1 Scope

1.1

This Standard applies to electric supply and communication lines and equipment located entirely outside of buildings and fenced supply stations and buildings, and also where the installations or equipment are inside buildings or sections of buildings where they are employed by a utility of

a) an electric system;

b) a communication system; or

c) a community antenna distribution system

in the exercise of its function as a utility..

1.2

Existing installations meeting the requirements of prior editions of this Standard need not be modified to comply with this edition of the Standard, except as might be required for safety reasons by the authority having jurisdiction.

1.3

This Standard, which forms part of the Canadian Electrical Code, Part III, provides requirements for the construction of overhead systems. It covers electric supply and communication circuits that

a) are installed alone;

b) are in joint-use;

c) are in proximity to each other or other facilities;

d) cross each other or other facilities; and

e) cross railways, highways, navigable waterways, or land that is likely to be traversed by vehicles or pedestrians.

1.4

This Standard presents a choice between deterministic and reliability-based design methods.
Reliability-based design methods are covered by CSA C22.3 No. 60826.

1.5

The requirements contained in this Standard do not constitute complete design and construction specifications, but rather prescribe the minimum design requirements that are most important to the

a) safety of persons;

b) continuity of service; and

c) protection of property.

1.6

Conditions not covered by this Standard are governed by equivalent Standards in common use or by the authority having jurisdiction.

1.7

In some cases in this Standard, specific types of construction are envisaged. This does not preclude the use of other types of construction, provided that the engineering representatives involved can demonstrate the safety and suitability of these alternatives.

1.8

The use of terms such as “where practicable” is not intended to provide an opportunity for not meeting the requirements of this Standard, but indicates the preferred clearance or method. Where an alternative is not specified, the engineering solution that most closely adheres to the preferred method should be used.

1.9

Where the requirements of more than one clause apply, all should be satisfied.

1.10

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.

IEC 60335-2-69:2016 deals with the safety of electrical motor-operated vacuum cleaners, including back-pack vacuum cleaners, and dust extractors, for wet suction, dry suction, or wet and dry suction, intended for commercial indoor or outdoor use with or without attachments. They may be provided with a blowing or inflating function. It also deals with the safety of centrally-sited vacuum cleaners, excluding the installation of the system.

Requirements on the safe installation of centrally-sited vacuum cleaners are not addressed by this standard but need to be taken into account. This standard applies to machines for commercial use.

1. Scope

1.1 This standard covers light-sensitive, photo electric control units of the plug-in, locking type, rated 600 volts, 60 Hz alternating current (ac) or less, that are intended for controlling outdoor electric luminaires of the magnetic ballast, electronic ballast, tungsten-filament type, or light-emitting-diode (LED) and their associated driver for wet and damp locations, and that are intended to be employed for area lighting and installed in accordance with the Canadian Electrical Code (CEC Part I).

1.2 This standard covers shorting and open-circuit devices of the locking configuration, used as substitutes, where necessary, for the light-sensitive control units.

1.3 Solid state photo electric control units including combination device for either dimming or switching a lighting load in addition are also evaluated in accordance with CSA C22.2 No. 184.1.

1.4 The receptacles covered by this standard are only those used as mating parts with the locking type photo-electric controls of configuration defined in this Standard.
 

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:
This clause of Part 1 is replaced by the following.

This standard deals with the safety of electric fishing machines by means of which water may be electrified for the purpose of catching fish or for providing barriers to all animals living in water.

The rated voltage of electric fishing machines is not more than 250 V for single phase machines and 480 V for other machines, except that the rated voltage of electric fishing machines for permanent connection to fixed wiring is not more than 1000 V.

Additional requirements for boat mounted electric fishing machines are given in Annex AA.

NOTE 101
Examples of electric fishing machines coming within the scope of this standard are:
– mains-operated electric fishing machines which include those supplied from portable or stationary
generator sets; – battery-operated electric fishing machines .
NOTE 102
Attention is drawn to the fact that

– for appliances intended to be used on board ships or boats, additional requirements may be necessary;
– in many countries, additional requirements are specified by the national health authorities, the national authorities responsible for the protection of labour, the national water supply authorities and similar authorities.

NOTE 103
This standard does not apply to
– electric fence energizers (IEC 60335-2-76); – electric animal stunning equipment (IEC 60335-2-87);
– shark deterrent devices that are carried by the user

Scope:
This clause of Part 1 is replaced by the following:
This part of IEC 60335 deals with the safety of electric animal-stunning equipment the rated voltage of which is not more than 250 V for single-phase appliances and 480 V for other appliances.

NOTE 101
Battery-operated appliances and other d.c. supplied appliances are within the scope of this standard. Dual supply appliances, either mains-supplied or battery-operated, are regarded as battery-operated appliances when operated in the battery mode.

This standard is applicable to electric animal-stunning equipment for industrial or commercial use, for use on farms or for use in areas where they may be a source of danger to the public.

So far as is practical, this standard deals with the common hazards presented by these types of appliances.

NOTE 102
Examples of electric animal-stunning equipment within the scope of this standard are those used to stun:
– bovines such as cattle, calves, cows, heifers and bulls;
– ovines such as sheep and lambs;
– caprines such as goats;
– cervids such as deer;
– solipeds such as horses, donkeys and mules;
– birds such as chickens, turkeys and guinea fowl;
– porcines such as pigs; – fur animals such as foxes, chinchilla, rabbits and possums;
– mustelids such as mink and polecats;
– other ruminants such as camels.

NOTE 103
The following types of electric animal-stunning equipment are covered by this standard:
– manual, semi-automatic and automatic.

NOTE 104
Attention is drawn to the fact that:
– for electric animal-stunning equipment intended to be used on board ships, additional requirements may be necessary;
– in many countries, additional requirements are specified by the national health authorities, the national authorities responsible for the protection of labour, the national water supply authorities and similar authorities;
– in many countries, additional requirements are specified concerning the humane slaughter of animals.

NOTE 105
This standard does not apply to:
– 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);
– electric fence energizers (see IEC 60335-2-76);
– electric fishing machines (see IEC 60335-2-86);
– meat tenderizers, carcass immobilizers, carcass stiffeners, spinal discharge equipment or similar equipment.

Draft Amendment to C22.2 No. 60601-2-54

Scope:

This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of VENTILATORY SUPPORT EQUIPMENT, as defined in 201.3.205, for VENTILATORY IMPAIRMENT, as defined in 201.3.202, hereafter also referred to as ME EQUIPMENT, in combination with its ACCESSORIES:
— intended for use in the HOME HEALTHCARE ENVIRONMENT;
— intended for use by a LAY OPERATOR; and
— intended for use with PATIENTS who have VENTILATORY IMPAIRMENT, the most fragile of these PATIENTS, would not likely experience injury with the loss of this artificial ventilation; and
— not intended for PATIENTS who are dependent on artificial ventilation for their immediate life support.

Scope:
This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.205, for ventilatory insufficiency, as defined in 201.3.204, hereafter also referred to as ME EQUIPMENT, in combination with its accessories:
— intended for use in the home healthcare environment;
— intended for use by a lay operator;
— intended for use with patients who have ventilatory insufficiency or failure, the most fragile of which would likely experience injury with the loss of this artificial ventilation;
— intended for transit-operable use;
— not intended for patients who are dependent on artificial ventilation for their immediate life support.

Scope: 

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred to as 188 ME EQUIPMENT.

This standard applies to PATIENT CABLES as defined in 201.3.109, but does not apply to LEADS as defined in 201.3.106.

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

NOTE See also 4.2 of the general standard.

This standard does not apply to the implantable parts of ACTIVE IMPLANTABLE MEDICAL DEVICES covered 191 by ISO 14708-1 This standard does not apply to EXTERNAL PACEMAKERS which can be connected directly or indirectly to a SUPPLY MAINS.

This standard does not apply to transthoracic and oesophageal pacing ME EQUIPMENT and 194 antitachycardia ME EQUIPMENT.

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for EXTERNAL PACEMAKERS AS DEFINED IN 201.3. 103.

Scope

This document applies to the basic safety and essential performance of a ventilator in combination with itsaccessories, 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 1 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 2 For the purposes of this document, such a ventilator can provide transport within a professional healthcare facility (i.e. be a transit-operable ventilator).

NOTE 3 A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an emergency and transport 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 utilize physiological closed loop control unless it uses a physiological patient variable to adjust the 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.

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, 7.2.13 and 8.4.1.

NOTE 4 Additional information can be found in IEC 60601-1:2005, 4.2.

This document is not applicable to me equipment or an me system operating 182 in ventilation modes intended for patients who are not dependent on artificial ventilation.

NOTE 5 A critical care ventilator, when operating in such a 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:

-  ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13 [2];
-  ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84 [3], the future replacement for ISO 10651-3 [4];
- ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-2-72 [5];

- ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO 80601-2-79 [6] and ISO 80601-2-80 [7], the replacements for ISO 10651-6 [8];
- sleep apnoea therapy me equipment, which are given in ISO 80601-2-70 [9];
- continuous positive airway pressure (CPAP) me equipment;
- high-frequency jet ventilators (HFJVs);
- high-frequency oscillatory ventilators (HFOVs) [10];
- oxygen therapy constant flow me equipment;
- cuirass or “iron-lung” ventilation equipment.

This document is a document in the IEC 60601 and IEC/ISO 80601 series of documents.

Scope:
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 for VENTILATOR-DEPENDENT PATIENTS;
- for use in the EMS ENVIRONMENT; and
- For invasive or non-invasive ventilation.

NOTE 1 An EMS VENTILATOR can also be used for transport within a PROFESSIONAL HEALTHCARE FACILITIES.

This document is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to a BREATHING SYSTEM of an EMS VENTILATOR, or to an EMS VENTILATOR, where the characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the EMS VENTILATOR.

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, 7.2.13 and 8.4.1.

NOTE 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.

This part of ISO 80601 does not specify the requirements for
- VENTILATORS or ACCESSORIES intended for VENTILATOR-DEPENDENT PATIENTS in critical care applications, which are given in ISO 80601-2-12 [3].
- VENTILATORS or ACCESSORIES intended for VENTILATOR-DEPENDENT PATIENTS in the HOME HEALTHCARE ENVIRONMENT, which are given in ISO 80601-2-72 [4].
- VENTILATORS or ACCESSORIES intended for anaesthetic applications, which are given in ISO 80601-2-13 [5].
-  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 [6] and ISO 80601-2-80 [7].
- Obstructive sleep apnoea therapy ME EQUIPMENT, which are given in ISO 219 80601-2-70 [8].
- OPERATOR-powered resuscitators, which are given in ISO 10651-4 [9].
- Gas-powered emergency resuscitators, which are given in ISO 10651-5 [10].
- Continuous positive AIRWAY PRESSURE (CPAP) ME EQUIPMENT.
- High-frequency jet VENTILATORS (HFJVs).
- High-frequency oscillatory VENTILATORS (HFOVs) [11].
- Cuirass or “iron-lung” VENTILATORS.

This part of ISO 80601 is a particular standard in the IEC 60601-1 and ISO/IEC 80601 series of documents.

Scope:

This particular standard applies to basic safety and essential performance of cerebral tissue oximeter equipment, that employs light at multiple wavelengths to derive a quantitative measure of oxygen saturation of haemoglobin within the volume of tissue sampled under the probe attached to the head. The cerebral tissue oximeter equipment can be based on continuous light, frequency domain or time domain technologies. This particular standard applies to ME equipment used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. Additional standards may apply to ME equipment for those environments of use.

NOTE 1 Cerebral tissue oximeters are sometimes referred to as near infrared spectroscopy equipment.

Not included within the scope of this particular standard are:
- invasive tissue or vascular oximeters
- oximeters that require a blood sample from the patient
- devices measuring dissolved oxygen
- ME equipment, or part thereof, that measures path-length-dependent haemoglobin change. The requirements for functional near-infrared spectroscopy equipment are found in ISO 80601-2-71.
- ME equipment, or part thereof, that measures arterial saturation based on pulsatile changes in tissue optical properties (SpO2). The requirements for pulse oximeter equipment are found in ISO 80601-2-61.
- ME equipment, or part thereof, that claims to monitor tissue in other parts of the 162 body other than head.

These requirements also apply to cerebral tissue oximeter equipment, including cerebral tissue oximeter monitors, cerebral tissue oximeter probes and probe cable extenders, which have been reprocessed.

This document is not applicable to cerebral tissue oximeter equipment intended for use in laboratory research applications.

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 201.11 and in 7.2.13 and 8.4.1 of the general standard.

NOTE 2 See also 4.2 of the general standard. “The general standard” is IEC 60601-1:2005+AMD1:2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.

This document can also be applied to ME equipment and their accessories used for compensation or alleviation of disease, injury or disability.

This document is not applicable to remote or slave (secondary) equipment that displays StO2 178 values that are located outside of the patient environment.

NOTE 3 ME equipment that provides selection between diagnostic and monitoring functions is expected to meet the requirements of the appropriate document when configured for that function.

This document is a particular standard in the IEC 60601-1 and ISO/IEC 80601 series of standards

Draft Amendment to C22.2 NO. 80601-2-35

Scope:

This document specifies requirements for metallic, non-metallic and composite cable ties and their associated fixing devices used for the management and support of wiring systems in electrical installations.

Cable ties and associated fixing devices may also be suitable for other applications and where so used, additional requirements may apply

This document does not contain requirements that evaluate any electrical insulation properties of the cable tie or mechanical protection of the cables provided by the cable tie.

This document contains requirements for the mechanical interface of an adhesive fixing device to a solid surface. It does not consider the mechanical behavior of the solid surface in itself.

This document does not consider the mechanical securement means used to secure a device to a mounting surface, for example the mounting screw