NTC-IEC 60601-1:2020

Equipo electromédico. Parte 1: Requisitos generales para la seguridad básica y el desempeño esencial

Medical electrical equipment. Part 1: General requirements for basic safety and essential performance

  • Estado Vigente
Esta norma se aplica a la Seguridad básica y el desempeño esencial de equipo electromédico y Sistemas Electromédicos; de aquí en adelante se denominará Equipo EM y Sistemas EM.

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Referencias de normas

  • ISO 10993-2:2006 Biological evaluation of medical devices-- Part 2: Animal welfare requirements
  • ISO 10993-17:2002 Biological evaluation of medical devices-- Part 17: Establishment of allowable limits for leachable
  • ISO 10993-14:2001 Biological evaluation of medical devices-- Part 14: Identification and quantification of degradation
  • ISO 10993-7:2008 Biological evaluation of medical devices-- Part 7: Ethylene oxide sterilization residuals
  • ISO 10993-5:2009 Biological evaluation of medical devices-- Part 5: Tests for in vitro cytotoxicity
  • ISO 80000-1:2009 Quantities and units-- Part 1: General
  • ISO 10993-13:2010 Biological evaluation of medical devices-- Part 13: Identification and quantification of degradation
  • ISO 10993-10:2010 Biological evaluation of medical devices-- Part 10: Tests for irritation and skin sensitization
  • ISO 10993-12:2012 Biological evaluation of medical devices-- Part 12: Sample preparation and reference materials
  • ISO 10993-3:2014 Biological evaluation of medical devices-- Part 3: Tests for genotoxicity, carcinogenicity and repro
  • ISO 780:2015 Packaging -- Distribution packaging -- Graphical symbols for handling and storage of packages
  • ISO 23529:2016 Rubber -- General procedures for preparing and conditioning test pieces for physical test methods
  • ISO 10993-6:2016 Biological evaluation of medical devices-- Part 6: Tests for local effects after implantation
  • ISO 10993-4:2017 Biological evaluation of medical devices-- Part 4: Selection of tests for interactions with blood
  • ISO 10993-16:2017 Biological evaluation of medical devices-- Part 16: Toxicokinetic study design for degradation produ
  • ISO 2878:2017 Rubber, vulcanized or thermoplastic -- Antistatic and conductive products -- Determination of electr
  • ISO 10993-11:2017 Biological evaluation of medical devices-- Part 11: Tests for systemic toxicity
  • IEC/TR 60083 Ed. 6.0 b Plugs and socket-outlets for domestic and similar general use standardized in member countries of IE
  • IEC 60112 Ed. 4.1 b Method for the determination of the proof and the comparative tracking indices of solid insulating m
  • IEC 60227-1 Ed. 3.0 b Polyvinyl chloride insulated cables of rated voltages up to and including 450/750 V - Part 1: Genera
  • IEC 60245-1 Ed. 4.1 b Rubber insulated cables - Rated voltages up to and including 450/750 V - Part 1: General requirement
  • IEC 60245-1 amd.1 Ed. 4.0 b Amendment 1 - Rubber insulated cables - Rated voltages up to and including 450/750 V - Part 1: Gener
  • IEC 60320-1 Ed. 2.1 b Appliance couplers for household and similar general purposes - Part 1: General requirements
  • IEC 60364-4-41 Ed. 5.0 b Low-voltage electrical installations - Part 4-41: Protection for safety - Protection against electri
  • IEC 60447 Ed. 3.0 b Basic and safety principles for man-machine interface, marking and identification - Actuating princi
  • IEC 60601-1-2 Ed. 3.0 b Medical electrical equipment - Part 1-2: General requirements for basic safety and essential perform
  • IEC 60851-5 Ed. 4.0 b Winding wires - Test methods - Part 5: Electrical properties
  • IEC 60884-1 Ed. 3.1 b Plugs and socket-outlets for household and similar purposes - Part 1: General requirements
  • IEC 61558-2-1 Ed. 2.0 b Safety of power transformers, power supplies, reactors and similar products - Part 2-1: Particular r
  • IEC 61965 Ed. 2.0 en Mechanical safety of cathode ray tubes
  • IEC 60252-1 Ed. 2.0 b AC motor capacitors - Part 1: General - Performance, testing and rating - Safety requirements - Guid
  • IEC 60851-6 Ed. 3.0 b Winding wires - Test methods - Part 6: Thermal properties
  • IEC 60601-1-8 Ed. 2.1 b Medical electrical equipment - Part 1-8: General requirements for basic safety and essential perform
  • IEC 62133 Ed. 2.0 b Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requiremen
  • IEC 60601-1-3 Ed. 2.1 b Medical electrical equipment - Part 1-3: General requirements for basic safety and essential perform
  • IEC 60950-1 Ed. 2.2 b Information technology equipment - Safety - Part 1: General requirements
  • IEC 60851-3 Ed. 3.1 b Winding wires - Test methods - Part 3: Mechanical properties
  • IEC 60601-1-6 Ed. 3.1 EN-FR Medical electrical equipment - Part 1-6: General requirements for basic safety and essential perform
  • IEC 60730-1 Ed. 5.0 EN-FR Automatic electrical controls - Part 1: General requirements
  • IEC 60086-4:2014 Primary batteries - Part 4: Safety of lithium batteries
  • IEC 60127-1:2015 Miniature fuses - Part 1: Definitions for miniature fuses and general requirements for miniature fus
  • IEC 62304:2015 Medical device software - Software life cycle processes
  • IEC 60335-1:2016 Household and similar electrical appliances - Safety - Part 1: General requirements
  • IEC 61058-1:2016 Switches for appliances - Part 1: General requirements
  • IEC 61672-2:2017 Electroacoustics - Sound level meters - Part 2: Pattern evaluation tests
  • ISO 1853:2018 Conducting and dissipative rubbers, vulcanized or thermoplastic -- Measurement of resistivity
  • ISO 10993-9:2019 Biological evaluation of medical devices -- Part 9: Framework for identification and quantification
  • ISO 10993-15:2019 Biological evaluation of medical devices -- Part 15: Identification and quantification of degradatio
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