1. IEC TC 62 presentation to DICOM 2012-06-26 1 Norbert Bischof Secretary IEC TC62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE Secretary IEC SC62B DIAGNOSTIC IMAGING EQUIPMENT

2. 2 Content: International Standards Organisations ISO and IEC IEC Technical Committee 62 IEC 62 standards International Medical Device Standards

3. 3 International Standardisation Organisations These organisations follow the WTOs * TBT** Code of Practice and accept one vote per country: ITU-TInternational Telecommunication Union ISOInternational Organisation for Standardisation IECInternational Electrotechnical Commission However, there are many organisations producing “International Standards”, such as: IAEA, ASTM, BSI,... *WTO World Trade Organisation **TBT Technical Barriers to Trade

4. 4 Content: International Standards Organisations ISO and IEC IEC Technical Committee 62 IEC 62 standards International Medical Device Standards

5. 5 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

6. 6 Medical Committees in ISO and IEC ISO/TC 76Transfusion, infusion and injection equipment ISO/TC 84Administration of medicinal products and intravascular catheters ISO/TC 106Dentistry ISO/TC 121Anaesthetic and respiratory equipment ISO/TC 150Implants for surgery ISO/TC 168Prosthetics and orthotics ISO/TC 170Surgical instruments ISO/TC 173Assistive products for persons with disability ISO/TC 184Industrial automation systems and integration ISO/TC 194Biological evaluation of medical devices ISO/TC 198Sterilization of health care products ISO/TC 210Quality Management Systems for Medical Devices ISO/TC 212Clinical laboratory testing and in vitro diagnostic test systems ISO/TC 215Health informatics IEC/TC 62Electrical equipment in medical practice

7. 7 Content: International Standards Organisations ISO and IEC IEC Technical Committee 62 IEC 62 standards International Medical Device Standards

8. 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

9. Technical Committee 62 9 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 CAG Chairman Advisory Group Chair 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 SNAG Software and Networks Advisory Group

10. 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

11. 11 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

12. 12 Content: International Standards Organisations ISO and IEC IEC Technical Committee 62 IEC 62 standards International Medical Device Standards

13. 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 Standards ** publication 2013

14. Imaging: Particular Standards in edition 3 of IEC 60601-1 DeviceIEC Standard X-ray60601-2-54 Interventional x-ray 60601-2-43 Mammography60601-2-45 Dental intra-oral60601-2-65 Dental extra-oral60601-2-63 Computed tomography60601-2-44 X-ray tube assemblies60601-2-28 MRI60601-2-33 Ultrasound60601-2-37

15. DICOM related work

16. Project Team 61910-1

17. 17 Thank you Questions welcome Norbert Bischof bischof@cocir.org