Health Care and Medical Devices

1.1 Purpose

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

1.2 Inclusions

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

a) processing;

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

c) recordkeeping;

d) error, accident, and adverse reaction investigation;

e) distribution;

f) importation or exportation; and

g) complaints and recalls.

Notes:

1) Examples of establishments or individuals include the following:

a) tissue banks;

b) tissue processing facilities;

c) transplant programs and facilities (hospital and clinic);

d) tissue retrieval organizations; and

e) other tissue-dispensing services.

2) For guidance on autologous tissues, see AORN Guideline for Autologous Tissue Management in Guidelines for Perioperative Practice.

1.3 Limitations

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

1.4 Priority

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

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.

1.1 Objectif

Cette norme aborde les questions relatives à la sécurité des tissus humains destinés à la transplantation. Elle porte également sur les exigences en matière de systèmes de qualité et sur des 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 tissus.

1.2 Inclusions

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

a) le traitement;

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

c) la tenue de dossiers;

d) les enquêtes relatives aux manquements, aux accidents et aux effets indésirables;

e) la distribution;

f) l’importation ou l’exportation; et

g) les plaintes et les rappels.

Notes :

1) Des exemples d’établissements ou de personnes comprennent :

a) banques de tissus;

b) établissements procédant au traitement des tissus;

c) programmes et établissements de transplantation (hôpitaux et cliniques);

d) organismes de prélèvement de tissus; et

e) autres services de distribution de tissus.

2) Pour obtenir des directives concernant les tissus autologues, voir la publication de l’AORN « Guideline for Autologous Tissue Management » dans Guidelines for Perioperative Practice.

1.3 Limites

Cette norme n’est pas destinée à remplacer des spécifications détaillées et des PON, mais plutôt à guider la préparation de celles-ci.

1.4 Priorité

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

1.5 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; « 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 Applicability of standard to laboratory fume hoods

This Standard applies to all types of laboratory fume hoods, including ductless fume hoods.

The following clauses are not relevant to ductless fume hoods: 4.6, 4.5.4, 5.4.3, 5.4.4, 5.4.6.1, 7.2, and 10.3.2.4 m) to q).

Note: Ductless fume hoods should not be considered acceptable substitutes for ducted fume hoods. They may be suitable alternatives provided there is an application-specific review (i.e., risk assessment) and written approval by the manufacturer. Some jurisdictions prohibit the use of ductless fume hoods with certain chemicals.

1.2 Standard specifications

This Standard specifies

a) safety requirements for fume hoods, their users, and service personnel;

b) requirements for fume hoods, including the supply and exhaust system, design and construction;

c) requirements for fume hood placement;

d) test methods for assessing fume hood performance;

e) requirements for the selection, use, and maintenance of fume hoods;

f) requirements for the education and training of fume hood users and maintenance personnel;

g) requirements regarding information to be exchanged between suppliers and users of fume hoods to ensure that installation, function, and maintenance are compatible with the intended use; and

h) requirements for commissioning.

Notes:

1) Users of this Standard should note that fume hood requirements are also established by authorities having jurisdiction.

2) Other fume hood requirements can be found in, e.g., the National Building Code of Canada, the National Fire Code of Canada, the Canadian Environmental Protection Act, and REGDOC-2.5.6 Design of Rooms Where Unsealed Nuclear Substances Are Used.

1.3 Standard exclusions

This Standard does not address detailed design considerations, such as hood design, fan selection, and duct/stack velocities.

This Standard does not apply to biological safety cabinets.

Notes:

1) Requirements applicable to the installation and field testing of biological safety cabinets are found in NSF/ANSI 49.

2) This Standard is not intended to be used by manufacturers for the certification of their fume hoods.

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 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.

1.1 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