Particular standards

In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in this standard as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements.

NOTE: Members of IEC and ISO maintain registers of valid International Standards. Users of this standard should consult these registers to determine which particular standards have been published.

A requirement of a particular standard takes priority over this standard.

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for use in the HOME HEALTHCARE ENVIRONMENT, as defined in 3.1, and specified by the MANUFACTURER in the instructions for use. This International Standard applies regardless of whether the ME EQUIPMENT or ME SYSTEM is intended for use by a LAY OPERATOR or by trained healthcare personnel.

The HOME HEALTHCARE ENVIRONMENT includes:

– the dwelling place in which a PATIENT lives;

– other places where PATIENTS are present both indoors and outdoors, excluding professional healthcare facility environments where OPERATORS with medical training are continually available when PATIENTS are present.

This International Standard does not apply to ME EQUIPMENT and ME SYSTEMS intended solely for use in the EMERGENCY MEDICAL SERVICES ENVIRONMENT, covered by IEC 60601-1-12 or solely for use in professional healthcare facilities covered by IEC 60601-1 without the additions of IEC 60601-1-12 or this collateral standard. Nonetheless, ME EQUIPMENT or ME SYSTEMS can be intended for multiple use environments, and as such, if also intended for use in the HOME HEALTHCARE ENVIRONMENT, are within the scope of this standard.

EXAMPLE ME EQUIPMENT or ME SYSTEMS intended for both the HOME HEALTHCARE ENVIRONMENT and the professional healthcare facility environment.

NOTE HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT and ME SYSTEMS can frequently be used in locations with unreliable electrical sources and poor electrical grounding.

 Scope

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for use in the HOME HEALTHCARE ENVIRONMENT, as defined in 3.1, and specified by the MANUFACTURER in the instructions for use. This International Standard applies regardless of whether the ME EQUIPMENT or ME SYSTEM is intended for use by a LAY OPERATOR or by trained healthcare personnel.

The HOME HEALTHCARE ENVIRONMENT includes:

– the dwelling place in which a PATIENT lives;

– other places where PATIENTS are present both indoors and outdoors, excluding professional healthcare facility environments where OPERATORS with medical training are continually available when PATIENTS are present.

This International Standard does not apply to ME EQUIPMENT and ME SYSTEMS intended solely for use in the EMERGENCY MEDICAL SERVICES ENVIRONMENT, covered by IEC 60601-1-12 or solely for use in professional healthcare facilities covered by IEC 60601-1 without the additions of IEC 60601-1-12 or this collateral standard. Nonetheless, ME EQUIPMENT or ME SYSTEMS can be intended for multiple use environments, and as such, if also intended for use in the HOME HEALTHCARE ENVIRONMENT, are within the scope of this standard.

EXAMPLE ME EQUIPMENT or ME SYSTEMS intended for both the HOME HEALTHCARE ENVIRONMENT and the professional healthcare facility environment.

NOTE HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT and ME SYSTEMS can frequently be used in locations with unreliable electrical sources and poor electrical grounding.

1.2 Object

The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards.

The requirements contained in this Model Code are based on the applicable requirements of SPE-1000 and selected requirements of CAN/CSA-C22.2 No. 60601-1 and IEC 62353.

The limits and methods of measurement laid down in this International Standard apply to industrial, scientific and medical (ISM) equipment as defined in Clause 2, and to electrodischarge machining (EDM) and arc welding equipment.

NOTE The limits have been determined on a probabilistic basis taking into account the likelihood of interference. In cases of interference, additional provisions may be required.

Procedures are given for the measurement of radio-frequency disturbances and limits are laid down within the frequency range 9 kHz to 400 GHz.

Requirements for ISM lighting apparatus operating in the ISM frequency bands of 915 MHz (only allowed in region 2 as defined by the ITU Radio Regulations), 2,45 GHz and 5,8 GHz are contained in this standard.

Requirements for other types of lighting apparatus are covered in CISPR 15.

This clause of Part 1* is applicable, except as follows.

* For the purposes of this Standard, the term Part 1 means CAN/CSA-C22.2 No. 62841-1 (first edition)/ UL 62841-1 (first edition).

Note: When this Standard states addition, modification, or replacement, the relevant text in Part 1 is to be adapted accordingly.

Addition:

This Standard applies to chain beam saws for cutting wood or similar material and designed for use by one person.

This Standard does not cover chain beam saws that can be installed with more than one guide bar length.

This Standard does not cover chain beam saw attachments that convert a circular saw or a chain saw into a chain beam saw.

This Standard does not cover

a) chain saws as defined in CAN/CSA-C22.2 No. 60745-2-13/UL 60745-2-13;

b) chain saws for tree service as defined in CSA Z62.1; or

c) pole cutters and pruners as defined in CSA C22.2 No. 147 or UL 82.

ASHRAE’s key standards guiding refrigerant identification and usage have been revised to meet governmental regulation and achieve improved performance. Standards 15 and 34 provide essential guidance to manufacturers, design engineers and operators who need to stay current with new air conditioning and refrigerating requirements.

Standard 34 describes a shorthand way of naming refrigerants and assigns safety classifications based on toxicity and flammability data, while Standard 15 establishes procedures for operating equipment and systems when using those refrigerants.

ASHRAE offers the standards as a set.

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1.

NOTE: See also 4.2.

This standard can also be applied to equipment used for compensation or alleviation of disease, injury or disability.

In vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT is covered by the IEC 61010 series 2). This standard does not apply to the implantable parts of active implantable medical devices covered by ISO 14708-1 3).

1.2 Object

The object of this standard is to specify general requirements and to serve as the basis for particular standards.

1.3 * Collateral standards

In the IEC 60601 series, collateral standards specify general requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE applicable to:

- a subgroup of ME EQUIPMENT (e.g. radiological equipment);

- a specific characteristic of all ME EQUIPMENT not fully addressed in this standard.

Applicable collateral standards become normative at the date of their publication and shall apply together with this standard.

NOTE 1 When evaluating compliance with IEC 60601-1, it is permissible to independently assess compliance with the collateral standards.

NOTE 2 When declaring compliance with IEC 60601-1, the declarer should specifically list the collateral standards that have been applied. This allows the reader of the declaration to understand which collateral standards were part of the evaluation.

NOTE 3 Members of IEC maintain a register of valid International Standards. Users of this standard should consult this register to determine which collateral standards have been published.

If a collateral standard applies to ME EQUIPMENT for which a particular standard exists, then the particular standard takes priority over the collateral standard.

1.4 * Particular standards

In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in this standard as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements.

NOTE: Members of IEC and ISO maintain registers of valid International Standards. Users of this standard should consult these registers to determine which particular standards have been published.

A requirement of a particular standard takes priority over this standard.

Health Canada may decide to stop using the 2nd Edition by Q4 2008. Device submissions to Health Canada prior to this tentative date will not be withdrawn.The cETL Mark will not be withdrawn for several years, and only if the device ismodified. You may start using the 3rd Edition now for both the cETL Mark and Health Canada. FDA and Health Canada are discussing a common effective date, which may cause Health Canada to extend their transition period.

The limits and methods of measurement laid down in this International Standard apply to industrial, scientific and medical (ISM) equipment as defined in Clause 2, and to electrodischarge machining (EDM) and arc welding equipment.

NOTE The limits have been determined on a probabilistic basis taking into account the likelihood of interference. In cases of interference, additional provisions may be required.

Procedures are given for the measurement of radio-frequency disturbances and limits are laid down within the frequency range 9 kHz to 400 GHz.

Requirements for ISM lighting apparatus operating in the ISM frequency bands of 915 MHz (only allowed in region 2 as defined by the ITU Radio Regulations), 2,45 GHz and 5,8 GHz are contained in this standard.

Requirements for other types of lighting apparatus are covered in CISPR 15.

Scope
1.1 This Standard specifies construction and testing requirements for portable power cables normally used in applications where the cables are subject to frequent flexing and where installation is in accordance with CSA M421 and/or the Canadian Electrical Code, Part I, where applicable.
1.2 The cable constructions specified in Clauses 5to 9and Clauses 12to 16of this Standard are suitable for use at a maximum conductor temperature of 90 °C under normal operating conditions in wet or dry locations, outdoors or in underground mines, and in rugged environments. The special cable constructions described in Clauses 10and 11are suitable for use at a maximum conductor temperature of 105 °C.
1.3 This Standard does not specify all types, sizes, and voltage ratings of portable power cables that can be required for particular applications.
1.4 This Standard specifies the following categories of cables:
Clause
Category
5 Thermoset and PUR multiconductor round cables for mining and general applications rated 5 kV – 35 kV
Types: SHD, SHD-BGC (balanced ground check), SHD-GC
6 Thermoset and PUR multiconductor round cables for mining and general applications rated 2 kV
Types: W, G, G-BGC (balanced ground check), G-GC, SHC-GC, SHD, SHD-BGC (balanced ground check), SHD-GC, SHD-R
7 Thermoset single-conductor cables for mining and general applications rated 2 kV – 35 kV
Types: W, SH
8 Thermoset two- and three-conductor flat cables for mining and general applications rated 2 kV — Suitable for underground applications only
Types: G, G-GC, W
9 Thermoset three-conductor round cables with a central bonding conductor for underground coal mining applications rated 2 kV – 5 kV
Types: SHD-PCG
10 Arc-welding cable
11 Single-conductor portable power cable rated 600 V
Clause
Category
Types: PPC, PPC/TPE
12 Single and multiconductor portable power cables for general applications rated 600 V – 2 kV
Types: PPC, PPC/TPE
13 Flexible multiconductor cable for use with cranes and hoists rated 600 V (festoon cable)
14 Variable frequency drive cable, multiconductor, round, for mining and general applications rated 2 kV – 15 kV
Types: VFD, VFD-GC, VFD-BGC (balanced ground check)
15 DLO (diesel locomotive) cable, single conductor, used for portable and general permanent applications rated 2 kV
16 Thermoset and PUR multiconductor round special construction cables for mining and general applications rated 2 kV – 35 kV
Types: SHD-SP, SHD-BGC-SP (balanced ground check), SHD-GC-SP
1.5 In this Standard, “shall” is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the Standard; “should” is used to express a recommendation or that which is advised but not required; and “may” is used to express an option or that which is permissible within the limits of the Standard.
Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material.
Notes to tables and figures are considered part of the table or figure and may be written as requirements.
Annexes are designated normative (mandatory) or informative (non-mandatory) to define their application.
1.6 The values given in SI units are the units of record for the purposes of this Standard.

Scope

1.1

This Standard applies to locking-type, pin and sleeve type plugs, receptacles, power inlets, connectors, junction boxes, and live-end covers rated up to 1200 A (for single- and multi-pole) and above 750 V to 35 kV ac, 50/60 Hz or up to 1500 V dc and which shall have one or more pilot contacts for multi-pole configuration and above 750 V to 1000 V ac or dc for single pole configuration. These devices are intended to provide portable power from branch circuits, or are for direct connection to the branch circuit in accordance with the Canadian Electrical Code, Part I, or National Electrical Code (NEC) using portable power cables with copper conductors, for use in either indoor or outdoor, nonhazardous locations.

1.2

The products covered in this Standard are commonly, but not exclusively, used in the following applications:

a) open pit mining;

b) underground mining;

c) tunneling;

d) shore to ship power;

e) portable power equipment;

f) general industrial use; and

g) drilling.

1.3

This Standard does not apply to

a) products covered in CSA C22.2 No. 182.1 and UL 1682;

b) devices intended to be separated or connected under load; and

c) products covered in CSA C22.2 No. 282 and UL 2251.

1.4

The values given in SI units are the units of record for the purposes of this Standard. The values given in parentheses are for information and comparison only.

1.5

In this Standard, shall is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the Standard; should is used to express a recommendation or that which is advised but not required; and may is used to express an option or that which is permissible within the limits of the Standard.

Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material.

Notes to tables and figures are considered part of the table or figure and may be written as requirements.

Annexes are designated normative (mandatory) or informative (non-mandatory) to define their application.

Scope
1.1 This standard applies to quick-connect terminals, both connectors and tabs, having nominal widths
of 2.8, 3.2, 4.8, 5.2, and 6.3 mm (0.110, 0.125, 0.187, 0.205, and 0.250 in). They are intended for internal
wiring connections in electrical equipment and for the field termination of conductors to electrical
equipment in accordance with Part I of the Canadian Electrical Code, CSA C22.1, in Canada, and the
National Electrical Code, NFPA 70, in the United States of America.
1.2 These requirements apply to quick-connect terminals intended for use with one or two 26 – 10 AWG
(0.13 - 5.3 mm2) copper conductors.
1.3 These requirements do not apply to terminals for use with aluminum conductors.
1.4 These requirements do not apply to multi-pole devices. Multi-pole devices are covered by UL 1977
and CSA C22.2 No. 182.3.
1.5 In Canada, general requirements applicable to this standard are given in CSA C22.2 No. 0.

Scope
1.1 The requirements in this standard cover sealed wire connector systems, including insulating caps,
covers, resins, tubing, and tapes provided with, or for use with, specific wire connectors. These systems
are intended for wet or damp locations and other installations such as:
a) Direct burial,
b) Below grade,
c) Above grade where exposed to sunlight; or
d) Where exposed to sea water or salt water.
The wire connectors covered by these requirements are intended for use with copper conductor, aluminum
conductor, or both in accordance with installations covered by the National Electrical Code, NFPA 70; CSA
C22.1, Canadian Electrical Code, Part I; and NOM 001 SEDE, Standard for Electrical Installations.
1.2 These requirements apply to sealed wire connector systems intended for use at 1500 V or less, with
currents not exceeding the ampacity of insulated conductor types noted below, rated either 75 °C (167 °F)
or 90 °C (194 °F):
a) 14 AWG (2.08 mm2) through 2,000 kcmil (1,012 mm2) conductors: Types RHW, RHW-2, USE,
USE-2, USEB90, USEI75, USEI90, THW, XHHW, XHHW-2, RW90 EP, RW90 XLPE , or TWU,
b) 30 AWG (0.05 mm2) through 16 AWG (1.31 mm2) conductors: Any Type insulation acceptable
for direct burial, below grade use, or wet locations.
1.3 These requirements also cover sealed wire connector systems intended for use with single or
multiple conductor underground feeder cable, golf course sprinkler cable, underground low energy cable,
irrigation cable, or other cable with insulation acceptable for direct burial, below grade use, or wet
locations.
1.4 This standard does not apply to twist-on style splicing sealed wire connectors.