ISO 9687:2015/Amd 1:2018

Overview

ISO 9687:2015/Amd 1:2018 is an amendment to the international standard ISO 9687:2015, developed by the International Organization for Standardization (ISO). This amendment focuses on graphical symbols for dental equipment and is part of ISO’s ongoing efforts to standardize symbols used in the dentistry field. The update introduces new standardized symbols that enhance clarity and usability in dental equipment manuals and packaging.

These symbols play a critical role in communicating information about dental devices, ensuring compliance, safety, and environmental responsibility. By using universally recognized symbols, manufacturers and dental professionals can reduce misunderstandings and support international trade and regulation adherence.

Key Topics

• New Graphical Symbols: ISO 9687:2015/Amd 1:2018 adds new symbols relevant to modern dental equipment, including:

  • Electronic instructions for use: A symbol indicating the availability of a digital or electronic user manual.
  • Ultrasonic scaler with illumination: Identifies dental tools equipped with ultrasonic scaling and integrated lighting for improved precision.
  • Recycling and waste disposal indicators: Symbols specifying recyclable packaging materials and prohibiting disposal in ordinary municipal waste systems to support environmental sustainability and compliance with waste regulations such as WEEE (Waste Electrical and Electronic Equipment Directive).

• Standardization and Compliance: This amendment ensures that symbols align with other ISO/IEC standards such as ISO 7000 and IEC 60417. Consistent use of these symbols helps manufacturers meet global regulatory requirements while simplifying user understanding.

• Technical Committee and Development: Created by ISO/TC 106, Subcommittee SC 6 for dental materials, this amendment is the product of international expert collaboration, reflecting best practices in dental equipment safety and environmental impact.

Applications

• Manufacturers of Dental Equipment: Using these standardized symbols in product documentation, packaging, and device labeling helps ensure compliance with international regulations. It aids in delivering clear instructions and warnings, reducing liability and enhancing user safety.

• Dental Professionals: Dentists and clinic technicians benefit from universally understood symbols that provide rapid identification of equipment features, proper disposal methods, and usage guidelines, especially when electronic manuals are involved.

• Regulatory Bodies and Inspectors: Harmonized symbols make it easier to assess compliance with health, safety, and environmental regulations across different countries, simplifying approvals and audits.

• Environmental Waste Management: Clear marking of recyclable materials and waste disposal instructions supports waste segregation and recycling initiatives, aligning dental industry practices with global environmental policies.

Related Standards

• ISO 7000 – Graphical symbols for use on equipment: The amendment incorporates symbols registered under ISO 7000 for electronic manuals and ultrasonic scalers, ensuring interoperability with this comprehensive symbol library.

• IEC 60417 – Graphical symbols for use on equipment: The disposal symbol aligns with IEC 60417 to communicate waste management instructions clearly.

• WEEE Directive (2012/19/EU): The amendment supports compliance with this European legislation, which regulates electronic waste disposal to reduce hazardous environmental impact.

• ISO/IEC Directives, Part 1 and Part 2: Provides the framework and rules for the preparation, approval, and maintenance of ISO standards including this amendment.

By adopting ISO 9687:2015/Amd 1:2018, stakeholders in the dental industry ensure they are using precise, internationally recognized symbols that enhance product usability, safety, and environmental responsibility. This amendment reflects ongoing advances in dental equipment technology and the global commitment to harmonization in medical device communication.