Standards

What each standard, pharmacopoeia monograph and guideline covers. 45 pages.

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Standards

• ACSS ET 08/2010: technical compressed air in hospitals (Portugal)ACSS ET 08/2010 V.2025 is the Portuguese specification for technical compressed air in hospitals: scope, exclusions, air quality class, pressure and pipework.
• ASTM B819-19 Seamless Copper Tube for Medical Gas SystemsASTM B819-19 on seamless copper tube for medical gas systems: status, Types K and L, temper, tests and cleaning, and the installation codes it names.
• CSA Z7396.1:22 Medical gas pipeline systems, Part 1 (Canada)CSA Z7396.1:22 is Canada's medical gas pipeline standard: scope, gases including oxygen 93 USP, exclusions, edition history and relation to ISO 7396.
• DIN 13260-2: probes and gas-specific connection points for outletsDIN 13260-2:2025-06 sets probe and connection point dimensions for medical gas outlets in Germany: scope, oxygen 93 probe, corrigendum and Part 1 status.
• EN 13348: copper tubes for medical gases and vacuumEN 13348:2016 is the European standard for seamless copper tube in medical gas and vacuum pipelines: 6 to 219 mm, up to 2,000 kPa. Status and what it means.
• EN 737-3 Medical gas pipeline systems, Part 3 (withdrawn)EN 737-3 on medical gas pipelines is withdrawn: DIN Media status, what replaced it (EN ISO 7396-1:2016 + A1:2019) and which standards to cite today.
• EN ISO 23402-3:2024 Dentistry: portable suction equipmentEN ISO 23402-3:2024 on portable dental suction equipment: edition and EVS status, what it covers and excludes, and related ISO 23402-1 and ISO 10079-1.
• FD S90-119 Terminal units for air for driving surgical tools (AFNOR)FD S90-119 (AFNOR, July 2006): the French connection system for surgical-tool air sockets and probes, its status, and its link to NF S90-116 and ISO 9170-1.
• FD S90-155: French guidance for medical gas networksFD S90-155 (November 2024) is the AFNOR informative guide that adds design and acceptance elements to NF EN ISO 7396-1 for medical gas networks in France.
• International Pharmacopoeia: medicinal oxygen monographsThe WHO International Pharmacopoeia (13th edition, 2025) defines medicinal oxygen as Oxygen 93%, 98% or 99.5%. Limits, status and what it means for hospitals.
• ISO 10083:2006 Oxygen concentrator supply systems (withdrawn)ISO 10083:2006 on oxygen concentrator supply systems was withdrawn in February 2016 and revised by ISO 7396-1:2016: what it covered and what to cite now.
• ISO 10524: pressure regulators for medical gasesISO 10524 covers medical gas pressure regulators in four parts: cylinder, manifold and line, VIPR and low-pressure units. Editions, status and hospital use.
• ISO 11197:2019 Medical supply unitsISO 11197:2019 covers the safety of medical supply units such as bed head units and pendants: scope, who counts as manufacturer and the fifth edition status.
• ISO 14971:2019 Application of risk management to medical devicesISO 14971:2019 sets the risk management process for medical devices: what it covers, what it leaves to manufacturers, its 2025 confirmation and gas uses.
• ISO 15001:2010 Compatibility with oxygenISO 15001:2010 sets oxygen compatibility rules for anaesthetic and respiratory equipment, including medical gas pipelines: scope, status and where cited.
• ISO 15002:2023: flow control devices for a medical gas supply systemISO 15002:2023 on flowmeters and other flow control devices for medical gases: edition and draft amendment, scope, exclusions and the related ISO standards.
• ISO 18082:2014 NIST low-pressure connectors for medical gasesISO 18082:2014 fixes NIST low-pressure connector dimensions for medical gases up to 1 400 kPa: scope, gases, amendment and the ISO/DIS 18082 revision.
• ISO 18119: periodic inspection of seamless gas cylindersISO 18119:2018 (Amd 1:2021, Amd 2:2024): periodic inspection of seamless steel and aluminium cylinders, scope, exclusions, the DIS revision and its uses.
• ISO 21969:2009: high-pressure flexible connections for medical gasesISO 21969:2009 covers high-pressure flexible connections for medical gas cylinders up to 25 000 kPa: scope, edition, status and how HTM and SHTM use it.
• ISO 32: colour coding of medical gas cylindersISO 32:1977 sets the marking and colours that identify medical gas cylinder contents. Edition, status, the European EN 1089-3 and what it means for hospitals.
• ISO 5359:2014 Low-pressure hose assemblies for medical gasesISO 5359:2014 covers low-pressure hose assemblies for medical gases and vacuum: scope, exclusions, the 2017 amendment and the ISO/DIS 5359 fifth edition.
• ISO 7396-1: pipelines for compressed medical gases and vacuumISO 7396-1:2016 sets the rules for medical gas and vacuum pipelines: scope, oxygen 93 ranges, edition in force, the 4th edition under way and design impact.
• ISO 7396-2: anaesthetic gas scavenging disposal systemsISO 7396-2:2007 covers anaesthetic gas scavenging disposal systems: scope, edition in force, separation from vacuum and what it means for hospital designers.
• ISO 7396-3: proportioning units for synthetic medical airISO 7396-3:2025 covers proportioning units that blend oxygen and nitrogen into synthetic medical air for hospital pipelines: scope, edition and design impact.
• ISO 80601-2-69:2026 Oxygen concentrator equipmentISO 80601-2-69:2026 sets safety and performance rules for oxygen concentrators: scope, accessories, pipeline exclusion and the April 2026 edition change.
• ISO 8573-1: compressed air purity classesISO 8573-1:2010 defines compressed air purity classes for particles, water and oil. Status, why it does not define medical air, and how hospitals apply it.
• ISO 8835-3:2007 AGSS transfer and receiving systems (withdrawn)ISO 8835-3:2007 on AGSS transfer and receiving systems was withdrawn in 2011 and revised by ISO 80601-2-13: what it covered and what to cite today.
• ISO 9170-1: terminal units for compressed medical gases and vacuumISO 9170-1:2017 covers terminal units for medical gas and vacuum pipelines: what it requires, why probe sizes differ by country and the edition in force.
• ISO 9170-2: terminal units for anaesthetic gas scavengingISO 9170-2:2008 covers terminal units for anaesthetic gas scavenging systems: the two unit types, the edition in force and their place in the AGSS chain.
• ISO 9809 Design, construction and testing of seamless steel cylindersISO 9809 sets design, construction and testing rules for refillable seamless steel gas cylinders: the four parts, editions in force and revisions under way.
• Lancet Global Health Commission on medical oxygen security (2025)The Lancet Global Health Commission on medical oxygen security (17 February 2025): 374 million people in need, a 70% gap in LMICs and 52 recommendations.
• NF S90-116: French medical gas sockets and probesNF S90-116 (October 2020) is the AFNOR standard for French medical gas sockets and probes: scope, link with ISO 9170-1, edition in force and design impact.
• NFPA 99: Health Care Facilities Code for medical gasesNFPA 99, the US Health Care Facilities Code: risk-based scope, the 2027 edition in force, its 2026 interim amendments and how it sits beside ISO 7396-1.
• Ph. Eur. 0417: Oxygen (minimum 99.5%)Ph. Eur. 0417 is the European monograph for cryogenic medicinal oxygen, minimum 99.5%. Status, how it differs from 2455, 3098 and USP, and what it means.
• Ph. Eur. 3098: Oxygen (98 per cent)Ph. Eur. 3098 is the European monograph for oxygen from two-stage adsorption plants, nominal 98.0%. Status, how it differs from oxygen 93 and what it means.
• PIC/S PI 025-2: aide-memoire for inspecting medicinal gasesPIC/S PI 025-2 (2007) is the inspection aide-memoire for medicinal gases: scope, the hospital addendum on air, oxygen and testing, and its status in 2026.
• UNDP REQ-OXY-001: requirements for oxygen plantsUNDP REQ-OXY-001 (in force since 1 January 2025): what UNDP procurement asks of PSA oxygen plant suppliers, from market clearance and markings to tests.
• USP monograph Oxygen (not less than 99.0%)USP Oxygen sets not less than 99.0% oxygen by volume: what the public USP-NF text shows and how it compares with USP Oxygen 93 Percent and Ph. Eur. 0417.
• USP Oxygen 93 Percent monographUSP Oxygen 93 Percent defines molecular sieve oxygen at 90.0% to 96.0% by volume. How it compares with Ph. Eur. 2455 and WHO specs, and what it means.
• WHO Foundations of medical oxygen systems (2023)WHO Foundations of medical oxygen systems (17 February 2023): what it covers, its five web annexes, key technical statements, status and outdated references.
• WHO technical specifications for health facility oxygen systems (2024)WHO technical specifications for health facility oxygen systems (31 Dec 2024): products covered, exclusions, status versus the 2020 PSA spec, key values.
• WHO technical specifications for PSA oxygen plantsWHO interim technical specifications for PSA oxygen plants (2020): purity, alarms, pressure, warranty and commissioning, its status today and how to use it.
• WHO TRS 1044 Annex 5: good manufacturing practices for medicinal gasesWHO TRS 1044 Annex 5 (14 November 2022): GMP for medicinal gases, its cylinder and batch rules, why it excludes hospital production, and related texts.
• WHO-UNICEF technical specifications for oxygen therapy devices (2019)WHO-UNICEF oxygen therapy device specifications (14 January 2019): the 15 Annex 1 tables, the 82% minimum, what it leaves out and the ISO standards it cites.

Service and projects

• Global Fund sustainability guidance for PSA oxygen plants (2024)The Global Fund overview of sustainability guidance for PSA oxygen plants (22 August 2024): who wrote it, what each section asks for, and its limits.