GB/T 13172-2009Molybdenum 99 - Technetium 99m chromatographic generator (fission) (English PDF)

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.

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.

5 Technical requirements

6 Test methods

8 Product marking, label and instruction manual

9 Packaging, transportation and storage