JJF 1290-2011_English: PDF (JJF1290-2011)
| 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 |
| 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 | 14,157 | | Date of Issue | 6/14/2011 | | Date of Implementation | 9/14/2011 | | Quoted Standard | JJF 1001-1998; JJF 1094-2002; PRC Pharmacopoeia (2010) | | Issuing agency(ies) | State 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
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.
......
|