Cart (0)
  • No items in cart.
Total
$0
There is a technical issue about last added item. You can click "Report to us" button to let us know and we resolve the issue and return back to you or you can continue without last item via click to continue button.
Home
Content
eLibrary
Filters:
FORMAT
EDITION
to
PUBLISHER
AABC
(1)
AAMI
(337)
ACI
(589)
AISC
(54)
ASA
(234)
ASCE
(996)
ASHRAE
(657)
ASME
(2161)
ASSE
(117)
ASTM
(94394)
AWC
(54)
AWWA
(568)
BHMA
(124)
BICSI
(33)
BIFMA
(21)
BOMA
(20)
BSI
(94534)
CHD
(3)
CRSI
(17)
IAHSS
(1)
IAPMO
(374)
ICC
(315)
IEEE
(6631)
IES
(241)
ISEA
(16)
Joint Commission
(184)
Joint Commission Int.
(1)
NETA
(6)
NFPA
(1646)
TCNA
(17)
TMS
(19)
USGBC
(28)
WILEY
(4)
 
AR
(6)
AZ
(7)
CA
(115)
CT
(3)
FL
(57)
ID
(5)
IL
(5)
IN
(1)
KY
(1)
LA
(2)
MI
(25)
MN
(27)
NC
(27)
NJ
(13)
NY
(61)
OH
(24)
OR
(22)
PA
(7)
RI
(8)
SC
(20)
SD
(1)
TX
(3)
VA
(50)
VT
(6)
WA
(31)
CONTENT TYPE
 Act
 Admin Code
 Announcements
 Bill
 Book
 CADD File
 CAN
 CEU
 Charter
 Checklist
 City Code
 Code
 Commentary
 Comprehensive Plan
 Conference Paper
 County Code
 Course
 DHS Documents
 Document
 Errata
 Executive Regulation
 Federal Guideline
 Firm Content
 Guideline
 Handbook
 Interpretation
 Journal
 Land Use and Development
 Law
 Legislative Rule
 Local Amendment
 Local Code
 Local Document
 Local Regulation
 Local Standards
 Manual
 Model Code
 Model Standard
 Notice
 Ordinance
 Other
 Paperback
 PASS
 Periodicals
 PIN
 Plan
 Policy
 Product
 Product - Data Sheet
 Program
 Provisions
 Requirements
 Revisions
 Rules & Regulations
 Standards
 State Amendment
 State Code
 State Manual
 State Plan
 State Standards
 Statute
 Study Guide
 Supplement
 Sustainability
 Technical Bulletin
 All
  • BSI
    PD CEN/TS 16827-3:2015 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for FFPE tissue - Isolated DNA
    Edition: 2015
    $313.97
    / user per year

Description of PD CEN/TS 16827-3:2015 2015

This Technical Specification gives recommendations for the handling, documentation and processing of FFPE tissue specimens intended for DNA analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e.g., in vitro diagnostic laboratories, laboratory customers, developers and manufacturers of in vitro diagnostics, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities). DNA integrity in tissues can change before and during formalin fixation, processing and storage. Chemical modifications introduced into DNA during tissue fixation might lead to fragmentation and sequence alterations [1], changes in the methylation status or even structural changes which can lead to e.g., spurious copy number changes in array-CGH profiles [2]. These modifications of the DNA molecules can impact the validity and reliability of the analytical test results. Therefore, it is essential to take special measures to minimize the described modifications for subsequent DNA analysis.

Standard NumberPD CEN/TS 16827-3:2015
TitleMolecular in vitro diagnostic examinations. Specifications for pre-examination processes for FFPE tissue - Isolated DNA
StatusWithdrawn
Publication Date2015-08-31
Withdrawn Date2019-01-28
Replaced ByBS EN ISO 20166-3:2019
Identical National Standard OfCEN/TS 16827-3:2015
DescriptorsMedical technology, Laboratories, Laboratory testing, Quality assurance systems, Quality, Management, Quality management, Medical sciences, Medical laboratory equipment, Laboratory accreditation, Quality assurance
ICS11.100.10 In vitro diagnostic test systems
CommitteeCH/212
ISBN978 0 580 85032 5
PublisherBSI
Pages20

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
GROUPS