Tenth Meeting of ISO/TC 212 in Utrecht was a Success

The tenth meeting of The International Organization for Standardization Technical Committee (ISO/TC) 212, Clinical laboratory testing and in vitro diagnostic test systems, was held 7-9 June in Utrecht, The Netherlands. The meeting was hosted by NEN (Nederlands Normalisatie-Instituut) and RIVM (Dutch National Institute for Public Health and the Environment), with supporting funds from Digene Corp, USA; Roche Diagnostics, Germany; Bio-Rad Laboratories France; CCKL, Dutch Foundation for accreditation of medical laboratories; Sysmex Corp., Japan; PerkinElmer/Wallac Finland; Becton Dickinson, Belgium; Biomerieux France; and Medtronic, USA.

ISO/TC 212 was established in 1995, based on a proposal by NCCLS. ISO granted the Secretariat to the American National Standards Institute (ANSI), who in turn delegated the Secretariat responsibility to NCCLS. As manager of ISO’s standards-development process in this field, NCCLS’s role is a global one carried out on behalf of the patient-testing community throughout the world. Currently, the membership of ISO/TC 212 is comprised of 33 participating member countries and 15 observer countries. As part of the organizational structure, ISO/TC 212 project development responsibilities are assigned to four working groups: Working Group 1, Quality management in the clinical laboratory; Working Group 2, Reference systems; Working Group 3, In vitro diagnostic products; and Working Group 4, Antimicrobial Susceptibility Testing.

The ISO/TC 212 meetings in Utrecht were very productive and addressed major items including: the review of work, target dates and working group structure, future work items, and harmonization of definitions. Along with the Technical Committee, Working Group 1 (WG1) and Working Group 3 (WG3) also met in Utrecht. ISO/TC 212 manages the development of its family of standards according to ISO’s established time line. Accordingly, at the meetings in Utrecht, the Committee reviewed the current documents being developed by all working groups. WG1 and WG3 presented reports directly and met over a two-day period to continue their work; written reports were received from the other working groups. 

WG1 recommended a title change, revised scope, and CD vote for a new proposal on risk management. Approved in May 2004, the proposal is being developed as a Technical Report, Medical laboratories – Reduction of error through risk management and continual improvement. ISO/TC 212 agreed with the recommendation and approved advancement of the document. In addition, the document, known as ISO/TR 22869, was approved for distribution and vote.

At the meeting of the ISO/TC 212/WG1 in Atlanta on 15 December 2003, Keith Shinton, ISO/TC212/WG1 Convener, announced his intention to resign at the close of the plenary meeting on 9 June 2004. In Utrecht, ISO/TC 212 unanimously approved the appointment of Des Kenny (Ireland) as the new convener. 

At the meeting of ISO/TC 212/WG3, significant progress was made in the development of a new work item, ISO 18112: Clinical laboratory testing and in vitro diagnostic test systems – In vitro diagnostic medical devices – Information supplied by the manufacturer. ISO/TC 212 approved the development of ISO 18112 in five parts which include: Part 1- General requirements; Part 2- Reagents for professional use; Part 3 – Instruments for professional use; Part 4 – Reagents for self-testing; and Part 5 – Instruments for self-testing. In addition, ISO/TC 212 approved ISO 17953, Clinical laboratory testing and in vitro diagnostic test systems — Requirements for in vitro monitoring systems for self-testing of oral anticoagulation therapy, for distribution and vote as a DIS with the inclusion of an informational annex.  

ISO/TC 210/JWG1 and ISO/TC 212/WG3 held a meeting to address comments and complete ISO/CD 14971, Annex H – Guidance on risk analysis for in vitro diagnostic medical devices. The working groups have worked diligently to meet established timelines. Once approved, the annex will become part of ISO 14971, and further revision will be the responsibility of TC 210/JWG1, with participation and concurrence by representatives of TC 212/WG3.

U.S.A. to Host 2005 Meeting

ISO/TC 212 accepted the formal invitation extended by the U.S.A. to hold its next meeting in the Washington, D.C. area in May 2005. The meeting will be co-sponsored by NIST and AdvaMed. The Technical Committee also accepted the invitation of Germany to hold its subsequent meeting in Berlin in 2006. [ return to top ]