ISO 13897:2018

Overview

ISO 13897:2018 - "Dentistry - Dental amalgam reusable mixing‑capsules" specifies requirements and test methods for reusable mixing‑capsules used to contain dental amalgam alloy powder and dental mercury during mixing. The standard focuses on the capsule as an essential component of the amalgam mixing process and defines dimensional, mass‑loss and retention performance criteria to ensure safe, reliable mixing and handling of dental amalgam.

Key topics and technical requirements

• Scope and purpose: Requirements apply only to reusable mixing‑capsules; single‑use capsule requirements are covered by ISO 20749:2017.
• Dimensional tolerances:
  • Overall length within ±1 mm of manufacturer’s specified length (sample size: 10 capsules).
  • Maximum external diameter within ±0.5 mm of manufacturer’s specified diameter (sample size: 10 capsules).
  • Measurement apparatus: micrometer or optical comparator with 0.05 mm accuracy.
• Loss of mass during mixing:
  • Maximum allowable loss from a capsule during mixing: 0.5 mg.
  • Test uses laboratory balance (0.1 mg accuracy), stereomicroscope, mixing machine per ISO 7488 and defined sampling (initial five; expand to ten if needed).
• Retention of dental amalgam:
  • Residual amalgam after pellet removal must not exceed 1% of the combined inserted mass of alloy and mercury.
  • Specific test methods and reporting requirements are provided in Section 6.
• Sampling, testing and reporting: Detailed test procedures, apparatus lists and reporting formats are defined (dimensions, loss of mass, retention).
• Labelling: Updated labelling requirements are included to support user information and safe use.

Applications and who uses this standard

ISO 13897 is relevant for:

• Dental device manufacturers designing or producing reusable amalgam mixing‑capsules (product design, quality control, certification).
• Quality assurance and regulatory teams ensuring conformity with international safety and performance requirements.
• Test laboratories performing conformity testing of mixing‑capsules (dimensional checks, mass loss and retention tests).
• Procurement and dental clinic managers who need to specify compliant reusable mixing‑capsules for use with mixing machines. The standard supports safer handling of dental mercury and consistent performance when used with mixing machines (see ISO 7488).

Related standards

• ISO 7488 - Mixing machines for dental amalgam (machine requirements).
• ISO 24234:2015 - Dentistry - Dental amalgam (materials).
• ISO 20749:2017 - Requirements for single‑use pre‑capsulated dental amalgam products.

Keywords: ISO 13897, dental amalgam, reusable mixing‑capsules, dental mercury, mixing machine, ISO 7488, ISO 24234.