UNI EN 1820 : 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
ANAESTHETIC RESERVOIR BAGS
16-08-2022
01-01-2009
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.
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| 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 |
| 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 (ISO 4135:2001) |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
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