WORKSHOP PARA USUÁRIOS
Convênio FNS/USP 2209/2008
Normas Técnicas, Gerenciamento de Risco,
Metrologia e Utilização de Produtos para a Saúde:
Porque participar e se envolver?
Profº Dr. José Carlos Teixeira de Barros Moraes Laboratório de Engenharia Biomédica/Escola Politécnica da USP
Estrutura e estado atual da produção normativa
do TC62 da IEC relativa a equipamentos
eletromédicos
INTERNALIZAÇÃO BRASILEIRA DE NORMAS
TÉCNICAS NO SETOR DE PRODUTOS PARA
A SAÚDE
José Carlos T. B. Moraes
Criação de Normas Técnicas
• Normas são desenvolvidas por organismos denormalização (em inglês, standard-developingorganization (SDO))
• Podem ser internacionais, nacionais ou regionais
Organismos de normalização
• Internacional– International Organization for Standardization - ISO– International Electrotechnical Comission - IEC– International Special Committee on Radio Interference
(CISPR)• Regional
– European Committee for Normalization - CEN– European Committee for Electrotechnical Standardization -
CENELEC– European Committee for Electronic Standards
• Nacionais– Associação Brasileira de Normas Técnicas - ABNT– British Standards Institute - BSI– Canadian Standards Association - CSA– Japanese Standards Association - JSA
Principais comitês internacionais de normalização de produtos para a saúde
• ISO TC 76 - Transfusion, infusion and injection equipmentfor medical and pharmaceutical use
• ISO TC 121 Anaesthetic and respiratory equipment
• ISO TC 150 - Implants for surgery
• ISO TC 194 - Biological evaluation of medical devices
• ISO TC 198 - Sterilization of health care products
• ISO TC 210 - Quality management and correspondinggeneral aspects for medical devices
• TC 212 - Clinical laboratory testing and in vitrodiagnostic test systems
• IEC - TC 62 - Electrical Equipment in Medical Practice
Principais comitês regionais de normalização de produtos para a saúde
• Biological evaluation of medical devices (CEN/TC 206)
• Clinical investigation of medical devices (CEN/TC 258)
• In vitro diagnostic medical devices (CEN/TC 140)
• Mais diversos
• CEN e CENELEC
– Acordo de Viena – Coordenação Normativa envolvendo ISO e IEC
Processo de desenvolvimento de Normas Técnicas internacionais
• Proposta de Novo Item de Trabalho (“New Work ItemProposal”) por especialistas (“experts”) ou por ComitêNacional ou por Organismo de Normalização Internacional
• Criação de um Projeto de Trabalho – “Working Draft” – WD
• Criação de um Projeto de Trabalho para o Comitê,“Committee Draft” - CD, que é circulado para conhecimento,análise e aprimoramento
• Criação de uma planilha de voto de Projeto de Trabalho parao Comitê, “Committee Draft for Vote” – CDV, que é circuladopara voto
• Análise dos votos e comentários, com respostas
• Criação de um Projeto de Norma Internacional Final, “FinalDraft Internacional Standard” – FDIS, com votação
• Publicação da Norma Internacional
Processo de desenvolvimento de Normas Técnicas internacionais (continuação)
Most standardization work takes place in a committee environment.
IEC’s International Membership provides access to experts from
corporations, governments and national standards committees from
all over the world
Reliable and well defined development procedures are therefore
essential for creation of international consensus standards, for
example, fairness, openness, transparency, and methods to ensure
consideration of the views for all interested parties
Proposed international consensus standards are published for public
review with an opportunity for comment
Processo de desenvolvimento de Normas Técnicas internacionais (continuação)
The development process for an international standard is amultidisciplinary process that includes the interaction ofseveral disciplines such as engineering, technology, science,conformity assessment, economics, trade, public policy andlaw.
Development of an international standard requiresfacilitating a proper balance of interests necessary toachieve the purposes of the international standard.
Análise e preparação de Normas Técnicas internacionais
Analysis and preparation are necessary to ensure the successful development of an international standard, for example, development typically includes the following:
• Reviewing existing consensus standards related to the standard being developed and reconciliation of such standards where necessary;
• Reviewing existing policies, laws and regulations where necessary;
• Reviewing specific issues such as health, safety, the environment, trade, and competition where necessary;
• Establishing a realistic development schedule; and
• Providing sufficient resources necessary to ensure the success of the project
Consequências de uma Norma Técnica internacional
International standards have consequences. Although international
standards are voluntary consensus standards developed within a
transparent system of checks and balances, these standards can have
enormous economic consequences within individual nations and
international markets as a whole.
Wide participation in the development of international standards is,
therefore, essential to ensure that all issues are fairly and adequately
evaluated, discussed and resolved.
It is essential that international standards be based on performance
concepts whenever possible, enhance global trade and competition,
and be supported by a strong consensus among the nations of the
world.
Perspectivas do valor de Normas Técnicas internacionais
• Access to global markets;
• Access to strategic sources of information on market
developments and state-of-the-art technical progress ;
• Access to strategic partnerships;
• Significant opportunities to reduce costs and improve
performance;
• Significant opportunities to enhance national, regional
and global markets;
• Significant opportunities to meet certification and
conformity assessment requirements.
Nova Norma Técnica–> proposta de novo item de trabalho
Nova Norma Técnica– proposta de novo item de trabalho (continuação)
Nova Norma Técnica– proposta de novo item de trabalho (continuação)
Committee Description
TC 1 Terminology
TC 2 Rotating machinery
TC 3 Information structures, documentation and graphical symbols
SC 3C Graphical symbols for use on equipment
SC 3D Data sets for libraries
TC 4 Hydraulic turbines
TC 5 Steam Turbines (IN STAND BY)
TC 7 Overhead electrical conductors
TC 8 System aspects for electrical energy supply
TC 9 Electrical equipment and systems for railways
TC 10 Fluids for electrotechnical applications
TC 11 Overhead lines
TC 13 Electrical energy measurement, tariff- and load control
TC 14 Power transformers
TC 15 Solid electrical insulating materials
TC 16 Basic and safety principles for man-machine interface, marking and identification
TC 17 Switchgear and controlgear
SC 17A High-voltage switchgear and controlgear
SC 17B Low-voltage switchgear and controlgear
SC 17C High-voltage switchgear and controlgear assemblies
SC 17D Low-voltage switchgear and controlgear assemblies
TC 18 Electrical installations of ships and of mobile and fixed offshore units
SC 18A Electric cables for ships and mobile and fixed offshore units
IEC - International Electrotechnical CommissionList of technical committees and subcommittees
Committee Description
TC 20 Electric cables
TC 21 Secondary cells and batteries
SC 21A Secondary cells and batteries containing alkaline or other non-acid electrolytes
TC 22 Power electronic systems and equipment
SC 22E Stabilized power supplies
SC 22F Power electronics for electrical transmission and distribution systems
SC 22G Adjustable speed electric drive systems incorporating semiconductor power converters
SC 22H Uninterruptible power systems (UPS)
TC 23 Electrical accessories
SC 23A Cable management systems
SC 23B Plugs, socket-outlets and switches
SC 23C World-wide plug and socket-outlet systems
SC 23E Circuit-breakers and similar equipment for household use
SC 23F Connecting devices
SC 23G Appliance couplers
SC 23H Industrial, plugs and socket-outlets
SC 23J Switches for appliances
TC 25 Quantities and units
TC 26 Electric welding
TC 27 Industrial electroheating equipment
TC 28 Insulation co-ordination
TC 29 Electroacoustics
IEC - International Electrotechnical CommissionList of technical committees and subcommittees
IEC - International Electrotechnical Commission
Committee Description
TC 31 Equipment for explosive atmospheres
SC 31G Intrinsically-safe apparatus
SC 31J Classification of hazardous areas and installation requirements
SC 31M Non-electrical equipment and protective systems for explosive atmospheres
TC 32 Fuses
SC 32A High-voltage fuses
SC 32B Low-voltage fuses
SC 32C Miniature fuses
TC 33 Power capacitors
TC 34 Lamps and related equipment
SC 34A Lamps
SC 34B Lamp caps and holders
SC 34C Auxiliaries for lamps
SC 34D Luminaires
TC 35 Primary cells and batteries
TC 36 Insulators
SC 36A Insulated bushings
SC 36B Insulators for overhead lines
SC 36C Insulators for substations
TC 37 Surge arresters
SC 37A Low-voltage surge protective devices
SC 37B Specific components for surge arresters and surge protective devices
TC 38 Instrument transformers
TC 39 Electronic tubes
List of technical committees and subcommittees
IEC - International Electrotechnical CommissionList of technical committees and subcommittees
Committee Description
TC 40 Capacitors and resistors for electronic equipment
TC 42 High-voltage testing techniques
TC 44 Safety of machinery - Electrotechnical aspects
TC 45 Nuclear instrumentation
SC 45A Instrumentation and control of nuclear facilities
SC 45B Radiation protection instrumentation
TC 46
Cables, wires, waveguides, R.F. connectors, R.F. and microwave passive components and
accessories
SC 46A Coaxial cables
SC 46C Wires and symmetric cables
SC 46F RF and microwave passive components
TC 47 Semiconductor devices
SC 47A Integrated circuits
SC 47D Mechanical standardization for semiconductor devices
SC 47E Discrete semiconductor devices
SC 47F Micro-electromechanical systems
TC 48 Electromechanical components and mechanical structures for electronic equipment
SC 48B Connectors
SC 48D Mechanical structures for electronic equipment
TC 49 Piezoelectric and dielectric devices for frequency control and selection
IEC - International Electrotechnical CommissionList of technical committees and subcommittees
Committee Description
TC 51 Magnetic components and ferrite materials
TC 55 Winding wires
TC 56 Dependability
TC 57 Power systems management and associated information exchange
TC 59 Performance of household and similar electrical appliances
SC 59A Electric dishwashers
SC 59C Heating appliances
SC 59D Home laundry appliances
SC 59F Floor treatment appliances
SC 59K Ovens and microwave ovens, cooking ranges and similar appliances
SC 59L Small household appliances
SC 59M Performance of electrical household and similar cooling and freezing appliances
TC 61 Safety of household and similar electrical appliances
SC 61B Safety of microwave ovens
SC 61C Household appliances for refrigeration
SC 61D Appliances for air-conditioning for household and similar purposes
SC 61E Safety of electrical commercial catering equipment
SC 61H Safety of electrically-operated farm appliances
SC 61J Electrical motor-operated cleaning appliances for commercial use
IEC - International Electrotechnical CommissionList of technical committees and subcommittees
Committee Description
TC 62 Electrical equipment in medical practice
SC 62A Common aspects of electrical equipment used in medical practice
SC 62B Diagnostic imaging equipment
SC 62C Equipment for radiotherapy, nuclear medicine and radiation dosimetry
SC 62D Electromedical equipment
TC 64 Electrical installations and protection against electric shock
TC 65 Industrial-process measurement, control and automation
SC 65A System aspects
SC 65B Devices & process analysis
SC 65C Industrial networks
SC 65E Devices and integration in enterprise systems
TC 66 Safety of measuring, control and laboratory equipment
TC 68 Magnetic alloys and steels
TC 69 Electric road vehicles and electric industrial trucks
TC 70 Degrees of protection provided by enclosures
TC 72 Automatic controls for household use
TC 73 Short-circuit currents
IEC - International Electrotechnical CommissionList of technical committees and subcommittees
Committee Description
TC 76 Optical radiation safety and laser equipment
TC 77 Electromagnetic compatibility
SC 77A Low frequency phenomena
SC 77B High frequency phenomena
SC 77C High power transient phenomena
TC 78 Live working
TC 79 Alarm systems
TC 80 Maritime navigation and radiocommunication equipment and systems
TC 81 Lightning protection
TC 82 Solar photovoltaic energy systems
TC 85 Measuring equipment for electrical and electromagnetic quantities
TC 86 Fibre optics
SC 86A Fibres and cables
SC 86B Fibre optic interconnecting devices and passive components
SC 86C Fibre optic systems and active devices
TC 87 Ultrasonics
TC 88 Wind turbines
TC 89 Fire hazard testing
IEC - International Electrotechnical CommissionList of technical committees and subcommittees
Committee Description
TC 90 Superconductivity
TC 91 Electronics assembly technology
TC 93 Design automation
TC 94 All-or-nothing electrical relays
TC 95 Measuring relays and protection equipment
TC 96 Transformers, reactors, power supply units and similar products for low voltage up to 1100 V
TC 97 Electrical installations for lighting and beaconing of aerodromes
TC 99
System engineering and erection of electrical power installations in systems with nominal
voltages above 1kV a.c. and 1.5kV d.c., particularly concerning safety aspects
TC 100 Audio, video and multimedia systems and equipment
TA 1 Terminals for audio, video and data services and contents
TA 2 Colour measurement and management
TA 4 Digital system interfaces and protocols
TA 5 Cable networks for television signals, sound signals and interactive services
TA 6 Professional electronics storage media, data structures and equipment
TA 7 Consumer electronics storage and related applications
TA 8 Multimedia home server systems
TA 9 Audio, video and multimedia applications for end-user network
IEC - International Electrotechnical CommissionList of technical committees and subcommittees
Committee Description
TA 10 Multimedia e-publishing and e-book
TA 11 Quality for audio, video and multimedia systems
TA 12 Energy Efficiency
TC 101 Electrostatics
TC 103 Transmitting equipment for radio communication
TC 104 Environmental conditions, classification and methods of test
TC 105 Fuel cell technologies
TC 106
Methods for the assessment of electric, magnetic and electromagnetic fields associated with
human exposure
TC 107 Process management for avionics
TC 108
Safety of electronic equipment within the field of audio/video, information technology and
communication technology
TC 109 Insulation co-ordination for low-voltage equipment
TC 110 Flat panel display devices
TC 111 Environmental standardization for electrical and electronic products and systems
TC 112 Evaluation and qualification of electrical insulating materials and systems
TC 113 Nanotechnology standardization for electrical and electronic products and systems
TC 114 Marine energy - Wave, tidal and other water current converters
TC 115
High Voltage Direct Current (HVDC) Transmission for DC voltages above 100kV
(Provisional)
TC 116 Safety of hand-held motor-operated electric tools
IEC - International Electrotechnical CommissionList of technical committees and subcommittees
Committee Description
CISPR International special committee on radio interference
CIS/A Radio-interference measurements and statistical methods
CIS/B
Interference relating to industrial, scientific and medical radio-frequency apparatus,
to other (heavy) industrial equipment, to overhead power lines, to high voltage
equipment and to electric traction
CIS/D
Electromagnetic disturbances related to electric/electronic equipment on vehicles
and internal combustion engine powered devices
CIS/F
Interference relating to household appliances tools, lighting equipment and similar
apparatus
CIS/H Limits for the protection of radio services
CIS/I
Electromagnetic compatibility of information technology equipment, multimedia
equipment and receivers
CIS/S Steering Committee of CISPR
ISO/IEC JTC 1 ISO/IEC Joint Technical Committee for information technology
ISO/IEC JTC 1/SC 2 Coded character sets
ISO/IEC JTC 1/SC 6 Telecommunications and information exchange between systems
ISO/IEC JTC 1/SC 7 Software engineering
ISO/IEC JTC 1/SC 17 Identification cards and related devices
IEC - International Electrotechnical CommissionList of technical committees and subcommittees
Committee Description
ISO/IEC JTC 1/SC 22 Programming languages, their environments and system software interfaces
ISO/IEC JTC 1/SC 23 Optical disk cartridges for information interchange
ISO/IEC JTC 1/SC 24 Computer graphics and image processing
ISO/IEC JTC 1/SC 25 Interconnection of information technology equipment
ISO/IEC JTC 1/SC 27 IT security techniques
ISO/IEC JTC 1/SC 28 Office equipment
ISO/IEC JTC 1/SC 29 Coding of audio, picture, multimedia and hypermedia information
ISO/IEC JTC 1/SC 31 Automatic data capture
ISO/IEC JTC 1/SC 32 Data management services
ISO/IEC JTC 1/SC 34 Document description and processing languages
ISO/IEC JTC 1/SC 35 User interfaces
ISO/IEC JTC 1/SC 36 Information Technology for Learning, Education and Training
ISO/IEC JTC 1/SC 37 Biometrics
Total number of TC/SCs 174IEC Technical Committees 94IEC Subcommittees 80
Secretariat : Germany
Chairman : (Term of office : 2010-04)
Mr Rodolfo J Godinez (US)
Secretary :
Mr Norbert Bischof (DE)
Technical Officer :
Mr Rémy Baillif
Scope :
To prepare international standards and technical reports concerning the manufacture, installation and application of electrical
equipment used in medical practice and their effects on patients, operators and its environment. This also concerns surgery,
dentistry and other specialities of healing arts.
NOTE : This scope includes systems, equipment and accessories which are within the scope of other technical committees;
attention will be confined to aspects in which special requirements for medical use arise, particularly as regards safety.
Liaisons :
Internal IEC Liaison : TC 8, TC 87, TC 96
Liaison ISO : ISO/TC 215
Liaison A : COCIR
Liaison B : GHTF
Subcommittee :
SC 62A - Common aspects of electrical equipment used in medical practice
SC 62B - Diagnostic imaging equipment
SC 62C - Equipment for radiotherapy, nuclear medicine and radiation dosimetry
SC 62D - Electromedical equipment
TC 62 - Electrical equipment in medical practice
Secretariat : United States of America
Chairman : (Term of office : 2011-07)Mr Lawrence Knuckey (AU)
Secretary : Mr Charles Sidebottom P.E. (US)
Assistant Secretary : Ms Hillary Woehrle (US)
Technical Officer : Mr Rémy Baillif
Scope : To prepare international standards concerning the common aspects of the manufacture, installation and application of electrical equipment used in medical practice, including systems, equipment, accessories, related terminology, concepts, terms, definitions and symbols.
Liaisons : Internal IEC Liaison : TC 66, TC 77, TC 111, CIS/B, ISO/IEC JTC 1/SC 7Liaison ISO : ISO/TC 150, ISO/TC 184/SC 2, ISO/TC 198, ISO/TC 210, ISO/TC 215
SC 62A - Common aspects of electrical equipment used in medical practice
Working Group :
WG 14 - Testing to General Safety Standard
WG 20 - Environmental protection
Maintenance Team :
MT 23 - Electromagnetic compatibility
MT 24 - Maintenance of IEC/TR 60930 Ed.1 and IEC/TR 61258
MT 25 - Ergonomics and graphical symbols
MT 26 - Medical electrical systems
MT 27 - Risk management
MT 28 - Electrical hazards
MT 29 - Mechanical hazards
MT 30 - Overheating, fire protection and additional hazards
MT 31 - Programmable electrical medical systems
MT 32 - Standardization of medical electrical equipment safety
Joint Working Group :
JWG 1 - Application of risk management to medical devices
JWG 2 - Joint working group on alarms
JWG 3 - Medical device software
JWG 4 - Medical devices - General requirements for safety and essential performance - Usability
JWG 5 - Physiologic Closed-Loop Controllers
JWG 6 - Medical electrical equipment and systems for use in home care applications
JWG 7 - Application of risk management to information technology (IT) networks incorporating medical devices
SC 62A - Common aspects of electrical equipment used in medical practice
Secretariat : Germany
Membership
Chairman : (Term of office : 2011-07)
Mr James Francis Malone (IE)
Secretary :
Mr Norbert Bischof (DE)
Technical Officer :
Mr Rémy Baillif
Scope :
To prepare international publications for safety and performance for all kind of medical diagnostic imaging equipment (e.g. X-ray imaging equipment, computed tomography, magnetic resonance imaging equipment) including related associated equipment and accessories as well as quality procedures (e.g. acceptance tests and constancy tests) to be applied during the life-time of imaging equipment.
Included is also the development of related terminology, concepts, terms and definitions.
Liaisons :
Internal IEC Liaison : SC 3C, TC 87, TC 106
Liaison ISO : ISO/TC 42, ISO/TC 85, ISO/TC 150, ISO/TC 150/SC6
Liaison B : DICOM, EU SENTINEL, IAEA, ICNIRP, ICRP, ICRU
SC 62B - Diagnostic imaging equipment
Working Group :
WG 33 - Characteristics of digital X-ray imaging devices - Determination of the detective quantum efficiency
WG 35 - IEC 62312-1: Magnetic resonance equipment for diagnostic imaging - Determination of characteristics - Part 1
WG 36 - Image display devices
WG 42 - IEC 60601-2-54: Medical electrical equipment - Part 2-54: Particular requirements for basic safety and essential performance of X-ray equipment for radiography and radioscopy
WG 43 - Exposure index of digital X-ray imaging systems
WG 45 - Items within the controlled access area of Magnetic resonance equipment for human application
WG 46 - Medical electrical equipment - Particular requirements for basic safety and essential performance of dental X-ray equipment
WG 48 - Classification criteria for pulse sequences of magnetic resonance equipment
Maintenance Team :
MT 30 - Computed tomography
MT 31 - Mammographic X-ray equipment
MT 32 - Requirements for X-ray source assemblies
MT 34 - Revision of 60601-2-37: Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
MT 37 - IEC 60601-1-3 Ed. 2 Medical electrical equipment - Part 1-3: General requirements for radiation protection in diagnostic X-ray equipment
MT 38 - Revision of IEC 61223-3-1 and IEC 61223-3-3
MT 39 - Dental Imaging Equipment
MT 40 - Magnetic resonance equipment for medical diagnosis
MT 41 - Revision of IEC 60601-2-43
MT 44 - Maintenance of IEC 62220-1 (2003-10)
MT 47 - Protective devices against diagnostic medical X-radiation
Joint Working Group :
JWG 1 - Requirements for the safety and compatibility of magnetic resonance imaging for patients with an active implantable medical device
SC 62B - Diagnostic imaging equipment
Secretariat : Germany
Chairman : (Term of office : 2010-05)Mr Geoffrey S. Ibbott (US)
Secretary : Mr Bernd Seidel (DE)
Technical Officer : Mr Rémy Baillif
Scope : The preparation of standards for the safety and performance of medical equipment using high-energy ionising radiation for the treatment of cancer; associated equipment such as simulators used in planning treatments and dosemeters for measuring the quantity of radiation delivered; nuclear medicine equipment used for imaging the distribution of radioactive substances within the human body for diagnostic purposes.
Liaisons : Liaison B : DICOM, IAEA, ICRP
Working Group :
WG 1 - Beam teletherapy and particle accelerators
WG 2 - Nuclear medicine instrumentation
WG 3 - Performance of dosimeters
SC 62C - Equipment for radiotherapy, nuclear medicine and radiation dosimetry
Secretariat : United States of America
Chairman : (Term of office : 2012-04)Mr Robert D. Schaefer (DE)
Secretary : Mr Michael W. Schmidt (US)
Assistant Secretary : Ms Hae Choe (US)
Technical Officer : Mr Rémy Baillif
Scope : To develop particular international standards and technical reports for electrical equipment used in medical practice. These documents cover the safety and/or performance of the equipment as well as related terminology, concepts, definitions and symbols.
Note.- Examples of the types of equipment covered by the scope of SC 62D include equipment used to diagnose patients, equipment used to monitor patients, and equipment used to treat or as an aid in the treatment of patients.
Exclusions:Medical diagnostic imaging and related equipment (see scope of SC 62B) and medical equipment using high-energy ionizing radiation in therapy (see scope of SC 62C) are excluded.
SC 62D - Electromedical equipment
Liaisons :
Internal IEC Liaison : SC 3C, TC 77Liaison ISO : ISO/TC 76, ISO/TC 106, ISO/TC 121, ISO/TC 121/SC1, ISO/TC 121/SC3, ISO/TC 150/SC6, ISO/TC 184/SC 2Liaison A : ASTM SC E31, ASTM SC F04, ASTM SC F29, OIML
Project Team :
PT 60601-2-62 - High intensity therapeutic ultrasound (HITU) systems
Maintenance Team :
MT 16 - Electro-optical equipment
MT 17 - High frequency surgical equipment
MT 18 - Therapy equipment
MT 19 - Defibrillators
MT 20 - Haemodialysis equipment
MT 21 - Paediatric equipment
MT 22 - Electromedical diagnostic and patient monitoring equipment
MT 23 - Infusion pumps
MT 24 - Extra-corporeal lithotripsy equipment
MT 26 - Electromyographs and evoked response equipment
MT 27 - Luminaires for surgery and diagnosis
MT 28 - Operating tables
SC 62D - Electromedical equipment
Joint Working Group :
J
WG 1 - Medical electrical equipment -: Particular requirements for basic safety and essential performance of critical care ventilators
JWG 2 - Medical electrical equipment - Particular requirements for basic safety and essential performance of an anaesthetic workstation
JWG 3 - Cardiac Pacemakers and Implantable Defibrillators
JWG 4 - Medical Beds
JWG 5 - Pulse Oximeters
JWG 6 - Respiratory Gas Monitors
JWG 7 - Non-Invasive sphygmomanometers - Clinical validation of automated measurement type
JWG 8 - Clinical thermometers
JWG 9 - Lens removal and vitrectomy devices for ophthalmic surgery
JWG 10 - Small bore connectors for liquids and gases in healthcare applications
JWG 11 - Electrical aspects of dental equipment
Joint Maintenance Team :
JMT 29 - Requirements for lung ventilators
JMT 30 - Requirements for cardiac pacemakers
SC 62D - Electromedical equipment
IEC 60601-1 Corr.1 (2006-12) Ed. 3.0 Bilingual English and French
Corrigendum 1 - Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance
Maintenance Result Date: 2012
IEC 60601-1 Corr.2 (2007-12) Ed. 3.0 Bilingual English and French
Corrigendum 2 - Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance
Maintenance Result Date: 2012
IEC 60601-1 IS1 (2008-04) Ed. 3.0 Bilingual English and French
Interpretation sheet 1 - Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance
Maintenance Result Date: 2012
IEC 60601-1 IS2 (2009-01) Ed. 3.0 Bilingual English and French
Interpretation sheet 2 - Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance
Maintenance Result Date: 2012
SC 62A - Common aspects of electrical equipment used in medical practice
Publications issued by SC 62A
IEC 60601-1-2 (2007-03) Ed. 3.0 Bilingual English and French
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
Maintenance Result Date: 2010
IEC 60601-1-2 (2007-03) Ed. 3.0 Spanish
Versión Oficial en Español - Equipos electromédicos. Parte 1-2: Requisitos generales para la seguridad
básica y funcionamiento esencial. Norma colateral: Compatibilidad electromagnética. Requisitos y
ensayos.
Maintenance Result Date: 2010
IEC 60601-1-6 (2006-12) Ed. 2.0 Bilingual English and French
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential
performance - Collateral standard: Usability
Maintenance Result Date: 2009
IEC 60601-1-6 (2006-12) Ed. 2.0 Spanish
Versión Oficial En español - Equipos electromédicos. Parte 1-6: Requisitos generales para la seguridad
básica y funcionamiento esencial. Norma colateral: Aptitud de uso.
Maintenance Result Date: 2009
SC 62A - Common aspects of electrical equipment used in medical practice
Publications issued by SC 62A
IEC 60601-1-8 (2006-10) Ed. 2.0 Bilingual English and French
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential
performance - Collateral Standard: General requirements, tests and guidance for alarm systems in
medical electrical equipment and medical electrical systems
Maintenance Result Date: 2011
IEC 60601-1-8 (2006-10) Ed. 2.0 Spanish
Versión Oficial en Español - Equipos electromédicos. Parte 1-8: Requisitos particulares para la
seguridad básica y características de funcionamiento esencial. Norma colateral: Requisitos generales,
ensayos y guía para los sistemas de alarma en equipos electromédicos y sistemas elect
Maintenance Result Date: 2011
IEC 60601-1-9 (2007-07) Ed. 1.0 Bilingual English and French
Medical electrical equipment - Part 1-9: General requirements for basic safety and essential
performance - Collateral Standard: Requirements for environmentally conscious design
Maintenance Result Date: 2012
IEC 60601-1-9 (2007-07) Ed. 1.0 Spanish
Versión Oficial En español - Equipos electromédicos. Parte 1-9: Requisitos generales para la seguridad
básica y funcionamiento esencial. Norma colateral: Requisitos para un diseño eco-responsable.
Maintenance Result Date: 2012
SC 62A - Common aspects of electrical equipment used in medical practice
Publications issued by SC 62A
IEC 60601-1-10 (2007-11) Ed. 1.0 Bilingual English and French
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential
performance - Collateral Standard: Requirements for the development of physiologic closed-loop
controllers
Maintenance Result Date: 2013
IEC 60601-1-10 (2007-11) Ed. 1.0 Spanish
Versión Oficial En español - Equipos electromédicos. Parte 1-10: Requisitos generales para la seguridad
básica y funcionamiento esencial. Norma colateral: Requisitos para el desarrollo de controladores
fisiológicos en bucle cerrado.
Maintenance Result Date: 2013
IEC 60601-1-SER (2008-04) Ed. 1.0 Bilingual English and French
Medical electrical equipment - ALL PARTS
IEC/TR 60878 (2003-07) Ed. 2.0 Bilingual English and French
Graphical symbols for electrical equipment in medical practice
Maintenance Result Date: 2009
SC 62A - Common aspects of electrical equipment used in medical practice
Publications issued by SC 62A
IEC/TR 60930 (2008-09) Ed. 2.0 English
Guidelines for administrative, medical and nursing staff concerned with the safe use of medical
electrical equipment and medical electrical systems
Maintenance Result Date: 2012
IEC/TR 61258 (2008-08) Ed. 2.0 English
Guidelines for the development and use of medical electrical equipment educational materials
Maintenance Result Date: 2012
IEC/TR 62296 (2009-01) Ed. 2.0 English
Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for
new requirements
Maintenance Result Date: 2012
IEC 62304 (2006-05) Ed. 1.0 Bilingual English and French
Medical device software - Software life cycle processes
Maintenance Result Date: 2011
IEC 62304 (2006-05) Ed. 1.0 Spanish
Versión Oficial En español - Software de dispositivos médicos. Procesos del ciclo de vida del software
Maintenance Result Date: 2011
SC 62A - Common aspects of electrical equipment used in medical practice
Publications issued by SC 62A
IEC/TR 62348 (2006-05) Ed. 1.0 Bilingual English and French
Mapping between the clauses of the third edition of IEC 60601-1 and the 1988 edition as amended
Maintenance Result Date: 2011
IEC 62353 (2007-05) Ed. 1.0 Bilingual English and French
Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
Maintenance Result Date: 2012
IEC 62353 (2007-05) Ed. 1.0 Spanish
Versión Oficial En español - Equipos electromédicos. Ensayos recurrentes y ensayos después de
reparación del equipo electromédico.
Maintenance Result Date: 2012
IEC 62366 (2007-10) Ed. 1.0 Bilingual English and French
Medical devices - Application of usability engineering to medical devices
Maintenance Result Date: 2012
IEC 62366 (2007-10) Ed. 1.0 Spanish
Versión Oficial En español - Dispositivos médicos. Aplicación de la ingeniería de aptitud de uso a los
dispositivos médicos.
Maintenance Result Date: 2012
SC 62A - Common aspects of electrical equipment used in medical practice
Publications issued by SC 62A
IEC/TR 60513 Ed. 3.0 - Standardization of medical electrical equipment safety
WGs : MT32 Project Leader : Lawrence Knuckey
IEC 60601-1 am1 Ed. 3.0 - Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance
WGs : WG14, MT25,26,27,,28,29,30,31 Project Leader : Charles Sidebottom
IEC 60601-1-2 Ed. 4.0 - Medical electrical equipment - Part 1-2: General requirements for basic
safety and essential performance - Collateral standard: Electromagnetic phenomena -
Requirements and tests
WGs : MT23 Project Leader : Jim Conrad
IEC 60601-1-6 Ed. 3.0 - Medical electrical equipment - Part 1-6: General requirements for basic
safety and essential performance - Collateral standard: Usability
WGs : MT25 Project Leader : Charles Sidebottom
IEC 60601-1-8 am1 Ed. 2.0 - Medical electrical equipment - Part 1-8: General requirements for
basic safety and essential performance - Collateral Standard: General requirements, tests and
guidance for alarm systems in medical electrical equipment and medical electrical systems
WGs : JWG2 Project Leader : John Hedley-Whyte
SC 62A - Common aspects of electrical equipment used in medical practice
Work Programme for SC 62A
IEC 60601-1-11 Ed. 1.0 - Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical system used in the home healthcare environment
WGs : JWG6Project Leader : Hubert Lasthaus
IEC 80001-1 Ed. 1.0 - Application of risk management to information technology (IT) networks incorporating medical devices - Part 1 - Roles, responsibilities and activities
WGs : JWG7Project Leader : Sherman Eagles
SC 62A - Common aspects of electrical equipment used in medical practice
Work Programme for SC 62A
IEC 60336 Corr.1 (2006-05) Ed. 4.0 Bilingual English and French
Corrigendum 1 - Medical electrical equipment - X-ray tube assemblies for medical diagnosis -
Characteristics of focal spots
Maintenance Result Date: 2009
IEC 60601-1-3 (2008-01) Ed. 2.0 Spanish
Versión Oficial En español - Equipos electromédicos. Parte 1-3: Requisitos particulares para la
seguridad básica y funcionamiento esencial. Norma colateral: Radioprotección en equipos de rayos X
para diagnóstico.
Maintenance Result Date: 2012
IEC 60601-2-33 (2008-04) Ed. 2.2 Bilingual English and French
Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance
equipment for medical diagnosis
Maintenance Result Date: 2011
IEC 60601-2-33-am1 (2006-02) Ed. 2.0 Spanish
Versión Oficial En español - Modificación 1 - Equipos electromédicos. Parte 2-33: Requisitos
particulares para la seguridad de los equipos de resonancia magnética para diagnóstico médico.
Maintenance Result Date: 2011
SC 62B - Diagnostic imaging equipment
Publications issued by SC 62B
IEC 60601-2-33-am2 (2007-11) Ed. 2.0 Bilingual English and French
Amendment 2 - Medical electrical equipment - Part 2-33: Particular requirements for the safety of
magnetic resonance equipment for medical diagnosis
Maintenance Result Date: 2011
IEC 60601-2-33-am2 (2007-11) Ed. 2.0 Spanish
Versión Oficial En español - Modificación 2 - Equipos electromédicos. Parte 2-33: Requisitos
particulares para la seguridad de los equipos de resonancia magnética para diagnóstico médico.
Maintenance Result Date: 2011
IEC 60601-2-37 (2007-08) Ed. 2.0 Bilingual English and French
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential
performance of ultrasonic medical diagnostic and monitoring equipment
Maintenance Result Date: 2011
IEC 60601-2-37 (2007-08) Ed. 2.0 Spanish
Versión Oficial En español - Equipos electromédicos. Parte 2-37: Requisitos particulares para la
seguridad básica de los equipos médicos de diagnóstico y monitorización por ultrasonidos.
Maintenance Result Date: 2011
SC 62B - Diagnostic imaging equipment
Publications issued by SC 62B
IEC 60601-2-44 (2009-02) Ed. 3.0 Bilingual English and French
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential
performance of X-ray equipment for computed tomography
Maintenance Result Date: 2011
IEC 60601-2-54 (2009-06) Ed. 1.0 Bilingual English and French
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential
performance of X-ray equipment for radiography and radioscopy
Maintenance Result Date: 2014
IEC 61223-2-6 (2006-11) Ed. 2.0 Bilingual English and French
Evaluation and routine testing in medical imaging departments Part 26: Constancy tests Imaging
performance of computed tomography X-ray equipment
Maintenance Result Date: 2010
IEC 61223-2-6 (2006-11) Ed. 2.0 Spanish
Versión Oficial en Español - Ensayos de evaluación e individuales en los departamentos de imagen
médica. Parte 2-6: Ensayos de constancia. Imágenes de equipos de rayos X para tomografía
computerizada
Maintenance Result Date: 2010
SC 62B - Diagnostic imaging equipment
Publications issued by SC 62B
IEC 61223-3-2 (2007-07) Ed. 2.0 Bilingual English and French
Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging
performance of mammographic X-ray equipment
Maintenance Result Date: 2012
IEC 61223-3-5 Corr.1 (2006-03) Ed. 1.0 Bilingual English and French
Corrigendum 1 - Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance
tests - Imaging performance of computed tomography X-ray equipment
Maintenance Result Date: 2010
IEC 62220-1-2 (2007-06) Ed. 1.0 Bilingual English and French
Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2:
Determination of the detective quantum efficiency - Detectors used in mammography
Maintenance Result Date: 2012
IEC 62220-1-2 (2007-06) Ed. 1.0 Spanish
Versión Oficial En español - Equipos electromédicos. Características de los dispositivos digitales de
imágenes de rayos X. Parte 1-2: Determinación de la eficiencia cuántica de detección. Detectores
usados en mamografía.
Maintenance Result Date: 2012
SC 62B - Diagnostic imaging equipment
Publications issued by SC 62B
IEC 62220-1-3 (2008-06) Ed. 1.0 Bilingual English and French
Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3:
Determination of the detective quantum efficiency - Detectors used in dynamic imaging
Maintenance Result Date: 2012
IEC 62464-1 (2007-01) Ed. 1.0 Bilingual English and French
Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality
parameters
Maintenance Result Date: 2009
IEC 62464-1 (2007-01) Ed. 1.0 Spanish
Versión Oficial en Español - Equipos de resonancia magnética para imágenes médicas. Parte 1:
Determinación de los parámetros de calidad esenciales de la imagen
Maintenance Result Date: 2009
IEC 62494-1 (2008-08) Ed. 1.0 Bilingual English and French
Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions
and requirements for general radiography
Maintenance Result Date: 2012
SC 62B - Diagnostic imaging equipment
Publications issued by SC 62B
IEC/PAS 61910-1 (2007-07) Ed. 1.0 English
Medical electrical equipment - Radiation dose documentation - Part 1: Equipment for radiography and
radioscopy
Maintenance Result Date: 2010
SC 62B - Diagnostic imaging equipment
Publications issued by SC 62B
ISO/TS 10974 Ed. 1.0 - Requirements for the safety and compatibility of magnetic resonance
imaging for patients with an active implantable medical device
Project Leader : Curt Sponberg, Hans Engels
IEC 60601-2-28 Ed. 2.0 - Medical electrical equipment - Part 2-28: Particular requirements for
basic safety and essential performance of X-ray tube assemblies for medical diagnosis
Project Leader : Tomas Bengtsson
IEC 60601-2-33 Ed. 3.0 - Medical electrical equipment - Part 2-33: Particular requirements for
the safety of magnetic resonance equipment for medical diagnosis
Project Leader : Hans Engels
IEC 60601-2-43 Ed. 2.0 - Medical electrical equipment - Part 2-43: Particular requirements for
basic safety and essential performance of X-ray equipment for interventional procedures
Project Leader : Lionel Desponds
IEC 60601-2-45 Ed. 3.0 - Medical electrical equipment - Part 2-45: Particular requirements for
basic safety and essential performance of mammographic X ray equipment and
mammomagraphic stereotactic devices
Project Leader : Jacqueline Gallet
SC 62B - Diagnostic imaging equipment
Work Programme for SC 62B
IEC 60601-2-63 Ed. 1.0 - Medical electrical equipment - Part 2-XX: Particular requirements for
basic safety and essential performance of dental X-ray equipment
Project Leader : Marie-Pierre Labat-Camy
IEC 60613 Ed. 3.0 - Electrical and loading characteristics of X -ray tube assemblies for medical
diagnosis
Project Leader : Tomas Bengtsson
IEC 62464-2 Ed. 1.0 - Medical electrical equipment - Magnetic resonance equipment for for
medical imaging - Classification criteria for pulse sequences
Project Leader : Herbert Köstler
IEC 62563-1 Ed. 1.0 - Medical electrical equipment - Medical image display systems - Part 1:
Evaluation methods
Project Leader : Matthias Wedel
IEC 62570 Ed. 1.0 - Magnetic resonance equipment for human application - Instructions for
marking items within the controlled access area
Project Leader : Gregor Schaefers
SC 62B - Diagnostic imaging equipment
Work Programme for SC 62B
IEC 60601-2-29 (2008-06) Ed. 3.0 Bilingual English and French
Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential
performance of radiotherapy simulators
Maintenance Result Date: 2009
IEC 60976 (2007-10) Ed. 2.0 Bilingual English and French
Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
Maintenance Result Date: 2014
IEC 60976 (2007-10) Ed. 2.0 Spanish
Versión Oficial En español - Equipos electromédicos. Aceleradores de electrones de uso médico.
Características funcionales.
Maintenance Result Date: 2014
IEC/TR 60977 (2008-07) Ed. 2.0 Bilingual English and French
Medical electrical equipment - Medical electron accelerators - Guidelines for functional performance
characteristics
Maintenance Result Date: 2014
SC 62C - Equipment for radiotherapy, nuclear medicine and radiation dosimetryPublications issued by SC 62C
IEC 61217 (2008-04) Ed. 1.2 Bilingual English and French
Radiotherapy equipment - Coordinates, movements and scales
Maintenance Result Date: 2011
IEC 61217-am2 (2007-11) Ed. 1.0 Bilingual English and French
Amendment 2 - Radiotherapy equipment - Coordinates, movements and scales
Maintenance Result Date: 2011
IEC 61217-am2 (2007-11) Ed. 1.0 Spanish
Versión Oficial En español - Modificación 2 - Equipos utilizados en radioterapia. Coordenadas,
movimientos y escalas.
Maintenance Result Date: 2011
IEC 61675-1 (2008-06) Ed. 1.1 English
Radionuclide imaging devices - Characteristics and test conditions - Part 1: Positron emission
tomographs
Maintenance Result Date: 2011
SC 62C - Equipment for radiotherapy, nuclear medicine and radiation dosimetryPublications issued by SC 62C
IEC 61675-1-am1 (2008-04) Ed. 1.0 English
Amendment 1 - Radionuclide imaging devices - Characteristics and test conditions - Part 1: Positron
emission tomographs
Maintenance Result Date: 2011
IEC 61675-1-am1 (2008-04) Ed. 1.0 Spanish
Versión Oficial En español - Modificación 1 - Dispositivos de imagen por radionucleidos.
Características y condiciones de ensayo. Parte 1: Tomógrafos por emisión de positrones.
Maintenance Result Date: 2011
IEC 61676 (2009-01) Ed. 1.1 English
Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray
tube voltage in diagnostic radiology
Maintenance Result Date: 2011
IEC 61676-am1 (2008-11) Ed. 1.0 English
Amendment 1 - Medical electrical equipment - Dosimetric instruments used for non-invasive
measurement of X-ray tube voltage in diagnostic radiology
Maintenance Result Date: 2011
SC 62C - Equipment for radiotherapy, nuclear medicine and radiation dosimetryPublications issued by SC 62C
IEC/TR 61948-4 (2006-11) Ed. 1.0 English
Nuclear medicine instrumentation - Routine tests - Part 4: Radionuclide calibrators
Maintenance Result Date: 2010
IEC 62467-1 (2009-06) Ed. 1.0 Bilingual English and French
Medical electrical equipment - Dosimetric instruments as used in brachytherapy - Part 1: Instruments
based on well-type ionization chambers
Maintenance Result Date: 2011
SC 62C - Equipment for radiotherapy, nuclear medicine and radiation dosimetryPublications issued by SC 62C
PNW 62C-477 Ed. 1.0 - Medical electrical equipment - Medical light ion accelerators - Functional
performance characteristics
Project Leader : Michael Moyers
PNW 62C-478 Ed. 1.0 - Medical electrical equipment - Part 2-X: Particular requirements for the
basic safety and essential performance of medical light ion accelerators in the range 10 MeV/n to
500 MeV/n
Project Leader : Michael Moyers
IEC 60601-2-1 Ed. 3.0 - Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
Project Leader : Hans Sethi
IEC 60601-2-8 Ed. 2.0 - Medical electrical equipment - Part 2-8: Particular requirements for basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
Project Leader : Stephen C. Lillicrap
IEC 60601-2-11 Ed. 3.0 - Medical electrical equipment - Part 2-11: Particular requirements for the safety and essential performance of gamma beam therapy equipment
Project Leader : Wilhelm Goldstein
SC 62C - Equipment for radiotherapy, nuclear medicine and radiation dosimetryWork Programme for SC 62C
IEC 60601-2-17 Ed. 3.0 - Medical electrical equipment - Part 2-17: Particular requirements for basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment
Project Leader : Geoffrey S.Ibbott
IEC 60731 Ed. 3.0 - Medical electrical equipment - Dosimeters with ionization chambers as used
in radiotherapy
Project Leader : Hans-Joachim Selbach
IEC 61217 Ed. 2.0 - Radiotherapy equipment - Coordinates, movements and scales
Project Leader : Claus-Peter Höppner
IEC 62083 Ed. 2.0 - Medical electrical equipment - Requirements for the safety of radiotherapy
treatment planning systems
Project Leader : Guido Ligthart
SC 62C - Equipment for radiotherapy, nuclear medicine and radiation dosimetryWork Programme for SC 62C
IEC 60601-2-2 (2009-02) Ed. 5.0 Bilingual English and French
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential
performance of high frequency surgical equipment and high frequency surgical accessories
Maintenance Result Date: 2012
IEC 60601-2-5 (2009-07) Ed. 3.0 Bilingual English and French
Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential
performance of ultrasonic physiotherapy equipment
Maintenance Result Date: 2012
IEC 60601-2-13-am1 (2006-05) Ed. 3.0 English
Amendment 1 - Medical electrical equipment - Part 2-13: Particular requirements for the safety and
essential performance of anaesthetic systems
Maintenance Result Date: 2009
IEC 60601-2-13-am1 (2006-05) Ed. 3.0 Spanish
Versión Oficial En español - Modificación 1 - Equipos electromédicos. Parte 2-13: Requisitos
particulares para la seguridad y funcionamiento esencial de los sistemas de anestesia
Maintenance Result Date: 2009
SC 62D - Electromedical equipment
Publications issued by SC 62D
IEC 60601-2-16 Corr.1 (2008-10) Ed. 3.0 English
Corrigendum 1 - Medical electrical equipment - Part 2-16: Particular requirements for basic safety and
essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
Maintenance Result Date: 2011
IEC 60601-2-16 (2008-04) Ed. 3.0 English
Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential
performance of haemodialysis, haemodiafiltration and haemofiltration equipment
Maintenance Result Date: 2011
IEC 60601-2-18 (2009-08) Ed. 3.0 Bilingual English and French
Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential
performance of endoscopic equipment
Maintenance Result Date: 2011
IEC 60601-2-19 (2009-02) Ed. 2.0 Bilingual English and French
Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential
performance of infant incubators
Maintenance Result Date: 2012
SC 62D - Electromedical equipment
Publications issued by SC 62D
IEC 60601-2-20 (2009-02) Ed. 2.0 Bilingual English and French
Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential
performance of infant transport incubators
Maintenance Result Date: 2012
IEC 60601-2-21 (2009-02) Ed. 2.0 Bilingual English and French
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential
performance of infant radiant warmers
Maintenance Result Date: 2012
IEC 60601-2-31 (2008-03) Ed. 2.0 Bilingual English and French
Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential
performance of external cardiac pacemakers with internal power source
Maintenance Result Date: 2010
IEC 60601-2-31 (2008-03) Ed. 2.0 Spanish
Versión Oficial En español - Equipos electromédicos. Parte 2-31: Requisitos particulares para la
seguridad básica y funcionamiento esencial de marcapasos externos cardiacos con fuente de
alimentación interna.
Maintenance Result Date: 2010
SC 62D - Electromedical equipment
Publications issued by SC 62D
IEC 60601-2-39 (2007-11) Ed. 2.0 Bilingual English and French
Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential
performance of peritoneal dialysis equipment
Maintenance Result Date: 2011
IEC 60601-2-41 (2009-08) Ed. 2.0 Bilingual English and French
Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential
performance of surgical luminaires and luminaires for diagnosis
Maintenance Result Date: 2014
IEC 60601-2-50 (2009-03) Ed. 2.0 Bilingual English and French
Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential
performance of infant phototherapy equipment
Maintenance Result Date: 2011
IEC 80601-2-30 (2009-01) Ed. 1.0 Bilingual English and French
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential
performance of automated non-invasive sphygmomanometers
Maintenance Result Date: 2011
SC 62D - Electromedical equipment
Publications issued by SC 62D
IEC 80601-2-58 (2008-10) Ed. 1.0 Bilingual English and French
Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential
performance of lens removal devices and vitrectomy devices for ophthalmic surgery
Maintenance Result Date: 2014
IEC 80601-2-59 (2008-10) Ed. 1.0 Bilingual English and French
Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential
performance of screening thermographs for human febrile temperature screening
Maintenance Result Date: 2013
IEC 80601-2-59 Corr.1 (2009-04) Ed. 1.0 Bilingual English and French
Corrigendum 1 - Medical electrical equipment - Part 2-59: Particular requirements for the basic safety
and essential performance of screening thermographs for human febrile temperature screening
Maintenance Result Date: 2013
SC 62D - Electromedical equipment
Publications issued by SC 62D
PNW 62D-767 Ed. 1.0 - Medical electrical equipment - Particular requirements for basic safety
and essential performance of medical supply units
PNW 62D-780 Ed. 1.0 - Guideline for the safe use of medical products in dialysis treatment
(Technical Report)
Project Leader : Hans-Juergen Flaig
PNW 62D-788 Ed. 1.0 - Small-bore connectors for liquids and gases in healthcare applications -
Part 6: Connectors for neuraxial applications
ISO 27427 Ed. 1.0 - Anaesthetic and respiratory equipment - Nebulizer systems and components
Project Leader : Terry Longman
IEC 60601-2-4 Ed. 3.0 - Medical electrical equipment - Part 2-4: Particular requirements for basic
safety and essential performance of cardiac defibrillators
Project Leader : Robert Zito
IEC 60601-2-23 Ed. 3.0 - Medical electrical equipment - Part 2-23: Particular requirements for
basic safety and essential performance of transcutaneous partial pressure monitoring equipment
Project Leader : Klaus Neuder
SC 62D - Electromedical equipment
Work Programme for SC 62D
IEC 60601-2-24 Ed. 2.0 - Medical electrical equipment - Part 2-24: Particular requirements for
basic safety and essential performance of infusion pumps and controllers
Project Leader : Klaus Neuder
IEC 60601-2-25 Ed. 2.0 - Medical electrical equipment - Part 2-25: Particular requirements for
the basic safety and essential performance of electrocardiographs
Project Leader : Klaus Neuder
IEC 60601-2-26 Ed. 3.0 - Medical electrical equipment - Part 2-26: Particular requirements for
basic safety and essential performance of electroencephalographs
Project Leader : Klaus Neuder
IEC 60601-2-27 Ed. 3.0 - Medical electrical equipment - Part 2-27: Particular requirements for
thebasic safety and essential performance ofelectrocardiographic monitoring equipment
Project Leader : Klaus Neuder
IEC 60601-2-34 Ed. 3.0 - Medical electrical equipment - Part 2-34: Particular requirements for
the basic safety and essential performance of invasive blood pressure monitoring equipment
Project Leader : Klaus Neuder
SC 62D - Electromedical equipment
Work Programme for SC 62D
IEC 60601-2-46 Ed. 2.0 - Medical electrical equipment - Part 2-46: Particular requirements for basic
safety and essential performance of operating tables
Project Leader : Herman Kieferle
IEC 60601-2-47 Ed. 2.0 - Medical electrical equipment - Part 2-47: Particular requirements for thebasic
safety and essential performance of ambulatory electrocardiographic systems
Project Leader : Klaus Neuder
IEC 60601-2-49 Ed. 2.0 - Medical electrical equipment - Part 2-49: Particular requirements for the basic
safety and essential performance of multifunction patient monitoring equipment
Leader : Klaus Neuder
IEC 60601-2-52 Ed. 1.0 - Medical electrical equipment - Part 2-52: Particular requirements for basic
safety and essential performance of medical beds
Project Leader : Klaus Neuder
IEC 60601-2-62 Ed. 1.0 - Medical electrical equipment - Part 2-60: Particular requirements for basic
safety and essential performance of high intensity therapeutic ultrasound (HITU) systems
Project Leader : Rob Hekkenberg
ISO 80369-1 Ed. 1.0 - Project Leader : To be determinedSmall bore connectors for liquids and gases in
healthcare applications - Part 1: General requirements
SC 62D - Electromedical equipment
Work Programme for SC 62D
ISO 80369-1 Ed. 1.0 - Project Leader : To be determinedSmall bore connectors for liquids and
gases in healthcare applications - Part 1: General requirements
ISO 80369-2 Ed. 1.0 - Small-bore connectors for liquids and gases in healthcare applications - Part
2: Connectors for breathing systems and driving gases
Project Leader : Scott Colburn
ISO 80601-2-12 Ed. 1.0 - Medical electrical equipment - Part 2-12: Particular requirements for
basic safety and essential performance of critical care ventilators
Project Leader : John Hedley-Whyte
IEC 80601-2-13 Ed. 4.0 - Medical electrical equipment - Part 2-13: Particular requirements for
basic safety and essential performance of an anaesthetic workstation
Project Leader : Christopher Joseph
IEC 80601-2-35 Ed. 2.0 - Medical electrical equipment - Part 2-35: Particular requirements for
the basic safety and essential performance of heating devices using blankets, pads and mattresses
and intended for heating in medical use
Project Leader : Jochim Koch
SC 62D - Electromedical equipment
Work Programme for SC 62D
ISO 80601-2-55 Ed. 1.0 - Medical electrical equipment - Part 2-55: Particular requirements for
basic safety and essential performance of respiratory gas monitors
Project Leader : D. Osborn
ISO 80601-2-60 Ed. 1.0 - Medical electrical equipment - Part 2-60: Particular requirements for
basic safety and essential performance of dental equipment
Project Leader : Fritz Kolle
ISO 80601-2-61 Ed. 1.0 - Medical electrical equipment - Part 2-61: Particular requirements for
the basic safety and essential performance of pulse oximeter equipment for medical use
Project Leader : John Hedley-Whyte
SC 62D - Electromedical equipment
Work Programme for SC 62D
IEC - International Electrotechnical Commission
Fonte de Pesquisa: http://www.iec.ch
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