Main Categories

Draft Amendment to C22.1

1.1

This Part is intended to be read together with the Standard for Low-Voltage Fuses – Part 1: General Requirements, hereafter referred to as Part 1. The titles of the Clauses in this Part correspond to the similarly titled Clauses in Part 1. The requirements of Part 1 apply unless modified by this Part. For the Part 1 requirements, refer to the Standard for Low-Voltage Fuses – Part 1: General Requirements, NMX-J-009-248/1-ANCE / CSA C22.2 No. 248.1 / UL 248-1.

1.2

This Part applies to semiconductor fuses rated 2000 Vac or less. DC ratings are optional.

NOTE: CSA C22.1, Canadian Electrical Code, Part I, defines low voltage as any voltage exceeding 30 V but not exceeding 1000 V inclusive and high voltage as any voltage exceeding 1000 V. The National Electrical Code, NFPA 70, defines high voltage as more than 600 V, nominal.

This part of IEC 61980 addresses communication and activities of magnetic field wireless power transfer (MF-WPT) systems.

The requirements in this document are intended to be applied for MF-WPT systems according to IEC 61980-3 and ISO 19363.

The aspects covered in this document include

–    operational and functional characteristics of the MF-WPT communication system and related activities, and

–    operational and functional characteristics of the positioning system. The following aspects are under consideration for future documents:

–    requirements for two- and three-wheel vehicles;

–    requirements for MF-WPT systems supplying power to EVs in motion;

–    requirements for bidirectional power transfer.

NOTE  Any internal communication at supply device or EV device is not in the scope of this document

This part of IEC 61980 applies to the off-board supply equipment for wireless power transfer via magnetic field (MF-WPT) to electric road vehicles for purposes of supplying electric energy to the RESS (rechargeable energy storage system) and/or other on-board electrical systems. The MF-WPT system operates at standard supply voltage ratings per IEC 60038 up to 1 000 V AC and up to 1 500 V DC from the supply network. The power transfer takes place while the electric vehicle (EV) is stationary.

Off-board supply equipment fulfilling the requirements in this document are intended to operate with EV devices fulfilling the requirements described in ISO 19363.

The aspects covered in this document include

–    the characteristics and operating conditions,

–    the required level of electrical safety,

–    requirements for basic communication for safety and process matters if required by a MF-WPT system,

–    requirements for positioning to assure efficient and safe MF-WPT power transfer, and

–    specific EMC requirements for MF-WPT systems.

The following aspects are under consideration for future documents:

–    requirements for MF-WPT systems for two- and three-wheel vehicles,

–    requirements for MF-WPT systems supplying power to EVs in motion,

–    requirements for bidirectional power transfer,

–    requirements for flush mounted primary device,

–    requirements for MF-WPT systems for heavy duty vehicle, and

–    requirements for MF-WPT systems with inputs greater than 11,1 kVA.

This document does not apply to

–    safety aspects related to maintenance, and

–    trolley buses, rail vehicles and vehicles designed primarily for use off-road.

NOTE  The terms used in this document are specifically for MF-WPT.

This document establishes requirements for assuring quality, safety, performance and documentation of laboratory-developed tests (LDTs) as per their intended use for the diagnosis, prognosis, monitoring, prevention or treatment of medical conditions.

It outlines the general principles and assessment criteria by which an LDT shall be designed, developed, characterized, manufactured, validated (analytically and clinically) and monitored for internal use by medical laboratories.

The scope includes regulatory authority approved IVD medical devices that are used in a manner differing from approved labelling or instructions for use for that device (e.g. use of a sample type not included in the intended use, use of instruments or reagents not included in the labelling).

While this document follows a current best practice and state-of-the art approach, it does not provide specific details on how to achieve these requirements within specific disciplines of the medical laboratory nor specific technology platforms.

This document does not specify requirements for examination procedures developed by research or academic laboratories developing and using testing systems for non-IVD purposes. However, the concepts presented in this document can also be useful for these laboratories.

This document does not apply to the design, development and industrial production of commercially used IVD medical devices.

This document provides guidance to anatomic pathology (AP) laboratories on implementing a management system to meet requirements for quality and competence of ISO 15189.
NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

This document provides requirements and recommendations for supervisors and operators of point-of-
care testing (POCT) services where POCT is performed without medical laboratory training, supervision or 
support. It includes the key components that should be considered to provide safe and reliable POCT results.
Self-testing is excluded from this document.

1 Scope

1.1 This document specifies requirements and guidelines for systems and equipment used to evacuate plume generated by medical devices.

1.2 This document applies to all types of plume evacuation systems (PESs), including

a) portable;

b) mobile;

c) stationary, including dedicated central pipelines;

d) PESs integrated into other equipment;

e) PESs for endoscopic procedures (e.g., minimally invasive, laparoscopic).

1.3 This document applies to all healthcare facilities where PESs are used, including, but not limited to

a) surgical facilities;

b) medical offices;

c) cosmetic treatment facilities;

d) medical teaching facilities;

e) dental clinics;

f) veterinary facilities.

1.4 This document provides guidance on the following aspects of PESs:

a) importance;

b) purchasing;

c) design;

d) manufacture;

e) documentation;

f) function;

g) performance;

h) installation;

i) commissioning;

j) testing;

k) training;

l) use;

m) risk assessment;

n) servicing;

o) maintenance.

1.5 This document does not apply to the following:

a) anaesthetic gas scavenging systems (AGSSs) which are covered in ISO 7396-2;

b) medical vacuum systems which are covered in ISO 7396-1;

c) heating, ventilation, and air-conditioning (HVAC) systems;

d) aspects of laser safety other than airborne contamination; and

e) aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.

1.1 Inclusions
 

This Standard applies to organizations that intend to create and sustain a psychologically healthy and safe workplace for all workers. It specifies the requirements of a management system that includes a framework for planning, implementation, evaluation, and continual improvement, including:

a) identifying and assessing psychosocial hazards at work that pose a risk of harm to workers;

b) eliminating, controlling, and mitigating workplace risks associated with psychosocial hazards that cannot be eliminated;

c)  implementing structures and practices that support, promote, and sustain psychological health and safety in the workplace; and

d) fostering a culture that protects, promotes and sustains psychological health and safety in the workplace.

1.1.1 Users
 

This Standard is intended to be used by employers, workers, human resources personnel, occupational health and safety committees, unions, worker representatives, and other parties involved in or concerned with health, safety, and well-being in the workplace.

1.1.2 Application
 

This Standard applies to any organization and to any location where work is performed. The PHSMS is intended to be integrated into an organization’s business practices and into existing occupational health and safety management system (OHSMS).
Note: Organizations are responsible to identify and comply with all applicable legal requirements related to maintaining a psychologically healthy and safe workplace refer to Clause 0.3.

1.2 Exclusions

This Standard does not apply to guidance related to the diagnosis or treatment of mental health conditions or mental illnesses.

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 Related standards

This Standard can be used in conjunction with other related CSA Standards listed below.
 

·   CSA Z1003.1:18 (R2022) Psychological health and safety in the paramedic service organization;

·   CSA Z1004:24 Workplace ergonomics and Z412:24 Office ergonomics;

·   CSAZ1005:21 Workplace incident investigation;

·   CSA Z1008:21 Management of impairment in the workplace;

·   CSA Z1008.1:21 Management of impairment in the workplace, with a focus on substance use;

·   CSA Z1011:20 Work disability management system;

·   CSA B701-17(R2021) Carer-inclusive and accommodating organizations;

·   CSA Z1600:17(R2022) Emergency and continuity management program;  and

·   CSA Z1615:22 First responder fatigue risk management system.

1.1 Inclusions
 

La présente norme s’applique aux organisations qui souhaitent créer et maintenir un milieu de travail psychologiquement sain et sécuritaire pour tous les travailleurs. Elle précise les exigences d’un système de gestion qui comprend un cadre pour la planification, la mise en œuvre, l’évaluation et l’amélioration continue, notamment :

a) déterminer et évaluer les risques psychosociaux au travail qui présentent un risque pour les travailleurs;

b) éliminer, maîtriser et atténuer les risques professionnels liés aux dangers psychosociaux qu’il n’est pas possible d’éliminer;

c)  la mise en place de structures et de pratiques qui favorisent, soutiennent et préservent la santé et la sécurité psychologiques en milieu de travail; et

d) favoriser une culture qui protège, favorise et préserve la santé et la sécurité psychologiques au travail.

1.1.1 Utilisateurs
 

La présente norme est destinée aux employeurs, aux travailleurs, au personnel des ressources humaines, aux comités de santé et de sécurité au travail, aux syndicats, aux représentants des travailleurs et aux autres parties impliquées ou concernées par la santé, la sécurité et le bien-être au travail.

1.1.2 Application
 

La présente norme s’applique à toute organisation ainsi qu’à tous les lieux de travail. Le SGSSP est destiné à être intégré dans les pratiques commerciales d’une organisation et dans son système de gestion de la santé et de la sécurité au travail (SGSST) existant.
Note : Les organisations sont responsables de déterminer et de respecter toutes les exigences légales applicables relatives au maintien d’un milieu de travail psychologiquement sain et sécuritaire (voir l’article 0.3).

1.2 Exclusions

La présente norme ne s’applique pas aux directives relatives au diagnostic ou au traitement des troubles mentaux ou des maladies mentales.

1.3 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 présente 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 présente norme.

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.

1.4 Normes connexes

La présente norme pourrait être utilisée conjointement avec les autres normes CSA connexes énumérées ci-dessous.
 

·   CSA Z1003.1:18 (R2022), Santé et sécurité psychologiques dans l’organisation des services paramédicaux.

·   CSA Z1004:24 Ergonomie sur le lieu de travails et Z412:24 Ergonomie au bureau;

·   CSAZ1005:21 Enquête sur les incidents en milieu de travail;

·   CSA Z1008:21 Gestion de l’affaiblissement des capacités au travail;

·   CSA Z1008.1:21 Gestion de l’affaiblissement des capacités au travail, en particulier l’incapacité liée à la consommation de substances;

·   CSA Z1011:20 Système de gestion de l’incapacité au travail;

·   CSA B701-17(R2021) Organisations favorisant et appuyant les aidants naturels;

·   CSA Z1600:17(R2022) Programme de gestion des urgences et de la continuité; et

·   CSA Z1615:22 Système de gestion des risques liés à la fatigue des premiers intervenants.

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

Addition:

This document applies to transportable single spindle vertical moulders, with a maximum tool holder diameter of 200 mm, designed to cut wood and analogue materials also covered with plastic laminate or edgings by hand-feed operation.

NOTE 101 Single spindle vertical moulders other than transportable are covered by ISO 19085-6:2024.