SIST EN ISO 9997:2020 PDF

Overview

EN ISO 9997:2020 - Dentistry - Cartridge syringes (ISO 9997:2020) specifies requirements and test methods for cartridge syringes used with dental local anaesthetic cartridges. It covers non‑aspirating, aspirating and self‑aspirating syringe types that use standard cartridges, and addresses materials, dimensions, functional tests and instructions for use. The standard applies to cartridge syringes with ISO metric thread sizes (Annex A notes the existence of imperial threads) and explicitly excludes syringes that use a mechanical‑advantage action to create high pressure.

Key topics and technical requirements

• Classification: Type 1 - non‑aspirating; Type 2 - aspirating (plunger‑drawn aspiration); Type 3 - self‑aspirating (diaphragm deflection).
• Materials: Metal and plastic components are permitted; manufacturers must demonstrate compliance through inspection and reprocessing tests.
• Dimensions and interfaces: Metric needle‑mounting hub threads must comply with ISO 261 and ISO 965‑1; syringe geometry (barrel, plunger rod, viewing port, finger grip) is specified for safe loading and use.
• Functional tests: Includes visual inspection, dimensional checks, secure loading, aspirating tests for Type 2 and Type 3, and plunger rod movement/displacement assessments.
• Resistance to reprocessing: New/strengthened requirements for the syringe’s ability to withstand cleaning, sterilization and reuse (where applicable) with associated test methods.
• Marking and information: Requirements for labelling on unit packs, syringe marking and instructions for use (including references to processing information in ISO 17664 and labelling symbols in ISO 15223‑1).
• Compatibility: Cartridge loading (side or breech), viewing of cartridge contents and plunger rod interaction with cartridge plunger are covered to ensure consistent performance with dental anaesthetic cartridges (see ISO 11499).

Applications and users

This standard is essential for:

• Manufacturers and designers of dental cartridge syringes - for product design, material selection, threaded interfaces and conformity assessment.
• Quality control and test laboratories - to perform dimensional, aspirating and reprocessing tests according to specified methods.
• Regulatory and procurement teams - to specify compliance in tenders, technical files and conformity documentation.
• Dental clinics and procurement departments - to understand compatibility, safe use, reprocessing expectations and labelling requirements.

Related standards

• ISO 11499 - Single‑use cartridges for local anaesthetics
• ISO 261 / ISO 965‑1 - Metric screw threads (general plan & tolerances)
• ISO 15223‑1 - Symbols for medical device labelling
• ISO 17664 - Information for processing (reprocessing) of medical devices

EN ISO 9997:2020 (adopted by CEN) supersedes the 1999 edition and includes updated normative references, added reprocessing requirements and tightened plunger rod tolerances.