JJF 1290-2011 English PDF

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JJF 1290-2011: Calibration specification for Particulate Analyzer
Status: Valid

JJF 1290: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
JJF 1290-2011	329	Add to Cart	3 days	Calibration specification for Particulate Analyzer	Valid
JJF 1290-1990	199	Add to Cart	2 days	O.T.N. of Contingent Primary Standard for Alternating-Current Electrical Energy	Obsolete

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Basic data

Standard ID: JJF 1290-2011 (JJF1290-2011)
Description (Translated English): Calibration specification for Particulate Analyzer
Sector / Industry: Metrology & Measurement Industry Standard
Classification of Chinese Standard: A60
Classification of International Standard: 17.18
Word Count Estimation: 14,145
Date of Issue: 6/14/2011
Date of Implementation: 9/14/2011
Quoted Standard: JJF 1001-1998; JJF 1094-2002; PRC Pharmacopoeia (2010)
Regulation (derived from): National AQSIQ 2011 No. 90 Notice
Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine
Summary: This standard applies to the use of insoluble particles assay (resist method), measuring particle size in the range of 2��m ~ 100 ��m, particle concentration range for each 1mL containing 10 to 100 000 particles of particle detector calibration.

JJF 1290-2011: Calibration specification for Particulate Analyzer

---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.
Calibration specification for Particulate Analyzer People's Republic of China National Metrology Technical Specifications Particle Detector Calibration Specification Issued on. 2011-06-14 2011-09-14 implementation The State Administration of Quality Supervision, Inspection and Quarantine released Particle Detector Calibration Specification zer This specification by the State Administration of Quality Supervision, Inspection and Quarantine approved on June 14, 2011, and from From September 14, 2011 into effect. Focal point. the National Technical Committee on Optical metrology Main drafting unit. Liaoning Provincial Institute of Metrology China Testing Technology Research Institute Participated in the drafting unit. Dalian metrological verification tests This specification committee commissioned by the National Optical measurement technology is responsible for interpreting The main drafters of this specification. Aiming Ze (Liaoning Provincial Institute of Metrology) Xiao Zhe (Liaoning Provincial Institute of Metrology) Li Xiaobin (China Testing Technology Research Institute) Tao Cheng (Liaoning Provincial Institute of Metrology) Drafters participate. Tang Jing (Dalian metrological verification tests)

table of Contents

1 Scope (1) 2. Referenced Documents (1) 3 Overview (1) 4 Metrological characteristics (2) Sample volume relative deviation of 4.1 (2) The relative error of 4.2 particle counting (2) 4.3 particle counting reproducibility (2) Resolution 4.4 channel (2) Calibration Condition 5 (2) 5.1 Calibration Environment (2) 5.2 standard devices and other equipment (2) 6 calibration items and calibration methods (2) 6.1 Calibration before the test (2) Sample volume relative deviation of 6.2 (2) The relative error of 6.3 particle counting (3) 6.4 particle counting reproducibility (3) Resolution 6.5 channel (3) 7 Calibration Results The expression (4) 8 Recalibration interval (4) Appendix A calibration record format (5) Appendix B Calibration Certificate page format (6) Appendix C Evaluation of Uncertainty in Measurement Example (7) Particle Detector Calibration Specification

1 Scope

This standard applies to the use of insoluble particles assays (resist method), measuring particle size in the range of 2μm ~ 100μm, Particle concentration in the range of 1mL each containing 10 to 100 000 particles of particle detector calibration.

2 Citations

This specification references the following documents. JJF 1001-1998 common measurement terms and definitions JJF 1094-2002 measuring instrument characteristics evaluation People's Republic of China Pharmacopoeia (2010 edition) When using this specification it should be noted that using the currently valid version of the documents cited.

3 Overview

Particle detector in accordance with the principles of the photoresist method, for checking intravenous injection (injection solution type, non-injectable Sterile powders, concentrated solution for injection) for intravenous injection and sterile bulk drugs, insoluble particles size and number of divisions Analysis of the instrument. When the liquid particles through a narrow detection zone, the liquid flow perpendicular to the incident, since the particle barrier Block weakened, thus reducing the sensor output signal, such a signal proportional to the change in cross-sectional area of the particles, by Data processing, to calculate the size and number of particles. Particle detector consists of a light source part of the system, detection system, a data processing system components.

1 a schematic diagram Fundamentals

A- source system; B- detecting system; the C-data processing system Note. The number of particles in a liquid, also known as particle concentration, per 1mL containing the number of particles with the symbol "particles/ml" said. ......

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