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ISO 9001: 13.21: Acceptable Quality Levels

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21) Acceptable quality levels (AQLs), or the maximum number of condoms that can be defective in each batch : The quality levels can be high by following the standards instruction and be stricter in the test procedures ISO 4074 22) Accreditation for laboratories that test condoms: The laboratories in which the test are done must be authorized and certified. ISO 17025:2005 23) The device should be quality controlled according to Quality Standards ISO 9000 series 24) The device shall not contain any elements that are not part of the product which may render the device unusable ISO 4074 25) The device must pass test criterions as stated under standard ISO 4074 26) The device must follow the regulations of manufacturing in the specific countries …show more content…

In addition, the outside surface of the package shall be clean and the package must be easy to open without damaging the condom. ISO 4074 32) The packaging of the device should be not be permeable to light, bacteria and other elements that could render the device unusable: The package shall be hermetically sealed and shall protect the product from bacteria, oxygen, ozone, water vapour, ultraviolet and visible light, Because if the condom exposure to the light, it will lead to interaction which cause damage to the condom. ISO 4074 33) The device shall undergo random sampling to ensure the product passes the quality tests: The samples for inspection shall be random sampling from the conformity products of the factory by the persons appointed by the certification body, and each sample must fulfil the specifications and standards according to the concerned regulations. ISO 2859-1:1999 ISO …show more content…

Nitrosamines migrate to the surface of rubber products during storage and usage. The standard EN12868 for nitrosamine migration from rubber teats and the ISO committee draft for nitrosamine migration from condoms have been established. The European directive 93/11/EEC regulated that the release of nitrosamines from teats and soothers should not exceed 10 µg/kg of material. 39) Determination of the amount of lubricant: There is Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms, This test method is not to be used to determine the safety of either the test lubricant or NRL (Natural Rubber Latex) condom. This test method is to be used only to determine if the tensile or airburst properties of the NRL condom have been significantly affected by the test lubricant. This test method is designed for use on NRL condoms that meet the criteria of Specification D3492 and can: (1) have a ring specimen cut in compliance with Appendix X1 of Specification D3492 and (2) be tested for burst properties in compliance with Annex A2 of Specification D3492 where D3492 Specification for Rubber Contraceptives (Male

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