UNE-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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
21-12-2022
Spanish, Castilian, English
19-11-2014
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1. Scope
2. Normative references
3. Terms and definitions
4. Cleaning and sterilization
5. Design requirements
6. Operational requirements
7. Physical requirements
8. Performance requirements for vacuum and flowrate
9. Resistance to environment
10. Marking
11. Information to be supplied by manufacturer
Annexes
A. (normative) Test methods
B. (informative) Table of typical range of volumes for
collection containers for specific uses
C. (informative) Rationale statement
Defines safety and performance requirements for manually powered medical suction equipment for oro-pharyngeal suction for establishing and maintaining the patency of the airway. Describes hand or foot operated equipment. Also includes non-electrical suction equipment which may be integrated with electrical equipment.
| Committee |
CTN 110
|
| DocumentType |
Standard
|
| Pages |
32
|
| PublisherName |
Asociacion Espanola de Normalizacion
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ONORM EN ISO 10079-2 : 2014 | Identical |
| DIN EN ISO 10079-2:2000-03 | Identical |
| ISO 10079-2:2014 | Identical |
| NBN EN ISO 10079-2 : 2014 | Identical |
| NEN EN ISO 10079-2 : 2014 | Identical |
| NS EN ISO 10079-2 : 2014 | Identical |
| I.S. EN ISO 10079-2:2014 | Identical |
| SN EN ISO 10079-2:2014 | Identical |
| UNI EN ISO 10079-2 : 2014 | Identical |
| BS EN ISO 10079-2:2014 | Identical |
| EN ISO 10079-2:2014 | Identical |
| NF EN ISO 10079-2 : 2014 | Identical |
| DIN EN ISO 10079-2:2014-09 | 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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