Информация

  • Секретариат: ANSI
    Менеджер комитета:
    Mr David Sterry
  • Председатель (до конца 2024):
    Dr Jack J. Zakowski
  • Менеджер ИСО по техническим программам [TPM]:
    Ms Isabelle Vega
    Менеджер ИСО по редакционным программам [EPM]:
    Ms Jasmin Lewis
  • Дата создания : 1994

Область деятельности

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).

Быстрый поиск

Цели в области устойчивого развития

Данный комитет занимается разработкой 2 стандарта для достижения следующих Цели в области устойчивого развития:

37

Опубликованных стандартов *

находящиеся в компетенции ISO/TC 212

17

Стандартов ИСО, находящихся *

находящиеся в компетенции ISO/TC 212

46

Полноправных членов

21

Наблюдатели

* число включает обновленную информацию

Ссылки Заголовок Тип
ISO/TC 212/WG 1 Quality and competence in the medical laboratory Working group
ISO/TC 212/WG 2 Reference systems Working group
ISO/TC 212/WG 3 In vitro diagnostic products Working group
ISO/TC 212/WG 4 Microbiology and molecular diagnostics Working group
ISO/TC 212/WG 5 Laboratory biorisk management Working group

Комитет по рабочим связям с ISO/TC 212

Комитет, указанный ниже, имеет доступ к следующим документам ISO/TC 212:

Ссылка Заголовок ИСО/МЭК
IEC/TC 66 Safety of measuring, control and laboratory equipment IEC
ISO/CASCO Committee on conformity assessment ISO
ISO/REMCO Committee on reference materials ISO
ISO/TC 34 Food products ISO
ISO/TC 34/SC 9 Microbiology ISO
ISO/TC 34/SC 16 Horizontal methods for molecular biomarker analysis ISO
ISO/TC 48 Laboratory equipment ISO
ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use ISO
ISO/TC 150/SC 7 Tissue-engineered medical products ISO
ISO/TC 176 Quality management and quality assurance ISO
ISO/TC 210 Quality management and corresponding general aspects for medical devices ISO
ISO/TC 215 Health informatics ISO
ISO/TC 276 Biotechnology ISO
ISO/TC 304 Healthcare organization management ISO

 

Комитеты по рабочим связям ISO/TC 212

ISO/TC 212 можно получить доступ к документам комитетов ниже

Ссылка Заголовок ИСО/МЭК
ISO/CASCO Committee on conformity assessment ISO
ISO/REMCO Committee on reference materials ISO
ISO/TC 34 Food products ISO
ISO/TC 34/SC 9 Microbiology ISO
ISO/TC 34/SC 16 Horizontal methods for molecular biomarker analysis ISO
ISO/TC 48 Laboratory equipment ISO
ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use ISO
ISO/TC 150/SC 7 Tissue-engineered medical products ISO
ISO/TC 176 Quality management and quality assurance ISO
ISO/TC 194 Biological and clinical evaluation of medical devices ISO
ISO/TC 207/SC 1 Environmental management systems ISO
ISO/TC 210 Quality management and corresponding general aspects for medical devices ISO
ISO/TC 215 Health informatics ISO
ISO/TC 262 Risk management ISO
ISO/TC 276 Biotechnology ISO
ISO/TC 283 Occupational health and safety management ISO
ISO/TC 304 Healthcare organization management ISO

 

Рабочие связи (Категории А и B)

Акроним Заголовок Тип рабочей связи
AHWP Asian Harmonization Working Party A
ASLM African Society for Laboratory Medicine A
BBMRI-ERIC Biobanking and BioMolecular resources Research Infrastructure A
BIPM International Bureau of Weights and Measures A
EC4 European Communities Confederation of Clinical Chemistry A
EC - European Commission European Commission A
EFLM European Federation of Clinical Chemistry and Laboratory Medicine A
EUROM European Federation of Precision Mechanical and Optical Industries A
ICSH International Council for Standardization in Haematology A
IFBLS International Federation of Biomedical Laboratory Science A
IFCC International Federation of Clinical Chemistry and Laboratory Medicine A
ILAC International Laboratory Accreditation Cooperation A
IUPAC International Union of Pure and Applied Chemistry A
MedTech Europe Alliance of European medical technology industry associations A
OECD Organisation for Economic Co-operation and Development, OECD A
WASPaLM World Association of Societies of Pathology and Laboratory Medicine A
WHO World Health Organization A

Рабочие связи (Категории С)

Рабочие связи категорий C, присутствующих в Рабочей группе

Акроним Заголовок Тип рабочей связи
ABSA American Biological Safety Association C
A-PBA Asia-Pacific Biosafety Association C
BACAC Biosafety Association for Central Asia and the Caucasus C
EBSA European Biosafety Association C
IFBA International Federation of Biosafety Associations C
OIE World Organization for Animal Health (OIE) C
Дата Меяц Местоположение ТК/ПК Примечание
4-8 November 2019 Cuauhtémoc (Mexico) ISO/TC 212  

* Информация определена, но заседание еще официально не проведено
** Предварительное

ISO/TC 212 - Секретариат

ANSI [United States]

Clinical and Laboratory Standards Institute
950 West Valley Road, Suite 2500
Wayne, PA 19087-1898
United States

Tel: +1 610 688 01 00
Fax: +1 610 688 07 00

Секретариат:

Mr David Sterry
Tel: +1 484 588 5942