Main Categories

Draft Amendment to C22.1

1.1 General

This Standard provides a set of hydraulic testing specifications and performance metrics for temporary emergency flood protection barriers in Canadian environments and intends to:

a)    define standard terminology to be used when describing floods and flood protection barriers;

b)   detail a set of hydraulic testing requirements for flood protection barriers(see exclusions in Clause 1.2);

c)    outline different environments for flood protection barrier use (environmental categories) and discuss the testing and performance requirements for these environments; and

d)   provide technology developers and testing laboratories with a defined set of hydraulic testing conditions required for flood barrier deployment in Canadian environments.

1.2 Assumptions and exclusions

This Standard is not intended to apply to anything outside of the hydraulic testing of temporarily deployed emergency flood protection barrier systems. The Standard is not intended to apply to initial planning, new development, new expansions and construction, or site closure/remediation. This Standard is also not intended to apply to stormwater (only) systems which is provided for in CSA W211:21 Management standard for stormwater systems. Out-of-scope items are noted for awareness only, but organizations may choose to include those aspects to fit their scope needs. These out-of-scope items are not limited to:

a)    any types of testing of the flood protection barrier outside of hydraulic testing (strength of materials, UV, foundation design, etc.);

b)   any type of permanently affixed or installed flood protection barrier (walls, sea walls, dykes, etc.);

c)    any type of flood protection barriers for structural openings (doors, windows, etc.);

d)   any testing of the barrier individual components (connection clamps, anchor bolts, materials testing, etc.);

e)    any specifications around or testing of auxiliary equipment that supports flood protection barrier deployment (flood abatement pumps, backwater valves, etc.); and

f)    any specifications around the manufacturing process of the flood protection barriers.

1.3 Application

This Standard applies to the hydraulic testing requirements of temporary emergency flood protection barriers. This Standard draws elements from, but is not limited to:

a)    ANSI/FM 2510 - American National Standard for Flood Mitigation Equipment; and

b)   BSI Standards Publication Parts 1 and 2.

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.

1.5 Units of measure

The units of measure used in this Standard are provided in SI (metric) and Imperial units where appropriate (Annex A.1).

Dimensional lumber discussions within the document have been listed in imperial measurements as the products are commonly referred to by their trade name in imperial measurements within Canada.

1.1 Inclusions

This Standard covers three-phase, alternating current, salient pole synchronous machines 150 kW and up, 200 through 13,800 volts, at rated machine frequencies and will assist in verifying the machine efficiency has been maintained.

Note: This Standard can be useful and applied with discretion to products outside the scope of this Standard.

1.2 Exclusions

Large 2-pole and 4-pole solid cylindrical rotor machines, typically used as generators for utility and large industrial applications, are excluded from this Standard.
 

Note: See Annex D.2 for information on generators

1.3 Terminology 

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

[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.

Replacement:

This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217, hereinafter referred to as ME EQUIPMENT.

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 201.7.2.13.

This document does not cover ultrasonic therapeutic equipment. Equipment used for the imaging or diagnosis of body structures by ultrasound in conjunction with other medical procedures is covered.

Draft Amendment to C22.1

This clause of Part 1 is replaced by the following.

This part of IEC 60335 specifies safety requirements for electrically operated commercial refrigerating appliances and ICE-MAKERS that have an incorporated motor-compressor or that are supplied in two units for assembly as a single appliance in accordance with the instructions (split system).

NOTE 101 Examples of appliances that are within the scope of this standard are

– REFRIGERATED DISPLAY and STORAGE CABINETS;

– refrigerated trolley cabinets;

– service counters and self-service counters;

– blast chillers and blast freezers;

– COMMERCIAL ICE-MAKERS.

As far as is practicable, this standard deals with the common hazards presented by these types of appliances including those that use FLAMMABLE REFRIGERANTS and appliances employing R-744 refrigerant.

This International Standard is not applicable to appliances with a mass of FLAMMABLE REFRIGERANT exceeding the limits specified in 22.110 or to appliances with that use refrigerants with a toxicity classification of B according to ISO 817.

It does not cover those features of construction and operation of refrigerating appliances that are dealt with in ISO standards.

NOTE 102 Attention is drawn to the fact that

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

– in many countries, additional requirements are specified by 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

– appliances using FLAMMABLE REFRIGERANT in TRANSCRITICAL REFRIGERATION SYSTEMS;

– domestic refrigerating appliances (IEC 60335-2-24);

– split systems having a REFRIGERANT CHARGE of FLAMMABLE REFRIGERANT exceeding 150 g in any REFRIGERATING CIRCUIT;

– industrial refrigerating systems;

– motor-compressors (IEC 60335-2-34);

– commercial dispensing appliances and vending machines (IEC 60335-2-75);

– commercial ice-cream appliances;

– cold temperature rooms;

– multiple refrigerated chambers with a remote motor-compressor.

1DV.1 D2 Modification to replace the second paragraph in Clause 1 of the Part 2 with the following:

This part of UL/CSA 60335 specifies safety requirements for electrically operated commercial refrigerating appliances that have an incorporated compressor, refrigerating appliances that are supplied in two or more units for assembly as a single appliance in accordance with the manufacturer's instructions (split system), and partial units intended for installation in a field erected system in accordance with:

– CSA C22.1, Canadian Electrical Code (CE Code) Part I, in Canada;

– NFPA 70, National Electrical Code (NEC), in the United States.

1DV.2 D2 Modification to add the following after the second paragraph in Clause 1 of the Part 2:

This standard also contains the requirements for:

– commercial refrigerators and freezers for use in fuel dispensing facilities (Annex 101.DVD);

– factory assembled walk in coolers/freezers (Annex 101.DVE);

– refrigerating units (Annex 101.DVF);

– PARTIAL UNITS (Annex 101.DVG);

– dispensing units (Annex 101.DVH);

– commercial refrigeration products with rated voltage up to 15 000V (Annex 101.DVR);

– Stirling refrigeration systems; and

– laboratory refrigerators and freezers (for US only).

1DV.3 D1 Modification of the sixth paragraph in Clause 1 of the Part 2 by replacing it with the following:

This standard does not take into account refrigerants other than refrigerant safety groups as defined by ISO 817 or ANSI/ASHRAE 34 as follows:

a) A1;

b) B1 [for use in appliances installed in machinery rooms as defined in accordance with ANSI/ASHRAE 15 (USA) or CSA B52 (Canada), or outdoors only]; and

c) A2L, A2, and A3, refrigerants.

1DV.4 DR Modification of Clause 1 of the Part 2 by adding the following paragraph:

All references to ISO 817 in this Part 2 also apply to ANSI/ASHRAE 34. ANSI/ASHRAE 34 shall take precedence over ISO 817.

1DV.5 D2 Modification of Note 103 in Clause 1 of the Part 2 by replacing it with the following:

NOTE 103 This standard does not apply to

– appliances using flammable refrigerant in transcritical refrigeration systems;

– domestic refrigerating appliances (IEC 60335-2-24);

– motor-compressors (IEC 60335-2-34);

– vending machines (IEC 60335-2-75);

– professional ice-cream appliances (IEC 60335-2-118);

– laboratory refrigerators and freezers (for Canada only. In Canada, the applicable standard for laboratory refrigerators and freezers is CSA C22.2 No. 61010-2-011.)

1.1

This Standard applies to mineral-insulated cables with copper, nickel/nickel alloy-clad copper, steel-clad copper, or nickel conductors, enclosed in a copper or stainless steel sheath.

1.2

The constructions covered by this Standard are intended for use in power, instrumentation, control, and fire alarm systems that are intended to be installed  in accordance with CSA C22.1, Canadian Electrical Code, Part I.

1.3

The constructions covered by this Standard are recognized for use where normal conditions are such that no part of the cable is subjected to a temperature in excess of 250 °C. When provided with an overall thermoplastic or thermoset protective covering, the use is restricted to 90 °C.

1.4

The constructions covered by this Standard are

a) Type MI mineral-insulated, copper-sheathed cable recognized for use on systems having a nominal voltage of 600 V or less;

b) Type SSMI mineral-insulated, stainless steel-sheathed cable recognized for use on systems having a nominal voltage of 600 V or less;

c) Type LWMI mineral-insulated, copper-sheathed cable recognized for use on systems having a nominal voltage of 600 V or less; and

d) Type SSLWMI mineral-insulated, stainless steel-sheathed cable recognized for use on systems having a nominal voltage of 600 V or less.

1.5

Optional requirements are provided for

a) twisted pair configurations;

b) copper or stainless steel shields;

c) overall thermoplastic or thermoset protective coverings;

d) flame test classification; and

e) fire rating.

1.6

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  

This Standard specifies requirements for Type NS75 and NS90 neutral-supported cables for use on outdoor overhead electrical systems that

(a)   have nominal voltages of 600 V or less; and

(b)   are intended for installation in accordance with the Canadian Electrical Code, Part I.

1.2 

Neutral-supported cables covered by this Standard consist of a maximum of five conductors (one, two, or three insulated phase conductors, a neutral conductor, and an optional insulated bonding  conductor). The conductors are insulated with polyethylene (PE) rated 75 °C or cross-linked polyethylene (XLPE) rated 75 or 90 °C.

Note: The option of additional bonding conductor is intended for cables which are used in the distribution system (in feeders and circuits) on the load side of the service box.

1.3  

Flame test requirements for neutral-supported cable insulations or coverings are also covered in this Standard, to the extent called for by the Canadian Electrical Code, Part I.

1.4  

In CSA standards, “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 Inclusions

These provisions apply to the construction, materials, performance, and testing of NPS 1-1/4 in (32mm) and smaller self-acting service-type regulators with overpressure protection devices utilized to control the pressure of gas delivered to a customer’s piping at a delivery pressure of 2 psi or less (14 kPa).

1.2 Temperature ratings

This standard includes regulators capable of operation over an ambient temperature range of –40 to 150°F (–40 to 65.6 °C) up to the pressure recommended by the manufacturer, but not exceeding 125 psi (861.8 kPa).

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 (nonmandatory) to define their application.

1.4 Units of measurement

The yard-pound units provided are the standard. The SI (metric) equivalents in parentheses may be approximate values and are provided for information only, or for markings where both units of measurement are required.

Draft Amendment to C22.1

Draft Amendment to C22.1

Draft Amendment to C22.1

Draft Amendment to C22.1

1.1 Purpose

This Standard specifies general requirements related to the safety of human CTOs used for transplantation, and includes quality system requirements. It includes aspects of safety for potential and actual donors and recipients, personnel, and others who might be exposed to or affected by the transplantation of CTOs.

1.2 Areas of application

This Standard applies to establishments and individuals involved in the following activities related to CTOs intended for transplantation:

a) processing;

b) evaluation of the safety of CTOs prior to transplantation;

c) transplantation procedures;

d) recordkeeping;

e) error, accident, and adverse reaction reporting;

f) distribution;

g) importation or exportation; and

h) complaints and recalls.

1.3 Inclusions

This Standard is intended to serve as a benchmark and provide minimum requirements for the verification of safe practices in each of the activities listed in Items a) to h) in Clause 1.2.

Note: Examples of establishments or individuals include the following:

a) organ donation organizations;

b) tissue retrieval organizations;

c) tissue banks;

d) eye banks;

e) cell or tissue processing facilities (e.g., including islet cells);

f) cell culture laboratories;

g) histocompatibility laboratories;

h) transplant programs and facilities (e.g., hospitals and special clinics);

i) programs for lymphohematopoietic cells, including clinical programs, collection and processing facilities;

j) health care professionals;

k) designated importers and exporters;

l) distributors; and

m) other cell-, tissue-, and organ-dispensing services.

1.4 Limitations of use

This Standard and its subset Standards (i.e., the CAN/CSA-Z900 series) are not intended to replace detailed specifications and standard operating procedures, but are intended to be used in their preparation.

1.5 Intended scope

This Standard applies to human CTOs retrieved from a living or deceased human body and intended for transplantation into humans. The requirements for cells and tissues in this Standard are intended for minimally manipulated cells and tissues intended for homologous use (i.e., the cells or tissues perform the same basic function after transplantation).

Notes:

1) Although the scope of this Standard refers to minimally manipulated cells and tissues, some of its requirements can also be relevant to other human cellular and tissue-based products.

2) It is recognized that the topics covered by this Standard can fall within more than one regulatory jurisdiction. Two specific topics covered by this Standard that are not within the current scope of Health Canada’s Safety of Human Cells, Tissues and Organs for Transplantation Regulations are

a) dura mater, which is classified as a medical device by Health Canada and is subject to the requirements of the Medical Devices Regulations; and

b) autologous cell and tissue banking.

3) Heart valves are classified by Health Canada as either a medical device or CTO.

1.6 Limitations of scope

This Standard does not apply to

a) tissues for assisted reproduction (see CAN/CSA-Z900.2.1);

b) human milk and other excreted or secreted substances;

c) whole blood (except for cord blood), blood components, or blood products; and

d) fecal transplantation.

Notes:

1) For blood components (i.e., red blood cells, granulocytes, platelets, plasma, and cryoprecipitate) and blood products (i.e., therapeutic products derived from plasma), see CAN/CSA-Z902.

2) CAN/CSA-Z900.2.5 includes specific requirements for cord blood.

1.7 Subset standards

Subset standards have been developed for CTOs (see Clause 2). Where an applicable subset standard exists, this Standard is to be used in conjunction with that subset standard.

Note: Where a subset standard exists and its requirements differ from this Standard’s requirements, the subset standard’s requirements apply.

1.8 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 Objectif

Cette norme établit des exigences générales relatives à la sécurité des CTO humains destinés à la transplantation et comprend des exigences relatives au système qualité. Elle porte également sur les aspects de sécurité relatifs aux donneurs et aux receveurs potentiels et réels, au personnel et aux autres personnes qui pourraient être exposées ou affectées par la transplantation de CTO.

1.2 Champs d’application

Cette norme vise les établissements et les personnes qui participent aux activités suivantes relatives aux CTO destinés à la transplantation :

a) le traitement;

b) l’évaluation de la sécurité des CTO avant la transplantation;

c) les procédures de transplantation;

d) la tenue de dossiers;

e) la déclaration des manquements, accidents et effets indésirables;

f) la distribution;

g) l’importation ou l’exportation; et

h) les plaintes et les rappels.

1.3 Inclusions

Conçue pour tenir lieu de point de référence, cette norme présente des exigences minimales de vérification en ce qui a trait aux saines pratiques dans le cadre de chacune des activités mentionnées aux alinéas a) à h) de l’article 1.2.

Note : Voici des exemples d’établissements ou de personnes :

a) les organismes de dons d’organes;

b) les organismes de prélèvement de tissus;

c) les banques de tissus;

d) les banques d’yeux;

e) les installations de traitement des cellules ou des tissus (p. ex., îlots de Langerhans);

f) les laboratoires de cultures cellulaires;

g) les laboratoires d’histocompatibilité;

h) les programmes et établissements de transplantation (p. ex., hôpitaux et cliniques spécialisées);

i) les programmes relatifs aux cellules lymphohématopoïétiques, y compris les programmes cliniques et les installations de collecte et de traitement;

j) les professionnels de la santé;

k) les importateurs et exportateurs désignés;

l) les distributeurs; et

m) tout autre service concernant les cellules, tissus et organes.

1.4 Limites d’utilisation

Cette norme et ses sous-ensembles (c.-à-d. les normes de la série CAN/CSA-Z900) ne visent pas à remplacer les spécifications détaillées ni les procédures d’opération normalisées. Ils ont plutôt été conçus pour guider la préparation de ces dernières.

1.5 Domaine d’application prévu

Cette norme s’applique aux CTO humains qui ont été prélevés sur des donneurs vivants ou décédés et qui serviront à des transplantations pratiquées sur des êtres humains. Les exigences visant les cellules et les tissus que renferme cette norme visent les cellules et les tissus qui ont fait l’objet d’une manipulation minimale et qui sont destinés à un usage homologue (c.-à-d. les cellules et tissus qui conservent leur fonction première après la transplantation).

Notes :

1) Bien que le domaine d’application de cette norme renvoie à des cellules et tissus ayant fait l’objet d’une manipulation minimale, certaines de ses exigences pourraient également être pertinentes pour les autres produits tissulaires et cellulaires humains.

2) Il est reconnu que les sujets couverts par cette norme pourraient relever de plus d’une autorité de réglementation. Deux sujets particuliers couverts par cette norme qui ne relèvent pas du domaine d’application actuel du Règlement sur la sécurité des cellules, tissus et organes humains destinés à la transplantation de Santé Canada sont les suivants :

a) la dure-mère, qui est classée par Santé Canada comme un instrument médical et est assujettie aux exigences du Règlement sur les instruments médicaux; et

b) la mise en banque de cellules et de tissus autologues.

3) Les valves cardiaques sont classées par Santé Canada soit comme un dispositif médical, soit comme CTO.

1.6 Limites d’application

Cette norme ne s’applique pas :

a) aux tissus destinés à la reproduction assistée (voir CAN/CSA-Z900.2.1);

b) au lait humain et aux autres substances sécrétées ou excrétées;

c) au sang total (à l’exception du sang de cordon), aux composants du sang ou aux produits sanguins; et

d) à la transplantation fécale.

Notes :

1) Pour les composants du sang (c.-à-d. globules rouges, granulocytes, plaquettes, plasma et cryoprécipités) et les produits sanguins (c.-à-d. produits thérapeutiques dérivés du plasma), voir CAN/CSA-Z902.

2) CAN/CSA-Z900.2.5 comprend des exigences particulières pour le sang de cordon.

1.7 Sous-ensembles de normes

Des sous-ensembles de normes ont été élaborés relativement aux CTO (voir l’article 2). Lorsqu’il existe un sous-ensemble applicable, cette norme nécessite d’être utilisée conjointement avec ce sousensemble.

Note : Lorsque les prescriptions d’un tel sous-ensemble de norme diffèrent de celles de cette norme, c’est le sous-ensemble qui a préséance.

1.8 Terminologie

Dans cette norme, le terme « doit » indique une exigence, c’est-à -dire 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 de faire; et « peut » indique une possibilité ou ce qu’il est permis de faire.

Les notes qui accompagnent les articles ne comprennent pas de prescriptions ni de recommandations. Elles servent à séparer du texte les explications ou les renseignements qui ne font pas proprement partie de la norme.

Les notes au bas des figures et des tableaux font partie de ceux-ci et peuvent être rédigées comme des prescriptions.

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

1.1 Purpose

This Standard addresses issues related to the safety of human perfusable organs used for transplantation. It includes quality system requirements and aspects of safety for potential and actual donors and recipients, personnel, and others who might be exposed to, or affected by, the transplantation of perfusable organs.

1.2 Areas of application

This Standard applies to establishments (or facilities) and individuals involved in the following activities related to perfusable organs intended for transplantation:

a) processing;

b) evaluation of the safety of perfusable organs prior to transplantation;

c) recordkeeping;

d) error, accident, and adverse reaction reporting;

e) distribution;

f) importation or exportation; and

g) recall of human organs intended for transplantation.

1.3 Inclusions

This Standard is intended to serve as a benchmark and provide minimum requirements for the verification of safe practices in each of the activities listed in Items a) to g) in Clause 1.2.

Note: Examples of establishments or individuals include the following:

a) organ donation organizations (ODOs);

b) transplant programs and facilities (hospitals and special clinics); and

c) HLA laboratories.

1.4 Limitations

This Standard is not intended to replace detailed specifications and standard operating procedures but is intended to be used in their preparation.

1.5 Priority

This Standard contains particular requirements for perfusable organs for transplantation and is intended to be used with CAN/CSA-Z900.1. Where differences exist, the requirements of this Standard apply.

1.6 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 Objectif

Cette norme aborde les questions relatives à l’innocuité des organes pleins humains destinés à la transplantation. Elle porte également sur les exigences relatives au système de qualité et les aspects de sécurité pour les donneurs et les receveurs potentiels et réels, le personnel et les autres personnes susceptibles d’être exposées ou affectées par la transplantation d’organes pleins.

1.2 Domaines d’application

Cette norme s’applique aux établissements (ou aux installations) et aux personnes participant aux activités suivantes liées aux organes pleins destinés à la transplantation :

a) le traitement;

b) l’évaluation de la sécurité des organes pleins avant la transplantation;

c) la tenue de dossiers;

d) les rapports concernant les manquements, les accidents et les réactions indésirables;

e) la distribution;

f) l’importation ou l’exportation; et

g) le rappel d’organes humains destinés à la transplantation.

1.3 Inclusions

Cette norme vise à servir de référence et à fournir des exigences minimales pour la vérification des pratiques sécuritaires dans chacune des activités énumérées aux alinéas a) à g) de l’article 1.2.

Note : Des exemples d’établissements ou de personnes comprennent :

a) organismes de dons d’organes (ODO);

b) programmes et établissements de transplantation (hôpitaux et cliniques spécialisées); et

c) laboratoires HLA.

1.4 Limites

Cette norme ne vise pas à remplacer des spécifications détaillées et des procédures d’opération normalisées, mais plutôt à guider la préparation de celles-ci.

1.5 Priorité

Cette norme contient des exigences particulières relatives aux organes pleins destinés à la transplantation et est destinée à être utilisée avec CAN/CSA-Z900.1. En cas de divergence entre les deux documents, les exigences de cette norme s’appliquent.

1.6 Terminologie

Dans cette norme, le terme « doit » indique une exigence, c’est-à-dire 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 de faire; et « peut » indique une possibilité ou ce qu’il est permis de faire.

Les notes qui accompagnent les articles ne comprennent pas de prescriptions ni de recommandations. Elles servent à séparer du texte les explications ou les renseignements de nature informative qui ne font pas proprement partie de la norme.

Les notes au bas des figures et des tableaux font partie de ceux-ci et peuvent être rédigées comme des prescriptions.

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

1.1 This Standard specifies the requirements for insulating tubing that is usually round in cross-section and that consists entirely of extruded compounds whose characteristic constituents are thermosetting, elastomeric, or thermoplastic polymers (see Table 1 for materials and ratings). These requirements also cover heat-shrinkable and crosslinked tubing.

1.2. Tubing is intended for use only in air – in dry and damp locations – as part of the internal wiring of electrical devices and appliances in accordance with the Canadian Electrical Code, Part I  (CE Code, Part 1 I) and ANSI/NFPA 70, National Electrical Code (NEC). It may be used for insulating one or more inadequately insulated conductors, bus bars, motor leads, transformer leads, terminal lugs, or small assemblies of electronic components. Tubing is not intended for use in contact with sharp edges, corners, or projections, or where subject to tension, compression, or repeated flexing. Tubing is not intended for use where it is feasible to employ a standard insulated conductor (appliance-wiring material) intended specifically for the purpose.

1.3 These requirements do not apply to fabric tubing, chemically dilated tubing, polymeric tubing extruded with reinforcement, or tubing intended only for mechanical protection.

1.4 The acceptability of tubing in any particular device or appliance depends upon its acceptability for continued use under the conditions that prevail in actual service. Accordingly, for a particular application, it will in some cases be necessary to employ tubing having features other than or in addition to those specified in these requirements. For example, tubing may be required to have a heavier wall thickness or a flat rather than a round cross-section; it may be required to have inherent resistance to the effects of immersion in water, oil, solvents, or other liquids (or their vapors); it may be required to be used in an environment conducive to the development of fungi and similar organisms.