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
    BS ISO 21151:2020 In vitro diagnostic medical devices. Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples
    Edition: 2020
    $435.35
    / user per year

Description of BS ISO 21151:2020 2020

This document specifies requirements for a protocol implemented by an international body to achieve equivalent results among two or more IVD MDs for the same measurand for cases where there are no reference measurement procedures and no fit-for-purpose certified reference materials or international conventional calibrators. In this case, the harmonisation protocol defines the highest level of metrological traceability for the stated measurand.

This document can be applied in cases when certified reference materials or international conventional calibrators exist but are not fit-for-purpose because, for example, they are not commutable with human samples.

NOTE

This document addresses one case of traceability of assigned and measured values described in 5.6 in ISO 17511:2020.



Standard NumberBS ISO 21151:2020
TitleIn vitro diagnostic medical devices. Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples
StatusDefinitive
Publication Date2020-05-27
Identical National Standard OfISO 21151
DescriptorsTest methods, Harmonization, Biological tests, Measurement, Medical equipment
ICS11.100.10 In vitro diagnostic test systems
CommitteeCH/212
ISBN978 0 539 01126 5
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