Health Care and Medical Devices

1.1 General

This Standard addresses the special requirements of plumbing systems pertinent to the design, construction, operation, and maintenance of health care facilities (HCFs). This Standard specifies requirements for the following in HCFs:

a) water supply systems, including domestic cold water systems and hot water systems;

b) plumbing fixtures and fittings;

c) drainage systems;

d) risk management;

e) monitoring and maintenance of water systems;

f) infection control;

g) business continuity planning;

h) specialized water systems (e.g., reverse osmosis, deionized, distilled);

i) hydraulic fire protection systems;

j) environmental sustainability; and

       k) appropriate climate change mitigation, adaptation and resilience                     measures.

Note: Special requirements for plumbing systems apply in HCFs because of the need to protect occupants of the facility and the adjacent surroundings from

a) infectious diseases;

b) hazards created by improper temperatures, leaks, and inadequate drainage; and

c) adverse conditions created by the failure or improper operation of plumbing systems.

1.2 Supplemental requirements

This Standard supplements the relevant standards and other applicable requirements for plumbing systems, fixtures, and fittings in general building applications.

Notes:

1) Relevant plumbing standards for plumbing fixtures and fittings can be found in the National Plumbing Code of Canada, adopted provincial/territorial plumbing codes, or both; local codes and bylaws; and other communications from authorities having jurisdiction.

2) Applicable requirements for plumbing systems are also contained in the National Building Code of Canada.

1.3 Intended use

This Standard is not intended to preclude the use of design concepts and the adoption of construction, installation, operations, and maintenance procedures more stringent than those specified in this Standard and in the documents listed in Clause 2.

1.4 Exclusions

This Standard does not apply to medical gas systems.

Note: See CSA Z7396.1 for pipelines for medical gases, medical vacuum, medical support gases, and anaesthetic gas scavenging systems.

1.5 Class of HCFs

This Standard applies to all Class A, Class B, and Classes C-1 and C-2 HCFs, unless specifically noted otherwise.

Note: Some requirements may be waived for critical HCF Classes as determined by the application of engineering principles and in consultation with the administrator and the authority having jurisdiction.

1.6 Retrofitting of existing systems

The requirements of this Standard apply to the retrofitting of existing systems when

a) an existing HCF is

i) extended; or

ii) undergoing material alteration or repair; and

b) the multidisciplinary team (MDT) determines that the plumbing in the existing facility is adversely affected.

1.7 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.

1.8 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 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 sous-ensemble.

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 General

1.1.1 Health care facility commissioning requirements

This Standard provides requirements for the commissioning of health care facilities and all related building systems. It applies to new facilities, and renovations and additions to existing facilities.

Preparation and implementation of commissioning plan. This Standard is intended to assist the commissioning team in the preparation and implementation of a commissioning plan. This plan specifies commissioning requirements for newly installed or renovated building systems and includes, but is not limited to, descriptions of the following:

a) the commissioning processes and procedures;

b) the resources required to complete commissioning;

c) the responsibilities of the commissioning team; 

d) the checklist and test plans verifying performance of systems; 

e) the sequence and integration of commissioning activities; and

f) handover (e.g., maintenance team, training, documentation); and

g) post-handover to contract closure.

Note: This Standard was developed based on CSA Z320, Building commissioning, with additions as appropriate to address the special requirements for health care facility commissioning.

1.1.2 Application of building services supporting medical equipment and systems

This Standard applies to building services that support medical equipment and systems, but does not apply to the operational commissioning of the equipment or systems, whether installed by the owner or by others.

Note: Although the commissioning activities under this Standard do not include the commissioning of medical equipment and systems (e.g., sterilizers and MRI machines) the facility commissioning process is likely to include steps to ensure that contracts with external companies for equipment commissioning are being followed.

1.1.3 Clinical commissioning

The Standard does not include clinical commissioning/operational readiness. However, the clinical commissioning/operational readiness team should have a representative on the commissioning team.

Note: Clinical commissioning refers to the activities undertaken to determine the readiness of staff, procedures, and other non-infrastructure elements of the clinical program prior to commencement of patient care. This is generally done in-house as part of the program team requirements.

1.2 Specific systems

The systems covered in this Standard include, but are not limited to those within the following divisions of construction information as defined by the Construction Specifications Institute (CSI)'s Master Format:

Building Enclosure (Divisions 3-8; as applicable to building enclosure);

Door Hardware (Division 8);

Specialties (Division 10); 

Equipment (Division 11); 

Furnishings (Division 12); 

Special Construction (Division 13); 

Conveying Equipment (Division 14); 

Fire Suppression (Division 21);

Plumbing (Division 22); 

Heating, Ventilating and Air Conditioning (Division 23); 

Integrated Automation (Division 25); 

Electrical (Division 26); 

Communications (Division 27); 

Electronic Safety and Security (Division 28);

Material processing and handling equipment (Division 41, 42-00); and

Exterior improvements (Division 32)

Utilities (Division 33).

Notes:

The systems used in the HCF, and the resulting commissioning requirements, will depend on the scope and complexity of the HCF. It is the intent of the Standard that all systems and equipment present in the design of the HCF within the divisions listed above are to be included within the scope of the commissioning process.

Architectural Systems (Interior Space Assemblies, Acoustic Barriers, and Acoustical Testing) are to be included in the scope of commissioning process.

Additional systems and divisions to be included within the OPR documents.

1.3 Terminology

In CSA standards, “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.