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GB/T 12415: Historical versions
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| GB/T 12415-2015 | English | 149 |
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Pharmaceutical glass containers glassware stress examination methods
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| GB/T 12415-1990 | English | 199 |
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Pharmaceutical glass containers. Stress examination. Test methods
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Basic data
| Standard ID | GB/T 12415-2015 (GB/T12415-2015) |
| Description (Translated English) | Pharmaceutical glass containers glassware stress examination methods |
| Sector / Industry | National Standard (Recommended) |
| Classification of Chinese Standard | N64 |
| Classification of International Standard | 81.040.01 |
| Word Count Estimation | 7,713 |
| Date of Issue | 2015-12-31 |
| Date of Implementation | 2016-07-01 |
| Older Standard (superseded by this standard) | GB/T 12415-1990 |
| Regulation (derived from) | State Standard Announcement 2015 No.43 |
| Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China |
| Summary | This standard prescribes the sample preparation, instrument requirements, test methods, calculation methods and contents of reports for stress testing in medicinal glass containers. This standard is applicable to the inspection of stress in medicinal glass containers. |
GB/T 12415-2015: Pharmaceutical glass containers glassware stress examination methods
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Pharmaceutical glass containers glassware stress examination methods
ICS 81.040.01
N64
National Standards of People's Republic of China
Replacing GB/T 12415-1990
Medicinal glass container stress testing methods
Issued on. 2015-12-31
2016-07-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard replaces GB/T 12415-1990 "within pharmaceutical glass container stress test methods."
This standard compared with GB/T 12415-1990, the main technical changes are as follows.
--- Added "2 Terms and Definitions";
--- Increased "3 principles";
--- In "5 Instrument Requirements" increased "5.6 polarizing strain gauge measurement accuracy. birefringent optical path difference is less than or equal to 3nm".
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
The standard proposed by China National Light Industry Council.
This standard by National Instrument Standardization Technical Committee on Glass (SAC/TC178) centralized.
This standard was drafted. Glass National Light Industry Product Quality Supervision and Inspection Center.
The main drafters of this standard. Yang Jianxin, Yuan Chunmei, Liang Ye.
This standard replaces the standards previously issued as follows.
--- GB/T 12415-1990.
Medicinal glass container stress testing methods
1 Scope
This standard specifies the sample preparation stress tests within the pharmaceutical glass containers, equipment requirements, test methods, calculation methods and report
Tolerance and so on.
This standard applies to glass containers in the pharmaceutical stress test.
2 Terms and definitions
The following terms and definitions apply to this document.
2.1
Polarizing plate polarizer
Polarizer
An optical device, through which natural light after a certain vibration direction into the plane of polarized light, and the light source being positioned generally measured
Between samples.
2.2
Check polarizing analyzer
The analyzer
Analysis mirror
An optical device, through which natural light after a certain vibration direction into the plane of polarized light, with the viewer being positioned generally be
Between the test sample.
Principle 3
3.1 usually glass isotropic homogeneous material, when stress is present, it will show anisotropy, birefringence phenomenon of light, bis
Refractive optical path difference between the S and the stress of a relationship.
ΔS = Kσ × d (1)
Where.
ΔS --- birefringent optical path difference;
Stress optical constant K --- glass, 10-6mm2/N;
σ --- perpendicular to the direction of light propagation two principal stress difference in units of cattle per millimeter (N/mm);
The total thickness d --- light through glass samples measured at the site, in millimeters (mm).
3.2 stresses the same variety of glass optical constant K is the same, so you can use the optical path difference per unit thickness value indicates the size of the stress.
3.3 standard polarizing strain gauge measuring the optical path difference, and the unit thickness of the optical path difference values \u200b\u200bto represent the size of the internal stress.
4 sample preparation
4.1 specimens should be tested without the other products.
4.2 The specimen shall be placed in advance in the laboratory for more than 30min.
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