Health Care and Medical Devices
1 Scope
a) a terminal unit conforming with ISO 9170-1 of a medical gas pipeline system conforming with ISO 7396-1:2016;
a) flowmeters;
NOTE Flow control devices that are classed as medical electrical equipment can be subject to additional requirements of IEC 60601-1.
— oxygen;
NOTE Flow control devices can be available for other gases.
a) for use with gases for driving surgical tools;
1 Scope
1.1 General
This Standard specifies safety requirements for pipelines for medical gases, medical vacuum, medical support gases, and anaesthetic gas scavenging systems in health care facilities, both public and private. It applies to all facilities providing health care services, regardless of type, size, location, or range of services, including, but not limited to
a) acute care hospitals;
b) in-patient continuing care hospitals;
c) long-term care facilities;
d) community-based providers;
e) leased/rental suites in office buildings; and
f) ambulatory and outpatient care clinics (e.g., day surgery, endoscopy clinics, dentists’ offices, and doctors’ offices).
1.2 Intended use
There is a commentary available for this Clause.
This Standard is intended for use by anyone involved in the design, installation, commissioning and testing, documentation, operation, and maintenance of pipelines for medical gases, medical vacuum, medical support gases, and anaesthetic gas scavenging systems. The requirements cover
a) the design of systems to ensure the continuous supply of gas or vacuum in normal condition or in single fault condition;
b) the selection of materials and components;
c) the non-interchangeability of equipment between different gas systems and services;
d) the cleanliness of materials and components and of the completed system;
e) installation procedures for supply systems and pipelines;
f) the configuration of system components;
g) control, monitoring, and alarm systems;
h) the markings and information to be supplied by the manufacturer or installer;
i) contaminant testing of pipelines;
j) the final testing of each medical gas pipeline prior to its use in patient care to ensure that it contains only the specified gas; and
k) maintenance and ongoing verification.
1.3 Application
There is a commentary available for this Clause.
This Standard applies to pipeline systems for
a) medical gases or medical gas mixtures, including
i) oxygen USP;
ii) oxygen 93 USP;
iii) medical air USP;
iv) nitrous oxide USP;
v) carbon dioxide USP;
vi) helium USP;
vii) oxygen USP/nitrous oxide USP mixtures;
viii) helium USP/oxygen USP mixtures; and
ix) other medical gases;
b) medical support gases, including
i) instrument air; and
ii) nitrogen NF;
c) medical vacuum; and
d) anaesthetic gas scavenging systems (AGSS).
1.4 Exclusion of plume evacuation systems (PES)
This Standard does not provide specific requirements for plume evacuation systems (PES) that is part of an overall medical gas pipeline distribution system. Informative guidance is provided in Annex R.
1.5 Exclusion of hyperbaric chambers
This Standard does not provide specific requirements for hyperbaric chambers connected to medical gas pipeline distribution systems. See Clause 7.6.4 for the hyperbaric demarcation point.
Note: Requirements for hyperbaric chambers are provided in CSA Z275.1.
1.6 Exclusion of veterinary and animal research facilities
This Standard does not apply to veterinary and animal research facilities.
Note: The relevant requirements of this Standard, particularly those regarding safety, should be incorporated in the design, installation, and maintenance of piping systems in veterinary and animal research facilities. These systems should be inspected and tested by inspection bodies.
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 (nonmandatory) to define their application.
1.8 Units of measure
The values given in SI (metric) units are the standard. The values given in parentheses are for information only. Unless otherwise specified, pressures and vacuum in this Standard are expressed as gauge pressure (i.e., atmospheric pressure is defined as 0).
1.1 Purpose
This Standard is for use by organizations when establishing and managing systems for accessible, equitable, and inclusive customer experiences. Any organization which designs and develops accessible customer service promotes opportunity and access for all people.
The purpose of this Standard is to guide organizations when developing, implementing, and maintaining accessible service management systems. This includes, but may not be limited to, defining accountability structures and policies, assessing service quality and accessibility outcomes, remaining responsive to evolving needs, and using customer-informed feedback to drive continuous improvement.
1.2 Figures and tables
Figures and tables are included for explanatory or illustrative purposes only and are not a mandatory part of the Standard.
1.3 Annexes
Annexes A and B provide additional information on topics considered in the Standard.
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 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 explanatory or informative material from the text.
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.