EN 1820:2005+A1:2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Prevention of electrostatic charges
6 Requirements for bags supplied sterile
7 Marking
8 Information to be supplied by the manufacturer
Annex A (informative) - Test for leakage
      A.1 Principle
      A.2 Apparatus
      A.3 Procedure
      A.4 Expression of results
Annex B (normative) - Determination of capacity
      B.1 Principle
      B.2 Apparatus
      B.3 Procedure
      B.4 Expression of results
Annex C (normative) - Test for security of attachment of
        plain neck to 22 mm male conical connector
      C.1 Principle
      C.2 Apparatus and materials
      C.3 Procedure
Annex D (normative) - Test for security of attachment of
        adaptor of assembled neck to bag
      D.2 Apparatus
      D.3 Procedure
Annex E (normative) - Test for resistance to pressure
        required to distend the bag (pressure/volume)
      E.1 Principle
      E.2 Apparatus
      E.3 Procedure
      E.4 Expression of results
Annex F (informative) - Test for resistance to pressure
        required to distend the bag using air (pressure/volume)
      F.1 Principle
      F.2 Apparatus
      F.3 Procedure
      F.4 Expression of results
Annex G (informative) - Recommendations for materials
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC Medical devices
Bibliography

This European Standard specifies requirements for antistatic and non-antistatic reservoir bags for use with anaesthetic apparatus or lung-ventilator breathing systems. It includes requirements for the design of the neck, size designation, distension and, where relevant, for electrical resistance.This document is not applicable to special-purpose bags, for example bellows and self-expanding bags. Bags for use with anaesthetic gas scavenging systems are not considered to be anaesthetic reservoir bags and are thus outside the scope of this document.