BS EN ISO 7864:2016 pdf free

BS EN ISO 7864:2016 pdf free.Sterile hypodermic needles for single use一Requirements and test methods
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), Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment一Part 1: General requirements
ISO 594-2), Conical fttings with 6 % (Luer) taper for syringes, needles and certain other medical equipment一Part 2: Lock fittings
ISO 3696, Water for analytical laboratory use一Specification and test methods
ISO 6009, Hypodermic needles for single use Colour coding for identification
ISO 8601, Data elements and interchange formats一Information interchange一Representation of dates and times
ISO 9626, Stainless steel needle tubing for the manufacture of medical devices一Requirements and test methods
ISO 10993-1, Biological evaluation of medical devices一Part 1: Evaluation and testing within a risk management process
ISO 14971, Medical devices一Application of risk management to medical devices
ISO 23908, Sharps injury protection一Requirements and test methods一Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
ISO 80369-1, Small-bore connectors for liquids and gases in healthcare applications 一Part 1: General requirements
ISO 15223-1:2012, Medical devices 一Symbols to be used with medical device labels, labelling and information to be supplied一Part 1: General requirements
The designation of needle point dimensions and the nomenclature used to describe the dimensions and features is shown for information in Figure 3. The needle points shown are of configurations commonly manufactured: other configurations may be equally satisfactory. It may not be necessary to use all the dimensions when describing the point configuration.
The needle point should be designed so as to minimize coring and fragmentation when penetrating vial closures. This International Standard does not specify requirements or test methods for these properties, but an example of a test method for determining the production of fragments from rubber closures is given in Annex B. Penetration testing can provide an indication of the needle point sharpness and lubrication. An example of a test method for determining the needle penetration performance is given in Annex D.BS EN ISO 7864 pdf download.