Draft Amendment to C22.1

Draft Amendment to C22.1

Draft Amendment to C22.1

CSA Scope

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This Standard applies to appliances that are permanently connected or cord-connected, intended for sterilization, garment treatment, deodorizing or with other similar functions.

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-      tumble dryers (CSA E60335-2-11, CSA C22.2 No. 112)

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-      Drying cabinets intended for drying washed clothes within a closed heated compartment (CSA C22.2 No. 112)

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This Standard applies to the safety of such equipment that is intended to be installed or used in accordance with CSA C22.1, 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 electric clothes dryers including clothes dryers intended for drying footwear or gloves, and towel rails for household and similar purposes, their rated voltage being not more than 250 V including direct current (DC) powered appliances and battery-operated appliances.

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

As far as is practicable, this standard deals with the common hazards presented by appliances that are encountered by all persons in and around the home. However, in general, it does not 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:

– spin extractors (IEC 60335-2-4);

– tumble dryers (IEC 60335-2-11);

– 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).

1 Scope

1.1 General

This Standard specifies safety requirements for pipelines for medical gases, medical vacuum, medical support gases, and anaesthetic gas scavenging systems in health care facilities, both public and private. It applies to all facilities providing health care services, regardless of type, size, location, or range of services, including, but not limited to

a)    acute care hospitals;

b)    in-patient continuing care hospitals;

c)    long-term care facilities;

d)    community-based providers;

e)    leased/rental suites in office buildings; and

f)     ambulatory and outpatient care clinics (e.g., day surgery, endoscopy clinics, dentists’ offices, and doctors’ offices).

1.2 Intended use

There is a commentary available for this Clause.

This Standard is intended for use by anyone involved in the design, installation, commissioning and testing, documentation, operation, and maintenance of pipelines for medical gases, medical vacuum, medical support gases, and anaesthetic gas scavenging systems. The requirements cover

a)    the design of systems to ensure the continuous supply of gas or vacuum in normal condition or in single fault condition;

b)    the selection of materials and components;

c)    the non-interchangeability of equipment between different gas systems and services;

d)    the cleanliness of materials and components and of the completed system;

e)    installation procedures for supply systems and pipelines;

f)     the configuration of system components;

g)    control, monitoring, and alarm systems;

h)    the markings and information to be supplied by the manufacturer or installer;

i)     contaminant testing of pipelines;

j)     the final testing of each medical gas pipeline prior to its use in patient care to ensure that it contains only the specified gas; and

k)    maintenance and ongoing verification.

1.3 Application

There is a commentary available for this Clause.

This Standard applies to pipeline systems for

a)    medical gases or medical gas mixtures, including

i)     oxygen USP;

ii)    oxygen 93 USP;

iii)   medical air USP;

iv)   nitrous oxide USP;

v)    carbon dioxide USP;

vi)   helium USP;

vii)  oxygen USP/nitrous oxide USP mixtures;

viii) helium USP/oxygen USP mixtures; and

ix)   other medical gases;

b)    medical support gases, including

i)     instrument air; and

ii)    nitrogen NF;

c)    medical vacuum; and

d)    anaesthetic gas scavenging systems (AGSS).

1.4 Exclusion of plume evacuation systems (PES)

This Standard does not provide specific requirements for plume evacuation systems (PES) that is part of an overall medical gas pipeline distribution system. Informative guidance is provided in Annex R.

1.5 Exclusion of hyperbaric chambers

This Standard does not provide specific requirements for hyperbaric chambers connected to medical gas pipeline distribution systems. See Clause 7.6.4 for the hyperbaric demarcation point.

Note: Requirements for hyperbaric chambers are provided in CSA Z275.1.

1.6 Exclusion of veterinary and animal research facilities

This Standard does not apply to veterinary and animal research facilities.

Note: The relevant requirements of this Standard, particularly those regarding safety, should be incorporated in the design, installation, and maintenance of piping systems in veterinary and animal research facilities. These systems should be inspected and tested by inspection bodies.

1.7 Terminology

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 (nonmandatory) to define their application.

1.8 Units of measure

The values given in SI (metric) units are the standard. The values given in parentheses are for information only. Unless otherwise specified, pressures and vacuum in this Standard are expressed as gauge pressure (i.e., atmospheric pressure is defined as 0).

Draft Amendment to C22.1

Replacement:

This part of IEC 62841 applies to rechargeable battery-powered motor-operated chain saws for tree service, hereinafter referred to as chain saws or machines, having a maximum mass of 5,0 kg. The mass includes the heaviest detachable battery pack(s), if any, as described in IEC 62841-1:2014, K.8.14.2 e) 2), but excludes the guide bar, saw chain and saw chain lubricant. Chain saws covered by this document are intended to be used for pruning and dismantling standing tree crowns.

The chain saws covered by this document are designed only to be operated with the right hand on the rear handle and the left hand on the front handle.

This document does not apply to

–   chain saws supplied by mains power or power from non-isolated sources that permit the machine to be used while connected to such power supplies; or

–   chain saws supplied by integral batteries; or

–   chain saws for cutting wood as covered by IEC 62841-4-1; or

–   chain saws designed for use in conjunction with a guide-plate and riving knife or in any other way such as with a support or as a stationary or transportable machine; or

–   pole-mounted pruners; or

  NOTE 1 Pole-mounted pruners are covered by IEC 62841-4-10.

–   pruning saws.

  NOTE 2  Pruning saws will be covered by a future part of IEC 62841-4.

The maximum rated voltage for machines and battery packs is 75 V d.c.

Battery machines covered by this document are not considered to be class I tools, class II tools or class III tools and therefore are not required to have basic insulation, supplementary insulation or reinforced insulation. Electric shock hazard is considered to exist only between parts of opposite polarity.

This document deals with the hazards presented by machines which are encountered by all persons in the normal use and reasonably foreseeable misuse of the machines.

When evaluating a rechargeable battery pack for protection against electric shock during charging, creepage distances, clearances and distances through insulation, the relevant requirements of this document are applicable with the battery pack fitted to the intended charger.

Since rechargeable battery packs for machines are submitted to different use patterns (such as rough use, high charging and discharging currents), their safety can be evaluated only by this document and not by using other standards for rechargeable battery packs, such as IEC 62133-1:2017 or IEC 62133-2:2017, unless otherwise indicated in this document. All relevant aspects related to the safety of rechargeable batteries are addressed in this document, such that the requirements of IEC 62133-1:2017 or IEC 62133-2:2017 are not required to be separately applied.

When evaluating the risk of fire associated with rechargeable battery packs for machines, consideration has been given to the fact that these battery packs are unattended energy sources and have been evaluated as such in this document. Requirements in other standards regarding the risk of fire due to the charging of these battery packs are therefore considered to be fulfilled.

This document also addresses requirements covering the use of lithium-ion cells employed in battery systems in machines. The following is considered within the context of these requirements:

– These requirements address the risk of fire or explosion of these batteries and not any possible hazards associated with toxicity nor potential hazards associated with transportation or disposal.

NOTE 3  IEC 62281:2019 covers the safety aspects of lithium-ion batteries during transport.

– Battery systems covered by these requirements are not intended to be serviced by the end user.

– These requirements are intended to provide comprehensive evaluation of a battery only if used in products covered by this document.

– These requirements address the safety of lithium-ion battery systems during storage and use including discharge and charge. These requirements are only considered to be supplementary requirements in regard to battery charger fire and electric shock.

– These requirements refer to and require parameters supplied in reference to the cells that establish conditions for safe use of those cells. Those parameters form the basis of acceptance criteria for a number of tests contained herein. This document does not independently evaluate the safety of cells. These parameters, taken as a set, constitute the "specified operating region" for a cell. There can be several sets of specified operating region(s).

This document does not apply to machines using general purpose batteries installed by the user and this document alone will not be sufficient to ensure that all hazards are considered for these products.

This document does not apply to the safety of battery chargers themselves.

NOTE 4  IEC 60335-2-29 covers a variety of chargers.

IEC 62841-1:2014, Clause 1 is applicable, except as follows.

Addition:

This document applies to transportable belt sanders, disc sanders and belt/disc sanders which are equipped with

– a sanding belt; or

– a sanding disc; or

– a sanding belt and a sanding disc

for sanding solid materials.

This document does not apply to hand-held disc-type sanders.

NOTE 101 Hand-held disc-type sanders are covered by IEC 62841-2-3.

This document does not apply to hand-held belt sanders.

NOTE 102 Hand-held belt sanders are covered by IEC 62841-2-4.

1.1 Inclusions

This Standard specifies requirements for precast segmental concrete paving units, manufactured from hydraulic and non-hydraulic cement concrete to be used in the construction of pedestrian and vehicular pavement and roof coverings. Segmental concrete paving units consist of either a single concrete throughout or two layers consisting of a backing concrete with a face that has a minimum thickness, commonly of 4 mm. This Standard includes units with architectural finishes or tactile surfaces.

Notes:

Annex A contains information on efflorescence and recommends methods for its removal.

The terms “paver”, “concrete paver”, “interlocking concrete paver”, “plank”, “slab”, and “concrete paving slab” are used exclusively in Clause 3 to facilitate industry classification of precast segmental concrete paving units.  To maintain clarity, these terms are not used in the subsequent sections of this Standard.

1.2 Terminology

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.

Draft Amendment to C22.1

This Standard outlines methods to manage continuous welded rail systems used in transit and passenger railways. It focuses on identifying and mitigating factors that contribute to track buckling and rail breaks under various operating conditions with particular focus on the impact of climate change. This Standard includes practices for design, construction, operation, and maintenance of CWR systems to ensure rail stability.

1.1 Inclusions

This Standard gives guidance on the appropriate rail neutral temperature for a passenger rail system including during design, construction and management of CWR in extreme hot and cold weather events caused by climate change. This standard also applies to the management of rail breaks caused by rail in tension.

1.2 Exclusions

This Standard does not apply to the management of rail breaks for reasons other than rail in tension such as corrosion, and surface and internal rail defects. Additionally, guidance for the maintenance and inspections (e.g., ultrasonic, track geometry, visual, etc.) of rail and track to prevent rail breaks is not covered in this standard.  This Standard does not provide specific guidance on how to manage risks associated with track disturbance caused by work such as surfacing, tie replacement, or other track work.

1.3 Terminology

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.

1.4 Units of measure

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, which includes imperial units.

Cette norme énonce les méthodes de gestion des systèmes de longs rails soudés utilisés dans les chemins de fer de transport collectif et de voyageurs. Elle se concentre sur l'identification et l'atténuation des facteurs qui contribuent au flambage de la voie et à la rupture des rails dans diverses conditions d'exploitation, en mettant l'accent sur l'impact du changement climatique. Cette norme comprend des exigences pour la conception, la construction, l’exploitation et l’entretien des systèmes LRS afin d’assurer la stabilité des rails.

1.1 Inclusions

Cette norme fournit des directives sur la température neutre appropriée des rails pour un système de transport ferroviaire de voyageurs, y compris lors de la conception, de la construction et de la gestion des LRS dans des conditions météorologiques extrêmes de chaleur et de froid causées par le changement climatique. Cette norme s’applique également à la gestion des ruptures causées par les rails en tension.

1.2 Exclusions

Cette norme ne s’applique pas à la gestion des ruptures des rails pour des raisons autres que les rails en tension, notamment la corrosion et les défaillances internes et de surface des rails. De plus, les directives pour l’entretien et les inspections (p. ex., ultrasoniques, géométrie de la voie, visuelles, etc.) des rails et de la voie pour prévenir les ruptures ne sont pas abordées dans cette norme.  Cette norme ne fournit pas de directives spécifiques sur la manière de gérer les risques associés aux perturbations de la voie causés par des travaux comme le surfaçage, le remplacement des traverses ou d'autres travaux sur la voie.

1.3 Terminologie

Dans cette norme, le terme « doit » indique une exigence, c’est-à-dire une prescription que l’utilisateur doit respecter pour assurer la conformité à la norme; « devrait » indique une recommandation ou ce qu’il est conseillé mais non obligatoire de faire; et « peut » indique une possibilité ou ce qu’il est permis de faire.

Les notes qui accompagnent les articles ne comprennent pas d’exigences ni d’exigences alternatives; le but d’une note accompagnant un article est de séparer du texte les éléments explicatifs ou informatifs.

Les notes au bas des tableaux et des figures font partie du tableau ou de la figure et peuvent être rédigées comme des exigences.

Les annexes sont qualifiées de normatives (obligatoires) ou d’informatives (facultatives) pour en préciser l’application.

1.4 Unités de mesure

Les valeurs indiquées en unités SI sont les valeurs officielles dans la présente norme. Les valeurs entre parenthèses, lesquelles comprennent les unités impériales, sont données à titre d’information et pour fin de comparaison seulement.

1.1 Scope

This Standard establishes criteria for an emergency and continuity management program.

1.2 Purpose

1.2.1 General

This Standard provides the requirements to develop, implement, evaluate, maintain, and continually improve an emergency and continuity management program for prevention and mitigation, preparedness, response, and recovery of an incident.

1.2.2 Continual improvement process

The elements of a continual improvement process included in this Standard are

a) program management;

b) planning;

c) implementation;

d) program evaluation; and

e) management review.

1.3 Application

This Standard applies to all organizations.

1.4 Terminology

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 (nonmandatory) to define their application.

1.1 Domaine d’application

Cette norme établit un ensemble de critères pour un programme de gestion des urgences et de la continuité, désigné ci-après par « le programme ».

1.2 Objet

1.2.1 Généralités

La présente norme énonce les exigences touchant l’élaboration, la mise en œuvre, l’évaluation, la tenue à jour et l’amélioration continue d’un programme de gestion des urgences et de la continuité pour la prévention, l’atténuation, la préparation, l’intervention et le rétablissement relativement à un incident.

1.2.2 Processus d’amélioration continue

Les éléments d’un processus d’amélioration continue compris dans cette norme sont les suivants :

gestion de programme;

planification;

mise en œuvre;

évaluation; et

examen par la direction.

1.3 Application

Cette norme s’applique à toutes les organisations

1.4 Terminologie

Dans la présente norme, le terme « doit » indique une exigence, c.-à-d. une prescription que l’utilisateur est obligé de respecter pour assurer la conformité à la norme; « devrait » indique une recommandation ou ce qu’il est conseillé, mais non obligatoire; et « peut » indique une option ou ce qui est permis compte tenu des limites de la norme.

Les notes qui accompagnent les articles ne comprennent pas d’exigences ni d’exigences alternatives; le but d’une note accompagnant un article est de séparer du texte les éléments explicatifs ou informatifs.

Les notes au bas des tableaux et des figures font partie du tableau ou de la figure et peuvent être rédigées comme des exigences.

Les annexes sont qualifiées de normatives (obligatoires) ou d’informatives (facultatives) pour en préciser l’application.

CSA Scope

[Add the following to the last sentence of the first paragraph]

and at flow capacities up to and including 300 g/s.

[Add the following note]

NOTE 1A For North American application, all references to rated pressure are considered to be equivalent to maximum allowable working pressure (MAWP).

ISO Scope

This document specifies the requirements for wire or textile reinforced hoses and hose assemblies suitable for dispensing hydrogen up to 70 MPa nominal working pressure, in the operating temperature range of −40 °C to 65 °C.

This document specifies safety requirements for material, design, manufacture and testing of gaseous hydrogen hose and hose assemblies for hydrogen fuelling stations.

This document does not apply to the following hoses and hose assemblies:

a) those used as part of a vehicle high pressure on-board fuel storage system;

b) those used as part of a vehicle low pressure fuel delivery system; and

c) flexible metal hoses.

NOTE 1 This document was developed primarily for hoses and hose assemblies for dispensing high-pressure hydrogen from refuelling dispensers to hydrogen vehicles. ISO 16964 addresses hoses used to deliver hydrogen from a transportable vessel (e.g. trailer) into a buffer storage of a station.

NOTE 2 Hose assemblies include a hose with connectors on each end (see Figure 1). Each connector has two basic functional elements that are addressed as described below.

a) Coupling to hose. This function is defined by requirements and verified (along with the hose itself) by performance-based tests in this document.

b) Fitting for transition and connection to the piping system or equipment. This function is addressed by reference to appropriate hydrogen equipment standards and piping codes.

1.1 Purpose

This Standard is for use by organizations when establishing and managing systems for accessible, equitable, and inclusive customer experiences.  Any organization which designs and develops accessible customer service promotes opportunity and access for all people.

The purpose of this Standard is to guide organizations when developing, implementing, and maintaining accessible service management systems. This includes, but may not be limited to, defining accountability structures and policies, assessing service quality and accessibility outcomes, remaining responsive to evolving needs, and using customer-informed feedback to drive continuous improvement.

1.2 Figures and tables

Figures and tables are included for explanatory or illustrative purposes only and are not a mandatory part of the Standard.

1.3 Annexes

Annexes A and B provide additional information on topics considered in the Standard.

1.4 Terminology

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 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 explanatory or informative material from the text.

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.

1.1 Applications

This Standard applies to the construction, performance, and installation procedures for a newly produced automatic damper device (referred to as “device” in this Standard) constructed entirely of new and unused parts and materials, and designed to be used with a gas-fired appliance listed by a nationally recognized certification body.

1.2 Inclusions

This Standard applies to the following automatic damper devices:

a)    vent;

b)   flue;

c)    fireplace chimney; and

d)   backflow prevention.

Flue damper devices have been in use for decades and have been tested and certified to this Standard by many nationally recognized certification bodies.

A backflow damper is designed to prevent flue gas from entering idle appliances when part of a positive pressure common vent system. These types of systems are becoming more commonly used in North America.

1.3 Gauge pressure

All references to “psi” throughout this Standard are to be considered gauge pressures unless otherwise specified.

1.4 Units of measurement

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

Note: See Annex F for conversion tables.

1.5 Terminology

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.

1.1 Inclusions

This Standard applies to fuel gas piping systems using corrugated stainless steel tubing (CSST), intended for installation in residential, commercial, or industrial buildings, and including the following components as a minimum:

a) corrugated stainless steel tubing (CSST) piping systems not exceeding a size of 2 in (50.8 mm), based on the nominal inside diameter of the tubing;

b) fittings for connection to the CSST; and

c) striker plates (see Clause 3) to protect the installed CSST from puncture threats.

Other components of piping systems referenced by this Standard include gas manifolds, gas pressure regulators, manual gas valves, quick-disconnect devices, excess flow valves, and gas convenience outlets (see Clauses 4.3, 4.4, and 4.5) .

Note: If such additional components are required to complete the piping system installation, they are either provided as part of the piping system or specified in the manufacturer’s installation instructions [see Clause 4.7 n)].

1.2 Additional inclusions

This Standard also applies to the following:

a) CSST piping systems in which portions of the piping are exposed to the outdoors, as required, to make connections to outdoor gas meters or to outdoor gas appliances, which are attached to, mounted on, or located in close proximity to the building structure; and

b) CSST piping systems that are used in conjunction with other approved fuel gas piping materials.

1.3 Exclusions

This Standard does not apply to the following:

a) CSST, whether coated or uncoated, intended for direct burial underground. Tubing is installed underground only when encased inside either an approved conduit or as part of an approved engineered system and in accordance with local codes and the manufacturer’s instructions; and

b) gas connectors for appliances. These connectors are covered by CSA/ANSI Z21.24 • CSA 6.10 and ANSI Z21.69 • CSA 6.16.

1.4 Concealment of tube fittings

This Standard includes criteria to establish the suitability of concealed mechanical tube fittings for use with concealed gas piping (see Clause 3).

1.5 System pressure ratings

This Standard applies to piping systems rated at

a) 5 psi (34.5 kPa) and intended for exposure to maximum actual operating pressures (see Clause 3) not exceeding 6.5 psi (44.8 kPa); or

b) 25 psi (172.5 kPa) and intended for exposure to maximum actual operating pressures not exceeding 30 psi (207 kPa).

Note: The manufacturer has the option to certify its system to either pressure rating.

1.6 Applicable fuels

This Standard applies to piping systems intended for use only with fuel gas as defined in Clause 3, but does not apply to piping systems intended for use with propane in the liquid state.

1.7 Pressure references

All references to psi throughout this Standard are to be considered gauge pressure unless otherwise specified.

1.8 Measurement units

If a value for measurement as given in this Standard is followed by an equivalent value in other units, the first stated value is to be regarded as the specification.

Note: This Standard contains SI (metric) units corresponding to the yard/pound quantities, the purpose being to allow this Standard to be used in SI (metric) units. IEEE/ASTM SI 10 or ISO 80000-1 is used as a guide in making metric conversion from yard/pound quantities. If a value for a measurement and a corresponding value in other units are both specified as a quoted marking requirement, the first stated unit, or both, are to be provided. Given corresponding values might be approximate. See also Annex D.

1.9 Terminology

In this Standard, “shall” Is used to express a requirement, i.e., a provision that the user shall 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.

CSA Scope

201.1.1 *Scope

[Add the following paragraph]

This Standard applies to ME EQUIPMENT and ME SYSTEMS that are intended to be installed or used in accordance with CSA C22.1, Canadian Electrical Code, Part I.

ISO/IEC Scope

IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 1, applies, except as follows:

201.1.1   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 ventilatory support equipment, as defined in 201.3.302, for ventilatory impairment, as defined in 201.3.300, hereafter also referred to as ME equipment, in combination with its accessories:

— intended for use in the home healthcare environment;

NOTE 2 In the home healthcare environment, the supply mains driving the ventilatory support equipment is often not reliable.

NOTE 3 Such ventilatory support equipment can also be used in professional health care facilities.

— intended for use by a lay operator;

— 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.

EXAMPLE 1

Patients with mild to moderate chronic obstructive pulmonary disease (COPD).

Ventilatory support equipment 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 breathing system of ventilatory support equipment for ventilatory impairment, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory impairment.

EXAMPLE 2

Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system.

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.

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

This document does not specify the requirements for:

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

— 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;

— ventilatory support equipment or accessories intended for ventilatory insufficiency, which are given in ISO 80601-2-80;

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

— high-frequency jet ventilators (HFJVs)[33], which are given in ISO 80601-2-87;

— high-frequency oscillatory ventilators (HFOVs)[22];

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

NOTE 6 Ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.

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

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

— oxygen therapy constant flow ME equipment; and

— cuirass or “iron-lung” ventilation equipment.

CSA Scope

201.1.1 *Scope

[Add the following paragraph]

This Standard applies to ME EQUIPMENT and ME SYSTEMS that are intended to be installed or used in accordance with CSA C22.1, Canadian Electrical Code, Part I.

ISO/IEC Scope

IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 1, applies, except as follows:

201.1.1   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 ventilatory support equipment, as defined in 201.3.302, for ventilatory insufficiency, as defined in 201.3.302, hereafter also referred to as ME equipment, in combination with its accessories:

— intended for use in the home healthcare environment;

NOTE 2 In the home healthcare environment, the supply mains driving the ventilatory support equipment is often not reliable.

NOTE 3 Such ventilatory support equipment can also be used in professional health care facilities.

— 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; and

— not intended for patients who are dependent on artificial ventilation for their immediate life support.

EXAMPLE 1

Patients with moderate to severe chronic obstructive pulmonary disease (COPD), moderate amyotrophic lateral sclerosis (ALS), severe bronchopulmonary dysplasia or muscular dystrophy.

Ventilatory support equipment 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 of ventilatory support equipment for ventilatory insufficiency, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory insufficiency.

EXAMPLE 2

Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system.

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.

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

This document does not specify the requirements for:

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

— 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;

— ventilatory support equipment or accessories intended for ventilatory impairment, which are given in ISO 80601-2-79;

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

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

— high-frequency oscillatory ventilators (HFOVs)[20];

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

NOTE 6 Ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.

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

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

— oxygen therapy constant flow ME equipment; and

— cuirass or “iron-lung” ventilation equipment.