ISO 28399-2021 PDF

Full title and description

ISO 28399:2021 — Dentistry — External tooth bleaching products. This International Standard specifies requirements and test methods for external tooth‑bleaching products intended for use in the oral cavity, whether for professional (in‑office) or consumer (home) application, and includes requirements for packaging, labelling and manufacturer's instructions for use.

Abstract

Specifies classification, compositional and performance requirements, and test methods for external tooth‑bleaching formulations (e.g., hydrogen peroxide / peroxide‑releasing agents), plus labelling and packaging requirements. The standard excludes products covered by ISO 11609, methods that change tooth colour by mechanical or restorative approaches (stain removal, veneers, crowns) and auxiliary devices/materials such as trays or lights. Biological safety testing is not specified in this document (biocompatibility referenced to other standards).

General information

• Status: Published.
• Publication date: March 22, 2021 (Edition 3 / 2021-03).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 97.170 (Body care equipment / dentistry related products).
• Edition / version: Edition 3 (2021).
• Number of pages: 22 pages (official ISO publication).

Scope

Applies to external tooth‑bleaching products placed in the oral cavity for colour modification of natural teeth by chemical (oxidative) means. Covers both professional and consumer uses, and sets requirements for product composition, declared active concentration, product stability, labelling, instructions for safe use, and packaging. The standard does not address biological safety testing (biocompatibility) within the document and excludes dentifrices or products covered by other standards such as ISO 11609.

Key topics and requirements

• Classification of products by intended use: professional (in‑office) and consumer (home use; professional home or non‑professional home use).
• Requirements for declared active bleaching agent concentration and acceptable measurement tolerances (measured concentration in unexpired product required to be within manufacturer’s stated concentration tolerances as specified in the standard).
• Stability and shelf‑life considerations, including labelling of expiry and storage conditions.
• Labelling and instructions for use: mandatory information for safe application, warnings, and professional vs consumer use statements.
• Packaging and safety requirements to ensure product integrity until point of use.
• Exclusions and cross‑references to other standards for materials, devices or biological testing (e.g., ISO 11609, ISO 10993‑1 referenced for biocompatibility where applicable).

Typical use and users

Manufacturers of tooth‑bleaching formulations and packaged products, dental product conformity assessors, regulatory affairs specialists, dental clinics offering in‑office bleaching, and consumer product quality teams preparing home‑use bleaching products. Also used by standards committees and testing laboratories that verify labelling, concentration, stability and packaging claims.

Related standards

Standards commonly referenced or relevant to ISO 28399 include ISO 11609 (other dentistry product specifications), ISO 10993‑1 (biological evaluation of medical devices — part 1: risk management for biocompatibility), ISO 7405 (evaluation of biocompatibility in dentistry), and other dentistry and medical device standards addressing packaging, labelling and test methods. National/adopted versions and regional modified adoptions (e.g., ANSI/ADA adoptions) may also exist.

Keywords

Tooth bleaching, external bleaching, hydrogen peroxide, carbamide peroxide, dentistry, bleaching agent concentration, packaging, labelling, test methods, stability, in‑office bleaching, home bleaching.

FAQ

Q: What is this standard?

A: ISO 28399:2021 is an international standard that sets requirements and test methods for external tooth‑bleaching products used in the oral cavity, covering both professional and consumer applications.

Q: What does it cover?

A: It covers product classification, active‑ingredient concentration requirements and tolerances, stability and shelf‑life, packaging integrity, labelling and instructions for safe use, and test methods to verify these claims. It excludes devices or materials covered by other standards (e.g., trays, lights) and does not itself define biological safety testing procedures.

Q: Who typically uses it?

A: Manufacturers, regulatory and quality teams, dental professionals, conformity assessment bodies, and testing laboratories involved with tooth‑bleaching products. Standards committees and purchasers may also refer to it when specifying requirements.

Q: Is it current or superseded?

A: ISO 28399:2021 is the current (third) edition published in March 2021. The standard is subject to periodic review and, per the ISO record, is staged for routine revision/review processes; users should check national or ISO catalogues for any amendments or newer editions after 2021.

Q: Is it part of a series?

A: It is a standalone standard for external tooth‑bleaching products but references and sits alongside other dentistry and medical device standards (for example, standards on dentifrices, biocompatibility and packaging). Related ISO documents (e.g., ISO 11609, ISO 10993 series, ISO 7405, ISO 7886 family for syringes in other contexts) are often considered for comprehensive compliance and testing strategies.

Q: What are the key keywords?

A: Tooth bleaching; external bleaching; hydrogen peroxide; carbamide peroxide; dentistry; test methods; labelling; packaging; stability; professional use; consumer use.