CSA Z7396.1:22 PDF

CSA Z7396.1:22 PDF

Preface

This is the fifth edition of CSA Z7396.1, Medical gas pipeline systems – Part 1: Pipelines for medical gases, medical vacuum, medical support gases, and anaesthetic gas scavenging systems . It supersedes the previous editions published in 2017, 2012, 2009, and 2006. It is comparable in scope to ISO 7396-1, Medical gas pipeline systems – Part 1: Pipeline systems for compressed medical gases and vacuum and ISO 7396-2, Medical gas pipeline systems – Part 2: Anaesthetic gas scavenging disposal systems, but contains requirements to reflect Canadian practices and safety considerations. This Standard is primarily intended to address new installations and does not require the retrofitting of existing systems. Clause 11.5 covers repairs, additions, and modifications to existing pipeline systems. For existing systems, the Subcommittee recommends that health care facilities document and survey their installations to determine the adequacy of the pipeline distribution system and to properly identify components requiring emergency repairs or maintenance. This edition of CSA Z7396.1 includes comprehensive requirements and guidance for safety in medical gas pipeline systems. This edition sees expansion in requirements and guidance on a) maintenance, with a new sample form Figure J.1 used for an audit or verification of a compliance with Clause 15; b) a new requirement for an emergency management program (Clause 4.11); c) medical supply unit concealed hoses compliance inspections; d) product quality updates (all gases); e) system design configurations with new and updated figures; f) enclosures including compounds and safety related updates; g) new technologies allowed for fitting and materials; h) AGSS safety and operation; i) commission and inspection body checklists; j) alarm tables format; k) importance of professional training and education; l) oxygen concentrators; m) alarms and monitoring; n) on-going verification; and o) new definitions. Also included are expanded informative, non-mandatory annexes for medical gas pipe sizing, pipeline installation test reporting, emergency preparedness and response, emergency procedures, alternate solutions, environmental, fire control, and plume evacuation systems. As well, the informative commentary on key clauses has been enhanced. Explanatory material has been added to clarify the content of this Standard. A symbol (C) beside a clause number identifies a clause for which further information is provided in Annex A. CSA Group acknowledges that the development of the fourth edition of this Standard was made possible, in part, by the financial support of the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Ontario, Prince Edward Island, Québec, Saskatchewan, and Yukon as administered by the Canadian Agency for Drugs and Technologies in Health (CADTH). This Standard was prepared by the Subcommittee on Medical Gas Systems, under the jurisdiction of the Technical Committee on Perioperative Safety and the Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.

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).