Main Categories

1.1 These requirements apply to DC conductive charging equipment intended to be supplied with a maximum input voltage of 1000 V ac or 1500 V dc, for recharging the propulsion batteries in over-the-road electric vehicles (EV). Equipment is intended to be installed in accordance with the Installation Codes in Annex A, Ref. No. 1. DC charging equipment, either standalone chargers or dispensers, with internal batteries exceeding 100 Wh and less than 20kWh serving as energy storage also is intended to be installed in accordance with the installation requirements in Annex A, Ref. No. AA. DC charging equipment with separable enclosures with internal batteries not in a standalone charger or charging dispenser shall be dual listed with the enclosures containing internal batteries also listed under UL 9540. DC charging equipment for EV installations are intended for either:

a) Dry location only, or

b) Dry, wet, and damp location.

1.2 The output of the DC charging equipment for EV covered by this standard does not exceed 1500 V dc.

1.3 For the purposes of this Standard, the term "electric vehicle", designated throughout by the initials "EV", is considered to cover electric vehicles, hybrid electric vehicles, and plug-in versions of these vehicles.

1.4 DC charging equipment for EV that is not a complete assembly and depends upon installation in an end product for compliance with the requirements in this Standard is investigated under the requirements of this Standard and the standard for the end product.

1.5 These requirements do not cover battery chargers covered by Annex A, Ref. Nos. 2 and 3.

1.6 These requirements do not cover on-board chargers.

1.7 These requirements do not cover electric vehicle supply equipment covered by Annex A, Ref. No. 4.

1.8 These requirements do not cover DC charging equipment for EV intended to be used in hazardous locations, such as near fuel dispensing stations.

1.9 These requirements do not apply to cover bi-directional charging equipment, or unidirectional power export equipment, covered by Annex A, Ref. No. 73B.

1.1 This Standard applies to conductive electric vehicle (EV) supply equipment with a primary source voltage of 1000 V ac or less, with a frequency of 50 or 60 Hz, and intended to provide ac power to an electric vehicle with an on-board charging unit. This Standard covers electric vehicle supply equipment intended for use where ventilation is not required.

1.2 With reference to 1.1, the following list of examples of electric vehicle supply equipment are included in this Standard:

a) EV Cord Sets – Rated 125 Vac maximum, 16 A maximum, intended for indoor and outdoor use;

b) Fastened in place EV Charging Stations – Rated 250 Vac maximum, 40 A maximum, intended for indoor or outdoor use;

c) Fixed in place EV Charging Stations – Rated 1000 Vac maximum, intended for indoor or indoor/outdoor use; and

d) Fixed in place EV Power Outlet – Rated 1000 Vac maximum, intended for indoor or indoor/outdoor use.

For Mexico, use 127 Vac where 120 or 125 Vac is referenced in this Standard. In Canada and the United States, this does not apply.

1.3 The products covered by this Standard are intended for use in accordance with the Installation Codes in Annex A, Ref. No. 1.

1.4 This Standard does not cover cord sets or power supply cords for applications other than EV charging cord sets. For cord sets and power supply cords not covered by this Standard, refer to Annex A, Ref. No. 2 and No. 3.

1.5 With reference to 1.2, this Standard does not cover electric vehicle charging equipment. For EV charging equipment not covered by this Standard, refer to Annex A, Ref. No. 4.

1.6 This Standard does not cover electric vehicle connectors. For electric vehicle connectors not covered by this Standard, refer to Annex A, Ref. No. 5.

1.7 This Standard does not cover regular-use power outlets. For regular-use power outlets not covered by this Standard, refer to Annex A, Ref. No. 6.

1.8 This Standard does not cover equipment intended for wireless power transfer, which may also be designated as wireless charging, inductive charging, magnetic resonance charging, or any other similar designation indicating the transfer of power from the EVSE to the vehicle through other than a conductive connection.

1.9 This standard does not cover electric vehicle export equipment, allowing bi-directional current flow from the vehicle to off board loads. For electric vehicle power export equipment, refer to Annex A, Ref. No. 75.

CSA Scope:
[Add the following]
This Standard applies to equipment intended to be installed or used in accordance with CSA C22.1, the Canadian Electrical Code, Part I.

IEC Scope:

This clause of Part 1 is replaced by the following.

This part of IEC 60335 deals with the safety of portable electric heating tools and similar appliances, their rated voltage being not more than 250 V including direct current (DC) supplied appliances and battery-operated appliances. 

Appliances not intended for normal household use, but which nevertheless can be a source of danger to the public, such as appliances intended to be used by laypersons in shops, in light industry and on farms, are within the scope of this standard.

Appliances that can also be used when mounted on a support are within the scope of this standard. Examples of appliances that are within the scope of this standard are

– branding tools;

– burning-in pens;

– conduit-soldering tools;

– dehorning tools;

– desoldering irons;

– firelighters;

– glue guns;

– heat guns;

– household film-welding appliances;

– paint strippers;

– plastic-cutting tools;

– soldering guns;

– soldering irons;

– stripping pliers;

– thermoplastic conduit-welding tools. 

As far as is practicable, this standard deals with the common hazards presented by appliances which are encountered by all persons in and around the home. However, in general, it does not in general take into account– persons (including children) whose

• physical, sensory or mental capabilities; or
• lack of experience and knowledge

prevents them from using the appliance safely without supervision or instruction;

– children playing with the appliance. 
Attention is drawn to the fact that

– for appliances intended to be used in vehicles or on board ships or aircraft, additional requirements can be necessary;

– in many countries additional requirements are specified by the national health authorities, the national authorities responsible for the protection of labour and similar authorities.

This standard does not apply to:

– hand-held motor-operated electric tools (IEC 60745 series, IEC 62841 series);

– transportable motor-operated electric tools (IEC 61029 series, IEC 62841 series);

– appliances intended exclusively for industrial purposes;

– appliances intended to be used in locations where special conditions prevail, such as the presence of a corrosive or explosive atmosphere (dust, vapour or gas);

– tools using high-frequency heating other than induction soldering irons;

– arc-welding equipment.

1 Scope

1.1 This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.

NOTE Although the scope is limited to medical devices, this document can be applicable to other products and equipment. This document covers radiation processes employing irradiators using:

a) the radionuclide 60Co or 137Cs;

b) a beam from an electron generator; or

c) a beam from an X-ray generator.

1.2 This document is not applicable to processes for inactivating viruses or the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.

NOTE For information on such processes, see ISO 22442-1, ISO 22442-2, ISO 22442-3, ISO 13022 and ICH Q5A.

1.2.1 This document does not specify requirements for designating a medical device as sterile.

NOTE Regional and national requirements can designate medical devices as sterile. See, for example, EN 556-1 or ANSI/AAMI ST67.

1.2.2 This document does not specify a quality management system for the control of all stages of production of medical devices.

NOTE It is not a requirement of this document to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices can require implementation of a complete quality management system and the assessment of that system by a third party.

1.2.3 This document does not require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release.

1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of irradiation facilities.

NOTE Regulations on safety requirements for occupational safety related to radiation can exist in some countries.

1.2.5 This document does not specify requirements for the sterilization of used or reprocessed devices.

1 Scope

1.1 Inclusions This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in health care products, components or raw materials using bacterial endotoxins test (BET) methods, using amebocyte lysate reagents.

1.2 Exclusions

1.2.1 This document is not applicable to the evaluation of pyrogens other than bacterial endotoxins. Other endotoxin detection methodologies are not included (see B.12).

1.2.2 This document does not address setting specific endotoxin limit specifications.