iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
CEN

EN ISO 20387:2020/A11:2024

(Amendment)

Biotechnology - Biobanking - General requirements for biobanking

Biotechnology - Biobanking - General requirements for biobanking

Biotechnologie - Biobanking - Allgemeine Anforderungen an das Biobanking

Biotechnologie - «Biobanking» - Exigences générales relatives au «biobanking»

Biotehnologija - Biobančništvo - Splošne zahteve za biobančništvo

General Information

Status
Published
Publication Date
16-Jul-2024
ICS
07.080 - Biology. Botany. Zoology
Technical Committee
CEN/CLC/TC 1 - Criteria for conformity assessment bodies
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
17-Jul-2024
Due Date
27-Oct-2026
Completion Date
17-Jul-2024
Directive
765/2008 - REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93
Mandate
M/580 - Standardisation request to the European Committee for Standardisation and the European Committee for Electrotechnical Standardisation in the area of accreditation and conformity assessment
Ref Project
SIST EN ISO 20387:2020/A11:2024 - Biotechnology - Biobanking - General requirements for biobanking

Relations

Amends
EN ISO 20387:2020 - Biotechnology - Biobanking - General requirements for biobanking (ISO 20387:2018)
Effective Date
26-Jun-2024

Buy Standard

EN ISO 20387:2020/A11:2024EN ISO 20387:2020/A11:2024
PreviousNext
Amendment
EN ISO 20387:2020/A11:2024
English language
4 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)


SLOVENSKI STANDARD
01-september-2024
Biotehnologija - Biobančništvo - Splošne zahteve za biobančništvo
Biotechnology - Biobanking - General requirements for biobanking
Biotechnologie - Biobanking - Allgemeine Anforderungen an Biobanking
Biotechnologie - «Biobanking» - Exigences générales relatives au «biobanking»
Ta slovenski standard je istoveten z: EN ISO 20387:2020/A11:2024
ICS:
07.080 Biologija. Botanika. Zoologija Biology. Botany. Zoology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN ISO 20387:2020/A11

NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2024
ICS 07.080
English version
Biotechnology - Biobanking - General requirements for
biobanking
Biotechnologie - "Biobanking" - Exigences générales Biotechnologie - Biobanking - Allgemeine
relatives au "biobanking" Anforderungen an Biobanking
This amendment A11 modifies the European Standard EN ISO 20387:2020; it was approved by CEN on 12 June 2024.

CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
inclusion of this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical
references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to
any CEN and CENELEC member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and United Kingdom.

CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2024 CEN/CENELEC All rights of exploitation in any form and by any means
Ref. No. EN ISO 20387:2020/A11:2024 E
reserved worldwide for CEN national Members and for
CENELEC Members.
Contents Page
European foreword . 3
Annex ZA (informative)  Relationship between this European Standard and the
requirements of Regulation (EC) No 765/2008 of the European Parliament and of
the Council of 9 July 2008 setting out the requirements for accreditation and
repealing Regulation (EEC) No 339/93 aimed to be covered . 4

European foreword
This document (EN ISO 20387:2020/A11:2024) has been prepared by Technical Committee
CEN/CLC/JTC 1 “Criteria for conformity assessment bodies” the secretariat of which is held by BSI.
This Amendment to the European Standard EN ISO 20387:2020 shall be given the status of a national
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

CEN
EN ISO 20387:2020(Main)
Biotechnology - Biobanking - General requirements for biobanking (ISO 20387:2018)
SIST EN ISO 20387:2020

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.

  • Standard
    45 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN 17881:2024(Main)
Food authenticity - DNA barcoding of bivalves and products derived from bivalves using a defined mitochondrial 16S rRNA gene segment
SIST EN 17881:2024

This document specifies a method for the taxonomic identification of a single bivalve or piece of bivalve to the genus or species level using DNA barcoding. It allows the identification of a large number of commercially important bivalve species.
This method was validated on raw mussels. Laboratory experience indicates additional applicability to processed bivalve products, e.g. cold smoked, hot smoked, salted, frozen, cooked, fried, and deep-fried samples.
The described method is usually unsuitable for the analysis of highly processed foods, e.g. tins of mussels, with highly degraded DNA where the fragment lengths are not sufficient for amplification of the target. Furthermore, it is not applicable for complex seafood products containing mixtures of two or more bivalve species.
The identification of bivalve species is carried out by PCR amplification of a segment of the mitochondrial 16S rRNA gene, followed by sequencing of the PCR products and subsequent sequence comparison with entries in databases.

  • Standard
    17 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN 17882:2024(Main)
Food authenticity - DNA barcoding of meat derived from mammals and birds using defined mitochondrial cytochrome b and cytochrome c oxidase I gene segments
SIST EN 17882:2024

This document specifies a method for the identification of meat derived from mammals and birds to the level of genus or species and allows the identification of a large number of commercially important as well as exotic meat species using DNA barcoding.
This method was validated on DNA isolated from single pieces of raw meat. This method can also be used for the identification of single meat animal species in some processed products.
The described method is unsuitable for the analysis of highly processed foods with highly degraded DNA where the fragment lengths are not sufficient for amplification of the targets. Furthermore, it is not applicable for complex meat products containing mixtures of two or more meat species.
The identification of meat species is carried out by PCR amplification of either a segment of the mitochondrial cytochrome b gene (cytb) or the cytochrome c oxidase I gene (cox1, syn COI) or both, followed by sequencing of the PCR products and subsequent sequence comparison with entries in databases.

  • Standard
    20 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Standard
    20 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
CEN/TS 17725:2022(Main)
Plant biostimulants - Determination of the quantity (indicated by mass or volume)
SIST-TS CEN/TS 17725:2023

This document specifies the methods to be used for the determination of quantity of solid and liquid forms of plant biostimulants in packages, containers or in bulk.
This document is not applicable to the quantity determination of: soil improvers, growing media, organic and organo-mineral fertilizers and fertilizing product blends whose main constituent is a growing media or soil improver. The method for quantity determination for these products is given in EN 15761, EN 15238 and EN 12580.

  • Technical specification
    14 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
CEN/TS 17705:2022(Main)
Plant biostimulants - Determination of phosphonates
SIST-TS CEN/TS 17705:2023

This document specifies a method for the extraction and determination of phosphonates (P–PO3) in plant biostimulants using ion chromatography and conductivity detection (IC-CD).
This document is also applicable to the blends of fertilizing products where plant biostimulants are the main part of the blend. Otherwise, the Technical Specification for the main part of the blend applies.

  • Technical specification
    12 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
CEN/TS 17703:2022(Main)
Plant biostimulants - Determination of chromium(VI)
SIST-TS CEN/TS 17703:2023

This document was developed to provide a method for verifying that hexavalent chromium (CrVI) is not present in plant biostimulants in a concentration that exceeds the respective limits outlined in the EU Regulation on Fertilising Products [1].
This document is applicable to all types of plant biostimulants (solid and liquid ) used in agriculture.
The method described is suitable to quantify the chromium(VI) content in plant biostimulants down to 2 mg/kg.
The results obtained from this method are strictly dependent on the extraction conditions. Results obtained by using other extraction procedures (extraction solution, pH, extraction time, etc.) are not comparable with the results produced by the procedure described in this document.

  • Technical specification
    16 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
CEN/TS 17704:2022(Main)
Plant biostimulants - Determination of dry matter
SIST-TS CEN/TS 17704:2023

This document specifies the procedure for the determination and calculation of the dry matter fraction of plant biostimulants for which the results of performed analysis are to be calculated to the dry matter basis.
This document is also applicable to the blends of fertilizing products where plant biostimulants are the main part of the blend. Otherwise, the Technical Specification for the main part of the blend applies.

  • Technical specification
    9 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
CEN/TS 17701-3:2022(Main)
Plant biostimulants - Determination of specific elements - Part 3: Determination of mercury
SIST-TS CEN/TS 17701-3:2023

This document specifies a method for determination of the content of mercury (Hg) in plant biostimulants using (cold) vapour generation apparatus coupled to an atomic absorption spectrophotometer and a method using a direct amalgamation technique. It is applicable to aqua regia digests prepared according to CEN/TS 17701-1.
NOTE    It is also possible to use other suitable methods for the determination of mercury described in Annex A if users prove that the method gives the same results as the methods described in this document.
This document is also applicable to the blends of fertilizing products where plant biostimulants are the main part of the blend. Otherwise, the Technical Specification for the main part of the blend applies.

  • Technical specification
    13 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
CEN/TS 17706:2022(Main)
Plant biostimulants - Determination of inorganic arsenic
SIST-TS CEN/TS 17706:2023

This document specifies a method for extraction, separation, and determination of inorganic arsenic (iAs) in plant biostimulants using anion-exchange high performance liquid chromatography (HPLC) or ion chromatography (IC) coupled to ICP-MS.
This document is also applicable to the blends of fertilizing products where plant biostimulants are the main part of the blend. Otherwise, the Technical Specification for the main part of the blend applies.

  • Technical specification
    15 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 20387:2020(Main)
Biotechnology - Biobanking - General requirements for biobanking (ISO 20387:2018)
SIST EN ISO 20387:2020

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.

  • Standard
    45 pages
    English language
    sale 10% off
    e-Library read for
    1 day