If you’ve ever wondered how standards impact your daily life, here’s a good document for you! And it’s just been revised. The ISO 11609 is titled Dentistry – Dentifrices – Requirements, test methods and marking. It contains the requirements for physical and chemical properties of the toothpaste (and other dentifrices) you use daily.
The ISO 11609 does not provide any guidelines on the validity of claims made by the manufacturer. These are provided by the U.S. FDA (Food and Drug Administration), the ADA (American Dental Association) and the FDI World Dental Federation. It does cover the appropriate test methods to use to verify the various properties of the product. It also provides the requirements for marking and packaging these items.
The standard was developed to ensure that adverse reactions and other side effects will not be caused by these products. Since they are intended to be used daily with a toothbrush, you can see that compounds that negatively impact your oral soft tissues need to be avoided.
So the ISO 11609 covers total fluoride content, heavy metals, pH, microbiology, abrasiveness, stability, and readily fermentable carbohydrates. Then a series of test methods used to determine these issues are provided. Sections 6 and 7 address marking and labeling as well as packaging. Three informative Annexes review the ADA abrasivity test procedure, a surface profile method of determining abrasivity, and a testing of total fluoride in dentifrices. A 44-item bibliography completes this 30 page standard.
This new 3rd Edition replaces the previous 2nd Edition from 2010, which is now obsolete. It is a technical revision and you’ll need a copy if you use this standard. Document Center Inc. is an authorized distributor for ISO. You can search for and order these standards at our webstore, www.document-center.com. Here is a direct link to the order page for ISO 11609 for your convenience. And if you’d like to see more standards like this, please see our Document Center Inc. List of Standards on Body Care. The ISO Standards section particularly addresses dentistry standards.
Document Center has been selling standards since 1982. We have a wide array of additional support services for those of you with compliance requirements. Check in with our staff for more information. You can reach us by phone (650-591-7600) and email (firstname.lastname@example.org). You’ll soon learn why so many folks make us their Standards Experts!