iec tc 62 presentation to dicom 2012-06-26 1 norbert bischof secretary iec tc62 electrical equipment...
TRANSCRIPT
IEC TC 62 presentation to DICOM 2012-06-26
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Norbert Bischof
Secretary IEC TC62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE
Secretary IEC SC62B DIAGNOSTIC IMAGING EQUIPMENT
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Content:
International Standards Organisations
ISO and IEC
IEC Technical Committee 62
IEC 62 standards
International Medical Device Standards
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International Standardisation Organisations
These organisations follow the WTOs* TBT** Code of Practice and accept one vote per country:
ITU-T International Telecommunication Union
ISO International Organisation for Standardisation
IEC International Electrotechnical Commission
However, there are many organisations producing “International Standards” , such as: IAEA, ASTM, BSI, ...
*WTO World Trade Organisation
**TBT Technical Barriers to Trade
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Content:
International Standards Organisations
ISO and IEC
IEC Technical Committee 62
IEC 62 standards
International Medical Device Standards
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ISO and IEC
ISO International Organisation for Standardization, founded 1946
IEC International Electrotechnical Commission, founded 1906
share a set of common directives
standards fit seamlessly together
are voluntary associations of MEMBER COUNTRIES establishing National Committees fully representing stakeholders in their countries: industry, government, consumers ..., etc.
ONE member per nation
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Medical Committees in ISO and IEC
ISO/TC 76 Transfusion, infusion and injection equipmentISO/TC 84 Administration of medicinal products and intravascular cathetersISO/TC 106 DentistryISO/TC 121 Anaesthetic and respiratory equipmentISO/TC 150 Implants for surgeryISO/TC 168 Prosthetics and orthoticsISO/TC 170 Surgical instrumentsISO/TC 173 Assistive products for persons with disabilityISO/TC 184 Industrial automation systems and integrationISO/TC 194 Biological evaluation of medical devicesISO/TC 198 Sterilization of health care productsISO/TC 210 Quality Management Systems for Medical DevicesISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systemsISO/TC 215 Health informatics
IEC/TC 62 Electrical equipment in medical practice
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Content:
International Standards Organisations
ISO and IEC
IEC Technical Committee 62
IEC 62 standards
International Medical Device Standards
TC 62 Electrical equipment in medical practice
Scope**:
To prepare international standards and other publications concerning electrical equipment, electrical systems and software used in healthcare and their effects on patients, operators, other persons and the environment.
NOTE: This scope includes items that are also within the scopes of other committees and will be addressed through cooperation. Attention will focus on safety and performance (e.g. radiation protection, data security, data integrity, data privacy and environmental aspects) and will contribute to regulatory frameworks. Healthcare includes medical practice as well as emergency medical services, homecare, and support of persons with disabilities in their daily lives (i.e. Ambient Assisted Living).”** as revised 2011-09-23 at the TC 62 meeting in Nuremberg and approved by the IEC Standards Management Board
Established in 1968
Technical Committee 62
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TC 62 Electrical equipment in medical practice
SC 62A Common aspects of electrical equipment used in medical practice
Chair Justin McCarthy Sec US Charles Sidebottom
CAGChairman Advisory
GroupChair Rudy Godinez /
Sec DE Norbert Bischof
SC 62B Diagnostic imaging equipment
Chair Jim Malone Sec DE Norbert Bischof
SC 62C Radiotherapy, nuclear medicine and radiation dosimetry
Chair Geoffrey S Ibbott Sec DE Claus-Peter Hoeppner
SC 62D Electromedical equipment
Chair Robert Schaefer Sec US Mike Schmidt
SNAGSoftware and Networks
Advisory Group
IEC TC 62 Key Data*
Founded in 1968
116 active publications
18 publications last year
58 active projects
27 Participating Member Countries
17 Observing Member Countries
5 Committees (incl. the main Committee)
70 Working Groups
960 Experts from BE, BR, CA, CN, DK, FI, FR, DE, HU, IN, IE, IT, JP, NL, NO, PK, PT, RO, RU, ZA, ES, SE, CH, GB, US
*per 2011-11-28
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IEC TC 62 has met September 2011 in Nuremberg in conjunction with its subcommittees.
The next meeting of IEC TC 62 and subcommittees will be held in Shanghai, China from April 8 to 19, 2013.
IEC TC 62 Meetings
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Content:
International Standards Organisations
ISO and IEC
IEC Technical Committee 62
IEC 62 standards
International Medical Device Standards
IEC 60601-2-x standards rule
•Within its scope a part 2 takes priority
over all part 1 standards.
•70 in IEC, many more in ISO
•Specific to a category of products.
•Modifications to requirements in part 1
•Addition,
•Replacement or
•Exemption
•Dated references to part 1 standards.
IEC 60601-1-2: Electromagnetic Compatibility
IEC 60601-1-3: Radiation Protection
IEC 60601-1-6: Usability
IEC 60601-1-8: Alarms
IEC 60601-1-9: Environment
Modular Structure of IEC 60601-Series
IEC 60601-1-10: Physiological Closed-Loop Controllers
IEC 60601-1-11: Home Healthcare Environment
ISO 14971 Risk management
IEC 60601-1-12: Emergency Services Environment**
IEC 60601-1: General requirements
Part 1: Generic Part 2: Particular
Collateral S
tandards
** publication 2013
Imaging: Particular Standards in edition 3 of IEC 60601-1
Device IEC Standard
X-ray 60601-2-54
Interventionalx-ray
60601-2-43
Mammography 60601-2-45
Dental intra-oral 60601-2-65
Dental extra-oral 60601-2-63
Computed tomography 60601-2-44
X-ray tube assemblies 60601-2-28
MRI 60601-2-33
Ultrasound 60601-2-37
DICOM related work
Project Team 61910-1
