I.S. EN 1820:2005
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
Hardcopy , PDF
31-03-2020
English
01-01-2005
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.
Dates of withdrawal of national standards are available from NSAI.
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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Withdrawn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 |
| Standards | Relationship |
| NS EN 1820 : 2005 + A1 2009 | Identical |
| EN 1820:2005+A1:2009 | Identical |
| NBN EN 1820 : 2005 + A1 2009 | Identical |
| BS EN 1820:2005 | Identical |
| UNI EN 1820 : 2009 | Identical |
| UNE-EN 1820:2006 | Identical |
| SN EN 1820 : 2005 + A1 2010 | Identical |
| NEN EN 1820 : 2005 + A1 2009 | Identical |
| NF EN 1820 : 2005 + A1 2009 | 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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