I.S. EN ISO 7396-2:2007
Current
The latest, up-to-date edition.
MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS
Hardcopy , PDF
English
01-01-2007
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
4.1 Safety
4.2 Alternative construction
4.3 Materials
4.4 Continuity of operation
5 Power device
6 Indicating systems
7 Pipelines, connecting assemblies and disposal
hoses
8 Disposal system characteristics and test methods
for pressure and flow
8.1 Requirements
8.2 Test methods for pressure and flow
8.3 Means to prevent backflow
9 Terminal units
10 Marking and colour coding
10.1 Marking
10.2 Colour coding
10.3 Test for durability
11 Pipeline installation
12 Testing, commissioning and certification
12.1 General
12.2 General requirements for tests
12.3 Tests, inspections and checks
12.4 Requirements for tests, inspections and
checks listed in 12.3
12.5 Certification of the system
12.6 Extensions or modifications
13 Information to be supplied by the manufacturer
13.1 General
13.2 Instructions for use
13.3 Operational management information
13.4 "As-installed" drawings
13.5 Electrical diagrams
Annex A (informative) Guidelines for power devices
consisting of fans, blowers or dedicated
vacuum pumps
Annex B (informative) Example of procedure for
testing and commissioning
Annex C (informative) Typical forms for certification
of AGS disposal systems
Annex D (informative) Risk management checklist
Annex E (informative) Rationale
Annex ZA (informative) Relationship between this International
Standard and the Essential Requirements of EU
Directive 93/42/EC on Medical devices
Bibliography
Describes requirements for the design, installation, function, performance, documentation, testing and commissioning of anaesthetic gas scavenging disposal systems to ensure patient safety and to minimize exposure of the operator and other persons to anaesthetic gases and vapours.
| DevelopmentNote |
Supersedes I.S. EN 737-2 and I.S. ISO 7396. (06/2007)
|
| DocumentType |
Standard
|
| Pages |
58
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 7396-2:2007-07 | Identical |
| NBN EN ISO 7396-2 : 2007 | Identical |
| ISO 7396-2:2007 | Identical |
| BS EN ISO 7396-2:2007 | Identical |
| EN ISO 7396-2:2007 | Identical |
| NF EN ISO 7396-2 : 2009 | Identical |
| NEN EN ISO 7396-2 : 2007 | Identical |
| NS EN ISO 7396-2 : 1ED 2007 | Identical |
| UNE-EN ISO 7396-2:2007 | Identical |
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