Health Care and Medical Devices

1.1 Cleaning and disinfecting of HCFs

This Standard applies to the cleaning and disinfecting of HCFs providing health care services including, but not limited to, inpatient services or outpatient services. It applies to all facilities, public or private, that provide health care treatments, health-related services, or diagnostic testing services, regardless of type, size, location, or range of services.

1.2 Cleaning and disinfecting practices in HCFs

This Standard is intended to address the cleaning and disinfecting of HCFs that includes both manual cleaning and disinfecting practices and automated environmental cleaning and disinfecting systems. This includes all environmental surfaces, and the air within the HCF.

1.3 Application to personnel performing cleaning and disinfecting in HCFs

This Standard applies to all personnel, regardless of their departmental affiliation or professional designation (whether directly employed by the HCF or out-sourced personnel) who perform cleaning and disinfecting functions in HCFs. This Standard also applies to all other parties involved in the cleaning and disinfecting process.

1.4 Exclusions to cleaning and disinfecting standard

This Standard does not apply to

a) cleaning and disinfecting of food services environments, except for the cleaning and disinfecting of food preparation areas (see Clause 5.3.11);

b) cleaning and disinfecting of critical or semi-critical medical devices (see CAN/CSA-Z314);

c) plumbing installation (see CSA Z317.1);

d) HVAC installation (see CSA Z317.2);

e) management of health care waste materials (see CSA Z317.10); and

f) laundering of reusable medical textiles (see CAN/CSA-Z314).

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.

This document defines terms in the field of the sterilization of health care products including related equipment and processes.

Le présent document définit les termes employés dans le domaine de la stérilisation des produits de santé, y compris les équipements et processus connexes.

1.1 Requirements for operation and maintenance of HCFs

This Standard describes the requirements, including quality system requirements, for the O&M of a HCF. It sets out specific requirements for

a) facility architectural systems;

b) exterior site elements related to the building and its functions;

c)  utilities;

d) the facility’s infrastructure, including but not limited to mechanical, electrical, and information management and information technology, and security systems;

e) health care equipment;

f) life safety systems;

g)  specialized functional programs, including but not limited to ORs, MDR, pharmacy, and laboratories;

h) permanently installed equipment as specified in Clause 1.4;

i) building services and interfaces for installed equipment, both medical and non-medical; and

j) best practices for sustainability, resilience, energy conservation, decarbonization and adaptation to climate change

Note: The HCF should be aware of federal, provincial/territorial, and municipal regulatory requirements applying to O&M and life safety systems, in addition to relevant CSA Group standards.

1.2 Establishing requirements for HCFs

This Standard establishes requirements for the HCF as a whole.

Note: HCFs vary widely in size, scope, and organization. This Standard sets out the essential O&M requirements for an HCF: it is expected that the HCF will develop the appropriate administrative structures and reporting relationships.

1.3 Organization and coordination with other departments in O&M activities

This Standard addresses the organization of, and the policies and procedures regarding other departments as they relate to O&M activities. It also includes requirements for the necessary coordination of O&M activities with other related HCF departments and functions.

Note: Examples of other departments and functions include security, biomedical engineering, environmental services, housekeeping, and nursing.

1.4 O&M of patient care equipment and interfaces

This Standard addresses the operation and maintenance of permanently installed equipment used to support patient care (e.g., call systems, human waste disposal units). It also includes requirements for the O&M of interfaces between equipment and building systems (e.g., equipment docking and charging stations).

Notes:

1) There is not always a clear line between the services and interfaces that support clinical equipment [see Clause 1.1, Item g)], and the clinical equipment itself. At a minimum, interfaces include physical space requirements and the use of utilities; however, there can be other connections (e.g., mechanical, electrical, computerization, telemetry, etc.). Problems can arise when different departments of the HCF each assume that the other is looking after a particular system. Among the tasks involved in planning an O&M program are to determine where the divisions are and then to document who is responsible for the different elements of the system.

2) In smaller facilities, O&M personnel or a department could have responsibility for equipment maintenance beyond the scope of this Standard. In that case, the person or department responsible for O&M should develop the appropriate expertise and consult relevant standards for these expanded duties (e.g., standards for biomedical engineering).

1.5 Non-assignment of responsibilities to specific job titles or departments

This Standard does not assign responsibilities to specific job titles or departments.

1.6 Exclusions

This Standard does not address the operation and maintenance of clinical equipment used for life support or therapeutic purposes (e.g., infusion pumps, anaesthetic workstations, and MRI machines).

1.7 Interpretation of terms and annex designation

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.

This document provides requirements for the development, validation and routine control of moist heat sterilization processes for medical devices. It also contains guidance which is intended to explain the requirements set forth in the normative sections. The guidance given is intended to promote good practice related to moist heat sterilization processes according to this document. The application within industrial and health care settings is considered

Le présent document spécifie les exigences relatives au développement, à la validation et au contrôle de routine des procédés de stérilisation des dispositifs médicaux à la chaleur humide. Il contient également des recommandations destinées à expliquer les exigences spécifiées dans les sections normatives. Les recommandations fournies sont destinées à promouvoir les bonnes pratiques relatives aux procédés de stérilisation à la chaleur humide conformément au présent document. Les applications dans les installations industrielles et les établissements de soins de santé sont prises en considération