ISO 9997:2020 pdf download

ISO 9997:2020 pdf download.Dentistry — Cartridge syringes
1 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).
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
3.3 cartridge syringe
syringe which is designed to include a cartridge as a removable part and which can be connected to a dental injection needle
3.4 plunger rod
rigid component which transmits the activating force to the cartridge plunger
3.5 unit pack
pack which contains the cartridge syringe
4 Classification
For the purposes of this document, cartridge syringes are classified into the following types:
— type 1: non-aspirating;
— type 2: aspirating (aspiration by force produced by drawing the plunger away from the needle);
— type 3: self-aspirating (aspiration by force produced by the deflection of a diaphragm in the cartridge).
5 Requirements
5.1 General
General requirements for cartridges for dental local anaesthetics as specified in ISO 11499 shall be met.
5.2 Materials
Cartridge syringes may be made from metal or have plastic components. The materials are at the manufacturer’s discretion provided that all of the requirements of this document shall be met.Test in accordance with 6.1 and 6.7.