CEI EN 60601-1-1 : 2003
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
Hardcopy , PDF
13-06-2020
English - Italian
01-01-2003
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SECTION 1 - GENERAL
1 SCOPE AND OBJECT
2 TERMINOLOGY AND DEFINITIONS
3 GENERAL REQUIREMENTS
6 IDENTIFICATION, MARKING AND
DOCUMENTS
SECTION 2 - ENVIRONMENTAL CONDITIONS
10 ENVIRONMENTAL CONDITIONS
SECTION 3 - PROTECTION AGAINST
ELECTRIC SHOCK HAZARDS
16 ENCLOSURES AND PROTECTIVE
COVERS
17 SEPARATION
19 CONTINUOUS LEAKAGE CURRENTS
AND PATIENT AUXILIARY CURRENTS
SECTION 4 - PROTECTION AGAINST
MECHANICAL HAZARDS
22 MOVING PARTS
SECTION 5 - PROTECTION AGAINST
HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
SECTION 6 - PROTECTION AGAINST
HAZARDS OF IGNITION OF
FLAMMABLE ANAESTHETIC
MIXTURES
SECTION 7 - PROTECTION AGAINST
EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
44 OVERFLOW, SPILLAGE, LEAKAGE, HUMIDITY,
INGRESS OF LIQUIDS, CLEANING,
STERILIZATION, DISINFECTION
AND COMPATIBILITY
49 INTERRUPTION OF THE POWER SUPPLY
SECTION 8 - ACCURACY OF OPERATING
DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
SECTION 9 - ABNORMAL OPERATION AND
FAULT CONDITIONS; ENVIRONMENTAL
TESTS
52 ABNORMAL OPERATION AND FAULT
CONDITIONS
SECTION 10 - CONSTRUCTIONAL
REQUIREMENTS
56 COMPONENTS AND GENERAL
ASSEMBLY
57 MAINS PARTS, COMPONENTS
AND LAYOUT
58 PROTECTIVE EARTHING - TERMINALS
AND CONNECTION
59 CONSTRUCTION AND LAYOUT
ANNEX AAA - GENERAL GUIDANCE
AND RATIONALE
ANNEX BBB - EXAMPLES OF
COMBINATIONS OF MEDICAL
ELECTRICAL EQUIPMENT AND
NON-MEDICAL ELECTRICAL
EQUIPMENT
ANNEX ZA (normative) - Normative
references to international
publications with their
corresponding European
publications
Bibliography
ANNEX EEE - REQUIREMENTS FOR MULTIPLE
PORTABLE SOCKET-OUTLETS
ANNEX FFF - EXAMPLES OF APPLICATION
OF MULTIPLE PORTABLE
SOCKET-OUTLETS
Describes the safety requirements necessary to provide protection for the PATIENT, the OPERATOR and surroundings.
| Committee |
CT 62
|
| DevelopmentNote |
Classificazione CEI 62-51 (09/2001)
|
| DocumentType |
Standard
|
| Pages |
38
|
| PublisherName |
Comitato Elettrotecnico Italiano
|
| Status |
Withdrawn
|
| Standards | Relationship |
| EN 60601-1-1:2001 | Identical |
| IEC 60601-1-1:2000 | Identical |
| EN 60825-1:2014/AC:2017-06 | SAFETY OF LASER PRODUCTS - PART 1: EQUIPMENT CLASSIFICATION AND REQUIREMENTS (IEC 60825-1:2014) |
| EN 60065:2014/AC:2017-01 | AUDIO, VIDEO AND SIMILAR ELECTRONIC APPARATUS - SAFETY REQUIREMENTS (IEC 60065:2014/COR2:2016) |
| IEC 60950:1999 | Safety of information technology equipment |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| IEC 60884-1:2002+AMD1:2006+AMD2:2013 CSV | Plugs and socket-outlets for household and similar purposes - Part1: General requirements |
| ISO 8359:1996 | Oxygen concentrators for medical use Safety requirements |
| EN 60950:2000/corrigendum:2002 | SAFETY OF INFORMATION TECHNOLOGY EQUIPMENT |
| ISO 7767:1997 | Oxygen monitors for monitoring patient breathing mixtures — Safety requirements |
| IEC 60825-1:2014 | Safety of laser products - Part 1: Equipment classification and requirements |
| CEI 76-2 : 1ED 1989 | APPARECCHI LASER - SICUREZZA DALLE RADIAZIONI, CLASSIFICAZIONE DEI MATERIALI E PRESCRIZIONI |
| ISO 9918:1993 | Capnometers for use with humans Requirements |
| ISO 10079-1:2015 | Medical suction equipment Part 1: Electrically powered suction equipment |
| CEI 96-1 : 1ED 1998 | |
| ISO 8185:2007 | Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems |
| CEI 23-50 : 2007 | PLUGS AND SOCKET-OUTLETS FOR HOUSEHOLD AND SIMILAR PURPOSES GENERAL REQUIREMENTS |
| IEC 60529:1989+AMD1:1999+AMD2:2013 CSV | Degrees of protection provided by enclosures (IP Code) |
| IEC 60989:1991 | Separating transformers, autotransformers, variable transformersand reactors. |
| CEI 70-1 : 1980 COR 1993 | |
| EN 60335-1:2012/A13:2017 | HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 1: GENERAL REQUIREMENTS (IEC 60335-1:2010, MODIFIED) |
| CEI 62-5 : 1ED 1980 | |
| EN 61010-1:2010 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
| EN 60601-1-4:1996/A1:1999 | MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS |
| EN 60529:1991/AC:2016-12 | DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) (IEC 60529 EDITION 2.2 CORRIGENDUM 2:2015) |
| EN ISO 8185:2009 | Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007) |
| IEC 61010-1:2010+AMD1:2016 CSV | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
| IEC 60601-1-4:1996+AMD1:1999 CSV | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
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