Reference number
ISO 20387:2018
International Standard
ISO 20387:2018
Biotechnology — Biobanking — General requirements for biobanking
Edition 1
2018-08
Preview
ISO 20387:2018
67888
недоступно на русском языке
Опубликовано (Версия 1, 2018)

ISO 20387:2018

ISO 20387:2018
67888
Язык
Формат
CHF 173
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Тезис

This document specifies general requirements for the competence, impartiality and consistent operation of biobanks including quality control requirements to ensure biological material and data collections of appropriate quality.

This document is applicable to all organizations performing biobanking, including biobanking of biological material from multicellular organisms (e.g. human, animal, fungus and plant) and microorganisms for research and development.

Biobank users, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others can also use this document in confirming or recognizing the competence of biobanks.

This document does not apply to biological material intended for food/feed production, laboratories undertaking analysis for food/feed production, and/or therapeutic use.

NOTE 1 International, national or regional regulations or requirements can also apply to specific topics covered in this document.

NOTE 2 For entities handling human materials procured and used for diagnostic and treatment purposes ISO 15189 and other clinical standards are intended to apply first and foremost.

Общая информация

  •  : Опубликовано
     : 2018-08
    : Международный стандарт подлежит пересмотру [90.92]
  •  : 1
  • ISO/TC 276
    07.080 
  • RSS обновления

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