YY/T 0702-2008Control material for hematology analyzer (English PDF)
血细胞分析仪用质控物（品）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
October 17, 2008
Implementation date
January 1, 2010
Scope
YY/T 0702-2008 is the English-translated version of 血细胞分析仪用质控物（品）.
YY/T 0702-2008 sets the requirements for the control materials used with hematology analyzers, the products laboratories run to monitor or evaluate the accuracy of blood cell counts.
It defines terms such as reference material, assayed and unassayed control material and homogeneity, then gives naming and classification, technical requirements, test methods and inspection rules.
Marking, labels and instructions for use, packaging, transport and storage complete the text. Requirements on the leukocyte differential scattergram produced from the control material are expressly not included.
Manufacturers of controls and the clinical laboratories that check analyzers, also called blood analyzers, are its natural readers. Issued on 17 October 2008, it has applied since 1 January 2010.
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Document preview — YY/T 0702-2008
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
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
1 Scope
This standard specifies the hematology analyzer with quality control material (product) (hereinafter referred to as quality control material) terms and definitions, naming and classification technology to Requirements, test methods, inspection rules, signs, labels and instructions, packaging, transport and storage. This standard does not give quality control substance of leukocyte classification map Shape technical requirements.
This standard applies to the blood cell analyzer using quality control material, quality control material used to monitor or evaluate the hematology analyzer (also known as blood analyzers) inspection Precision measurement results.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
GB 9969.1-1998 Instructions General Industrial Products JJF1001-1988 common measurement terms and definitions JJF1005-2005/ISO Guide 30.1992 standard materials commonly used terms and definitions
WS/T 124-1999 clinical chemistry in vitro diagnostic kit for Quality Inspection General
3 Terms and Definitions
The following terms and definitions apply to this standard.
3.1 Reference material
Having one or more sufficiently homogeneous and well established characteristics used to calibrate the measuring device or measuring method to evaluate the material assignment A material or substance. [JJF1001-1998, definitions 8.13/VIM definitions 6.13]
3.2 Control material
It is a stable material, equipment or procedures for checking the performance of analytical instruments or methods. When the substance of the instruments used to check or party.
When the current method of routine test performance, it must analyze the characteristics of patients with similar samples.
3.3 Assayed control material
On the Identity value quality control substance, manufacturers need to provide a reference value and the reference range.
3.4 Unassayed control material
On the identification of non-value quality control substance, manufacturers are not required to provide a reference value and the reference range, without specifying a particular analysis system.
3.5 Homogeneity
With one or more properties of the material associated with the same structure or composition of the state. By measuring from different packing units (such as.
Sample bottles, bags, etc.) or from the same packaging unit, the specific size measurements fall within the specified range of uncertainty can be considered standard The amount of the material properties of the specified uniform.
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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
GB 9969.1-1998 — General principles for preparation of instructions for use of industrial products
WS/T 124-1999 — Inspection criteria of the quality of clinical chemistry in vitro diagnostic kits. General guideline
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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