ISO 1135-4:2015 pdf download

ISO 1135-4:2015 pdf download

ISO 1135-4:2015 pdf download.Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed
1 Scope
This part of ISO 1135 specifies requirements for single use transfusion gravity sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment.
Secondary aims of this part of ISO 1135 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets, to present designations for transfusion set components, and to ensure the compatibility of sets with a range of cellular and plasma blood components.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 1135.
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 ).
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 3826-1:2013, Plastics collapsible containers for human blood and blood components — Part 1: Conventional containers
ISO 3826-2, Plastics collapsible containers for human blood and blood components — Part 2: Graphical symbols for use on labels and instruction leaflets
ISO 7864, Sterile hypodermic needles for single use
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 10993-4, Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
ISO 14644-1, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
5.4.2 The closure-piercing device shall be capable of piercing and penetrating the closure of a container for blood and blood components without prepiercing. No coring should occur during this procedure. NOTE 1 A carefully controlled surface treatment of the closure-piercing device (e.g. siliconization) is recommended to facilitate its insertion into the blood bag port. The same effect can be achieved by a careful selection of material for the closure-piercing device. Typical results including test equipment for penetration forces between spikes and blood bag ports have been published. See References [9] and [lb]. NOTE 2 A central closure-piercing device tip is preferred to an asymmetric design in order to aid its insertion.