BS EN ISO 9997 pdf free download
BS EN ISO 9997-2020 pdf free download.Dentistry – Cartridge syringes.
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).
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
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
ISO 1942, Dentistry — Vocabulary
ISO 11499, Dentistry — Single-use cartridges for local anaesthetics
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — 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
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942, ISO 11499 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
3.1 aspiration
process by which blood or body fluid is drawn into an anaesthetic cartridge
3.2 cartridge
container for local anaesthetics
5.4 Special requirements
5.4.1 Loading and cartridge size
The cartridge shall be capable of being loaded either from the side or from the back (breech type). The cartridge syringe shall permit the appropriate size of local anaesthetic cartridge to be securely held and incapable of being dislodged during use.
Test in accordance with 6.3.
5.4.2 Viewing of contents
The cartridge syringe shall allow the solution for injection to be observed, including the result of aspiration.
Test in accordance with 6.1, 6.2, 6.3 and 6.4.
5.4.3 Plunger rod
5.4.3.1 Plunger rod design
The cartridge end of the plunger rod shall contain either a permanently attached tip or a means of securing various plunger tips supplied by the manufacturer of the cartridge syringe.
Test in accordance with 6.1.
5.4.3.2 Plunger rod movement
The plunger rod shall be capable of travelling freely and smoothly the whole length under the force of gravity in both vertical directions.
Test in accordance with 6.6.1.
5.4.3.3 Plunger rod displacement
The maximum sideways displacement of the plunger rod tip shall not exceed 1 mm in any direction from the central axis of the syringe.
Test in accordance with 6.6.2.
5.4.4 Aspirating syringes
5.4.4.1 General
Aspirating syringes shall permit aspiration at any time during use.
WARNING — Some aspirating syringes are intended for use only with cartridges fitted with specially designed plungers. These syringes may not aspirate when used with any other cartridges.
5.4.4.2 Type 2 syringes
When used with a cartridge in accordance with ISO 11499, the reagent shall have been aspirated into the cartridge and the harpoon or threaded portion of the plunger rod shall not have been disengaged.
Test in accordance with 6.4.
5.4.4.3 Type 3 syringes
Use a cartridge in accordance with ISO 11499. After testing, the reagent (see 6.4.1) shall have been aspirated into the cartridge.
Test in accordance with 6.5.BS EN ISO 9997 pdf download.
