I.S. EN ISO 10079-2:2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 2: MANUALLY POWERED SUCTION EQUIPMENT (ISO 10079-2:2014)
Hardcopy , PDF
06-22-2022
English
01-01-2014
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.
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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
Describes safety and performance requirements for manually powered suction equipment intended for oro-pharyngeal suction.
| DocumentType |
Standard
|
| Pages |
36
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| UNI EN ISO 10079-2 : 2014 | Identical |
| NF EN ISO 10079-2 : 2014 | Identical |
| UNE-EN ISO 10079-2:2014 | Identical |
| EN ISO 10079-2:2014 | Identical |
| ISO 10079-2:2014 | Identical |
| NBN EN ISO 10079-2 : 2014 | Identical |
| NEN EN ISO 10079-2 : 2014 | Identical |
| BS EN ISO 10079-2:2014 | Identical |
| DIN EN ISO 10079-2:2014-09 | Identical |
| SN EN ISO 10079-2:2014 | Identical |
| NS EN ISO 10079-2 : 2014 | Identical |
| DIN EN ISO 10079-2:2000-03 | Identical |
| ONORM EN ISO 10079-2 : 2014 | Identical |
| ISO 8836:2014 | Suction catheters for use in the respiratory tract |
| 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 |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| ISO 10079-3:2014 | Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
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