GB 13172-2009_English: PDF (GB13172-2009)
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[GB/T 13172-2009] Molybdenum 99 -- Technetium 99m chromatographic generator (fission) [Renamed to GB/T 13172-2009]
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GB 13172-2009
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Standards related to: GB 13172-2009
| Standard ID | GB 13172-2009 (GB13172-2009) | | Description (Translated English) | [GB/T 13172-2009] Molybdenum 99. Technetium 99m chromatographic generator (fission) [Renamed to GB/T 13172-2009] | | Sector / Industry | National Standard | | Classification of Chinese Standard | F54 | | Classification of International Standard | 27.120.01 | | Word Count Estimation | 8,847 | | Date of Issue | 2009-03-13 | | Date of Implementation | 2010-03-01 | | Older Standard (superseded by this standard) | GB 13172-1991 | | Quoted Standard | GB 11806; GB/T 15239; EJ/T 843-1994; EJ/T 845-1994; States Food and Drug Administration Note [ 2006 ] No. 264; two Chinese Pharmacopoeia (2005 edition) | | Drafting Organization | China Institute of Atomic Energy | | Administrative Organization | National Standardization Technical Committee of Nuclear Energy | | Regulation (derived from) | Announcement of Newly Approved National Standards No. 3, 2009 (No. 143 overall) | | Proposing organization | China National Nuclear Corporation | | Issuing agency(ies) | Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China; Standardization Administration of China | | Summary | This Chinese standard specifies the fission molybdenum 99 technetium 99m chromatographic generator technical requirements, test methods, inspection rules, marking, inspection certificates and instructions, packaging, transportation, storage and so on. This standard applies to medical Al2O3 as adsorbent molybdenum 99 technetium 99m chromatographic generator, does not apply to other types of technetium 99m generators. | GB 13172-2009
GB
NATIONAL STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 27.120.01
F 54
Replacing GB 13172-1991
Molybdenum 99-Technetium 99m
chromatographic generator (fission)
裂变钼 99-锝 99m色层发生器
ISSUED ON. MARCH 13, 2009
IMPLEMENTED ON. MARCH 01, 2010
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine of the People's Republic of China;
Standardization Administration of the People's Republic of
China.
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Table of contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 5
4 Product specifications ... 6
5 Technical requirements ... 7
6 Test methods ... 8
7 Inspection rules ... 10
8 Product marking, label and instruction manual ... 11
9 Packaging, transportation and storage ... 11
Foreword
All the technical contents of this standard are mandatory.
This standard replaces GB 13172-1991 “Molybdenum 99-Technetium 99m
chromatographic generator (fission)”. As compared with GB 13172-1991, the
main changes of this standard are as follows.
a) MODIFY the standard name;
b) ADD 5 normative references;
c) CHANGE the test and determination in the original standard into
inspection;
d) DELETE clause 3.3 of the original standard; ADD such items as the
elution, eluate, calibration time, and aluminum concentration, etc.;
e) CHANGE the sodium chloride injection of the original standard into
elution;
f) DELETE the Chapter 4 from the original standard;
g) ADD the new product specifications;
h) DELETE the clause 6.1.1 and 6.1.4 from the original standard;
i) ADD the technical requirements for radioactive contamination of the
generator surface;
j) ADJUST the clause 6.2.9 of the original standard into the technical
requirements of the generator;
k) DELETE the clause 7.2 from the original standard;
l) ADD the chapter of inspection rules;
m) SPLIT the original chapter 8 into two chapters. Marking, sign and
instruction manual, AND packaging, transportation, and storage.
This standard was proposed by China National Nuclear Corporation.
This standard shall be under the jurisdiction of the National Nuclear Energy
Standardization Technical Committee.
The drafting organization of this standard. China Atomic Energy Research
Institute.
The drafters of this standard. Niu Xuxiang, Chen Daming, Liu Guangyu.
Molybdenum 99-Technetium 99m
chromatographic generator (fission)
1 Scope
This standard specifies the technical requirements, inspection methods,
inspection rules, marking, inspection certificate and instruction manual,
packaging, transportation and storage of molybdenum 99-Technetium 99m
chromatographic generator (fission).
This standard applies to the medical molybdenum 99-Technetium 99m
chromatographic generator which uses the Al2O3 as the adsorbent; AND it is
not applicable to the technetium 99m generator of other types.
2 Normative references
The provisions in following documents become the provisions of this Standard
through reference in this Standard. For the dated references, the subsequent
amendments (excluding corrections) or revisions do not apply to this Standard;
however, parties who reach an agreement based on this Standard are
encouraged to study if the latest versions of these documents are applicable.
For undated references, the latest edition of the referenced document applies.
GB 11806 Regulations for the safe transport of radioactive material
GB/T 15239 Sampling procedures and tables for isolated lot inspection by
attributes
EJ/T 843-1994 Radioactive nuclide activity measurement - Well-type
ionization chamber method
EJ/T 845-1994 Radioactive drug solution – pH determination method
State Food and Drug Administration Note [2006] No.264 “Detailed rules for
the radioactive drug instruction specification”
People's Republic of China Pharmacopoeia II (2005 version)
3 Terms and definitions
The following terms and definitions apply to this standard.
3.1
Molybdenum 99-technetium 99m chromatographic generator (fission)
89Sr. 6 × 10-5%
90Sr. 6 × 10-6%
α impurity nuclide. 1 × 10-7%
Other total β, γ nuclide. 1 × 10-2%
5.2.5 Radiochemical purity
Na99mTcO4 content shall not be less than 98%.
5.2.6 Activity
The activity of the 99mTc eluted from the generator shall be 90.0% ~ 110.0% of
the indicated amount if calculated in accordance with the calibration time.
5.2.7 Bacterial endotoxin
It shall comply with the provisions of the People's Republic of China
Pharmacopoeia II (2005 version).
5.2.8 Sterile
It shall comply with the provisions of the People's Republic of China
Pharmacopoeia II (2005 version).
6 Test methods
6.1 Generator test
6.1.1 Eluting efficiency
In accordance with the calibration time and product specifications,
CALCULATE the activity A1 of the 99mTc in the generator at the time of eluting;
USE 10 mL of elution to elute the generator; DETERMINE the activity A2 of the
99mTc in the generator; USE the formula (1) to calculate the eluting efficiency η.
Where.
η - Eluting efficiency, expressed as a percentage;
A1 - The activity of the 99mTc in the generator at the time of eluting, in
becquerel (Bq);
A2 - The activity of the 99mTc in the eluate, in becquerel (Bq).
6.1.2 Surface radioactive contamination
8 Product marking, label and instruction manual
8.1 Marking
Generator outer packaging shall have the following markings.
a) Radioactive marking;
b) Radioactive transportation level marking;
c) Markings of rainproof, handle with care, and face upwards.
8.2 Label
The label is divided into inner packaging label and outer packaging label. The
inner packaging label is attached to the generator surface; AND the outer
packaging label is attached to the outer packaging. The label shall have the
following information.
a) Product name;
b) Radioactive marking;
c) Approval document number;
d) Specifications;
e) Product lot number;
f) Radioactive activity;
g) Calibration time (or reference time);
h) Validity period;
i) Manufacturer.
8.3 Instruction manual
The generator shall be supplied with the instruction manual at the time of
exit-factory. The contents of the instruction manual shall be in accordance with
the provisions of the State Food and Drug Administration [2006] No.264.
9 Packaging, transportation and storage
9.1 Packaging
Product packaging is lead can, foam liner, and iron drum in the order in the
order from the inside out, AND the surface radioactive pollution levels and
radiation levels shall comply with the provisions of GB 11806.
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