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.

1 Scope

1.1 Inclusions

1.1.1 This document provides requirements for the development, validation and routine monitoring and control of a low temperature sterilization process for medical devices using vaporized hydrogen peroxide (VH2O2) as the sterilizing agent.

1.1.2 This document is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, organizations performing process validation of VH2O2 sterilization, and organizations responsible for sterilizing medical devices.

NOTE VH2O2 sterilizers can be used in both health care and industrial facilities, and this document acknowledges the similarities and differences between the two applications.

1.2 Exclusions

1.2.1 Processes that use other sterilizing agents, or hydrogen peroxide solution in combination with other chemicals as the sterilizing agent are not addressed in this document.

NOTE See ISO 14937 for guidance on validation of such processes.

1.2.2 This document does not specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies, e.g. scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

NOTE Some VH2O2 sterilizers have processes that demonstrate some level of inactivation of the causative agents of spongiform encephalopathies, e.g. scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob Disease. However, this inactivation is process, cycle, and test protocol specific, therefore this inactivation is outside the scope of this document, and no specific test methods are provided (see [14], [26], and [30] for more information).

1.2.3 This document does not specify requirements for designating a medical device as sterile. NOTE See for example EN 556–1 or ANSI/AAMI ST67.

1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of VH2O2 sterilization equipment.

NOTE For further information on safety, see examples in the Bibliography. National or regional regulations can also exist.

1.2.5 This document does not apply to the contents of contained product, i.e. product for which the environment within the sterilizer chamber during any stage of the sterilization process does not come into direct contact with the product, such as a solution in a sealed bottle.

1.2.6 This document does not cover hydrogen peroxide decontamination systems for use in rooms, enclosures or environmental spaces.

NOTE These decontamination systems operate at ambient conditions (e.g. temperature and pressure) and in general utilise an approach that is different to that of VH2O2 sterilization processes addressed in this document.

1.1 Application

1.1.1

This Standard applies to free-standing poles of ferrous metal, aluminum, polymeric, concrete, fibre-reinforced structures, and wood, and to their accessories, for use in the support of lighting equipment having ratings of 1000 V and less and intended to be installed in the commercial and industrial nonhazardous locations in accordance with the Rules of the Canadian Electrical Code, Part I.

1.1.2

This Standard includes the electrical features of poles as well as to the mechanical strength aspects and the ability to support their design loads. The poles may also serve as supports for aerial conductors, PV modules, wind turbines used to supply the lighting equipment, smart city communication, and data transmission devices, and, in the case of concrete or metal poles, provide wireways for conductors entering the poles.

This Standard does not apply to the erection of poles or the installation of accessories on site.

Notes:

1) Lighting equipment includes luminaires, electric signs, and traffic lights.

2) Lighting poles for residential applications less than 4 m in height may be evaluated to the requirements of CSA C22.2 No. 250.0 for electrical safety only and be marked NOT EVALUATED FOR STRUCTURAL STRENGTH/N’A PAS ÉTÉ ÉVALUÉ QUANT À LA RÉSISTANCE STRUCTURALE.

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.

1.3 Dual measurements

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.

Draft amendment to C22.1

Draft amendment to C22.1

Draft amendment to C22.1

CSA O80.0:21

1 Scope

1.1 Subjects Covered

The CSA O80 Series of Standards specifies requirements related to the preservation and fire retardance of wood through chemical treatment (pressure and thermal impregnation). The subjects covered include materials and their analysis, pressure and thermal impregnation procedures, and fabrication and installation to put treated wood into service.

1.2 Definitions and differences

This Standard lists reference publications and provides definitions applicable to the entire CSA O80 Series of Standards. This Standard also describes how the CSA O80 Series of Standards differs from related AWPA Standards and addresses the need for preservative registration. Recommendations on the use of the CSA O80 Series of Standards and related AWPA Standards can be found in Annex A.

Note: In Canada, preservative registration is carried out through Health Canada’s Pest Management Regulatory Agency.

1.3 Recommendations

The requirements and recommendations of the CSA O80 Series of Standards are based solely on the treatment efficacy of the chemicals in question. The CSA O80 Series of Standards does not necessarily take all laws and regulations into account.

Note: It is the responsibility of the users of the CSA O80 Series of Standards to ensure that their use of preservatives does not conflict with applicable laws and regulations.

1.4 Language

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.

CSA O80.1:21

1 Scope

1.1 Intention

This Standard is intended to help specifiers identify appropriate requirements for specific wood products and end use environments.

Note: The existence of a particular requirement in this Standard does not imply that the permitted combination of preservatives, processes, and/or wood species will be recognized by a regulatory body.

1.2 Language

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.

CSA O80.2:21

1 Scope

1.1 Requirements

This Standard specifies minimum requirements for treatment of wood products covered by the CSA O80 Series of Standards, including conditioning for treatment, treatment processes and limitations, end results of treatment, post-treatment handling, and quality control. Treatment practices and results should comply with the CSA O80 Series of Standards as a whole and, subject to Clause 4 of CSA O80.0, the relevant AWPA Standards.

1.2 Language

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.

CSA O80.3:21

1 Scope

1.1 Specifications

This Standard specifies preservative requirements not referenced elsewhere.

Note: It is intended that this Standard will be used to accommodate additional preservative formulations (if any) in future editions of the CSA O80 Series of Standards.

1.2 Language

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.

CSA O80.5:21

1 Scope

1.1 Specifications

This Standard specifies requirements for preparation and use of CCA preservative/additive combinations for utility poles permitted by CSA O80.1 and CSA O80.2.

1.2 Language

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 Scope

1.1 General

This Standard applies to motor vehicles other than passenger cars (as defined in Section 2 of the Motor Vehicle Safety Regulations) designed and manufactured, or altered, and equipped for the purpose of transporting persons with disabilities.

1.2 Inclusions

This Standard specifies

a) the design, manufacture and alteration of vehicles equipped with lifts or ramps;

b) the mobility aid location and securement; and

c) the required safety equipment.

1.3 Exclusions

This Standard does not apply to any transit bus and any over-the-road bus.

This Standard also does not apply to school bus (see CSA D250).

1.4 Units of Measurement

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 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 Domaine d’application

1.1 Généralités

Cette norme vise les véhicules automobiles autres que les voitures de tourisme (selon la définition de la Section 2 de la Loi sur la sécurité automobile) conçus, fabriqués ou adaptés pour assurer le transport des personnes handicapées.

1.2 Inclusions

La norme spécifie :

la conception, la fabrication et la modification de véhicules équipés de plates-formes élévatrices ou de rampes d’accès;

l’emplacement et l’arrimage des aides à la mobilité; et

les équipements de sécurité exigés.

1.3 Exclusions

Cette norme ne s’applique pas aux autobus urbains ni aux autobus routiers.

Cette norme ne s’applique pas aux autobus scolaires.

1.4 Unités de mesure

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

1.5 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.

Draft amendment to C22.1 

Draft amendment to C22.1

Draft amendment to C22.1

1.1

This Standard applies to motor-operated vacuum cleaners and blower cleaners, and to household use floor sweepers and floor finishing machines to be employed in accordance with CSA C22.1, Canadian Electrical Code, Part I, and NFPA 70.

1.2

These requirements cover:

a) Vacuum cleaners, including central vacuum cleaners, ash vacuum cleaners and vacuum cleaners with steam cleaning attachments, for:

1) Household or commercial use;

2) Marine or RV installation;

3) Portable, stationary or fixed appliances;

4) Wet or dry pick-up;

5) Indoor or outdoor use;

6) Coin-operation; and

7) Battery-operation, including automatic battery powered floor cleaners 

b) Blower cleaners for:

1) Household or commercial use;

2) Indoor or outdoor use

2.1) Coin-operation; and

3) Battery-operation

c) Floor sweepers for:

1) Household use; and

2) Battery-operation

d) Floor finishing machines including floor polishers, floor scrubbers, floor sanders, rug shampooers, extraction-type floor cleaning machines, rug and floor washers and similar machines, for:

1) Household use;

2) Indoor or outdoor use; and

3) Battery-operation

e) Current-carrying hoses and wall valves for:

1) Household use;

2) Wet or dry pick-up; and

3) Indoor use

f) Battery-operated cleaners as noted in (a) – (d), including:

1) automatic battery powered floor cleaners for:

i) Household or commercial use;

ii) Units with a mass of 20 kg (44 lbs) or less, not including the docking station; and

iii) Indoor use only

1.3

These requirements do not cover appliances rated more than 250 V. An appliance that utilizes some other source of energy, such as gas or steam, in addition to electric energy is to be investigated under these requirements and under such additional requirements as are applicable to the appliance under consideration.

1.4

These requirements do not cover appliances for use in locations such as those areas of hospitals, laboratories, institutions, and the like where dispersion of pathological, chemical, physical, radioactive or other agents could produce a risk to health. Appliances intended for use in such locations are investigated under these requirements and under such additional requirements as are applicable to the appliance, with appropriate consideration being given to the specific intended use.

1.5

These requirements apply only to a specific type or types of appliances, such as a vacuum cleaner or floor finishing machine, if the requirement is so identified by specific reference to the type or types involved. Absence of such specific reference or use of the term "appliance" indicates that the requirement applies to all appliances covered by this Standard.

1.6

This Standard does not apply to:

a) Internal-combustion engine powered floor cleaning machines for industrial/commercial use with or without traction drive, such as floor buffers, scrubbers, sweepers, spray extraction machines, and polishers, (UL/ULC (ORD) 558, UL/CSA 60335-2-67, UL/CSA 60335-2-68, UL/CSA 60335-2-72;

b) Battery-operated floor cleaning machines for industrial/commercial use with traction drive; (UL 583, UL/CSA 60335-2-72);

c) Commercial robotic floor treatment machines (CSA/ANSI C22.2 No. 336);

d) Commercial floor finishing machines (UL 561, CSA C22.2 No. 10, UL/CSA 60335-2-67, UL/CSA 60335-2-68, UL/CSA 60335-2-72); and

e) Steam cleaners (CSA C22.2 No. 64, CSA E60335-2-54, UL 499). For steam cleaners with suction, the vacuum function is covered by this Standard.

1.7

These requirements do not cover machines that generate pressure in excess of 2.5 MPa (360 psi).

1.8

Specific constructions, tests, markings, guards, and the like are detailed for some common designs. Specific features and appliances not covered are to be given appropriate consideration. See Marking, Section 11.

1.1

This Standard applies to newly produced gas-fired low-pressure steam and hot water boilers with gas inlet pressure ratings not exceeding 0.5 psi (3.5 kPa) and having input ratings of less than 12 500 000 Btu/h (3 663 389 W) (see Clause 3), hereinafter referred to as boilers,* constructed entirely of new unused parts and materials,

a) for operation at or below the following pressures and temperatures:

i) steam heating boilers: 15 psi (103.42 kPa) steam pressure;

ii) hot water heating boilers:

1) 160 psi (1.10 MPa) water pressure; and

2) 250 °F (121 °C) water temperature;

iii) hot water supply boilers:

1) 160 psi (1.10 MPa) water pressure; and

2) 250 °F (121 °C) water temperature;

b) for use with

i) natural gas;

ii) propane gas;

iii) LP gas-air mixtures; and

c) for recreational vehicle installation for use with

i) propane gases only; and

ii) natural gas and propane gases when provision is made for the simple conversion from one gas to the other.

The construction of boilers is covered under Clause 4 and the performance of boilers is covered under Clause 5.

* See Clause 7.2 for boilers covered in Canada that exceed the above limits in gas inlet pressure and/or input ratings.

Rationale: RFC#31, RFC#44 and RFC#42

1.2

This Standard applies to indoor boilers, of other than the direct vent type that are categorized according to vent pressure and temperature as either Category I, Category II, Category III, or Category IV (see Clause 3), and to outdoor type boilers.

1.3

This Standard also applies to direct vent boilers (see Clause 3). A direct vent boiler anticipated by this Standard is essentially a balanced flue appliance with the air intake and vent outlet in proximity. Other designs are subjected to such additional tests as believed necessary at the discretion of the certification body.

Rationale: Part of RFC#48, as editorial change.

1.4

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

1.5

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: IEEE/ASTM SI 10 or ISO 80000-1 can be used as a guide when converting imperial units to metric units.

1.6

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

1.7

Clause 7 contains clauses unique to, and required by, Canada.

1.8

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.

Draft amendment to C22.1 

1 Inclusions

This Document establishes requirements for:

a)   hydrogen fuel cell powered rolling stock, including retrofit and new-build units;

b)   the onboard compressed hydrogen gas fuel storage and delivery system from the refuelling receptacle to the fuel cell power system; and

c)   the proton exchange membrane (PEM) fuel cell power systems.

Notes:

1)   Rolling stock may have additional power source(s). For onboard lithium-ion batteries, see CSA TS-602.

2)   This document is limited to the scope indicated above and it is assumed that integrators apply other standards and regulations as needed, for example AAR MSRP-M and AAR M-1004 (for freight applications) or APTA PR-PS-WP-007 (for passenger applications), etc.

1.2 Exclusions          

This Document does not:

a)   include requirements for hydrogen internal combustion engines;

b)   include requirements for fuel cell power system technologies other than PEM;

c)   include requirements for liquid hydrogen or cryo-compressed hydrogen fuel systems;

d)   apply to wayside or mobile refuelling equipment;

e)   address systems related to interchange to the extent that they are covered by AAR specifications; and

f)    address hazards, risks, or requirements for components and systems that are typical and common to diesel-powered rolling stock.

1.3 Terminology

In this Document, “shall” is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the Document; “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 Document.

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 Document. The values given in parentheses are for information and comparison only.

Canadian / US deviation

[Add the Note 1 after the third paragraph]

Note 1: Additional information for hybrid systems containing hydrogen fuel cell equipment can be found in CSA TS-601.

[Add the following to the scope]

For the purposes of this Technical Specification, hybrid traction systems are categorized as follows:

a) Non-plug-in hybrid system:

A traction system in which the onboard rechargeable energy storage system (RESS) is intended to be charged only by energy generated or recovered onboard the vehicle (e.g., from an onboard power generation unit or through regenerative braking).

A non-plug-in hybrid may include a physical charging interface intended exclusively for maintenance, commissioning, or emergency use. However, such an interface shall not be used in normal service operation and shall not be considered a means for routine traction battery charging.

b) Plug-in hybrid system:

A traction system in which the onboard RESS is designed to be charged both from onboard energy sources and from an external electric power supply intended for regular operational use.

This document applies to batteries which are used for traction power at any time, whether the batteries provide additional functions as well.

Notes:

This document does not apply to batteries solely used for auxiliary power as these batteries are covered by UL 1973 and NFPA 130.

This document is limited to the scope indicated above and it is assumed that integrators apply other standards and regulations as needed, for example AAR MSRP-M and AAR M-1004 (for freight applications) or APTA PR-PS-WP-007 (for passenger applications), etc.

The document does not include requirements for other batteries chemistry beyond the lithium-ion family.

This document does not apply to the recharging interface to the wayside connector.

This document does not apply to any wayside batteries.