GB/T 21415-2008 English Version, GB/T 21415-2008 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (English Version)

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Position: Chinese Standard in English/GB/T 21415-2008

GB/T 21415-2008 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (English Version)
Standard No.:	GB/T 21415-2008	Status:	to be superseded remind me the status change Email:
Target Language:	English	File Format:	PDF
Word Count:	10500 words	Translation Price(USD):	120.0 remind me the price change Email:
Implemented on:	2008-9-1	Delivery:	via email in 1~3 business day

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Standard No.:	GB/T 21415-2008
English Name:	In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
Chinese Name:	体外诊断医疗器械生物样品中量的测量校准品和控制物质赋值的计量学溯源性
Chinese Classification:	C44 Medical laboratory equipment
Professional Classification:	GB National Standard
Source Content Issued by:	AQSIQ; SAC
Issued on:	2008-1-22
Implemented on:	2008-9-1
Status:	to be superseded
Superseded by:	GB/T 21415-2025
Superseded on:	2026-3-1
Target Language:	English
File Format:	PDF
Word Count:	10500 words
Translation Price(USD):	120.0
Delivery:	via email in 1~3 business day

GB/T 21415-2008 is referred in:

*YY/T 1721-2020 Free thyroxine (FT4) testing kit

Standard

GB/T 21415-2008 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (English Version)
Standard No.	GB/T 21415-2008
Status	to be superseded
Language	English
File Format	PDF
Word Count	10500 words
Price(USD)	120.0
Implemented on	2008-9-1
Delivery	via email in 1~3 business day

Detail of GB/T 21415-2008

Standard No.

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Professional Classification

ICS Classification

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Implemented on

Status

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Superseded on

Abolished on

Superseding

Language

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Introduction of GB/T 21415-2008

本标准规定了对以建立或确认测量正确度为目的的校准品和控制物质赋值的计量学溯源性进行确认的方法。校准品和控制物质由制造商提供，作为体外诊断医疗器械的一部分或与其一起使用。由国际公认的参考测量系统或国际公认的约定参考测量系统赋值的、已证实具有互换性的室间质量评价样品适用于本标准。本标准等同采用ＩＳＯ１７５１１：２００３《体外诊断医疗器械　生物样品中量的测量　校准品和控制物质
赋值的计量学溯源性》。

Contents of GB/T 21415-2008

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Keywords:
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