I.S. EN ISO 10079-3:2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE (ISO 10079-3:2014)
Hardcopy , PDF
English
01-01-2014
23-06-2022
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.
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Cleaning, disinfection and sterilization
6 Design requirements
7 Operational requirements
8 Physical requirements for field and
transport use suction equipment
9 Performance requirements for vacuum
level and flowrate
10 Resistance to environment of suction equipment
for field and/or transport use
11 Marking
12 Information to be supplied by the
manufacturer
Annex A (normative) - Test methods
Annex B (informative) - Rationale statement
Annex C (informative) - Lumen size and its effect
on flowrate
Annex D (informative) - Schematic of suction
equipment
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42/EEC
Provides safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source generating venturi suction.
| DevelopmentNote |
2014 Edition incorporates corrigendum. (08/2014)
|
| DocumentType |
Standard
|
| Pages |
50
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NS EN ISO 10079-3 : 2014 | Identical |
| BS EN ISO 10079-3:2014 | Identical |
| NF EN ISO 10079-3 : 2014 | Identical |
| NEN EN ISO 10079-3 : 2014 | Identical |
| DIN EN ISO 10079-3:2014-09 | Identical |
| EN ISO 10079-3:2014 | Identical |
| NBN EN ISO 10079-3 : 2014 | Identical |
| ISO 10079-3:2014 | Identical |
| DIN EN ISO 10079-3:2000-03 | Identical |
| ONORM EN ISO 10079-3 : 2014 | Identical |
| UNE-EN ISO 10079-3:2014 | Identical |
| ISO 8836:2014 | Suction catheters for use in the respiratory tract |
| ISO 3744:2010 | Acoustics — Determination of sound power levels and sound energy levels of noise sources using sound pressure — Engineering methods for an essentially free field over a reflecting plane |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| IEC 60601-1-6:2010+AMD1:2013 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| ISO 5356-1:2015 | Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets |
| ISO 10651-4:2002 | Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators |
| ISO 10079-1:2015 | Medical suction equipment — Part 1: Electrically powered suction equipment |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| ISO 5359:2014 | Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| ISO 10079-2:2014 | Medical suction equipment — Part 2: Manually powered suction equipment |
| CGA V 5 : 2008(R2013) | DIAMETER INDEX SAFETY SYSTEM (NON-INTERCHANGEABLE LOW PRESSURE CONNECTIONS FOR MEDICAL GAS APPLICATIONS) |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects — Good clinical practice |
| ISO 9170-1:2017 | Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO 7000:2014 | Graphical symbols for use on equipment — Registered symbols |
| ISO 10524-1:2006 | Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices |
| ISO 15223-1:2016 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements |
| ISO 7396-1:2016 | Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum |
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