What is ISO 19351-Requirements and test methods for fallopian rings about?
ISO 19351 discusses fallopian rings. ISO 19351 is an international standard that provides requirements and test methods for fallopian rings.
ISO 19351 outlines minimum requirements and test methods for fallopian rings used for tubal occlusion in women for permanent contraception.
ISO 19351 has been necessitated because of the product marketing experience gained by manufacturers and procurement agencies.
Note: ISO 19351 does not address the applicator or other accessories used to place the fallopian rings.
Who is ISO 19351- Requirements and test methods for fallopian rings for?
ISO 19351 on requirements and test methods for fallopian rings is useful for:
- Fallopian rings manufacturers
- Medical laboratories
- Regulatory authorities
Why should you use ISO 19351- Requirements and test methods for fallopian rings?
Fallopian rings are devices that provide permanent contraception. These devices are elastic bands made from medical-grade silicone. They are implanted bilaterally using a laparoscopic surgical procedure.
After the rings are applied to each fallopian tube, they cut off the blood supply and occlude the tubal lumen. This stops the ova from traveling to the uterus, thereby preventing fertilisation. ISO 19351 guidelines assist you with requirements on Quality verification, Physical requirements, Packaging, Biological requirements, Radio-opacity, Clinical evaluation, Storage condition, Labelling, and Shelf life for fallopian rings. This helps in standardizing the quality of fallopian rings.
ISO 19351 assists in preventing any hazardous situation that may occur due to fallopian rings. By adopting ISO 19351 the user can enhance the standard and quality of fallopian rings to ensure effective permanent contraception.
