DIN EN 60601-2-35 : 1997
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF BLANKETS, PADS AND MATTRESSES, INTENDED FOR HEATING IN MEDICAL USE
01-08-2010
12-01-2013
Vorwort
Einführung
HAUPTABSCHNITT EINS - ALLGEMEINES
1 Anwendungsbereich und Zweck
2 Begriffe und Definitionen
3 Allgemeine Anforderungen
5 Einteilung der Geräte (Klassifikation)
6 Bezeichnungen, Aufschriften und Begleitpapiere
HAUPTABSCHNITT ZWEI - UMWELTBEDINGUNGEN
HAUPTABSCHNITT DREI - SCHUTZ GEGEN DIE GEFAHR EINES
ELEKTRISCHEN SCHLAGES
17 Trennung
19 Dauer-Ableit- und Patientenhilfsströme
HAUPTABSCHNITT VIER - SCHUTZ GEGEN MECHANISCHE GEFÄHRDUNG
21 Mechanische Festigkeit
HAUPTABSCHNITT FÜNF - SCHUTZ GEGEN GEFAHREN DURCH
UNERWÜNSCHTE ODER ÜBERMÄSSIGE STRAHLUNG
36 Elektromagnetische Verträglichkeit
HAUPTABSCHNITT SECHS - SCHUTZ GEGEN EXPLOSIONSGEFAHREN
IN MEDIZINISCH GENUTZTEN RÄUMEN
HAUPTABSCHNITT SIEBEN - SCHUTZ GEGEN ÜBERMÄSSIGE
TEMPERATUREN UND ANDERE GEFÄHRDUNGEN
42 Übermässige Temperaturen
44 Überlaufen, Verschütten, Auslaufen, Luftfeuchte,
Eindringen von Flüssigkeiten, Reinigung, Sterilisation,
Desinfektion und Verträglichkeit
46 Menschliches Versagen
49 Unterbrechung der Stromversorgung
HAUPTABSCHNITT ACHT - GENAUIGKEIT DER BETRIEBSDATEN
UND SCHUTZ GEGEN GEFÄHRDENDE AUSGANGSWERTE
50 Genauigkeit der Betriebsdaten
51 Schutz gegen gefährdende Ausgangswerte
HAUPTABSCHNITT NEUN - NICHT BESTIMMUNGSGEMÄSSER BETRIEB
UND FEHLERFÄLLE; UMWELTPRÜFUNGEN
52 Nicht bestimmungsgemässer Betrieb und Fehlerfälle
HAUPTABSCHNITT ZEHN - KONSTRUKTIVE ANFORDERUNGEN
54 Allgemeines
56 Bauteile und Allgemeines zum Zusammenbau
57 Netzteile, Bauteile und Ausführung
59 Aufbau und Anordnung
Bilder
Anhänge
Anhang AA (informativ) Allgemeine Erklärung und Begründung
Anhang BB (normativ) Merkmale des Isoliermaterials
Anhang CC (normativ) Verfahren zur Bestimmung, ob eine
Wärmeeinrichtung eine hohe oder geringe
Wärmeübertragung von der Wärmequelle zur
Kontaktoberfläche (das heisst hin zum Patienten)
aufweist
Anhang DD (normativ) Verfahren zur Bestimmung, ob eine
Wärmeeinrichtung eine hohe oder geringe
Wärmeübertragung von der Kontaktoberfläche zur
Wärmequelle (das heisst weg vom Patienten) aufweist
Anhang EE (normativ) Bedingungen einer angemessenen
Wärmeabgabe
Anhang ZA (normativ) Normative Verweisungen auf internationale
Publikationen mit Ihren entsprechenden europäischen
Publikationen
Anhang ZB (informativ) Andere in dieser Norm zitierte
internationale Publikationen mit ihren entsprechenden
europäischen Publikationen
Defines requirements for blankets, pads and mattresses, includes air flotation mattresses and forced air systems. ALSO NUMBERED AS BS 5724 SECTION 2.35 1997
| DocumentType |
Standard
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| UNE-EN 60601-2-35:1997 | Identical |
| BS EN 60601-2-35:1997 | Identical |
| I.S. EN 60601-2-35:1998 | Identical |
| EN 60601-2-35:1996 | Identical |
| IEC 60601-2-35:1996 | Identical |
| SN EN 60601-2-35 : 1996 | Identical |
| EN 60601-2-20:2009/A1:2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-20: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT TRANSPORT INCUBATORS (IEC 60601-2-20:2009/A1:2016) |
| IEC 60601-2-21:2009+AMD1:2016 CSV | Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers |
| IEC 60601-2-19:2009+AMD1:2016 CSV | Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators |
| IEC 60384-14:2013+AMD1:2016 CSV | Fixed capacitors for use in electronic equipment - Part 14: Sectional specification - Fixed capacitors for electromagnetic interference suppression and connection to the supply mains |
| DIN EN 60601-1-1 : 2002 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS |
| ISO 3743-2:1994 | Acoustics Determination of sound power levels of noise sources using sound pressure Engineering methods for small, movable sources in reverberant fields Part 2: Methods for special reverberation test rooms |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| DIN EN 60601-1-3 : 2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008 + A1:2013) |
| VDE 0847-4-6 : 2014 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-6: TESTING AND MEASUREMENT TECHNIQUES - IMMUNITY TO CONDUCTED DISTURBANCES, INDUCED BY RADIO-FREQUENCY FIELDS (IEC 61000-4-6:2013) |
| VDE 0750-1-2 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES REQUIREMENTS AND TESTS (IEC 60601-1-2:2014) |
| EN 60601-2-19:2009/A1:2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-19: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT INCUBATORS (IEC 60601-2-19:2009/A1:2016) |
| IEC 60601-2-20:2009+AMD1:2016 CSV | Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transportincubators |
| EN 60601-1-1:2001 | Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
| VDE 0725-1 : 1992 AMD 2 1998 | SAFETY OF ELECTRICALLY HEATED BLANKETS, PADS AND SIMILAR FLEXIBLE HEATING APPLIANCES FOR HOUSEHOLD USE |
| IEC 61000-4-6:2013 | Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| EN 60601-1-2:2015 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| DIN EN 61000-4-6 : 2014 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-6: TESTING AND MEASUREMENT TECHNIQUES - IMMUNITY TO CONDUCTED DISTURBANCES, INDUCED BY RADIO-FREQUENCY FIELDS (IEC 61000-4-6:2013) |
| EN 60601-2-21:2009/A1:2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS (IEC 60601-2-21:2009/A1:2016) |
| DIN VDE 0725-1 : 1992 | SAFETY OF ELECTRICALLY HEATED BLANKETS, PADS AND SIMILAR FLEXIBLE HEATING APPLIANCES FOR HOUSEHOLD USE |
| VDE 0625-1 : 2016 | APPLIANCE COUPLERS FOR HOUSEHOLD AND SIMILAR GENERAL PURPOSES - PART 1: GENERAL REQUIREMENTS (IEC 60320-1:2015 + COR1:2016) |
| DIN 49440-6:1989-12 | TWO-POLE SOCKET-OUTLETS WITH EARTHING CONTACT, 10 A 250 V D.C., 16 A 250 V A.C., FOR SURFACE MOUNTING AND AS PORTABLE TYPE; DIMENSIONS |
| ISO 2439:2008 | Flexible cellular polymeric materials Determination of hardness (indentation technique) |
| VDE 0750-1-1 : 2002 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY; 1 COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS |
| DIN 53576:1984-01 | TESTING OF FLEXIBLE CELLULAR MATERIALS; HARDNESS TESTING BY INDENTATION TECHNIQUES |
| EN 61000-4-6:2014/AC:2015 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-6: TESTING AND MEASUREMENT TECHNIQUES - IMMUNITY TO CONDUCTED DISTURBANCES, INDUCED BY RADIO-FREQUENCY FIELDS (IEC 61000-4-6:2013) |
| DIN EN 60320-1 : 2016 | APPLIANCE COUPLERS FOR HOUSEHOLD AND SIMILAR GENERAL PURPOSES - PART 1: GENERAL REQUIREMENTS (IEC 60320-1:2015 + COR1:2016) |
| DIN 49440-1:2006-01 | TWO-POLE SOCKET-OUTLETS WITH EARTHING CONTACT, 16 A 250 V A.C. - PART 1: MAIN DIMENSIONS |
| 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) |
| IEC 60601-1-1:2000 | Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
| DIN EN ISO 3743-2:2009-11 | Acoustics - Determination of sound power levels of noise sources using sound pressure - Engineering methods for small, movable sources in reverberant fields - Part 2: Methods for special reverberation test rooms (ISO 3743-2:1994) |
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