SN/T 3838-2014Determination of N-nitrosamines and N-nitrosatable substances from condoms for import and export - Mass spectrometry method (English PDF)

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules.

Determination of Nitrosamines move from natural rubber latex condoms - the 2010 "Condoms. The standard reference method using redrafted ISO 29941 Shift "preparation, and ISO 29941:2010 is equivalent to the degree of non-conformity.

This standard is proposed and managed by the National Certification and Accreditation Administration Committee.

This standard was drafted. Tianjin People's Republic of China Exit Inspection and Quarantine, Shaanxi University of Science and Technology.

1 Scope

This standard specifies the system of natural latex condoms measured in N- nitrosamines and nitroso compounds by gas chromatography - mass spectrometry method.

This standard applies to the determination of natural latex condoms made of N- nitrosamines and nitroso compound content.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.

GB/T 6682 Water Analysis Laboratory specifications and test methods (ISO 3696) GB 7544 Natural latex rubber condoms technical requirements and test methods (ISO 4074)

3 Terms and Definitions

The following terms and definitions apply to this document.

Condom

When worn on the penis intercourse for contraception and prevention of sexually transmitted diseases medical devices.

NOTE. If consumers can be confident that if an appliance as condoms (with shape, packaging and other reasons), then you can make this standard condoms.

N- nitrosamines N-nitrosamine Substances having -NN = O functional group, usually consisting of an amine (usually a secondary amine) and nitroso substances (such as nitrite), low pH values Under the reaction occurs.

N- nitroso compound N-nitrosatablesubstances N- nitrosamines generated a class of substances by nitrosation effects under certain conditions.

Principle 4

Sample N- nitrosamine and N- nitroso compound was extracted with water, separated and concentrated to form the final test solution, when there is N- nitroso when the presence of the compound, to be separated and concentrated before acidification. Gas chromatography - mass spectrometry, internal standard.

5 Reagents and materials

Unless otherwise specified, the reagents should be of analytical grade and distilled water, or at least in line with GB/T 6682 three water equivalent purity water.