Z7396.1-17
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Medical gas pipeline systems - Part 1: Pipelines for medical gases, medical vacuum, medical support gases, and anaesthetic gas scavenging systems
Hardcopy , PDF
01-01-2022
English, French
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.
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)
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DocumentType |
Standard
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ISBN |
978-1-4883-0835-2
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Pages |
0
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PublisherName |
Canadian Standards Association
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Status |
Superseded
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SupersededBy | |
Supersedes |
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).
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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 |
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 Z305.8 : 2003 : R2013 | MEDICAL SUPPLY UNITS |
CSA Z305.8 : 2003 : UPD 1 | MEDICAL SUPPLY UNITS |
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 |
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 Z8001 : 2013 | COMMISSIONING OF HEALTH CARE FACILITIES |
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 |
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 |
IEST RP CC001.5 : 2009 | HEPA AND ULPA FILTERS |
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 |
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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