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ASTM F1313-25

Standard Specification for Volatile <emph type="bdit">N</emph>-Nitrosamine Levels in Rubber Nipples on Pacifiers
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This specification applies to the nitrosamine content of rubber used in the manufacture of nipples for infant pacifiers. This specification is intended for use in reducing the normal exposure to nitrosamines. Methylene chloride extraction method shall be used to determine the nitrosamine levels.

1.1 This specification applies to the nitrosamine content of rubber used in the manufacture of nipples for infant pacifiers.

1.2 This specification does not apply to plastic nipples (on pacifiers).

1.3 The purpose of this specification is to establish a maximum level of allowed nitrosamines in rubber nipples and to outline a uniform testing method to determine such level.

1.4 The values stated in SI units are to be regarded as standard. The values given in parentheses are for information only.

1.5 The following precautionary statement pertains only to the test method portions, Sections 5, and Appendix X4 of this specification. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. Specific hazards are given in Appendix X2.

1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

3.1 This specification is intended for use in reducing the normal exposure to nitrosamines.

3.2 This specification refers only by way of example to the seven volatile N-nitrosamines identified below:

3.2.1 N-nitrosodimethylamine,

3.2.2 N-nitrosodiethylamine,

3.2.3 N-nitrosodibutylamine,

3.2.4 N-nitrosomorpholine,

3.2.5 N-nitrosopiperidine,

3.2.6 N-nitrosopyrrolidine,

3.2.7 N-ethylphenylnitrosamine.

SDO ASTM: ASTM International
Document Number F1313
Publication Date Sept. 1, 2025
Language en - English
Page Count 7
Revision Level 25
Supercedes
Committee F15.22
Publish Date Document Id Type View
Sept. 1, 2025 F1313-25 Revision
Feb. 1, 2011 F1313-90R11 Revision
Sept. 1, 2005 F1313-90R05 Revision
Sept. 10, 1999 F1313-90R99 Revision