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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
06-14-2022
05-07-2014
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
ISO 10079-2:2014 specifies safety and performance requirements for medical, manually powered suction equipment intended for oro-pharyngeal suction. It covers equipment operated by foot or by hand or both. Annex C illustrates the three parts of ISO 10079 by providing a schematic for typical systems.ISO 10079-2:2014 has additional requirements for suction equipment intended for field use or transport use.
| Committee |
CEN/TC 215
|
| DevelopmentNote |
Supersedes PREN ISO 10079-2. (05/2009)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 10079-2:2000-03 | Identical |
| ONORM EN ISO 10079-2 : 2014 | Identical |
| I.S. EN ISO 10079-2:2014 | Identical |
| UNI EN ISO 10079-2 : 2014 | Identical |
| NF EN ISO 10079-2 : 2014 | Identical |
| ISO 10079-2:2014 | Identical |
| NS EN ISO 10079-2 : 2014 | Identical |
| PN EN ISO 10079-2 : 2014 | Identical |
| UNE-EN 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 |
| I.S. EN 740:1999 | ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS |
| 12/30266576 DC : 0 | BS EN 13718-2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS OF AIR AMBULANCES |
| EN 13718-2:2015 | Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances |
| BS 5724-2.204(1999) : 1999 | ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS |
| UNE-EN 13976-2:2011 | Rescue systems - Transportation of incubators - Part 2: System requirements |
| DIN EN 1789:2014-12 | MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
| UNI EN 13976-2 : 2011 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| DIN EN 13718-2:2015-05 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
| UNE-EN 13718-2:2015 | Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances |
| I.S. EN 1789:2007 | MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
| EN 1789:2007+A2:2014 | Medical vehicles and their equipment - Road ambulances |
| PREN 13976-2 : DRAFT 2016 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| 16/30333925 DC : 0 | BS EN 13976-2 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| I.S. EN 13976-2:2011 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| BS EN 13976-2:2011 | Rescue systems. Transportation of incubators System requirements |
| BS EN 1789 : 2007 | MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
| UNE-EN 1789:2007 | Medical vehicles and their equipment - Road ambulances |
| BS EN 13718-2:2015 | Medical vehicles and their equipment. Air ambulances Operational and technical requirements for air ambulances |
| BS EN 740:1999 | Anaesthetic workstations and their modules. Particular requirements |
| I.S. EN 13718-2:2015 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
| DIN EN 13976-2 E : 2011 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| I.S. EN 13718-2:2015+A1:2020 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
| EN 740:1998/A1:2004 | ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS |
| EN 13976-2:2011 | Rescue systems - Transportation of incubators - Part 2: System requirements |
| DIN EN 13976-2:2016-03 (Draft) | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| DIN EN 13976-2:2011-08 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| UNI EN 1789 : 2014 | MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
| 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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