I.S. EN ISO 10079-1:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 1: ELECTRICALLY POWERED SUCTION EQUIPMENT (ISO 10079-1:2015)
Hardcopy , PDF
06-08-2019
01-01-2015
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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National Foreword
European foreword
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 suction equipment
for field use
9 Performance requirements for vacuum level
and flowrate
10 Resistance to environment of suction equipment
for field and/or transport use
11 Information to be supplied by the manufacturer
(labelling and instructions for use)
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 Directive 93/42/EEC [OJ L 169]
aimed to be covered
Defines safety and performance requirements for electrically powered medical and surgical suction equipment.
| DocumentType |
Standard
|
| Pages |
52
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NF EN ISO 10079-1 : 2016 | Identical |
| DIN EN ISO 10079-1:2016-05 | Identical |
| NS EN ISO 10079-1 : 2015 | Identical |
| ONORM EN ISO 10079-1 : 2016 | Identical |
| ISO 10079-1:2015 | Identical |
| NBN EN ISO 10079-1 : 2015 | Identical |
| NEN EN ISO 10079-1 : 2015 | Identical |
| EN ISO 10079-1:2015 | Identical |
| UNE-EN ISO 10079-1:2016 | Identical |
| BS EN ISO 10079-1:2015 | Identical |
| SN EN ISO 10079-1:2016 | Identical |
| UNI EN ISO 10079-1 : 2009 | 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 |
| 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 |
| IEC TR 60878:2015 | Graphical symbols for electrical equipment in medical practice |
| ISO 10079-2:2014 | Medical suction equipment Part 2: Manually powered suction equipment |
| IEC 60529:1989+AMD1:1999+AMD2:2013 CSV | Degrees of protection provided by enclosures (IP Code) |
| 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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