Name: UNI EN 1820 : 2009
Brand: UNI

UNI EN 1820 : 2009

Superseded

View Superseded by

ANAESTHETIC RESERVOIR BAGS

Superseded date

08-16-2022

Published date

01-01-2009

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

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.

DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
SupersededBy	UNI EN ISO 5362 : 2020
Supersedes	UNI EN 1820 : 2005

Standards	Relationship
I.S. EN 1820:2005	Identical
BS EN 1820:2005	Identical
UNE-EN 1820:2006	Identical
NEN EN 1820 : 2005 + A1 2009	Identical
NS EN 1820 : 2005 + A1 2009	Identical
EN 1820:2005+A1:2009	Identical
NF EN 1820 : 2005 + A1 2009	Identical
NBN EN 1820 : 2005 + A1 2009	Identical
SN EN 1820 : 2005 + A1 2010	Identical
DIN EN 1820:2009-12	Identical

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