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
    19/30361173 DC BS ISO 21474. In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids - Part 1. Terminology and general requirements for nucleic acid quality evaluation
    Edition: 2019
    $44.66
    / user per year

Description of 19/30361173 DC 2019

This document provides the terms and general requirements for the evaluation of the quality of nucleic acids as the analytes for multiplex molecular tests, which simultaneously identify two or more nucleic acid target sequences of interest. This document is applicable to all multiplex molecular methods used for examination using in vitro diagnostic (IVD) medical devices and laboratory developed tests (LDTs). It provides information for both qualitative and quantitative detection of nucleic acid target sequences.

This document is intended as guidance for multiplex molecular assays that detect and/or quantify human nucleic acid target sequences or microbial pathogen nucleic acid target sequences from human clinical specimens. This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. This document is not applicable to metagenomics.

NOTE

An examination procedure developed for a laboratory’s own use is often referred to as a “laboratory developed test”, “LDT”, or “in-house test”.



Standard Number19/30361173 DC
TitleBS ISO 21474. In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids - Part 1. Terminology and general requirements for nucleic acid quality evaluation
StatusDefinitive
Publication Date2019-08-29
Identical National Standard OfISO/DIS 21474-1
DescriptorsNucleic acids, Testing, Terminology, Evaluation, Quality
ICS11.100.10 In vitro diagnostic test systems
CommitteeCH/212
PublisherBSI
Pages28

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