workshop para usuÁrios convênio fns/usp 2209/2008 … · 2011-05-30 · –european committee for...

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)

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


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 Commission


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



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



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



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



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



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



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



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



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


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



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


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


JWG 1 - Requirements for the safety and compatibility of magnetic resonance imaging for patients with an active implantable medical device



Chairman : (Term of office : 2010-05)Mr Geoffrey S. Ibbott (US)

Secretary : Mr Bernd Seidel (DE)


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)


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.


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



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


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



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



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




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


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.




performance - Collateral standard: Usability


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.






performance - Collateral Standard: General requirements, tests and guidance for alarm systems in

medical electrical equipment and medical electrical systems


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




performance - Collateral Standard: Requirements for environmentally conscious design


IEC 60601-1-9 (2007-07) Ed. 1.0 Spanish


básica y funcionamiento esencial. Norma colateral: Requisitos para un diseño eco-responsable.






performance - Collateral Standard: Requirements for the development of physiologic closed-loop

controllers


IEC 60601-1-10 (2007-11) Ed. 1.0 Spanish


básica y funcionamiento esencial. Norma colateral: Requisitos para el desarrollo de controladores

fisiológicos en bucle cerrado.


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




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


IEC/TR 61258 (2008-08) Ed. 2.0 English

Guidelines for the development and use of medical electrical equipment educational materials


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


IEC 62304 (2006-05) Ed. 1.0 Bilingual English and French

Medical device software - Software life cycle processes


IEC 62304 (2006-05) Ed. 1.0 Spanish

Versión Oficial En español - Software de dispositivos médicos. Procesos del ciclo de vida del software





Mapping between the clauses of the third edition of IEC 60601-1 and the 1988 edition as amended



Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment


IEC 62353 (2007-05) Ed. 1.0 Spanish

Versión Oficial En español - Equipos electromédicos. Ensayos recurrentes y ensayos después de

reparación del equipo electromédico.



Medical devices - Application of usability engineering to medical devices


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.




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


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


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


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.



Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance

equipment for medical diagnosis


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.



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


IEC 60601-2-33-am2 (2007-11) Ed. 2.0 Spanish


particulares para la seguridad de los equipos de resonancia magnética para diagnóstico médico.



Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential

performance of ultrasonic medical diagnostic and monitoring equipment


IEC 60601-2-37 (2007-08) Ed. 2.0 Spanish


seguridad básica de los equipos médicos de diagnóstico y monitorización por ultrasonidos.






performance of X-ray equipment for computed tomography




performance of X-ray equipment for radiography and radioscopy



Evaluation and routine testing in medical imaging departments Part 26: Constancy tests Imaging

performance of computed tomography X-ray equipment


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





Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging

performance of mammographic X-ray equipment


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



Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2:

Determination of the detective quantum efficiency - Detectors used in mammography


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.





Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3:

Determination of the detective quantum efficiency - Detectors used in dynamic imaging


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


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



Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions

and requirements for general radiography




IEC/PAS 61910-1 (2007-07) Ed. 1.0 English

Medical electrical equipment - Radiation dose documentation - Part 1: Equipment for radiography and

radioscopy




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


the safety of magnetic resonance equipment for medical diagnosis

Project Leader : Hans Engels


basic safety and essential performance of X-ray equipment for interventional procedures

Project Leader : Lionel Desponds


basic safety and essential performance of mammographic X ray equipment and

mammomagraphic stereotactic devices

Project Leader : Jacqueline Gallet


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


Work Programme for SC 62B



performance of radiotherapy simulators



Medical electrical equipment - Medical electron accelerators - Functional performance characteristics


IEC 60976 (2007-10) Ed. 2.0 Spanish

Versión Oficial En español - Equipos electromédicos. Aceleradores de electrones de uso médico.

Características funcionales.



Medical electrical equipment - Medical electron accelerators - Guidelines for functional performance

characteristics


SC 62C - Equipment for radiotherapy, nuclear medicine and radiation dosimetryPublications issued by SC 62C


Radiotherapy equipment - Coordinates, movements and scales


IEC 61217-am2 (2007-11) Ed. 1.0 Bilingual English and French

Amendment 2 - Radiotherapy equipment - Coordinates, movements and scales


IEC 61217-am2 (2007-11) Ed. 1.0 Spanish

Versión Oficial En español - Modificación 2 - Equipos utilizados en radioterapia. Coordenadas,

movimientos y escalas.


IEC 61675-1 (2008-06) Ed. 1.1 English

Radionuclide imaging devices - Characteristics and test conditions - Part 1: Positron emission

tomographs



IEC 61675-1-am1 (2008-04) Ed. 1.0 English

Amendment 1 - Radionuclide imaging devices - Characteristics and test conditions - Part 1: Positron

emission tomographs


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.


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


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



IEC/TR 61948-4 (2006-11) Ed. 1.0 English

Nuclear medicine instrumentation - Routine tests - Part 4: Radionuclide calibrators



Medical electrical equipment - Dosimetric instruments as used in brachytherapy - Part 1: Instruments

based on well-type ionization chambers



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



performance of high frequency surgical equipment and high frequency surgical accessories




performance of ultrasonic physiotherapy equipment


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


IEC 60601-2-13-am1 (2006-05) Ed. 3.0 Spanish


particulares para la seguridad y funcionamiento esencial de los sistemas de anestesia



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


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




performance of endoscopic equipment




performance of infant incubators






performance of infant transport incubators




performance of infant radiant warmers




performance of external cardiac pacemakers with internal power source


IEC 60601-2-31 (2008-03) Ed. 2.0 Spanish


seguridad básica y funcionamiento esencial de marcapasos externos cardiacos con fuente de

alimentación interna.





Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential

performance of peritoneal dialysis equipment




performance of surgical luminaires and luminaires for diagnosis




performance of infant phototherapy equipment




performance of automated non-invasive sphygmomanometers






performance of lens removal devices and vitrectomy devices for ophthalmic surgery




performance of screening thermographs for human febrile temperature screening


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




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


basic safety and essential performance of transcutaneous partial pressure monitoring equipment

Project Leader : Klaus Neuder


Work Programme for SC 62D


basic safety and essential performance of infusion pumps and controllers



the basic safety and essential performance of electrocardiographs



basic safety and essential performance of electroencephalographs



thebasic safety and essential performance ofelectrocardiographic monitoring equipment



the basic safety and essential performance of invasive blood pressure monitoring equipment





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


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


safety and essential performance of medical beds



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



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


basic safety and essential performance of an anaesthetic workstation

Project Leader : Christopher Joseph


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




basic safety and essential performance of respiratory gas monitors

Project Leader : D. Osborn


basic safety and essential performance of dental equipment

Project Leader : Fritz Kolle


the basic safety and essential performance of pulse oximeter equipment for medical use

Project Leader : John Hedley-Whyte



IEC - International Electrotechnical Commission

Fonte de Pesquisa: http://www.iec.ch

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