ISO/TC 157/WG 3 - Intra-uterine devices

ISO 7439:2015 specifies requirements and tests for single-use, copper-bearing contraceptive intrauterine devices (IUDs) and their insertion instruments. It is not applicable to IUDs consisting only of a plastics body or whose primary purpose is to release progestogens.

ISO 7439:2010 specifies requirements and tests for single-use, copper-bearing contraceptive intrauterine devices (IUDs) and their insertion instruments. (Some aspects can be applicable to medicated intrauterine devices and IUDs not containing copper.) It is not applicable to IUDs consisting only of a plastics body or whose primary purpose is to release progestogens.

ISO 7439:2002 is applicable to single-use copper-bearing intra-uterine contraceptive devices and their insertion instruments. ISO 7439:2002 is not applicable to intra-uterine contraceptive devices consisting only of a plastics body and intra-uterine contraceptive devices whose primary purpose is to release progestogens. Some aspects of ISO 7439:2002 are applicable to medicated intra-uterine devices and intra-uterine devices that do not contain copper.

Lays down recommendations on storage conditions to be considered by manufacturers and distributors.

Specifies a measuring method. This method is not applicable to diaphragms with springs designed to form an arc when compressed. Compression of the article across its diameter with a mass of 280 g using a suitable apparatus. Determination of the change in diameter after 15 s.

Gives requirements. Each article shall be individually packaged in a container designed to protect it from contamination and mechanical damage during normal handlung, transport and storage. Articles and containers shall be legibly marked with some important information.

Includes a measuring method consisting in the measurement of the external diameter by a measuring device the scale of which is graduated in millimeters.

Gives a method for measurement by means of a specified dial gauge which is graduated in divisions of not more than 0,01 mm.

Specifies a measuring method. This method is not applicable to diaphragms with springs designed to form an arc when compressed. Compression of the rim of the article across its diameter using a suitable apparatus. Determination of the deviation of the rim from the horizontal plane.

Includes methods for determining the resistance to deterioration. Conditioning of the test pieces at an elevated temperature for a specified time. Examination of the test pieces followed by measuring of the tensile strength and elongation at break in accordance with ISO 8009-5.

Specifies a measuring method consisting in stretching the article including the thread where provided, until breakage of article or thread occurs. Measuring of the force required to cause breakage.

Specifies requirements. The article and insertion instruments shall be either packaged individually or in multiple packages containing up to 100 articles and which may also contain an appropriate number of insertion instruments.

Describes basic requirements for these devices, associated insertion instruments, and for packaging, labelling and storage of such devices. The more important performance criteria have to be assessed by clinical experience and consequently remain outside the scope of the Technical Report.