ДСТУ EN ISO 8835-2:2019 Системы ингаляционной анестезии. Часть 2. Анестетические дыхательные системы (EN ISO 8835-2:2009, IDT; ISO 8835-2:2007, IDT)

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EN ISO 8835-2:2009

Inhalational anaesthesia systems —
Part 2: Anaesthetic breathing systems
(ISO 8835-2:2007)

прийнято як національний стандарт
методом «підтвердження» за позначенням
 

ДСТУ EN ISO 8835-2:2019
(EN ISO 8835-2:2009, IDT;
ISO 8835-2:2007, IDT)

Системи інгаляційної анестезії.
Частина 2. Анестетичні дихальні системи

З наданням чинності від 2019–08–01

Contents

Foreword

Introduction

1 Scope

2 Normative references

3 Terms and definitions

4 General

4.1 Materials

4.2 Anaesthetic breathing system component packaging

4.3 Electrical requirements

4.4 Alternative test methods

5 Connection ports

5.1 Patient connection port

5.2 Y-Piece

5.3 Exhaust connection port

5.4 Interchangeable non-rebreathing exhaust valves

5.5 Reservoir bag connection port

5.6 Anaesthetic ventilator connection port

5.7 Connection ports of interchangeable anaesthetic breathing system components

5.8 Inspiratory and expiratory connection ports of an interchangeable circle absorber assembly

5.9 Other connection ports

6 Reservoir bag/anaesthetic ventilator selector switch

7 Complete anaesthetic breathing system either supplied assembled or assembled in accordance with the manufacturer’s instructions

7.1 Leakage

7.2 Inspiratory and expiratory pressure/flow characteristics

8 Interchangeable anaesthetic breathing system components — Exhaust valves

8.1 Direction of movement of controls

8.2 Pressure/flow characteristics

8.3 Opening pressure

8.4 Leakage

9 Circle absorber assemblies

9.1 Construction

9.2 Absorbent bypass mechanism

9.3 Pressure/flow characteristics

9.4 Inspiratory and expiratory valves

10 Pressure monitoring and limitation

10.1 Pressure monitoring

10.2 Pressure-limiting device

11 Location of components in an anaesthetic breathing system containing a circle absorber assembly (as defined in 3.3)

11.1 Exhaust valve

11.2 Reservoir bag connection port

11.3 Fresh gas inlet

11.4 Inspiratory and expiratory valves

12 Marking

12.1 Marking of complete anaesthetic breathing systems and anaesthetic breathing system components

12.2 Marking of packages

13 Information to be provided by the manufacturer or supplier

13.1 General

13.2 For anaesthetic breathing systems supplied complete

13.3 For anaesthetic breathing system components

Annex A (normative) Typical test arrangements and methods

Annex В (informative) Rationale

Annex C (informative) Environmental aspects

Annex D (normative) Antistatic requirements

Bibliography

Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42 EEC