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DIN EN 1820:2009-12

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

ANAESTHETIC RESERVOIR BAGS

Available format(s)

Hardcopy , PDF

Superseded date

07-03-2021

Language(s)

English

Published date

01-01-2009

€99.44
Excluding VAT

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
Annex B (normative) Determination of capacity
Annex C (normative) Test for security of attachment
         of plain neck to 22 mm male conical connector
Annex D (normative) Test for security of attachment of
         adaptor of assembled neck to bag
Annex E (normative) Test for resistance to pressure
         required to distend the bag (pressure/volume)
Annex F (informative) Test for resistance to pressure
         required to distend the bag using air (pressure/volume)
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

Defines requirements for antistatic and non-antistatic reservoir bags for use with anaesthetic apparatus or lung-ventilator breathing systems.

DocumentType
Standard
Pages
22
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded

ISO 4287:1997 Geometrical Product Specifications (GPS) — Surface texture: Profile method — Terms, definitions and surface texture parameters
EN ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015)
ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO 11607:2003 Packaging for terminally sterilized medical devices
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
EN ISO 4135:2001 Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001)
EN 980:2008 Symbols for use in the labelling of medical devices

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