ДСТУ EN ISO 7396-1:2019 Системы трубопроводов для медицинского негорючего газа. Часть 1. Газопроводы для сжатых медицинских газов и вакуума (EN ISO 7396-1:2016, IDT; ISO 7396-1:2016, IDT)

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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