YY/T 1461-2016Ischemia-modified albumin test reagent (English PDF)
缺血修饰白蛋白测定试剂（盒）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
January 26, 2016
Implementation date
January 1, 2017
Scope
YY/T 1461-2016 is the English-translated version of 缺血修饰白蛋白测定试剂（盒）.
YY/T 1461-2016 is the Chinese pharmaceutical industry standard for the ischemia-modified albumin test reagent based on the albumin-cobalt binding method.
It specifies the terms, the requirements, the test methods, the labels, the instructions and the rules for packaging, transport and storage, covering the appearance, the blank absorbance, the accuracy, the linear range, the precision, the interference and the stability.
It applies to reagents that determine ischemia-modified albumin quantitatively in human serum. Issued on 26 January 2016, it has applied since 1 January 2017.
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Document preview — YY/T 1461-2016
National Standard of the People's Republic of China
- ICS
- 11.100
- Classification
- C 44
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative reference documents
- 3 Terminology
- 4 Requirements
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the terms, requirements, test methods, labels for the use of ischemic modified albumin determination reagents (cassettes) (albumin-cobalt binding) With instructions, packaging, transportation and storage.
This standard is applicable to reagents (cartridges) for quantitative detection of ischemic modified albumin (IMA) in human serum using albumin-cobalt binding methods, Based on spectrophotometric principles, including hand reagents and reagents used in semi-automatic, fully automated biochemical analyzers.
2 Normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.
YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements
3 Terminology
The following terms and definitions apply to this document.
3.1 1U/mL "ischemic modified albumin"
1 mL of healthy human serum albumin (45 g/L) was defined as 1 U/mL & quot; ischemic modified albumin & quot; when bound to 1 [mu] g of Co2, When expressed as albumin cobalt ion binding capacity, it is converted to the value of "ischemic modified albumin" by the formula specified by the manufacturer.
4 Requirements
4.1 Appearance
Should specify the normal appearance requirements.
4.2 Capacity
The net content of the liquid reagent shall be not less than the indicated value.
4.3 Reagent Blank absorbance
Reagent blank absorbance should be not less than 0.6.
4.4 Analyze sensitivity
The absorbance difference (deltaA) should be less than 0.15 when the test result is 78.0U/mL.
4.5 Linearity
The linear range of reagent (box) should be covered [40.0,120.0] U/mL.
a) linear correlation coefficient ︱ r︱ should not be less than 0.995;
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
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Related Standards
YY/T 0466.1-2009 — Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
YY/T 0466.1-2016 — Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
YY/T 0466.1-2023 — Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
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YY/T 1461-2016
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