ISO 9997:2020 PDF

Scope: This document specifies 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 dental local anaesthetics. This document is not applicable to cartridge syringes having a mechanical-advantage action for creating high pressure. This document 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 (see Annex A).

ISO 9997:2020 Referenced Document

ISO 11499 Dentistry - Single-use cartridges for local anaesthetics
ISO 15223-1 Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements
ISO 17664 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
ISO 1942 Dentistry — Vocabulary — Amendment 1
ISO 261 ISO general purpose metric screw threads - General plan
ISO 965-1 ISO general purpose metric screw threads — Tolerances — Part 1: Principles and basic data — Amendment 1*， 2021-09-29 Update