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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 |
|
ISO 9626:2016
|
Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods |
|
DIN ISO 2859-1:2014-08
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SAMPLING PROCEDURES FOR INSPECTION BY ATTRIBUTES - PART 1: SAMPLING SCHEMES INDEXED BY ACCEPTANCE QUALITY LIMIT (AQL) FOR LOT-BY-LOT INSPECTION (ISO 2859-1:1999 + COR. 1:2001 + AMD.1:2011) |
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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 |
|
ISO 11608-5:2012
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Needle-based injection systems for medical use Requirements and test methods Part 5: Automated functions |
|
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 |
|
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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DIN ISO 3951-1:2016-06
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Sampling procedures for inspection by variables - Part 1: Specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection for a single quality characteristic and a single AQL (ISO 3951-1:2013); Text in German and English |
|
DIN EN ISO 178 E : 2013
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PLASTICS - DETERMINATION OF FLEXURAL PROPERTIES (ISO 178:2010 + AMD.1:2013) |
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DIN ISO 11040-5 E : 2013
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PREFILLED SYRINGES - PART 5: PLUNGER STOPPERS FOR INJECTABLES (ISO 11040-5:2012) |
|
ISO 527-2:2012
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Plastics — Determination of tensile properties — Part 2: Test conditions for moulding and extrusion plastics |
|
ISO 2039-2:1987
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Plastics Determination of hardness Part 2: Rockwell hardness |
|
ISO 11608-2:2012
|
Needle-based injection systems for medical use Requirements and test methods Part 2: Needles |
|
ISO 11135-1:2007
|
Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
|
ISO 4802-2:2016
|
Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 2: Determination by flame spectrometry and classification |
|
DIN EN ISO 8871-1:2004-11
|
ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 1: EXTRACTABLE IN AQUEOUS AUTOCLAVATES |
|
ISO 7886-1:2017
|
Sterile hypodermic syringes for single use — Part 1: Syringes for manual use |
|
DIN ISO 720:1989-12
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Glass; Hydrolytic resistance of glass grains at 121 ?C; method of test and classification; identical with ISO 720:1985 |
|
ISO 180:2000
|
Plastics Determination of Izod impact strength |
|
ISO 15378:2017
|
Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) |
|
ISO 10993-7:2008
|
Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
|
DIN EN ISO 9626 E : 2016
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STAINLESS STEEL NEEDLE TUBING FOR THE MANUFACTURE OF MEDICAL DEVICES - REQUIREMENTS AND TEST METHODS (ISO 9626:2016) |
|
ISO 7864:2016
|
Sterile hypodermic needles for single use — Requirements and test methods |
|
ISO 80369-1:2010
|
Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements |
|
ISO 14644-1:2015
|
Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration |
|
DIN EN ISO 2039-2 E : 2000
|
PLASTICS - DETERMINATION OF HARDNESS - PART 2: ROCKWELL HARDNESS |
|
ISO 4802-1:2016
|
Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 1: Determination by titration method and classification |
|
ISO 80369-7:2016
|
Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications |
|
ISO 23908:2011
|
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 554:1976
|
Standard atmospheres for conditioning and/or testing — Specifications |
|
DIN EN ISO 11608-2 E : 2012
|
NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES (ISO 11608-2:2012) |
|
ISO 594-2:1998
|
Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings |
|
ISO 178:2010
|
Plastics Determination of flexural properties |
|
ISO 594-1:1986
|
Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements |
|
ISO 17665-1:2006
|
Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
|
DIN EN ISO 7886-1 E : 1997
|
STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE |
|
ISO/IEC Guide 98-3:2008
|
Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) |