CEI EN 60601-1-1 : 2003
Withdrawn
MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
Hardcopy , PDF
English - Italian
03-01-2003
06-13-2020
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Withdrawn
|
| Supersedes |
| 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 | Separation transformers, autotransformers, variable transformers and reactors |
| 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 |