Health Care and Medical Devices

Origin: CSA
Close date: Jun 30, 2024
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1 Scope

1.1 General

This Standard provides requirements for the planning, design, construction, commissioning, operation, and maintenance of HVAC systems in HCFs. In general, these requirements are more stringent than those applied to non-health care facilities.

Note: See Annex A for general guidelines on HVAC system design. Table 1 provides specific design parameters for HVAC systems.

1.2 Description

This Standard

a) specifies minimum values for certain parameters;

b) establishes the suitability of different design options;

c) establishes recommendations for zoning, controls, and monitoring; and

d) outlines best practice for energy conservation, decarbonization and adaptation to climate change.

1.3 Inclusions

This Standard is not intended to preclude the use of design concepts and the adoption of installation, operations, and maintenance procedures more stringent than those specified in this Standard. In cases where clinical evidence supports additional measures to improve the safety and efficacy of HCFs, such additional measures should be considered in the design, installation commissioning, operation, and maintenance of the HVAC system.

1.4 Applicability

This Standard applies to new buildings, additions to existing buildings, and alterations to existing buildings (alterations include changes in function or size of spaces and the rearrangement, replacement, or addition of HVAC equipment).

Note: “Like for like” replacement of worn or failed components is generally considered to be routine maintenance; however, a more in-depth analysis should take place when replacing major components. See Clause 5.8.4.

1.5 Exclusions

This Standard does not address requirements for other elements of a building that are not directly a part of the HVAC system but can affect the design, performance, or operation of these systems, including but not limited to

a) building envelope;

b) structure;

c) electrical power and lighting systems;

d) plumbing system; and

e) fire protection system.

1.6 Terms

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.

1.7 SI Units

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.

Origin: CSA
Close date: Jul 12, 2024
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1.1 Safety guidance for use of energy based medical and surgical devices

This Standard presents guidance to ensure the safety of persons (e.g., personnel and patients/clients, etc.) at risk in locations where energy based medical and surgical devices are used. This includes, but is not limited to, guidance on purchasing, education, training, installation, use, servicing, maintenance, engineering and administrative controls, and personal protective equipment.

1.2 Standard application

This Standard applies to the use of energy based medical and surgical devices, which include but are not limited to laser systems, ultrasonic instruments, and electrosurgical devices, whenever they are used during medical, clinical, cosmetic/aesthetic, and surgical procedures.  

1.3 Standard inclusions

This Standard applies to all practice settings where energy based medical and surgical devices are used, including, but not limited to, the following:

a) health care facilities;

b) dental clinics, and outpatient facilities;

c) veterinary facilities;

d) laboratories and other research facilities;

e) physician offices;

f) cosmetic and aesthetic treatment facilities;

g) teaching facilities;

h) professional exhibitions and trade shows; and

i) energy based medical and surgical device servicing organizations.

1.2 Controls for safe use of energy based medical and surgical devices

This Standard presents the engineering, procedural, and administrative controls, as well as personal protective equipment necessary to ensure the safety of persons at risk during the use of health care energy based medical and surgical devices, based upon a risk assessment.

Note: A risk assessment is a thorough analysis of the workplace to identify situations, processes, etc. that can cause harm. A risk assessment, performed before policies and procedures are developed, is useful for determining engineering, administrative, and procedural controls and work practices to reduce exposure risks by

a) identification of hazards;

b) analysis or evaluation of the risks associated with those hazards; and

c) determining appropriate ways to eliminate or control the hazards.

1.2.1 Control measures

The control measures described in this Standard do not restrict or limit the use of energy based medical and surgical devices, of any type, that can be intentionally administered for diagnostic, therapeutic, cosmetic/aesthetic, or research purposes. It is intended to apply to all persons within the area where energy based medical and surgical devices are in use.

1.3 Standard exclusions

This standard does not comment on specific manufacturers, equipment, or devices. Technology assessment and risk assessment are the responsibility of the health care facility and providers, however, best practices and evidence-based recommendations in their safe use are included.

1.4 Standard 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.

Origin: CSA
Close date: Jul 20, 2024
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1 Scope

This document applies to the basic safety and essential performance of an infant cardiorespiratory monitor, as defined in 3.10, hereafter also referred to as ME equipment, in combination with its accessories:
— intended for use in the home healthcare environment; 
— intended for use by a lay operator;
— intended to monitor cardiorespiratory parameters in sleeping or resting children under three years of age; and
— intended for transit-operable use.


NOTE An infant cardiorespiratory monitor can also be used in professional health care facilities.
This document is also applicable to those accessories intended by their manufacturer to be connected to the infant cardiorespiratory monitor, where the characteristics of those accessories can affect the basic safety or essential performance of the infant cardiorespiratory monitor.


EXAMPLE probes, cables distributed alarm system 

Origin: CSA
Close date: Jul 20, 2024
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1 Scope

This document specifies requirements for user-powered resuscitators intended for use with all age groups and which are intended to provide lung ventilation to patients whose breathing is inadequate. User-powered resuscitators are designated according to ideal body mass range.


Example user-powered resuscitators include:
— self-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by elastic recoil; and


NOTE 1 Self-inflating bag resuscitators are generally transit-operable and can be used in a wide range of environmental and emergency situations.
— flow-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by a flow from a medical gas source.


This document is also applicable to those accessories that are intended for use with resuscitators where the characteristics of those accessories can affect the safety of the user-powered resuscitator.


Examples of such accessories include face masks, PEEP valves, capnometric indicators, manometers, metronomes, flow restrictors, filters, gas refill valves, oxygen gas mixers, connectors, electronic feedback devices, electronic sensors and transmission of data to other equipment.
This document is also applicable to point-of-use packaging.


This document does not specify the requirements for:
— gas-powered emergency resuscitators, which are given in ISO 10651-5; 
— electrically-powered resuscitators;
— gas powered resuscitators for professional healthcare facilities; and
— anaesthetic reservoir bags, which are given in ISO 5362.


NOTE 2 This document has been prepared to address the relevant essential principles[24] and labelling[25] guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex D.


NOTE 3 This document has been prepared to address the relevant essential principles of safety and performance of ISO 16142-1:2016 as indicated in Annex E.


NOTE 4 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745[23] as indicated in Annex F.

Origin: CSA
Close date: Aug 3, 2024
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1 Scope

1.1 Purpose

This Standard specifies minimum accessibility requirements for self-service interactive devices (such as, but not limited to, automated banking machines, retail self-checkout, self check-in devices, ticket vending kiosks, smart card sales, query and reload devices).

Note: While the purpose of this Standard is to make a product as accessible and usable as practicable, it is possible that some people will have needs greater than or different from the needs addressed by this Standard, and having the ability to interact with a person can be supportive. See Annex A for common design barriers for people with disabilities.

1.2 Application

This Standard specifies technical requirements applicable to the design, manufacture, site preparation, and installation of self-service interactive devices.

1.3 Limitations

This Standard does not cover

a) physical environment of drive up self-service interactive devices; and

b) websites and web applications that are beyond the control of the service provider and accessed from public devices.

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 (non-mandatory) to define their application.

1.5 Alt text

Alt text is provided in the captions associated with figures and tables.

Origin: CSA
Close date: Aug 3, 2024
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1 Domaine d’application

1.1 Objet

Cette norme énonce les exigences minimales relatives à l’accessibilité pour les dispositifs interactifs libre-service (tels que, mais sans s’y limiter, les guichets automatiques bancaires, les caisses libre-service des commerçants, les dispositifs d’enregistrement, les kiosques distributeurs de billets, les ventes de cartes à puce, les dispositifs de consultation et de recharge).

Note : Bien que cette norme vise à rendre les produits aussi accessibles et faciles d’utilisation que pratiques, il est possible que certaines personnes aient des besoins plus importants ou différents que ceux dont il est question ici et le fait d’avoir la capacité d’interagir avec une personne pourrait être aidant. Voir l’annexe A au sujet des obstacles communs de conception auxquels font face les personnes atteintes d’une incapacité.

1.2 Application

Cette norme énonce les exigences techniques relatives à la conception, à la fabrication, à la préparation du site et à l’installation de dispositifs interactifs libre-service.

1.3 Limites

Cette norme ne s’applique pas :

a) à l’environnement physique des dispositifs interactifs libre-service au volant; et

b) aux sites et aux applications Web sur lesquels le fournisseur de services n’a aucune maîtrise et qui sont accessibles depuis un dispositif public.

1.4 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.

1.5 Texte alternatif

Du texte alternatif est fourni dans les légendes associées aux figures et aux tableaux.