iec tc 62 presentation to dicom 2012-06-26 1 norbert bischof secretary iec tc62 electrical equipment...

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

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Thank you

Questions welcomeNorbert Bischofbischof@cocir.org