What is ISO 9997 about?
ISO 9997 discusses cartridge syringes for dentistry. ISO 9997 outlines requirements and test methods for cartridge syringes used in dentistry. These syringes are of the non-aspirating, aspirating, and self-aspirating types using cartridges with a dental local anaesthetic.
ISO 9997 specifies requirements for cartridge syringes with ISO metric thread sizes. However, attention is drawn to the existence of a variety of syringes with imperial thread sizes.
Note: ISO 9997 does not apply to cartridge syringes having a mechanical-advantage action for creating high pressure.
Who is ISO 9997 for?
ISO 9997 on cartridge syringes for dentistry is useful for:
- Manufacturers of cartridge syringes for dentistry
- Dentists
- Test laboratories for dentistry
- Regulatory authorities
Why should you use ISO 9997?
Aspiration is a process by which blood or body fluid is drawn into an anaesthetic. The cartridge syringe is designed to include a cartridge as a removable part that can be connected to a dental injection needle.
ISO 9997 guideline provides requirements for materials, dimensions, special requirements, measurements, labelling and marking for cartridge syringes for dentistry. ISO 9997 also provides test methods for visual inspection, dimensions, secure loading, cartridge syringes of Type 2, cartridge syringes of Type 3, Plunger rod, and Resistance to reprocessing for cartridge syringes for dentistry. This helps in improving the quality and resistance for reprocessing of cartridge syringes.
What’s changed since the last update?
BS EN ISO 9997:2020 supersedes ISO 9997:2020, which has been withdrawn. BS EN ISO 9997:2020 has some technical changes with respect to ISO 9997:2020.
These include:
- The normative references have been updated
- The requirement for reprocessing has been added in 5
- The tolerance for plunger rod movement has been tightened in 6