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Quality and Standards

As the only ISO 13485:2003 certified menstrual cup manufacturer and head office in the world, Diva International Inc. is challenging the 100 year old menstrual status quo of chemically manufactured products, disposable slogans and menstrual shame.

We believe that all women should have a happy and healthy period experience. That is why we do everything we can to ensure our products are certified, registered and manufactured with women’s health and comfort in mind.

Our ISO 13485:2003 certification ensures your DivaCup is produced, tried and tested within International standards. ISO 13485 is a Quality Standard governed by the International Organization of Standardization in Geneva, Switzerland, and is recognized and practiced in over 160 countries around the world. ISO 13485 is the quality standard for medical devices and is required by Health Canada for all medical device manufacturers worldwide. It has been designed to ensure that companies follow strict guidelines for the highest quality of products, as well as meeting applicable government requirements.

Because of our ISO certification and compliance to FDA, Health Canada and Australian TGA health regulations we can guarantee that each DivaCup is made with the same silicone material and grade approved for healthcare applications for over fifty years and that it does not contain any of the following: latex, plastic, PVC, acrylic, acrylate, BPA, phthalate, elastomer and polyethylene and is free of colors and dyes. Silicone products have been shown to be biocompatible (i.e. accepted by the human body without adverse reaction), durable, flexible, and easy to sterilize. What’s more, our award-winning DivaCup is the only menstrual cup allowed to be sold in Canada by Health Canada.

How The DivaCup is made:

The silicone starts as a liquid and then the molecules are bound together (or vulcanized) with very high heat to form a solid stable piece of silicone (similar to the feel of soft rubber). The DivaCup is cured after production in an oven at a very high temperature to make sure all the molecules are bound and “chain linked” together. Since the end product is a solid material, yet flexible and durable, there is no possibility for anything to leak into the body (no leaching). Even when boiled for cleaning, The material used to manufacture The DivaCup has been tested to ensure none of the molecules will break away from the product.

 

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