Информация

  • Секретариат: ANSI (United States)
    Менеджер комитета:
    Ms DeeDee Meadows
  • Председатель (до конца 2027):
    Mr Jesus Rueda Rodriguez
  • Менеджер ИСО по техническим программам [TPM]:
    Ms Isabelle Vega
    Менеджер ИСО по редакционным программам [EM]:
    Ms Valeria Agamennone
  • Дата создания : 1994

Область деятельности

Standardization and guidance in the field of medical laboratories and in vitro diagnostic systems. This includes, for example, quality management, pre- and postanalytical 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 ISO/TC 334 the 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 51 стандарта для достижения следующихЦели в области устойчивого развития:

1
Ликвидация нищеты
3
Хорошее здоровье и благополучие
4
Качественное образование
8
Достойная работа и экономический рост
9
Индустриализация, инновации и инфраструктура
10
Уменьшение неравенства
11
Устойчивые города и населенные пункты
12
Ответственное потребление и производство
13
Борьба с изменением климата
55

Опубликованных стандартов *

23

Стандартов ИСО, находящихся *

45
Полноправных членов
32
Наблюдатели

* число включает обновленную информацию

Ссылки Заголовок Тип
ISO/TC 212/JWG 6   Joint ISO/TC 212 - ISO/TC 276 WG: Quality practice for detection of SARS-CoV-2 Рабочая группа
ISO/TC 212/STTF   Spanish translation task force Рабочая группа
ISO/TC 212/WG 1   Quality and competence in the medical laboratory Рабочая группа
ISO/TC 212/WG 2   Reference systems Рабочая группа
ISO/TC 212/WG 3   In vitro diagnostic products Рабочая группа
ISO/TC 212/WG 4   Microbiology and molecular diagnostics Рабочая группа
ISO/TC 212/WG 5   Laboratory biorisk management Рабочая группа

Совместные рабочие группы, находящиеся в компетенции другого комитета

Ссылки Заголовок
ISO/TC 34/SC 9/JWG 1 Joint ISO/TC 34/SC 9, ISO/TC 34/SC 16 and ISO/TC 212: Whole Genome Sequencing - Based Detection of Antimicrobial Resistance Determinants

Комитет по рабочим связям с ISO/TC 212

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

Ссылка Заголовок ИСО/МЭК
IEC/SC 62D Particular medical equipment, software, and systems IEC
IEC/TC 62 Medical equipment, software, and systems IEC
IEC/TC 66 Safety of measuring, control and laboratory equipment IEC
ISO/CASCO Committee on conformity assessment 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 147/SC 4 Microbiological methods 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 products with a health purpose including medical devices ISO
ISO/TC 215 Health informatics ISO
ISO/TC 276 Biotechnology ISO
ISO/TC 276/SC 1 Analytical methods ISO
ISO/TC 283 Occupational health and safety management ISO
ISO/PC 302 Guidelines for auditing management systems ISO
ISO/TC 304 Healthcare organization management ISO
ISO/TC 334 Reference materials ISO
ISO/TC 336 Laboratory design ISO

 

Комитеты по рабочим связям ISO/TC 212

ISO/TC 212 можно получить доступ к документам комитетов ниже

Ссылка Заголовок ИСО/МЭК
IEC/SC 62D Particular medical equipment, software, and systems IEC
ISO/CASCO Committee on conformity assessment 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 products with a health purpose including medical devices ISO
ISO/TC 215 Health informatics ISO
ISO/TC 229 Nanotechnologies ISO
ISO/TC 262 Risk management ISO
ISO/TC 276 Biotechnology ISO
ISO/TC 283 Occupational health and safety management ISO
ISO/PC 302 Guidelines for auditing management systems ISO
ISO/TC 304 Healthcare organization management ISO
ISO/TC 334 Reference materials ISO

 

Рабочие связи (Категории А и B)

Акроним Заголовок Тип рабочей связи
ASLM African Society for Laboratory Medicine A
BBMRI-ERIC Biobanking and BioMolecular resources Research Infrastructure A
BIPM International Bureau of Weights and Measures A
CLSI Clinical and Laboratory Standards Institute, Inc A
EC - European Commission European Commission A
EC4 European Communities Confederation of Clinical Chemistry A
EFLM European Federation of Clinical Chemistry and Laboratory Medicine A
EUROM European Federation of Precision Mechanical and Optical Industries A
GHWP Global Harmonization Working Party 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
A-PBA Asia-Pacific Biosafety Association C
ABSA American Biological Safety Association C
BACAC Biosafety Association for Central Asia and the Caucasus C
Bigpicture Bigpicture C
EBSA European Biosafety Association C
EMPAIA EMPAIA International e. V. C
IARC International Agency for Research on Cancer C
IFBA International Federation of Biosafety Associations C
WOAH World Organization for Animal Health (WOAH) C
Дата Меяц Местоположение ТК/ПК Примечание
21-22 October 2026 Singapore (Singapore) ISO/TC 212  

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

ISO/TC 212 - Секретариат

ANSI (United States)

Clinical and Laboratory Standards Institute
5 Great Valley Parkway, Suite 219
Malvern 19355 PA
United States

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

  2. Участие
  3. Кто разрабатывает стандарты
  4. Технические комитеты
  5. ISO/TC 212