EN ISO 7396-1:2016

European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Supply systems
6 Monitoring and alarm systems
7 Pipeline distribution systems
8 Shut-off valves
9 Terminal units gas-specific connectors
   medical supply units pressure regulators
   and pressure gauges
10 Marking and colour coding
11 Pipeline installation
12 Testing and commissioning
13 Information to be supplied by the manufacturer
Annex A (informative) - Schematic representations of typical
        supply systems and area distribution systems
Annex B (informative) - Guidelines for location of cylinder
        manifolds cylinder storage areas and stationary vessels
        for cryogenic or non-cryogenic liquids
Annex C (informative) - Example of procedure for testing
        and commissioning
Annex D (informative) - Typical forms for documenting compliance
        of the pipeline systems for compressed medical gas and
        vacuum
Annex E (informative) - Temperature and pressure relationships
Annex F (informative) - Risk management checklist
Annex G (informative) - Operational management
Annex H (informative) - Rationale
Annex I (informative) - Rationale for compressor hazards
Annex J (informative) - Considerations for implementation and
        use of oxygen 93
Annex K (informative) - Manufacture of medical gases on site
        Responsibility for medical gas quality
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC
         on Medical devices

ISO 7396-1:2016 specifies requirements for design, installation, function, performance, testing, commissioning and documentation of pipeline systems used in healthcare facilities for the following:- oxygen;- nitrous oxide;- medical air;- carbon dioxide;- oxygen/nitrous oxide mixtures (see Note 1);- helium/oxygen mixtures;- (*) oxygen 93;- gases and gas mixtures classified as medical device, gases delivered to medical devices or intended for medical purposes or gases and gas mixtures for medicinal use not specified above;- air for driving surgical tools;- nitrogen for driving surgical tools;- vacuum.NOTE 1 Regional or national regulations may prohibit the distribution of oxygen/nitrous oxide mixtures in medical gas pipeline systems.NOTE 2 Anaesthetic gas scavenging disposal systems are covered in ISO 7396‑2.This part of ISO 7396 includes requirements for supply systems, pipeline distribution systems, control systems, monitoring and alarm systems and non-interchangeability between components of different gas/vacuum systems.This part of ISO 7396 specifies safety requirements for pipeline systems used in healthcare facilities, both public and private. It applies to all facilities providing healthcare services regardless of type, size, location or range of services, including, but not limited to:a) acute care healthcare facilities;b) internal patient continuing care healthcare facilities;c) long-term care facilities;d) community-based providers;e) ambulatory and external patient care clinics (e.g. day surgery, endoscopy clinics and doctors' offices).NOTE 3 This part of ISO 7396 may also be used as reference for pipeline systems for medical gases and vacuum intended to be installed in places other than healthcare facilities.ISO 7396-1:2016 applies to the following different types of oxygen supply systems:- supply systems in which all sources of supply deliver oxygen; in this case the concentration of the oxygen will be greater than 99%;- supply systems in which all sources of supply deliver oxygen 93; in this case the concentration of the oxygen may vary between 90% and 96%;NOTE 4 A mixture of oxygen 93 and oxygen may be delivered by a medical gas supply system. In this case the concentration of the gas can vary between 90% and >99%.ISO 7396-1:2016 also applies to:- extensions of existing pipeline distribution systems;- modifications of existing pipeline distribution systems;- modifications or replacement of supply systems or sources of supply.Oxygen concentrators for domiciliary use are excluded from the scope of this part of ISO 7396.NOTE 5 Requirements for oxygen concentrators for domiciliary use are specified in ISO 80601‑2-69.(*) EN 14931 defines additional requirements for hyperbaric application, in particular for flows and pressures of compressed air required to pressurize the hyperbaric chamber and to drive other connected services. Also included are requirements for oxygen and other treatment gases administered to patients.ISO 7396-1:2016 does not apply to vacuum systems intended to be used in dentistry.ISO 7396-1:2016 does not apply to filling systems for transportable cylinders and transportable cylinder bundle systems.