ДСТУ EN ISO 7396-1:2019 Системи трубопроводів для медичного незаймистого газу. Частина 1. Газопроводи для стиснутих медичних газів і вакууму (EN ISO 7396-1:2016, IDT; ISO 7396-1:2016, IDT)
ПІДТВЕРДЖУВАЛЬНЕ ПОВІДОМЛЕННЯ
Державне підприємство
«Український науково-дослідний і навчальний центр
проблем стандартизації, сертифікації та якості»
(
(ДП «УкрНДНЦ»))
Наказ від 12.12.2019 № 409
EN ISO 7396-1:2016
Medical gas pipeline systems —
Part 1: Pipeline systems for compressed
medical gases and vacuum
(ISO 7396-1:2016)
прийнято як національний стандарт
методом
підтвердження за позначенням
ДСТУ EN ISO 7396-1:2019
(EN ISO 7396-1:2016, IDT; ISO 7396-1:2016, IDT)
Системи трубопроводів для медичного незаймистого газу.
Частина 1. Газопроводи для стиснутих медичних газів і вакууму
З наданням чинності від 2020–01–01
Contents
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Safety
4.2 Alternative construction
4.3 Materials
4.4 System design
5 Supply systems
5.1 System components
5.2 General requirements
5.3 Supply systems with cylinders, cylinder bundles or high-pressure reservoir(s)
5.4 Supply systems with cryogenic or non-cryogenic vessels
5.5 Supply systems for air
5.6 Supply systems with oxygen concentrator(s)
5.7 Supply systems for vacuum
5.8 Location of supply systems
5.9 Location of cylinder manifolds
5.10 Location of stationary cryogenic vessels
6 Monitoring and alarm systems
6.1 General
6.2 Installation requirements
6.3 Monitoring and alarm signals
6.4 Provision of operating alarms
6.5 Provision of emergency clinical alarms
6.6 Provision of emergency operating alarms
7 Pipeline distribution systems
7.1 Mechanical resistance
7.2 Distribution pressure
7.3 Low-pressure hose assemblies and low-pressure flexible connections
7.4 Double-stage pipeline distribution systems
8 Shut-off valves
8.1 General
8.2 Service shut-off valves
8.3 Area shut-off valves
9 Terminal units, gas-specific connectors, medical supply units, pressure regulators and pressure gauges
10 Marking and colour coding
10.1 Marking
10.2 Colour coding
11 Pipeline installation
11.1 General
11.2 Pipeline supports
11.3 Pipeline joints
11.4 Extensions and modifications of existing pipeline systems
12 Testing and commissioning
12.1 General
12.2 General requirements for tests
12.3 Inspections and checks before concealment
12.4 Tests, checks and procedures before use of the system
12.5 Requirements for inspections and checks before concealment
12.6 Requirements for tests, checks and procedures before use of the system
12.7 Statement of compliance to this part of ISO 7396
13 Information to be supplied by the manufacturer
13.1 General
13.2 Instructions for installation
13.3 Instructions for use
13.4 Operational management information
13.5 “As-installed” drawings
13.6 Electrical diagrams
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
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