BS EN ISO 7864:2016 pdf – Sterile hypodermic needles for single use — Requirements and test methods (ISO 7864:2016).
1 Scope This International Standard specifies requirements for sterile hypodermic needles for single use of designated metric sizes 0,18 mm to 1,2 mm. It does not apply to those devices that are covered by their own standard such as dental needles and pen needles. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 594-1 1) , Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment – Part 1: General requirements ISO 594-2 2) , Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment – Part 2: Lock fittings ISO 3696, Water for analytical laboratory use — Specification and test methods ISO 6009, Hypodermic needles for single use Colour coding for identification ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and times ISO 9626, Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process ISO 14971, Medical devices — Application of risk management to medical devices
3.1 gauge legacy size designation; a particular gauge size corresponds to a designated metric size defining limits for outer diameters 3.2 unit packaging packaging of an individual device, intended to maintain its sterility 3.3 user packaging packaging, which contains one or more items of unit packaging, designed to provide labelling information to the user 3.4 needle cap cover intended to physically protect the needle tube prior to use 3.5 tapered needle needle with conical needle tube which has an outer diameter spanning at least two consecutive designated metric sizes 4 Requirements 4.1 General Testing finished products shall be conducted on sterilized products. 4.2 Statistics and reproducibility of test methods Any suitable test system can be used when the required accuracy (calibration) and precision [Gauge repeatability and reproducibility (R&R)] can be obtained. 4.3 Cleanliness When inspected by normal or corrected-to-normal vision without magnification under an illuminance of 300 lx to 700 lx, the surface of the hypodermic needle tube shall appear free from particles and extraneous matter. When examined under 2,5× magnification, the hub socket (fluid path surface) shall appear free from particles and extraneous matter. 4.4 Limits for acidity or alkalinity When determined with a laboratory pH meter and using a general purpose electrode, the pH value of an extract prepared in accordance with Annex A shall be within one unit of pH of that of the control fluid.
4.6 Size designation 4.6.1 Tubular needle designation The size of the hypodermic needle shall be designated by the following: a) the designated metric size of the needle tube, may also be expressed in millimetres — considering the regional distribution of the products, optionally the needle size expressed in gauge size; b) the nominal length of the needle tube, expressed in millimetres (Figure 2); c) optionally, the wall thickness of the needle, expressed as RW (regular wall), TW (thin wall), ETW (extra thin wall), or UTW (ultra-thin wall). EXAMPLE 0,8 mm × 40 mm TW. 4.6.2 Tapered needle designation Details necessary for the user to identify the needle, including the designated metric size, shall be provided in accordance with the following expression: OD (tip)/OD (hub) × L where OD (tip) is the designated metric size of the needle tube at the first full diameter from the tip (measuring point 2, at the end of the bevel geometry as shown in Figure 1) expressed in millimetres; OD(hub) is the designated metric size of the needle tube at the hub side, measured at the first full diameter from the top of the hub or from the top of the jointing medium, if used, (measuring point 1 at the end of the hub geometry as shown in Figure 1) expressed in millimetres; L is the nominal length of the needle tube, expressed in millimetres (Figure 2). EXAMPLE 0,23 mm/0,25 mm × 6 mm TW.