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Successful 12th Meeting of ISO/TC 212 in Berlin
Reflects Strength of Collaboration for Global Standards Development
The 12th meeting of The International Organization for Standardization Technical Committee (ISO/TC) 212, Clinical laboratory testing and in vitro diagnostic test systems, was held 31 May - 2 June 2006 in Berlin, Germany. The meeting was hosted by DIN Medical Standards Committee, with financial support from: Bio-Rad Laboratories GmbH; BNLD; INSTAND e.V.; MSD Sharp and Dohme GmbH; Roche Diagnostics GmbH; and Wyeth Pharma GmbH. Radiometer Copenhagen also provided support for the meeting.
John Zlockie, CLSI Vice President, Standards, and Secretary, ISO/TC 212, comments, “The successful meeting in Berlin emphasizes the strength of cooperation and importance of efforts of countries around the world to effectively collaborate on consensus standards for the global medical-testing community.”
ISO/TC 212 was established in 1995, based on a proposal by CLSI (formerly NCCLS). ISO granted the Secretariat to the American National Standards Institute (ANSI), who in turn delegated the Secretariat responsibility to CLSI. CLSI serves as manager of ISO’s standardization and guidance in the field of laboratory medicine and in vitro diagnostic test systems, including quality management, pre- and postanalytical procedures, analytical performance, laboratory safety, reference systems, and quality assurance. Currently, the membership of ISO/TC 212 is comprised of 33 participating member countries and 16 observer countries. As part of the organizational structure, ISO/TC 212 project development responsibilities are assigned to four working groups: Working Group 1 (WG1), Quality and competence in the medical laboratory; Working Group 2 (WG2), Reference systems; Working Group 3 (WG3), In vitro diagnostic products; and Working Group 4 (WG4), Antimicrobial Susceptibility Testing.
ISO/TC 212 Document Development Moving Forward
The ISO/TC 212 meetings in Berlin were very productive and addressed major items, including: the review of document development work, target dates, working group structure, future projects, and cooperation with other technical committees and international organizations for global harmonization. ISO/TC 212 manages the development of its family of standards according to ISO’s established timeline. Therefore, ISO/TC 212 reviewed and accepted reports of the standards development projects from Working Groups 1, 2, 3, and 4 at the meeting. Along with the Technical Committee, WG1, WG2, and WG3 also met in Berlin to continue their work.
WG1 recommended the immediate start of the revision of ISO 15190, Medical laboratories – Requirements for safety, by a project group led by John James (UK), Phil Barnes (NZ), Luci Berte (USA), Michael Noble (Canada), and Zhai Peijun (China), with the intention of having a finished working draft for review before the group’s next meeting. This draft will be shared with CEN/TC 140.
A new title was approved for ISO 25680, Medical laboratories – Estimation and expression of measurement uncertainty, a project being developed by WG2. It was agreed that the document will be circulated as a technical specification.
Under the work items for WG3, ISO/TC 212 approved distribution of ISO 17593, Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy, for Final Draft International Standard (FDIS) vote and recognized Dr. Michael Spannagl (Germany), project team leader, and the project team for this accomplishment. In addition, the Committee approved distribution of ISO 18113, In vitro diagnostic medical devices – information supplied by the manufacturer (labeling): Parts 1-5, for Draft International Standard (DIS) vote and asked CEN for parallel enquiry. ISO/TC 212 recognized Ms. Kay Setzer (USA), project team leader, and the project team for this accomplishment.
ISO/TC 212 recognized the excellent support and cooperation received from ISO/TC 210/JWG1 in preparation of ISO 14971, Annex H – Guidance on risk analysis for in vitro diagnostic medical devices. The working groups have collaborated diligently to meet established timelines.
Dr. Klaus E. Stinshoff Term as ISO/TC 212 Chairman Ends in 2006
Dr. Donald M. Powers to Serve as New Chairman in 2007
At the meeting, the Technical Committee thanked Klaus E. Stinshoff, Dr.rer.nat. for his outstanding leadership and service to TC 212, as Chair, a former convenor, and an esteemed colleague. Dr. Stinshoff also serves as a CLSI volunteer and member of the Board of Directors and has made many contributions to further harmonization and coordination of efforts for global standards development. In 2003, Dr. Stinshoff received CLSI’s highest award, the Russell J. Eilers Memorial Award, for his commitment to volunteer consensus and for his leadership of ISO/TC 212. Dr. Stinshoff will complete his term as Chairman of TC 212 in December 2006,
In Berlin, ISO/TC 212 supported the nomination of Donald M. Powers, PhD as the new chairman of TC 212, starting 1 January 2007. Dr. Powers, an active CLSI consensus participant, is a leader in the development of global and national standards. With more than 35 years of practical experience with IVD medical device and pharmaceutical firms, medical center laboratories, and research institutes, Dr. Powers brings extensive quality systems, regulatory compliance, and premarket submissions expertise to this new role. Dr. Powers has global experience with subsidiaries and regulatory authorities, including Australia, Canada, France, Germany, Japan, and the UK. He is also a frequent author and speaker on quality systems and regulatory issues.
China to Host 2007 Meeting
ISO/TC 212 accepted the formal invitation extended by Technical Committee 136 of the Peoples Republic of China to hold its next meeting in Beijing on 21-23 May 2007. The Technical Committee also accepted the invitation of the Canadian Standards Association (CSA) to hold its subsequent meeting in Vancouver, Canada in 2008.
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