Family Planning and Contraceptives Overview
Discover a comprehensive guide on family planning and contraceptives in India, including information on different types of contraceptives, their designs, standards, and labelling requirements. Learn about barrier methods, hormonal contraception, intrauterine devices, condoms, diaphragms, and more. Explore how India is progressing towards achieving universal access to sexual and reproductive health-care services as part of the Sustainable Development Goals. Stay informed about the latest advancements in contraceptive technologies and practices.
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Presentation Transcript
Introduction Family planning in India - India has achieved a Total Fertility Rate of 2.0 as per NFHS-5 (2019 21) which is aligned with the National Population Policy 2000 and the National Health Policy 2017 (TFR of 2.1) Barrier methods Hormonal contraception SDG 3 targets to ensure universal access to sexual and reproductive health-care services, including for family planning, information and education, and reproductive health into national strategies and programmes, Intrauterine devices (IUDs) Permanent contraception the integration of
1. Condoms Natural rubber latex design Synthetic i. IS/ISO 4074 : 2015 Natural rubber latex male condoms - Requirements and test methods stability and shelf life bursting volume and pressure ii.IS/ISO 23409 : 2015 Male condoms Requirements and test methods for condoms made from synthetic materials freedom from holes package integrity
2. Diaphragms Prevents pregnancy by blocking sperm from entering the uterus. a. design Dome-shaped cup made of silicone that fits over the cervix. b. dimensions IS/ISO Contraceptives Reusable Natural and Silicone Rubber Diaphragms Requirements and Tests. 8009 : 2014 Mechanical Contraceptive c. compression resistance mechanical properties like d. freedom from visible defects
3. Intra-uterine Devices Copper bearing or Hormonal IUDs design T-shaped devices that are inserted into the uterus to prevent pregnancy dimensions Copper copper ions to inhibit fertilization. IUDs- continuous release of stability Single use sterile medical devices materials IS Contraceptive Requirements and Tests. 18593 : 2024 Copper-Bearing Devices Intrauterine force to withstand breakage elastic recovery
3. Intra-uterine Devices- Labelling Labelling of the primary container shall contain: e) lot number; a) name or trade name and address of the manufacturer; f) insert before date; g) the words Sterile Medical Device for single use only , or equivalent, or the appropriate graphical symbol in accordance with ISO 15223-1; b) specific identification marks as required by country and regional regulatory bodies, such as unique device identifier; h) details of any special precautions for storage; c) the word STERILE ; i) any additional information required by local regulatory bodies. d) method of sterilization; same information on the primary container and content of the container shall be given on the secondary container
3. IUDs- Instructions for health care providers a) a statement that the device shall be inserted and removed by a trained health care provider; b) device trade name; c) name and address of the manufacturer; d) description of design, dimensions and compositions of IUD; e) a statement that the device is a sterile medical contraceptive device for single use only; f) a statement not to use the device if: 1) insert before date has passed; 2) seal of individual packing is broken; g) a statement directing the health care provider to discuss the contraceptive effectiveness, side effects, health benefits, health risks, and complications associated with copper bearing IUDs with the client;
4. Fallopian Rings Permanent contraception Tensile properties Elastic memory Elastic bands made from medical grade silicone Dimensions Provided sterile and packaged as a set of two Freedom from visible defects Packaging Sterility Storage conditions and shelf life Biological safety
4. Fallopian Rings - Labelling Each individual container shall be marked with the following: In addition, each individual package shall carry the following text: a) warning-sterile unless package is opened or damaged; a) full name and address of manufacturer; b) batch number; b) fallopian rings shall not be kept loaded on the applicator for more than 15 minutes; c) method, month and year of sterilization (for year use four digits); c) a reference to this document (i.e. ISO 19351:2019) and reference to the instructions for use; d) storage directives; e) use/implant before (specify month and year, or year and month as per the national regulation; use four digits for year). d) the pouch/blister pack, once opened, shall not be resealed; e) any other requirement(s) mandated by the regulatory authorities in the country of use.
List of product standards on contraceptives IS No. Title IS/ISO 4074 : 2015 Natural Rubber Latex Male Condoms Requirements and Test Methods IS 18593 : 2024 Copper-Bearing Contraceptive Intrauterine Devices Requirements and Tests IS/ISO 8009 : 2014 Mechanical Contraceptives Reusable Natural and Silicone Rubber Contraceptive Diaphragms Requirements and Tests IS 13009 : 2021/ISO 19351 : 2019 Fallopian Rings Requirements and Test Methods 10 IS 17962 : 2022/ISO 25841: 2017 Female Condoms Requirements and Test Methods IS/ISO 23409 : 2011 Male Condoms Requirements and Test Methods for Condoms Made from Synthetic Materials
