Overview - ISO 21850-2:2025 (Dentistry - Materials for dental instruments - Part 2: Polymers)
ISO 21850-2:2025 specifies polymers commonly used in the manufacture of dental instruments. It covers polymers used for an entire instrument or part of an instrument, for both single‑use and reusable hand‑held tools, and for instruments that may be connected to power-driven systems. The standard explicitly excludes oral appliances and long‑term intra‑oral devices (e.g., crowns, implants) and non‑polymeric devices.
Key polymers listed include ABS, PA, PBT, PBT‑PC, PC, PE, PEEK, PEI, POM, PP, PPS, PPSU, PS, PSU, PTFE, PUR, silicone and others that are commonly employed in dental instrument manufacture.
Key topics and technical requirements
- Material designation and naming: Polymer chemical composition and designation should follow ISO 1043‑1 and related plastics vocabulary (ISO 472).
- Selection criteria: Choose polymers based on functional properties required for the intended use, with consideration of manufacturing, handling, sterilization and storage effects.
- Demonstration of suitability: Suitability must be shown either by a design evaluation (see Clause 6) or by selecting from Table 1 polymers with documented clinical use in similar applications.
- Certification of analysis: Manufacturers shall confirm polymer composition; analytical methods are at manufacturer’s discretion, using standardized methods where appropriate.
- Examples of use: The standard provides examples (Table 2) linking specific polymers to typical instruments - e.g., PEEK for rotary excavation instruments and intraoral camera bodies, PC for filling instruments, PTFE for irrigation syringes, PP for mouth props.
- Pre‑clinical (biological) evaluation: Final products or representative samples require biological evaluation in accordance with ISO 10993‑1 and ISO 7405.
Practical applications and users
Who will use ISO 21850-2:
- Dental instrument manufacturers and product designers selecting polymer materials.
- Quality assurance, regulatory and compliance teams ensuring material declaration and biocompatibility.
- Procurement specialists specifying materials for single‑use and reusable dental tools.
- Testing laboratories performing material verification and pre‑clinical biological evaluation.
- Device developers integrating polymers into powered handpieces, handles, trays, syringes, retractors, mirror handles and more.
Practical benefits:
- Harmonizes material selection and approval across jurisdictions.
- Reduces duplicated testing by providing a common reference for suitable polymers.
- Clarifies linkage between polymer choice and sterilization/handling considerations.
Related standards
Normative and referenced documents include:
For manufacturers and regulators, ISO 21850‑2:2025 is a practical, standards‑based guide to polymer selection, material designation, and pre‑clinical evaluation for dental instruments.