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EN 1820:2005+A1:2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 (ISO 5362:2000, modified)
Superseded date

03-08-2022

Published date

08-12-2009

Publisher

Comite Europeen de Normalisation

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.

Committee
CEN/TC 215
DevelopmentNote
2005 Edition Re-issued in August 2009 & incorporates AMD 1 2009. (09/2009)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

I.S. EN 740:1999 ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS
BS EN 794-2:1997 Lung ventilators Particular requirements for home care use
BS 5724-2.204(1999) : 1999 ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS
DIN EN 794-1:2001-02 LUNG VENTILATORS - PART 1: PARTICULAR REQUIREMENTS FOR CRITICAL CARE VENTILATORS
I.S. EN 794-3:1998 LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS
UNI EN 794-3 : 2009 LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS
PREN ISO 15883-2 : DRAFT 2002 WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, HOLLOWWARE, UTENSILS, GLASSWARE, ETC
BS EN 794-3 : 1999 LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS
BS EN 740:1999 Anaesthetic workstations and their modules. Particular requirements
EN 740:1998/A1:2004 ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS
EN 794-3:1998+A2:2009 Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
03/700194 DC : DRAFT FEB 2003 BS EN ISO 15883-2 - WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, HOLLOWWARE, UTENSILS, GLASSWARE, ETC.
DIN EN 794-3:2009-12 Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators; German version EN 794-3:1998+A2:2009
UNE-EN 794-3:1999 LUNG VENTILATORS. PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS.

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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