CEI UNI EN ISO 20387:2021
Current
Biotechnology - Biobanking - General requirements for biobanking (ISO 20387:2018)
Hardcopy , PDF
English - Italian
07-01-2021
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 |
| ISO 20387:2018 | Identical |
| ISO/IEC 17000:2004 | Conformity assessment — Vocabulary and general principles |
| ISO 17034:2016 | General requirements for the competence of reference material producers |
| ISO/IEC 20944-1:2013 | Information technology — Metadata Registries Interoperability and Bindings (MDR-IB) — Part 1: Framework, common vocabulary, and common provisions for conformance |
| 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 20184-1:2018 | Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 1: Isolated RNA |
| ISO/IEC Guide 99:2007 | International vocabulary of metrology — Basic and general concepts and associated terms (VIM) |
| 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 8459:2009 | Information and documentation — Bibliographic data element directory for use in data exchange and enquiry |
| 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 17100:2015 | Translation services — Requirements for translation services |
| ISO 27799:2016 | Health informatics — Information security management in health using ISO/IEC 27002 |
| ISO/IEC 17021-1:2015 | Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 1: Requirements |
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