ISO 15747:2018 pdf free download.Plastic containers for intravenous injections.The size of the pdf file is 5.42M.It is shared by a net friend named Jenny.Thanks.
ISO 15747:2018 specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.
ISO 15747:2018 is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.
2 Normative references
ISO 2768-1, General tolerances-Part 1: Tolerances for linear and angular dimensions without individual tolerance indications;
ISO 2768-2, General tolerances-Part 2: Geometrical tolerances for features without individual tolerance indications;
ISO 8536-4, Infusion equipment for medical use-Part 4: Infusion sets for single use, gravity feed;
ISO 10993-1, Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process;
ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity;
4.1.1 Manufacturing process compatibility
The infusion container shall be in accordance with the requirements given in 4.1.2 to 4.1.5 and 4.1.7 to 4.1.12 after the manufacturing process (such as sterilization).
4.1.2 Resistance to temperature, pressure and leakage
ghar infusion container shall withstand alternating thermal stress, shall be resistant to pressure and shall be leak-free when tested as specified in A.3.
4.1.3 Resistance to dropping
The infusion container shall sustain no damage after being dropped when tested as specified in A.4.
4.1.4 Transparency
The infusion container shall be sufficiently transparent so that suspended particles, turbidity and discoloration can be recognised when tested as specified in A. 5. Alternative procedures may be used.
Blocking of UV radiation should be considered depending on the content of the container.