ДСТУ EN ISO 7396-1:2015 Системи трубопроводів для медичного незаймистого газу. Частина 1. Газопроводи для стиснутих медичних газів і вакууму (EN ISO 7396-1:2007, IDT; ISO 7396-1:2007, IDT)
ПІДТВЕРДЖУВАЛЬНЕ ПОВІДОМЛЕННЯ
Державне підприємство
«Український науково-дослідний і навчальний центр
проблем стандартизації, сертифікації та якості»
(
(ДП «УкрНДНЦ»))
Наказ від 25.12.2015 № 208
EN ISO 7396-1:2007
Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum
прийнято як національний стандарт
методом «підтвердження» за позначенням
ДСТУ EN ISO 7396-1:2015
(EN ISO 7396-1:2007, IDT; ISO 7396-1:2007, IDT)
Системи трубопроводів для медичного незаймистого газу. Частина 1. Газопроводи для стиснутих медичних
газів і вакууму
З наданням чинності від 2016–01–01
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 or cylinder bundles
5.4 Supply systems with mobile or stationary 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, commissioning and certification
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 Certification of the systems
13 Information to be supplied by the manufacturer
13.1 General
13.2 Instructions for use
13.3 Operational management information
13.4 “As-installed” drawings
13.5 Electrical diagrams
Annex A (informative) Schematic representations of typical supply systems and area distribution systems
Annex В (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 certification of the medical gas pipeline system
Annex E (informative) Temperature and pressure relationships
Annex F (informative) Risk management checklist
Annex G (informative) Operational management
Annex H (informative) Rationale
Bibliography
Annex ZA (informative) Relationship between this International Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical devices
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