ISO 7864-16-2016 pdf free download.Sterile hypodermic needles for single use – Requirements and test methods.
ISO 7864-16 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 594.11), Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment – Part 1: General requirements
ISO 594.22). Conicalfittings with 6% (Luer) caperforsyringes. needles and certain ot her 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
ISO 23908, Sharps injury protection — Requirements and test methods — 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 — Part 1: General requirements
ISO 15223-1:2012, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply:
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 IGauge repeatability and reproducibility (R&R)J 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,Sx magnification, the hub socket (fluid path surface) shall appear free from particles and extraneous matter.ISO 7864-16 pdf download.