TC 212

Clinical laboratory testing and in vitro diagnostic test systems

  • Secretariat: ANSI
  • Secretary: Mr. David Sterry
  • Chairperson: Dr. Donald M. Powers (USA) until end 2012
  • Creation date: 1994

Scope:

Standardization and guidance in the field of laboratory medicine and in vitro diagnostic test systems. This includes, for example, quality management, pre- and post-analytical procedures, analytical performance, laboratory safety, reference systems and quality assurance.

Excluded:

  • generic quality management standards dealt with by ISO / TC 176;
  • quality management standards for medical devices dealt with by ISO / TC 210;
  • reference materials guidelines dealt with by the ISO Committee on Reference Materials (REMCO);
  • conformity assessment guidelines dealt with by the ISO Committee on Conformity assessment (CASCO).

Total number of published ISO standards related to the TC and its SCs: 23
Number of published ISO standards under the direct responsibility of TC 212: 23
Participating countries: 31
Observing countries: 20

ISO committees in liaison:

TC 48, TC 76, TC 150/SC 7, TC 210, TC 215

IEC committees in liaison:

IEC/TC 66

Organizations in liaison:

BIPM, EC4, EDMA, ELM, EUROM, ICSH, IFBLS, IFCC, ILAC, IUPAC, OECD, WASPaLM, WHO

Subcommittees/Working Groups:

Subcommittee/Working Group Title
TC 212/WG 1 Quality and competence in the medical laboratory
The convener can be reached through the secretariat
TC 212/WG 2 Reference systems
The convener can be reached through the secretariat
TC 212/WG 3 In vitro diagnostic products
The convener can be reached through the secretariat
TC 212/WG 4 Antimicrobial susceptibility testing
The convener can be reached through the secretariat

Meeting calendar

* Information definite but meeting not yet formally convened
** Provisional

Month Location  
June 2010 2-4 Seoul (Korea, Republic of) ** TC 212
 
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