DIN EN 60601-1-1 : 2002

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MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS

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Withdrawn date: 11-21-2022

Language(s):

Published date: 01-12-2013

Publisher: Verband Deutscher Elektrotechniker

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Table of Contents - (Show below) - (Hide below)

VORWORT
ANERKENNUNGSNOTIZ
HAUPTABSCHNITT EINS - ALLGEMEINES
1 Anwendungsbereich und Zweck
   1.201 Anwendungsbereich
2 Begriffe und Begriffsbestimmungen
   2.201 KOPPLUNG
   2.202 INDIREKTES BERÜHREN
   2.203 MEDIZINISCHES ELEKTRISCHES SYSTEM
   2.204 PATIENTENUMGEBUNG
   2.205 TRENNVORRICHTUNG
3 Allgemeine Anforderungen
   3.201 Allgemeine Anforderungen an das SYSTEM
4 Allgemeines über die Prüfungen
   4.201 Allgemeines über die Prüfungen des SYSTEMS
6 Bezeichnungen, Aufschriften und Begleitpapiere
          6.1.201 Aufschriften
          6.8.201 BEGLEITPAPIERE
HAUPTABSCHNITT ZWEI - UMWELTBEDINGUNGEN
HAUPTABSCHNITT DREI - SCHUTZ GEGEN DIE GEFAHR EINES
ELEKTRISCHEN SCHLAGES
16 GEHÄUSE und SCHUTZABDECKUNGEN
   16.201 GEHÄUSE
17 Trennung
   17.201 Elektrische Trennung
19 Dauer-ABLEIT- und PATIENTENHILFSSTRÖME
   19.201 ABLEITSTRÖME
          19.201.1 GEHÄUSEABLEITSTROM
          19.201.2 PATIENTENABLEITSTROM
          19.201.3 Anschluss von SIGNALEINGANGSTEILEN Oder
                   SIGNALAUSGANGSTEILEN
HAUPTABSCHNITT VIER - SCHUTZ GEGEN MECHANISCHE GEFÄHRDUNG
22 Bewegte Teile
          22.7.201 Schutzvorrichtung
HAUPTABSCHNITT FÜNF - SCHUTZ GEGEN GEFAHREN DURCH
UNERWÜNSCHTE ODER ÜBERMÄSSIGE STRAHLUNG
HAUPTABSCHNITT SECHS - SCHUTZ GEGEN GEFAHREN DURCH
ZÜNDUNG BRENNBARER GEMISCHE
HAUPTABSCHNITT SIEBEN - SCHUTZ GEGEN ÜBERMÄSSIGE
TEMPERATUREN UND ANDERE GEFÄHRDUNGEN
   43.201 Brandverhütung
          44.7.201 Reinigung, Sterilisation und Desinfektion
   49.201 Unterbrechung der Stromversorgung
HAUPTABSCHNITT ACHT - GENAUIGKEIT DER BETRIEBSDATEN UND
SCHUTZ GEGEN GEFÄHRDENDE AUSGANGSWERTE
HAUPTABSCHNITT NEUN - NICHT BESTIMMUNGSGEMÄSSER BETRIEB
UND FEHLERFÄLLE; UMWELTPRÜFUNGEN
HAUPTABSCHNITT ZEHN - KONSTRUKTIVE ANFORDERUNGEN
          56.3.201 Verbindungen
   58.201 SCHUTZLEITERANSCHLUSS
   59.201 Schutz der Leitungen
BILDER
   201: PATIENTENUMGEBUNG
   202: Bildzeichen 14, Tabelle D1, Anhang D der IEC 601-1
ANHÄNGE
AAA (informativ) Allgemeine Erklärung und Begründung
BBB (informativ) Kombinationsbeispiele von MEDIZINISCHEN
    ELEKTRISCHEN GERÄTEN und nichtmedizinischen elektrischen
    Geräten
ZA (normativ) Andere in dieser Norm zitierte internationale
    Publikationen mit den Verweisungen auf die entsprechenden
    europäischen Publikationen
ZB (informativ) Literaturhinweise

Abstract - (Show below) - (Hide below)

Describes the safety requirements for medical electrical systems to give protection for the patient, the operator and surroundings. Coverage includes environmental conditions, protection against electric shock hazards, protection against mechanical hazards, protection against hazards from unwanted or excessive radiation, protection against hazards of ignition of flammable anaesthetic mixtures, protection against excessive temperatures and other safety hazards, accuracy of operating data and protection against hazardous output, abnormal operation and fault conditions, and constructional requirements. Also includes annexes and diagrams.

General Product Information - (Show below) - (Hide below)

Document Type	Standard
ISBN
Pages
Published
Publisher	Verband Deutscher Elektrotechniker
Status	Withdrawn

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
I.S. EN 60601-1-1:2001	Identical
BS EN 60601-1-1:2001	Identical
EN 60601-1-1:2001	Identical
UNE-EN 60601-1-1:2002	Identical
SN EN 60601-1-1 : 2001	Identical
NF EN 60601-1-1 : 2001	Identical
IEC 60601-1-1:2000	Identical
VDE 0750-1-1 : 2002	Corresponds
VDE 0750-1-1 : 2002	Identical

Standards Referenced By This Book - (Show below) - (Hide below)

DIN EN 60601-2-40 : 1998	MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROMYGRAPHS AND EVOKED RESPONSE EQUIPMENT
DIN EN ISO 15254:2009-10	Ophthalmic optics and instruments - Electro-optical devices for enhancing low vision (ISO 15254:2009)
DIN EN ISO 21649:2010-01	Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)
DIN EN 60601-2-7 : 2000	MEDICAL ELECTRICAL EQUIPMENT - PART 2-7: PARTICULAR REQUIREMENTS FOR THE SAFETY OF HIGH-VOLTAGE GENERATORS OF DIAGNOSTIC X-RAY GENERATORS
DIN EN ISO 17510-2:2009-07	SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES
DIN EN ISO 17510-1:2009-07	Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)
DIN EN ISO 11608-4:2016-03 (Draft)	PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS
DIN EN ISO 10651-2:2011-06	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
VDE 0750-2-7 : 2000	MEDICAL ELECTRICAL EQUIPMENT - PART 2-7: PARTICULAR REQUIREMENTS FOR THE SAFETY OF HIGH-VOLTAGE GENERATORS OF DIAGNOSTIC X-RAY GENERATORS
DIN EN 60601-2-35 : 1997	MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF BLANKETS, PADS AND MATTRESSES, INTENDED FOR HEATING IN MEDICAL USE
DIN EN ISO 10651-6:2011-06	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
DIN EN ISO 12866:2009-03	OPHTHALMIC INSTRUMENTS - PERIMETERS
VDE 0750-2-40 : 1998	MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT
DIN EN ISO 8835-5:2009-07	INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHESIA VENTILATORS
DIN EN ISO 21649 E : 2010	NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS
DIN EN ISO 16201:2006-12	Technical aids for persons with disability - Environmental control systems for daily living (ISO 16201:2006)
DIN EN ISO 15004-1:2009-07	Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006); German version EN ISO 15004-1:2009

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