ISO 7864:2016- Sterile hypodermic needles for single use test machine

ISO 7864:2016- Sterile hypodermic needles for single use test machine

ISO 7864:2016- Sterile hypodermic needles for single use — Requirements and test methods

Bond between hub and needle

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.
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.
  •  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 594-11, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment – Part 1: General requirements
    ISO 594-22, 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
    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

[1]          ISO 7000, Graphical symbols for use on equipment — Registered symbols

[2]          ISO 8362-1, Injection containers and accessories — Part 1: Injection vials made of glass tubing

[3]          ISO 8362-2, Injection containers and accessories — Part 2: Closures for injection vials

[4]          ISO 8362-3, Injection containers and accessories — Part 3: Aluminium caps for injection vials

[5]          ISO 8362-4, Injection containers and accessories — Part 4: Injection vials made of moulded glass

[6]          ISO 8362-5, Injection containers and accessories — Part 5: Freeze drying closures for injection vials

[7]          ISO 8362-6, Injection containers and accessories — Part 6: Caps made of aluminium-plastics combinations for injection vials

[8]          ISO 8362-7, Injection containers and accessories — Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part

[9]          ISO 8537, Sterile single-use syringes, with or without needle, for insulin

[10]        ISO 8871 (all parts), Elastomeric parts for parenterals and for devices for pharmaceutical use

[11]        ISO/TR 19244, Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters

[12]        ISO 80369-73, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications

[13]        ISO 80369-20, Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods

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