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Z7396.1-17

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Medical gas pipeline systems - Part 1: Pipelines for medical gases, medical vacuum, medical support gases, and anaesthetic gas scavenging systems

Available format(s)

Hardcopy , PDF

Superseded date

01-01-2022

Language(s)

English, French

Published date

01-01-2017

Preface
1 Scope
2 Reference publications
3 Definitions
4 General requirements
5 Supply systems
6 Monitoring and alarm systems
7 Pipeline distribution system
8 Shut-off valves
9 Terminal units and medical supply units
10 Marking
11 Pipeline installation
12 Commissioning and compliance testing
13 Information to be supplied by the installer
14 Special exemptions for small, stand-alone medical
   gas pipeline systems
15 Maintenance and ongoing verification
Annex A (informative) - Rationale and commentary on
        clauses in this Standard
Annex B (normative) - Installation tests
Annex C (normative) - Inspection of supply systems and
        supply system alarms for certification
Annex D (normative) - Inspection of pipelines, valves,
        and zone alarms for certification
Annex E (informative) - Medical gas pipe sizing
Annex F (informative) - Suggested terminal unit
        distribution chart
Annex G (normative) - Medical gas zone valves
Annex H (informative) - Suggested protocols for
        managing medical gas pipelines
Annex I (normative) - Maintenance, repair, modification,
        and additions
Annex J (normative) - Audit or verification of compliance
        with Clause 15 - Maintenance and ongoing
        verification
Annex K (informative) - Medical gas piping system
        provisional inspection report
Annex L (informative) - Pipeline installation test report
Annex M (informative) - Emergency preparedness and
        response
Annex N (informative) - Guidelines for emergency
        procedures
Annex O (informative) - Alternate solutions
Annex P (informative) - Environmental
Annex Q (informative) - Fire control
Annex R (informative) - Plume evacuation systems (PES)
Annex S (informative) - Manufacture of medical gases on
        site - Responsibility for medical gas quality
Annex T (normative) - Qualified persons

Defines 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.

Preface This is the fourth 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 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; b) qualified person designations; c) oxygen concentrators*; * Content referenced from CAN/CSA-Z10083 for oxygen concentrator supply systems in the 2012 edition of CSA Z7396.1 has been fully incorporated into the 2017 edition. d) alarms and monitoring; e) quality of medical air made on-site; f) on-going verification; g) updated source diagrams; h) terminal unit distribution and flowrate charts; and i) new definitions. Also included are new 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 fourthedition 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 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 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 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 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 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 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 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 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).

DevelopmentNote
Supersedes CSA Z305.1. (09/2006) 2009 Edition along with GEN INS 1 is still active, available in English & French. (03/2013) 2012 Edition is still active. (07/2017) French Edition issued on 01-12-2017. (01/2018)
DocumentType
Standard
ISBN
978-1-4883-0835-2
Pages
0
PublisherName
Canadian Standards Association
Status
Superseded
SupersededBy
Supersedes

CSA S832 : 2014 SEISMIC RISK REDUCTION OF OPERATIONAL AND FUNCTIONAL COMPONENTS (OFCS) OF BUILDINGS
CSA Z10524-3 : 2012 : R2017 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES
CSA Z10524-1 : 2012 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES
13/30242951 DC : 0 BS ISO 16571 - MEDICAL GAS SYSTEMS - SYSTEMS FOR EVACUATION OF PLUME GENERATED BY MEDICAL DEVICES
CSA Z10083 : 2008 : R2013 OXYGEN CONCENTRATOR SUPPLY SYSTEMS FOR USE WITH MEDICAL GAS PIPELINE SYSTEMS
ASTM B 819 : 2018 : REDLINE Standard Specification for Seamless Copper Tube for Medical Gas Systems
CSA Z10083 : 2008 OXYGEN CONCENTRATOR SUPPLY SYSTEMS FOR USE WITH MEDICAL GAS PIPELINE SYSTEMS
CSA Z314.8 : 2014 DECONTAMINATION OF REUSABLE MEDICAL DEVICES
CAN/CSA-C22.2 NO. 80601-2-72:17 Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (Adopted ISO 80601-2-72:2015, first edition, 2015-09-01, with Canadian deviations)
BS EN ISO 7396-1:2016 Medical gas pipeline systems Pipeline systems for compressed medical gases and vacuum
ISO 16571:2014 Systems for evacuation of plume generated by medical devices
CSA Z10524-2 : 2012 : R2017 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 2: MANIFOLD AND LINE PRESSURE REGULATORS
CAN/CSA-ISO 16571:16 SYSTEMS FOR EVACUATION OF PLUME GENERATED BY MEDICAL DEVICES
CSA Z10524-2 : 2012 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 2: MANIFOLD AND LINE PRESSURE REGULATORS
EN ISO 7396-1:2016 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016)
CAN/CSA-Z15002:12 (R2017) Flow-metering devices for connection to terminal units of medical gas pipeline systems (Adopted ISO 15002:2008, second edition, 2008-07-01, with Canadian deviations)
CSA Z1500:2012 FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS
CSA Z305.8 : 2003 MEDICAL SUPPLY UNITS
I.S. EN ISO 7396-1:2016 MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016)
Z7000-18 General requirements for quality management and safety in perioperative settings
Z305.0-13 Safety of personnel in perioperative environments
CSA C22.2 No. 80601-2-12 : 2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS
CSA Z10524-1 : 2012 : R2017 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES
CSA Z10524-3 : 2012 : INC : AMD 1 : 2017 : R201700 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES
13/30255929 DC : 0 BS EN ISO 7396-1 - MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM
CSA Z10524-4 : 2012 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS
CAN/CSA-Z305.8-03 (R2018) Medical Supply Units
CAN/CSA-Z314-18 Canadian medical device reprocessing
CSA Z317.1 : 2016 SPECIAL REQUIREMENTS FOR PLUMBING INSTALLATIONS IN HEALTH CARE FACILITIES
CSA Z275.1 : 2016 HYPERBARIC FACILITIES
CSA Z5359 : 2016 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES, MEDICAL VACUUM, MEDICAL SUPPORT GASES, AND ANAESTHETIC GAS SCAVENGING SYSTEMS
DIN EN ISO 7396-1:2016-09 MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016)
CSA Z8000 : 2011 CANADIAN HEALTH CARE FACILITIES
CSA Z8000 : 2011 : R2016 CANADIAN HEALTH CARE FACILITIES
CSA Z8000 : 2011 : INC : UPD 1 : 2013 CANADIAN HEALTH CARE FACILITIES
CSA C22.2 No. 80601-2-12 : 2012(R2017) MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS
BS ISO 16571:2014 Systems for evacuation of plume generated by medical devices
CSA Z8185 : 2008 RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
CSA Z9170.1 : 2011 : R2015 TERMINAL UNITS FOR MEDICAL GAS PIPELINE SYSTEMS - PART 1: TERMINAL UNITS FOR USE WITH COMPRESSED MEDICAL GASES, VACUUM, AND ANAESTHETIC GAS SCAVENGING SYSTEMS
CSA Z9170.1 : 2011 TERMINAL UNITS FOR MEDICAL GAS PIPELINE SYSTEMS - PART 1: TERMINAL UNITS FOR USE WITH COMPRESSED MEDICAL GASES, VACUUM, AND ANAESTHETIC GAS SCAVENGING SYSTEMS
CSA Z305.8 : 2003 : R2013 MEDICAL SUPPLY UNITS
CSA Z305.8 : 2003 : UPD 1 MEDICAL SUPPLY UNITS
CSA Z8001 : 2013 COMMISSIONING OF HEALTH CARE FACILITIES
Z317.5-17 Illumination design in health care facilities
UNE-EN ISO 7396-1:2016 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016)
ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
CSA Z10524-3 : 2012 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES
CAN/CSA-Z10524-4:12 (R2017) Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (Adopted ISO 10524-4:2008, first edition, 2008-06-01, with Canadian deviations)
CSA Z8185 : 2008(R2013) RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
CSA Z305.13 : 2013(R2018) PLUME SCAVENGING IN SURGICAL, DIAGNOSTIC, THERAPEUTIC, AND AESTHETIC SETTINGS
CSA Z317.2 : 2010 SPECIAL REQUIREMENTS FOR HEATING, VENTILATION, AND AIR-CONDITIONING (HVAC) SYSTEMS IN HEALTH CARE FACILITIES
CSA B51 : 2014 BOILER, PRESSURE VESSEL, AND PRESSURE PIPING CODE

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
CSA Z305.13 : 2013(R2018) PLUME SCAVENGING IN SURGICAL, DIAGNOSTIC, THERAPEUTIC, AND AESTHETIC SETTINGS
CSA Z317.2 : 2010 SPECIAL REQUIREMENTS FOR HEATING, VENTILATION, AND AIR-CONDITIONING (HVAC) SYSTEMS IN HEALTH CARE FACILITIES
CGA V 1 : 2013 STANDARD FOR COMPRESSED GAS CYLINDER VALVE OUTLET AND INLET CONNECTIONS
C22.1-15 Canadian Electrical Code, Part I (23rd Edition), Safety Standard for Electrical Installations
CSA B51 : 2014 BOILER, PRESSURE VESSEL, AND PRESSURE PIPING CODE
CAN/CSA-ISO 13485:16 Medical devices - Quality management systems - Requirements for regulatory purposes (Adopted ISO 13485:2016, third edition, 2016-03-01)
CSA Z462 : 2015 WORKPLACE ELECTRICAL SAFETY
ISO 7396-2:2007 Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems
AWS A5.8/A5.8M : 2013 SPECIFICATION FOR FILLER METALS FOR BRAZING AND BRAZE WELDING
CSA Z180.1 : 2013 COMPRESSED BREATHING AIR AND SYSTEMS
NFPA 55 : 2016 COMPRESSED GASES AND CRYOGENIC FLUIDS CODE
CAN/CSA-ISO 16571:16 SYSTEMS FOR EVACUATION OF PLUME GENERATED BY MEDICAL DEVICES
IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
CSA Z275.1 : 2016 HYPERBARIC FACILITIES
NFPA 99 : 2018 HEALTH CARE FACILITIES CODE
CGA V 5 : 2008(R2013) DIAMETER INDEX SAFETY SYSTEM (NON-INTERCHANGEABLE LOW PRESSURE CONNECTIONS FOR MEDICAL GAS APPLICATIONS)
CSA ISO 9001 : 2016 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS
CSA Z5359 : 2016 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES, MEDICAL VACUUM, MEDICAL SUPPORT GASES, AND ANAESTHETIC GAS SCAVENGING SYSTEMS
ASME B16.50 : 2013 WROUGHT COPPER AND COPPER ALLOY BRAZE-JOINT PRESSURE FITTINGS
ASME PV CODE SET : 2017 BOILER AND PRESSURE VESSEL CODE - COMPLETE SET
CSA Z32 : 2015 ELECTRICAL SAFETY AND ESSENTIAL ELECTRICAL SYSTEMS IN HEALTH CARE FACILITIES
CGA G 4.1 : 2009 CLEANING EQUIPMENT FOR OXYGEN SERVICE
ASME B16.22 : 2013 WROUGHT COPPER AND COPPER ALLOY SOLDER-JOINT PRESSURE FITTINGS
CGA G 8.1 : 2013 STANDARD FOR NITROUS OXIDE SYSTEMS AT CUSTOMER SITES
ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum

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