Health Care and Medical Devices

1.1 Purpose

This Standard is intended to support the use of technology in the provision of home and community care, and in making investments that will improve the quality of care while prioritizing the safety, security, and privacy of both clients and care providers and their personal health information.

1.2 Application

The standard provides requirements and recommendations for technology to support the continuum of care of clients being supported in the home and community care settings. This includes, but is not limited to mechanisms for evaluation, selection, procurement, infrastructure requirements, set-up, implementation, information management, data management, data entry, transfer, storage, emergency planning, communication and maintenance.

This standard is intended for all those who are directly or indirectly associated with the support and use of technology in home and community care environments. This includes governments, institutions (both public and private), service providers, other partners (e.g., designers, manufacturers, suppliers), clients and their care partners assisting in home and community care.

1.3 Limitations

This Standard does not address requirements for

a)    HCC technology purchased privately;

Note: HCC technology purchased privately as part of a contract with an HCC organization will be subject to the requirements of the standard.

b)   the management of medications, medication devices and systems, and medication reconciliation (see CAN/HSO 34014:2019);

c)    home hemodialysis or peritoneal dialysis (see CSA Z364.5 and CSA Z364.6).

Note: This standard is complementary to CSA Z364.5 and Z364.6.

d)   direct client care; and

Note: Direct client care includes professional practice guidance (e.g. wound care by nurse) and clinical care.

e)    The standard will apply in general to the HCC technology which incorporate AI  however does not specifically look at the unique considerations likely required for technology of this nature.

Note: This is considering the urgency of how AI is shaping health care.

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 measure

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 General

This Standard provides requirements and guidance for a consistent approach on how to plan and conduct a study to evaluate different HCF design features while ensuring that the resources required and level of rigour match the undertaking.

Note: The focus of these studies should be aligned with the objectives of the funding agency or study sponsor to address HCF planning or design issues or to learn from elements of the completed projects to inform future projects. The study can include planning, design, and construction (PDC) studies and post-occupancy evaluations (POE).

1.2 Application

This Standard applies to HCF projects, including new construction or redevelopments of existing facilities (e.g., additions, renovations), and is intended to be used by HCFs providing services regardless of type, level of care, size, or location.

1.3 Inclusions

This Standard is developed for a broad range of users, including, but not limited to, HCFs, funding agencies, governments, professional designers and planners, architects, engineers, infection prevention and control professionals, health care teams and clinical staff, vendors, researchers, and internal and external evaluators.

This Standard supports interdisciplinary design teams (IDT) for an HCF project as defined in CSA Z8000 that includes key members of the HCF as subject matter experts: administrators, health care program and clinical planners, clinical staff, infection prevention and control professionals, facility operations and maintenance staff, patients and their families, and non-clinical support staff. Other key members of the IDT may include non-HCF individuals (e.g., professional designers, vendors, funding agencies).

1.4 Climate change mitigation and adaptation

This standard incorporates studies which assess the effectiveness, efficacy, and implementation of climate change mitigation and adaptation.

1.5  Clinical practice and operations

This Standard is not intended for the evaluation of clinical practice or facility operations except as it influences the planning, design, and construction process (i.e., third-party operational reviews).

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 it from the explanatory text of 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 General

This Standard provides a framework for the requirements and guidance for a consistent approach on how to plan and conduct functional suitability and technical performance assessments of existing HCFs/NHFs, to determine their ability the support current and future health care service delivery.

1.1.1 Categories of assessments

There are two categories of assessments: Functional Suitability Assessments (see Clauses 4.4.1 and 6) and Technical Performance Assessments (See Clauses 4.4.2 and 7).

1.1.2 Types of assessments

In each of the two categories of assessments, there are three types of assessments to create a tiered approach which may be tailored to the purpose of the assessment: Current State, Gap Analysis and Future State Options (See Clauses 3.1, 4.5, 6.2 and 6.3.3).

These types are typically progressive, although not necessarily mutually exclusive:  a Gap Analysis will require that a Current State is completed prior to or as a part of the Gap Analysis. Future State Options will require some elements of Current State and Gap Analysis information to be available. See Figure 1.

1.2 Application

This Standard applies to HCFs, including existing hospitals, LTCH, outpatient HCFs, and NHF or settings being considered for use in the delivery of health care services. 

It is intended to be used by HCFs providing services regardless of type, level of care, size, or location.

Where applicable by AHJs, the focus of the assessment should be aligned with the objectives of the funding agency or study sponsor to address HCF planning or design issues, to inform capital planning and investment, or to learn from elements of the completed assessments to inform future studies and/or projects.

Future studies can include planning, design, and construction (PDC) studies and post-occupancy evaluations (POE) and Sustainability or Climate Resilience Plans (See CSA Z8003 for more information on PDC and POE).

1.3  Inclusions, users and interdisciplinary teams (IDT)

This Standard is developed for a broad range of users, including, but not limited to, HCFs, funding agencies, governments, professional design and planning teams, architects, engineers, infection prevention and control professionals (IPC), health care teams, providers and clinical staff, vendors, researchers, and internal and external evaluators.

This Standard supports IDT involvement in the assessments, in order to determine the scope of the assessment and to guide an assessment of the functional suitability and the technical performance of the building systems.

As applicable, input from health care authorities may also be necessary to establish the assessment purpose and scope.

Note: The IDT members of the HCF become the subject matter experts (SME) for the assessments and include administrators, health care program and clinical planners, clinical staff, infection prevention and control professionals, facility operations and maintenance staff, patients and their families, and non-clinical support staff. Other key members of the IDT may include non-HCF individuals (e.g., professional design and planning teams, vendors, funding agencies).

 

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.