Verkkokauppa
SFS-EN ISO 20387:2020:en
Biotechnology. Biobanking. General requirements for biobanking (ISO 20387:2018)
Soveltamisala
Suomenkielistä soveltamisalaa ei ole saatavissa.
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.
Tämän julkaisun valmistelusta Suomessa vastaa SFS Suomen Standardit, puh. 09 149 9331.
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.
Tämän julkaisun valmistelusta Suomessa vastaa SFS Suomen Standardit, puh. 09 149 9331.
Sisällysluettelo
Tuoteryhmä(t)
Sidokset
Velvoittavat viittaukset
ISO 8601:2004 Data elements and interchange formats -- Information interchange -- Representation of dates and times
Tekninen komitea
Direktiivi
765/2008 Tuotteiden kaupan pitämiseen liittyvää akkreditointia ja markkinavalvontaa koskevista vaatimuksista ja neuvoston asetuksen (ETY) N:o 339/93 kumoamisesta
http://ec.europa.eu »
http://ec.europa.eu »
Vahvistuspäivä
02.10.2020
Julkaisupäivä
06.10.2020
Painos
1
Sivumäärä
42
Julkaisun kieli
englanti