DIN EN ISO 10079-1:2016-05
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT (ISO 10079-1:2015)
Hardcopy , PDF
29-01-2021
German, English
01-05-2016
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National foreword
National Annex NA (informative) - Bibliography
European foreword
Annex ZA (informative) - Relationship between this European
Standard and the essential requirements of
Directive 93/42/EEC [OJ L 169] aimed to
be covered
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
This part of ISO 10079 specifies safety and performance requirements for electrically powered medical and surgical suction equipment.
| Committee |
TC 215
|
| DevelopmentNote |
DIN EN ISO 10079-1 issue 07-2009 remains valid alongside this standard until 30-11-2018. (06/2016) DRAFT AMD 1 issued in December 2016. (12/2016)
|
| DocumentType |
Standard
|
| Pages |
42
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN ISO 10079-1:2015 | Identical |
| NS EN ISO 10079-1 : 2015 | Identical |
| NBN EN ISO 10079-1 : 2015 | Identical |
| NEN EN ISO 10079-1 : 2015 | Identical |
| UNE-EN ISO 10079-1:2016 | Identical |
| BS EN ISO 10079-1:2015 | Identical |
| UNI EN ISO 10079-1 : 2009 | Identical |
| NF EN ISO 10079-1 : 2016 | Identical |
| ONORM EN ISO 10079-1 : 2016 | Identical |
| ISO 10079-1:2015 | Identical |
| I.S. EN ISO 10079-1:2015 | Identical |
| SN EN ISO 10079-1:2016 | Identical |
| DIN EN ISO 8836:2015-02 | Suction catheters for use in the respiratory tract (ISO 8836:2014); German version EN ISO 8836:2014 |
| DIN EN ISO 10079-3:2014-09 | Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014) |
| DIN EN ISO 10079-2:2014-09 | Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014); German version EN ISO 10079-2:2014 |
| DIN ISO 7000:2008-12 | Graphical symbols for use on equipment - Index and synopsis (ISO 7000:2004 + ISO 7000 Database:2008 up to ISO 7000-2750) |
| ISO 8836:2014 | Suction catheters for use in the respiratory tract |
| DIN EN ISO 15223-1:2015-08 (Draft) | MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03) |
| 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 |
| DIN EN 61672-1:2014-07 | ELECTROACOUSTICS - SOUND LEVEL METERS - PART 1: SPECIFICATIONS (IEC 61672-1:2013) |
| DIN EN ISO 10651-4:2009-08 | Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002) |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| DIN EN 60601-1-6 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010 + A1:2013) |
| 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 |
| DIN EN 62366 : 2016 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014) |
| 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 |
| DIN EN ISO 10079-3:2014-09 | Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014) |
| DIN EN ISO 14971:2013-04 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
| VDE 0750-1-6 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010 + A1:2013) |
| DIN EN ISO 3744:2011-02 | 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 (ISO 3744:2010) |
| 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 |
| VDE 0750-241 : 2016 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014) |
| 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 |
| DIN EN ISO 5356-1:2015-06 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 1: CONES AND SOCKETS (ISO 5356-1:2015) |
| IEC 60529:1989+AMD1:1999+AMD2:2013 CSV | Degrees of protection provided by enclosures (IP Code) |
| DIN EN ISO 14155:2012-01 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011 + COR. 1:2011) |
| DIN EN 60529 : 2014-09 | DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) (IEC 60529:1989 + A1:1999 + A2:2013) |
| ISO 10079-3:2014 | Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source |
| DIN EN ISO 10079-2:2014-09 | Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014); German version EN ISO 10079-2:2014 |
| 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 |
| DIN EN ISO 8836:2015-02 | Suction catheters for use in the respiratory tract (ISO 8836:2014); German version EN ISO 8836:2014 |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| VDE 0750-1 : 2013 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012) |
| VDE 0750-1-11 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT (IEC 60601-1-11:2015) |
| DIN EN 60601-1-12 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT (IEC 60601-1-12:2014) |
| VDE 0750-1-12 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT (IEC 60601-1-12:2014) |
| DIN EN 60601-1-11 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT (IEC 60601-1-11:2015) |
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