DIN ISO 29941-2014 Condoms - Determination of nitrosamines migrating from natural rubber latex condoms (ISO 29941 2010)《避孕套 天然胶乳橡胶避孕套中可迁移亚硝胺的测定 (ISO 29941-2010)》.pdf
《DIN ISO 29941-2014 Condoms - Determination of nitrosamines migrating from natural rubber latex condoms (ISO 29941 2010)《避孕套 天然胶乳橡胶避孕套中可迁移亚硝胺的测定 (ISO 29941-2010)》.pdf》由会员分享,可在线阅读,更多相关《DIN ISO 29941-2014 Condoms - Determination of nitrosamines migrating from natural rubber latex condoms (ISO 29941 2010)《避孕套 天然胶乳橡胶避孕套中可迁移亚硝胺的测定 (ISO 29941-2010)》.pdf(14页珍藏版)》请在麦多课文档分享上搜索。
1、December 2014Translation by DIN-Sprachendienst.English price group 9No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS
2、 11.200!%Zj“2275571www.din.deDDIN ISO 29941Condoms Determination of nitrosamines migrating from natural rubber latexcondoms (ISO 29941:2010),English translation of DIN ISO 29941:2014-12Kondome Bestimmung von aus Naturkautschuklatexkondomen migrierenden Nitrosaminen(ISO 29941:2010),Englische bersetzu
3、ng von DIN ISO 29941:2014-12Prservatifs Dosage des nitrosamines migrant des prservatifs en latex de caoutchouc naturel(ISO 29941:2010),Traduction anglaise de DIN ISO 29941:2014-12www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 14 pages1
4、2.14 2A comma is used as the decimal marker. Contents Page National foreword .3 National Annex NA (informative) Bibliography .4 1 Scope .5 2 Normative references .5 3 Terms and definition.5 4 Principle .5 5 Reagents and materials .6 6 Apparatus 7 7 Procedure 9 8 Calculation and evaluation of the res
5、ults of the N-nitrosamine content of the solution 11 9 Confirmation of the detected N-nitrosamines 12 10 Test report 13 Bibliography . 14 DIN ISO 29941:2014-12National foreword The text of this document (ISO 29941:2010) has been prepared by Technical Committee ISO/TC 157 “Non-systemic contraceptives
6、 and STI barrier prophylactics”. The responsible German body involved in its preparation was the DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-01-04 AA Kondome und Intrauterinpessare. Attention is drawn to the possibility that some of the elements of this d
7、ocument may be the subject of patent rights. DIN and/or DKE shall not be held responsible for identifying any or all such patent rights. In addition to the legal units of measurement, this standard also uses the unit “inch”. It should be noted that the Gesetz ber Einheiten im Messwesen (German Law o
8、n units in metrology) prohibits the use of this unit for official and commercial purposes in Germany. The indication of this unit solely serves to facilitate the communication with those countries where this unit is used (import-export business). Conversion: Non-SI unit SI unit Conversion Subscript
9、in (inch) mm 1 inch = 25,4 mm “ The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 3696 DIN ISO 3696 ISO 4074 DIN EN ISO 4074 ISO/IEC 17025 DIN EN ISO/IEC 17025 3DIN ISO 29941:2014-12National Annex NA (informative) Bibliography DIN ISO 369
10、6, Water for analytical laboratory use Specification and test methods DIN EN ISO 4074, Natural latex condoms Requirements and test methods DIN EN ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories 4DIN ISO 29941:2014-12Condoms Determination of nitrosamines
11、 migrating from natural rubber latex condoms 1 Scope This International Standard specifies a test method to determine the release of N-nitrosamines from condoms made from natural rubber latex. The method can also be used for other products such as probe covers, prophylactic dams, female condoms and
12、condoms made from synthetic materials, although there was no experience of testing such products at the time of publication of this International Standard. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the
13、 edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 3696, Water for analytical laboratory use Specification and test methods ISO 4074, Natural rubber latex condoms Requirements and test methods ISO/IEC 17025, General r
14、equirements for the competence of testing and calibration laboratories 3 Terms and definition For the purposes of this document, the following terms and definitions apply. 3.1 condom medical device used by consumers, which is intended to cover and be retained on the penis during sexual activity, for
15、 purposes of contraception and prevention of sexually transmitted infections NOTE If a consumer could responsibly consider a device to be a condom (due to its shape, packaging, etc.), it is considered a condom for the purpose of this International Standard. 4 Principle WARNING Owing to their toxicit
16、y, N-nitrosamines can be detrimental to human health. The testing laboratories should take special care to observe the occupational health and safety standards. N-nitrosamines are extracted into water. After having been concentrated, the water is tested for its N-nitrosamine content by means of gas
17、chromatography (GC) using a chemiluminescence detector. The test is performed in an environment that is free of volatile N-nitrosamines. The released N-nitrosamines are given in nanograms per grams (ng/g) of the sample. 5DIN ISO 29941:2014-125 Reagents and materials IMPORTANT Owing to the fact that
18、N-nitrosamines are decomposed by UV light, the exposure to sunlight or fluorescent light of the standardized solutions during the preparation should be avoided. Standardized solutions, migrate solutions and water should be protected by means of aluminium foil and stored in the dark at temperatures b
19、elow 5 C. Use only reagents of recognized analytical grade and only water conforming to ISO 3696, grade 3, unless otherwise specified. 5.1 Dichloromethane, which should be checked for the absence of N-nitrosamines. 5.2 Diatomaceous earth, from liquid-liquid extraction, with a specific surface area o
20、f 1 m2/g, a pore size of 3 000 nm to 8 500 nm and a particle size of 150 m to 650 m. Heat for 1 h at 200 C and wash with dichloromethane (5.1) after cooling. Another separating agent can be used providing it has been validated against diatomaceous earth. 5.3 n-Hexane. 5.4 Sodium hydroxide solution i
21、n water, c(NaOH) = 1 mol/l. 5.5 Nitrogen, with a volume fraction of at least 99,996 %. 5.6 Boiling chips. 5.7 Sintered glass frit for columns (6.3 and 6.4). 5.8 Acetone. 5.9 N-nitrosamine standardized solutions. Prepare standardized solutions with known quantities of the N-nitrosamines to be determi
22、ned in n-hexane (5.3) in the concentration range of 100 ng/l to 300 ng/l. The following N-nitrosamines are of importance for condoms from elastomer or rubber. The list is, however, not comprehensive: N-nitrosodimethylamine (NDMA); N-nitrosodiethylamine (NDEA); N-nitrosodibutylamine (NDBA). If there
23、are indications of the presence of other N-nitrosamines relevant for toxicology or if the nature of the used vulcanization accelerators supports this indication these other N-nitrosamines should also be tested, examples could be: N-nitrosodibenzylamine (NDBzA); N-nitrosodiisononylamine (NDiNA), i.e.
24、 N-nitroso-3,3,5-trimethylhexylamine. 5.10 Solution of the internal standard of 200 ng/ml N-nitrosodiisopropylamin (NDiPA) in acetone (5.8). The solution shall be free of other N-nitrosamines. 6DIN ISO 29941:2014-125.11 Water-free sodium sulfate, granulated, or a suitable phase separation filter for
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