CEI UNI EN ISO 20387:2021
Current
Current
The latest, up-to-date edition.
Biotechnology - Biobanking - General requirements for biobanking (ISO 20387:2018)
Amended by
Available format(s)
Hardcopy , PDF
Language(s)
English - Italian
Published date
01-07-2021
Publisher
Important note : Users cannot be edited or removed once added to your Multi user PDF.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.
| Committee |
CT 501
|
| DevelopmentNote |
New child AMD 11 2024 is now added
|
| DocumentType |
Standard
|
| Pages |
70
|
| ProductNote |
New child AMD 11 2024 is now added
|
| PublisherName |
Comitato Elettrotecnico Italiano
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 20387:2020 | Identical |
| UNI EN ISO 20387:2020 | Identical |
| ISO 20387:2018 | Identical |
| ISO/IEC 17000:2004 | Conformity assessment Vocabulary and general principles |
| ISO 15189:2012 | Medical laboratories — Requirements for quality and competence |
| ISO 26000:2010 | Guidance on social responsibility |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 19011:2018 | Guidelines for auditing management systems |
| ISO/IEC 17025:2017 | General requirements for the competence of testing and calibration laboratories |
| ISO/TS 20658:2017 | Medical laboratories — Requirements for collection, transport, receipt, and handling of samples |
| ISO 9001:2008 | Quality management systems Requirements |
| ISO 17511:2003 | In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials |
| ISO/IEC 17020:2012 | Conformity assessment — Requirements for the operation of various types of bodies performing inspection |
| ISO/IEC 17043:2010 | Conformity assessment — General requirements for proficiency testing |
| ISO Guide 30:2015 | Reference materials — Selected terms and definitions |
| ISO 15378:2017 | Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) |
| ISO 20186-1:2019 | Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNA |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 17364:2013 | Supply chain applications of RFID — Returnable transport items (RTIs) and returnable packaging items (RPIs) |
| ISO 27799:2016 | Health informatics Information security management in health using ISO/IEC 27002 |
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