BS EN ISO 7885:2001 pdf – Sterile dental injection needles for single use

BS EN ISO 7885:2001 pdf – Sterile dental injection needles for single use.
1 Scope This International Standard gives dimensional and performance requirements for sterile, single-use injection needles for dental cartridge syringes for injection of dental local anaesthetics. It does not cover needles for special applications or techniques. Materials of construction other than those of the needle tubing are not specified. This International Standard does not give requirements for validated sterilization processes. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 6009:1 992, Hypodermic needles forsingle use — Colourcoding foridentification. ISO 7000, Graphicalsymbols foruse on equipment— Index andsynopsis. ISO 7864:1 993, Sterile hypodermic needles forsingle use. ISO 8601 , Data elements and interchange formats — Information interchange — Representation of dates and times. ISO 9626, Stainless steelneedle tubing formanufacture ofmedicaldevices. ISO 9997, Dentalcartridge syringes. ISO 1 5223, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied. 3 Terms and definitions For the purposes of this International Standard, the following terms and definitions apply. 3.1 needle unit the primary container, needle and hub See Figure 1 .
4 Requirements of assembled needle and hub 4.1 Freedom from extraneous matter The surface of the assembled needle and hub shall be clean and free from extraneous matter when viewed by normal or corrected vision without magnification. Lubricant on the external surface shall not be visible as droplets of fluid under normal or corrected vision without magnification. 4.2 Limits for extractable metals Limits and tests for extractable metals shall be in accordance with ISO 7864:1 993, clause 6. 4.3 Union between hub and needle The union between the hub and needle shall not break under a force of 22 N applied at the rate of 1 mm/s in both directions along the needle axis. 4.4 Biocompatibility See the Introduction for guidance on biocompatibility. NOTE 1 If freedom from pyrogenic material is required by national legislation, reference to ISO 1 0993-1 1 is suggested. NOTE 2 If freedom from abnormal toxicity is required by national legislation, reference to ISO 1 0993-1 is suggested. 5 Requirements of needle tubing 5.1 Material The tubing used for construction of the needle shall comply with ISO 9626. 5.2 Dimensions 5.2.1 The nominal outside diameter of the needle tubing in accordance with ISO 9626 shall be between 0,25 mm and 0,5 mm. 5.2.2 The effective needle length (see l 1 in Figure 1 ) of the needle tubing shall be within ? 2 mm of that stated by the manufacturer. 5.2.3 The size of the needle shall be designated by the nominal outside diameter and the effective needle length, expressed in millimetres, e.g. 0,4 mm ? 34 mm. 5.3 Butt end 5.3.1 The angle at the butt end shall be between 1 5° and 55° when measured through the long needle axis (see Figure 1 , detail A). 5.3.2 The butt-end length (see l 2 in Figure 1 ) shall be between 9,0 mm and 1 4,0 mm.
6.2 Socket depth The depth of the socket of the hub (l 3 in Figure 1 ) shall be not less than 5 mm. 6.3 Colour coding The nominal outside diameter of the needle tubing shall be identified by colour coding in accordance with ISO 6009 (see Table 2 below). This colour coding shall be on the primary container or on the needle hub. NOTE 1 Attention is drawn to the sets of reference hubs available as reference colour samples (see annex A of ISO 6009:1 992) NOTE 2 The colour zones of opaque colours and the nearest colour samples in a number of colour atlases are given for information in annexes B and C of ISO 6009:1 992, respectively.