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ISO 8871-1:2003
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Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates |
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ISO 7619-1:2010
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Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness) |
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ISO 720:1985
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Glass Hydrolytic resistance of glass grains at 121 degrees C Method of test and classification |
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ISO 9626:2016
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Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods |
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DIN 13097-4:2009-08
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HYPODERMIC NEEDLES - PART 4: POINT GEOMETRY, REQUIREMENTS AND TESTING |
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ISO 11040-5:2012
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Prefilled syringes — Part 5: Plunger stoppers for injectables |
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ISO 11608-5:2012
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Needle-based injection systems for medical use Requirements and test methods Part 5: Automated functions |
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ISO 14937:2009
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Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
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ISO 11040-7:2015
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Prefilled syringes Part 7: Packaging systems for sterilized subassembled syringes ready for filling |
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ISO 527-2:2012
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Plastics — Determination of tensile properties — Part 2: Test conditions for moulding and extrusion plastics |
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ISO 2039-2:1987
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Plastics Determination of hardness Part 2: Rockwell hardness |
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ISO 11608-2:2012
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Needle-based injection systems for medical use Requirements and test methods Part 2: Needles |
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ISO 11135-1:2007
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Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
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ISO 4802-2:2016
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Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 2: Determination by flame spectrometry and classification |
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ISO 7886-1:2017
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Sterile hypodermic syringes for single use — Part 1: Syringes for manual use |
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ISO 180:2000
|
Plastics Determination of Izod impact strength |
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ISO 15378:2017
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Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) |
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ISO 10993-7:2008
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Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
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ISO 7864:2016
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Sterile hypodermic needles for single use — Requirements and test methods |
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ISO 10993-1:2009
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Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
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ISO 80369-1:2010
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Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements |
|
ISO 14644-1:2015
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Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration |
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ISO 4802-1:2016
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Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 1: Determination by titration method and classification |
|
ISO 23908:2011
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Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling |
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ISO 554:1976
|
Standard atmospheres for conditioning and/or testing — Specifications |
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ISO 594-2:1998
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Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings |
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ISO 178:2010
|
Plastics Determination of flexural properties |
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ISO 594-1:1986
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Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements |
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ISO 17665-1:2006
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Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
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ISO/IEC Guide 98-3:2008
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Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) |