ISO 8536-1-2011 pdf free.Infusion equipment for medical use -Part 1: Infusion glass bottles. This part of ISO 8536 specifies the dimensions, performance and requirements of infusion glass bottles necessary to ensure functional interchangeability. It is applicable only to infusion bottles for single use. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 719:1985, Glass — Hydrolytic resistance of glass grains at 98 °C — Method of test and classification ISO 720:1985, Glass — Hydrolytic resistance of glass grains at 121 °C — Method of test and classification ISO 4802-1 :2010, Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 1: Determination by titration method and classification ISO 4802-2:2010, Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 2: Determination by flame spectrometry and classification ISO 7458, Glass containers — Internal pressure resistance — Test methods ISO 7459, Glass containers — Thermal shock resistance and thermal shock endurance — Test methods 3 Terms and definitions For the purposes of this document, the terms and…

ISO 8536-12-2021 pdf free download.Infusion equipment for medical use Part 12: Check valves for single use. This document specifies requirements for check valves intended for single use and used with infusion equipment both with gravity-feed infusion and with pressure infusion apparatus. The functional requirements in this document also apply to inline check valves. 2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 7886-1. Sterile hypodermic syringes for single use — Part 1: Syringes for manual use ISO 8536-4, Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed ISO 887 1-1, Elasto,neric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavates ISO 8871-2, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 2: Identification and characterization ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process ISO 15223-1, Medical devices — Symbols to be used…

ISO 8536-11-2015 pdf free.Infusion equipment for medical use 一 Part 11: Infusion filters for single use with pressure infusion equipment. This part of ISO 8536 applies to sterilized infusion filters for single use used up to 200 kPa (2 bar) on fluid lines of pressure infusion equipment and infusion set as specified in ISO 8536-8. It does not include the effectiveness of filters for separation of particles or germs. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536. 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 594-2,flConical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings ISO 7000, Graphical symbols for use on equipment — Registered symbols ISO 8536-4:2010, Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed ISO 10993-4, Biological evaluation of medical devices — Part 4: Selection of tests for interactions…

ISO 8536-9-2015 pdf free.Infusion equipment for medical use – Part 9: Fluid lines for single use with pressure infusion equipment. This part of Iso 8536 applies to sterilized fluid lines for single use for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar). The following items are covered by this part of Iso 8536: a) syringe pump lines (SPL); b) connecting lines (CL); c) lines with integrated injection cannula (LIC). In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536, 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 594-2,1)Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings ISO 7000, Graphical symbols for use on equipment — Registered symbols ISO 7864, Sterile hypodermic needles for single use ISO 8536-4:2010, Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed ISO…

ISO 8536-10-2015 pdf free.Infusion equipment for medical use – Part 10: Accessories for fluid lines for single use with pressure infusion equipment. This part of Iso 8536 applies to sterilized accessories for single use in fluid lines and pressure infusion equipment as specified in ISO 8536-8. This part of ISO 8536 includes the following: a) two-way stopcocks, three-way stopcocks, four-way stopcocks, and stopcocks manifold; NOTE Designation of a stopcock depends on the number of connections. The number of possible functional positions can be expressed by addition of a complementary note, using a diagonal stroke and a numeral indicating the number of possible stopcock positions, e.g. 3/4-way stopcock for three-way stopcock with four possible positions. b) units with injection site or check valve; c) stoppers or adapters. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536. 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 594-2’), Conical fittings with 6 %…

BS EN ISO 8536-4:2020 pdf free.Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed. This document specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment. Secondary aims of this document are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components. 2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 3696, Water for analytical laboratory use — Specification and test methods ISO 7864, Sterile hypodermic needles for single use — Requirements and test methods ISO 8536-13, Infusion equipment for medical use — Part 13: Graduated flow regulators for single use with fluid contact ISO 8536-14, Infusion equipment for medical use — Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact 150 14644-1, Cleanrooms and associated controlled…