ISO 16408:2015
Dentistry — Oral care products — Oral rinses
Dentistry — Oral care products — Oral rinses
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Количество страниц:
- 9
- Дата публикации:
- 17 августа 2015 г.
- Издание:
- ISO IS 16408 edition 2 version 1
- ICS:
- 97.170
ISO 16408:2015 specifies physical and chemical requirements and test methods for oral rinses. It also specifies the accompanying information such as the manufacturer's instructions for use, marking, and/or labelling requirements. ISO 16408:2015 is not applicable to other delivery systems (e.g. mouthsprays, foams, powders). It is not intended to describe regulatory aspects, e.g. methods of prescription. ISO 16408:2015 is not applicable to oral rinses available by prescription only.
Abstract
Overview - ISO 16408:2015 (Oral rinses)
ISO 16408:2015 is an international dentistry standard that specifies physical and chemical requirements and test methods for oral rinses (mouthrinses/mouthwashes). It covers formulation limits, stability testing, contamination limits, and required accompanying information (labelling and instructions). The standard applies to consumer oral rinses (ready‑to‑use, concentrates, or mixing solutions) and excludes other delivery systems (mouthsprays, foams, powders) and prescription‑only products.
Key topics and technical requirements
- pH range: Oral rinses must have a pH between 3.0 and 10.5. Rinses with pH
Технические детали
- Технический комитет
- ISO/TC 106/SC 7 - Oral care products
- SKU
- ISO 16408:2015
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