BS EN ISO 9997 pdf free download

BS EN ISO 9997 pdf free download. Dentistry – Cartridge syringes.
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 displace 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. 5.5 Resistance to reprocessing All components of the cartridge syringe shall (including those made of plastic) comply with the requirements of 5.3 and 5.4, and in addition, shall show no signs of corrosion after 100 reprocessing cycles when tested in accordance with 6.7. If the manufacturer states a maximum number of reprocessing cycles less than 100, this maximum number shall be used instead. 6 Measurement and test methods 6.1 Visual inspection Carry out visual inspection with normal visual acuity and without magnification. 6.2 Dimensions Measure the dimensions using a measuring device that is accurate to 1/10 of the tolerance to be measured. 6.3 Secure loading Place an appropriate size of local anaesthetic cartridge in a cartridge syringe. Move the syringe forward/backward and sideways and assess if the cartridge is securely placed.BS EN ISO 9997 pdf download.