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YY/T 1227-2014: In vitro diagnostic reagent(kit)nomenclature for clinical chemistry
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1227-2014 | English | 459 |
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In vitro diagnostic reagent(kit)nomenclature for clinical chemistry
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YY/T 1227-2014
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Basic data | Standard ID | YY/T 1227-2014 (YY/T1227-2014) | | Description (Translated English) | In vitro diagnostic reagent(kit)nomenclature for clinical chemistry | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 20,238 | | Date of Issue | 6/17/2014 | | Date of Implementation | 7/1/2015 | | Quoted Standard | ISO 18113.1-2009 | | Regulation (derived from) | China Food and Drug Administration in 2014 Bulletin No. 30 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard applies to the use of spectrophotometry using automatic biochemical analyzer, semi-automatic biochemical analyzer or spectrophotometer, medical laboratory for quantitative detection of clinical chemistry in vitro diagnostic reagents (box) pr | YY/T 1227-2014: In vitro diagnostic reagent(kit)nomenclature for clinical chemistry---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
In vitro diagnostic reagent (kit) nomenclature for clinical chemistry
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Clinical chemistry in vitro diagnostic reagents (box) named
Issued on. 2014-06-17
2015-07-01 implementation
China Food and Drug Administration released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
Please note that some of the content of this document may involve patents. Distribution of this document
Institutions do not assume the responsibility to identify these patents.
This standard was proposed by the China Food and Drug Administration.
This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized.
This standard was drafted. Beijing Drug Administration Medical Device Evaluation Center, Beijing Medical Device Testing.
The main drafters of this standard. Zhao, Bi Chunlei, Zhang, He Xueying.
Introduction
This standard is based on a lot of research carried out on the basis of the State Food and Drug Administration issued the "in vitro diagnostic reagents Registry
After (Trial) "(SFDA [2007] No. 229), repeatedly seek expert advice in clinical, manufacturing, regulatory and other aspects of development. needle
For the spectrophotometric principle, the use of automatic biochemical analyzer, spectrophotometer or semi-automatic biochemical analyzer, medical laboratory
In vitro diagnostic reagents clinical chemistry project quantitative test used (box).
The purpose of this is to develop standards of in vitro diagnostic reagents product names provide a reference for manufacturers, for regulators regulate markets
Basis, in order to standardize in vitro diagnostic reagents product name to facilitate clinical use.
Clinical chemistry in vitro diagnostic reagents (box) named
1 Scope
This standard specifies the principles of clinical chemistry in vitro diagnostic kit named to be followed, and part of the project to develop a specific named instance.
This standard contains the scope, normative references, terms and definitions and requirements and so on.
This standard applies to the use of spectrophotometry using automatic biochemical analyzer, spectrophotometer or semi-automatic biochemical analyzer, medical
Laboratory for quantitative detection of clinical chemistry in vitro diagnostic reagents (box) products.
This standard does not apply to calibration, controls.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
ISO 18113-1.2009 In vitro diagnostic medical device manufacturers to provide information (labeling) - Part 1. Terms, definitions and general
Requirements (Invitrodiagnosticmedicaldevices-Informationsuppliedbythemanufacturer (labeling) -
Part 1. Terms, definitionsandgeneralrequirements)
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
IVD invitrodiagnosticreagent
It intended by the manufacturer to be used for in vitro diagnostic medical devices for chemical, biological or immunological components, solutions or preparation.
[ISO 18113-1.2009, definitions 3.28]
3.2
Clinical chemistry in vitro diagnostic reagents (box) Invitrodiagnosticreagent (kit) forclinicalchemistry
On automatic biochemical analyzer, semi-automatic biochemical analyzer or spectrophotometer chemical detection of human body fluids and life related activities
Quality, to provide clinical diagnosis, treatment, diagnostic kits observe the condition, health assessment and other information.
3.3
Analyte (analyte) analyte measured
Component having a measurable property of the sample.
Example. In the "plasma glucose concentration of the substance", the "glucose" analyte "concentration" feature.
[Adapted from GB/T 21415-2008/ISO 17511.2003, 3.2 Definition]
3.4
Intended use intendeduse
In vitro diagnostic manufacturers specifications, instructions for use and in vitro diagnostic manufacturers to provide information about the given product, process or service
Operational objectives intended to be used for.
[ISO 18113-1.2009, definitions 3.31]
Note. in vitro diagnostic label may include a description of the intended use of two parts, the description of the function in vitro diagnostic medical devices (for example, a serum or
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