UNE-EN 60601-1:2008
Current
Current
The latest, up-to-date edition.
Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
Amended by
Available format(s)
Hardcopy , PDF
Published date
14-05-2008
Publisher
Important note : All end users must be registered with an Account prior to user licenses being assigned.| Committee |
CTN 209/SC 62
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| DevelopmentNote |
Supersedes UNE 20613-1. (02/2014) Supersedes UNE EN 60601-1-1 & UNE EN 60601-1-4. (06/2014) CORR 2014 issued on 25.06.2014 has been withdrawn ON 13.11.2014. (06/2015) New Child AMD 2 2021 now added
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| DocumentType |
Standard
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| Pages |
384
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| ProductNote |
NEW CHILD COR 1 IS ADDED NOW New Child AMD 12 2014 now added new child err 2008 is added NEW CHILD ERR 1 2008 IS NOW ADDED NEW CHILD AMD 1 2013 IS NOW ADDED New Child AMD 2 2021 now added
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| PublisherName |
Asociacion Espanola de Normalizacion
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| Status |
Current
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| Supersedes |
| Standards | Relationship |
| EN 60601-1:2006/A12:2014 | Identical |
| NBN EN 60601-1 : 2007 AMD 2/COR 15 | Identical |
| IEC 60601-1:2005+AMD1:2012 CSV | Identical |
| SN EN 60601-1 : 2006 AMD 11 2011 | Identical |
| EN 60601-1:2006 | Identical |
| I.S. EN 60601-1:2006&A1:2013&AC:2014&A12:2014 | Identical |
| BS EN 60601-1 : 2006 | Identical |
| IEC 60601-1:2005 | Identical |
| DIN EN 60601-1 : 2010-05 | Identical |
| IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV | Information technology equipment - Safety - Part 1: General requirements |
| IEC 60112:2003+AMD1:2009 CSV | Method for the determination of the proof and the comparative tracking indices of solid insulating materials |
| IEC 60320-1:2015 | Appliance couplers for household and similar general purposes - Part 1: General requirements |
| IEC 61672-2:2013+AMD1:2017 CSV | Electroacoustics - Sound level meters - Part 2: Pattern evaluation tests |
| IEC 61558-2-1:2007 | Safety of power transformers, power supplies, reactors and similar products - Part 2-1: Particular requirements and tests for separating transformers and power supplies incorporating separating transformers for general applications |
| IEC 60245-1:2003+AMD1:2007 CSV | Rubber insulated cables - Rated voltages up to and including 450/750 V - Part 1: General requirements |
| ISO 7010:2011 | Graphical symbols Safety colours and safety signs Registered safety signs |
| 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 |
| UL 1439:5ED 2015-04-21 | Tests for Sharpness of Edges on Equipment |
| IEC 60364-7-710:2002 | Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations |
| IEC 60127-6:2014 | Miniature fuses - Part 6: Fuse-holders for miniature fuse-links |
| IEC 60050-195:1998 | International Electrotechnical Vocabulary (IEV) - Part 195: Earthing and protection against electric shock |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| IEC 60695-1-1:1999 | Fire hazard testing - Part 1-1: Guidance for assessing the fire hazard of electrotechnical products - General guidelines |
| IEC 60364-4-41:2005+AMD1:2017 CSV | Low voltage electrical installations - Part 4-41: Protection for safety - Protection against electric shock |
| IEC 60073:2002 | Basic and safety principles for man-machine interface, marking and identification - Coding principles for indicators and actuators |
| ISO 23529:2016 | Rubber General procedures for preparing and conditioning test pieces for physical test methods |
| ISO 2882:1979 | Rubber, vulcanized — Antistatic and conductive products for hospital use — Electrical resistance limits |
| ISO 9614-1:1993 | Acoustics — Determination of sound power levels of noise sources using sound intensity — Part 1: Measurement at discrete points |
| IEC 60050-151:2001 | International Electrotechnical Vocabulary (IEV) - Part 151: Electrical and magnetic devices |
| IEC 60884-1:2002+AMD1:2006+AMD2:2013 CSV | Plugs and socket-outlets for household and similar purposes - Part1: General requirements |
| IEC 61000-4-11:2004+AMD1:2017 CSV | Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations immunity tests |
| IEC 60050-441:1984 | International Electrotechnical Vocabulary (IEV) - Part 441: Switchgear, controlgear and fuses |
| IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
| ISO 13852:1996 | Safety of machinery Safety distances to prevent danger zones being reached by the upper limbs |
| 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 |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| IEC 60825-1:2014 | Safety of laser products - Part 1: Equipment classification and requirements |
| NFPA 53 : 2016 | MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES |
| IEC 60601-1-8:2006+AMD1:2012 CSV | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
| IEC TR 60513:1994 | Fundamental aspects of safety standards for medical electrical equipment |
| IEC 60127-1:2006+AMD1:2011+AMD2:2015 CSV | Miniature fuses - Part 1: Definitions for miniature fuses andgeneral requirements for miniature fuse-links |
| IEC 60851-6:2012 | Winding wires - Test methods - Part 6: Thermal properties |
| IEC 60079-5:2015 RLV | Explosive atmospheres - Part 5: Equipment protection by powder filling "q" |
| IEC 60851-5:2008+AMD1:2011 CSV | Winding wires - Test methods - Part 5: Electrical properties |
| IEC 60227-1:2007 | Polyvinyl chloride insulated cables of rated voltages up to and including 450/750 V - Part 1: General requirements |
| EN 563:1994/A1:1999/AC:2000 | SAFETY OF MACHINERY - TEMPERATURES OF TOUCHABLE SURFACES - ERGONOMICS DATA TO ESTABLISH TEMPERATURE LIMIT VALUES FOR HOT SURFACES |
| IEC 60601-2-4:2010 | Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
| 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 |
| IEC 60085:2007 | Electrical insulation - Thermal evaluation and designation |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| IEC 61558-1:2017 | Safety of transformers, reactors, power supply units and combinations thereof - Part 1: General requirements and tests |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| ISO 3746:2010 | Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane |
| IEC 60447:2004 | Basic and safety principles for man-machine interface, marking and identification - Actuating principles |
| IEC TR 60878:2015 | Graphical symbols for electrical equipment in medical practice |
| ISO 780:2015 | Packaging Distribution packaging Graphical symbols for handling and storage of packages |
| ISO 14708-1:2014 | Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer |
| MIL-HDBK-217 Revision F:1991 | RELIABILITY PREDICTION OF ELECTRONIC EQUIPMENT |
| IEC 60529:1989+AMD1:1999+AMD2:2013 CSV | Degrees of protection provided by enclosures (IP Code) |
| IEC 61058-1:2016 | Switches for appliances - Part 1: General requirements |
| NFPA 99 : 2018 | HEALTH CARE FACILITIES CODE |
| IEC 60068-2-2:2007 | Environmental testing - Part 2-2: Tests - Test B: Dry heat |
| IEC 60695-11-10:2013 | Fire hazard testing - Part 11-10: Test flames - 50 W horizontal and vertical flame test methods |
| IEC 60601-1-3:2008+AMD1:2013 CSV | Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
| IEC 60079-6:2015 | Explosive atmospheres - Part 6: Equipment protection by liquid immersion "o" |
| IEC 60079-0:2011 | Explosive atmospheres - Part 0: Equipment - General requirements |
| ISO 8041:2005 | Human response to vibration Measuring instrumentation |
| IEC 60851-3:2009+AMD1:2013 CSV | Winding wires - Test methods - Part 3: Mechanical properties |
| IEC 62079:2001 | Preparation of instructions - Structuring, content and presentation |
| ISO 2878:2017 | Rubber, vulcanized or thermoplastic Antistatic and conductive products Determination of electrical resistance |
| IEC 60086-1:2015 | Primary batteries - Part 1: General |
| ISO 3864-1:2011 | Graphical symbols Safety colours and safety signs Part 1: Design principles for safety signs and safety markings |
| IEC 60252-1:2010+AMD1:2013 CSV | AC motor capacitors - Part 1: General - Performance, testing andrating - Safety requirements - Guidance for installation and operation |
| ISO 407:2004 | Small medical gas cylinders Pin-index yoke-type valve connections |
| IEC 60050-826:2004 | International Electrotechnical Vocabulary (IEV) - Part 826: Electrical installations |
| IEC 61965:2003 | Mechanical safety of cathode ray tubes |
| ISO 5349-1:2001 | Mechanical vibration Measurement and evaluation of human exposure to hand-transmitted vibration Part 1: General requirements |
| ISO 11134:1994 | Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| IEC 60086-4:2014 | Primary batteries - Part 4: Safety of lithium batteries |
| ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| IEC 60317-43:1997+AMD1:2010 CSV | Specifications for particular types of winding wires - Part 43: Aromatic polyimide type wrapped round copper wire, class 240 |
| IEC 61140:2016 | Protection against electric shock - Common aspects for installation and equipment |
| ISO 1853:2011 | Conducting and dissipative rubbers, vulcanized or thermoplastic Measurement of resistivity |
| ISO 11137:1995 | Sterilization of health care products Requirements for validation and routine control Radiation sterilization |
| IEC 60309-1:1999+AMD1:2005+AMD2:2012 CSV | Plugs, socket-outlets and couplers for industrial purposes - Part 1: General requirements |
| IEC 60601-2-49:2011 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
| IEC 61010-1:2010+AMD1:2016 CSV | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
| IEC 60601-1-1:2000 | Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
| IEC 60445:2017 | Basic and safety principles for man-machine interface, marking and identification - Identification of equipment terminals, conductor terminations and conductors |
| IEC 60664-1:2007 | Insulation coordination for equipment within low-voltage systems - Part 1: Principles, requirements and tests |
| IEC 60601-1-4:1996+AMD1:1999 CSV | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
| IEC 60990:2016 | Methods of measurement of touch current and protective conductor current |
| ISO 5805:1997 | Mechanical vibration and shock — Human exposure — Vocabulary |
| IEC 60730-1:2013+AMD1:2015 CSV | Automatic electrical controls - Part 1: General requirements |
| ISO 15223:2000 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied |
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