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I.S. EN 1820:2005

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

ANAESTHETIC RESERVOIR BAGS
Available format(s)

Hardcopy , PDF

Withdrawn date

03-31-2020

Language(s)

English

Published date

01-01-2005

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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 result
Annex B (normative) Determination of capacity
  B.1 Principle
  B.2 Apparatus
  B.3 Procedure
  B.4 Expression of result
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.1 Principle
  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 result
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. It includes requirements for the design of the neck, size designation, distension and, where relevant, for electrical resistance.

DevelopmentNote
2005 Edition Re-issued in September 2009 & incorporates AMD 1 2009. (09/2009)
DocumentType
Standard
Pages
22
PublisherName
National Standards Authority of Ireland
Status
Withdrawn
Supersedes

EN ISO 4287:1998/A1:2009 GEOMETRICAL PRODUCT SPECIFICATIONS (GPS) - SURFACE TEXTURE: PROFILE METHOD - TERMS, DEFINITIONS AND SURFACE TEXTURE PARAMETERS
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)
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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
EN 980:2008 Symbols for use in the labelling of medical devices

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