UNI EN 1820 : 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

Describes requirements for antistatic and non-antistatic reservoir bags for use with anaesthetic apparatus or lung-ventilator breathing systems. Also covers requirements for the design of the neck, size designation, distension and, where relevant, for electrical resistance.