Health Care and Medical Devices

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.