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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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DIN ISO 4802-2:2016-08 (Draft)
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GLASSWARE - HYDROLYTIC RESISTANCE OF THE INTERIOR SURFACES OF GLASS CONTAINERS - PART 2: DETERMINATION BY FLAME SPECTROMETRY AND CLASSIFICATION (ISO 4802-2:2016)
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DIN EN ISO 7864:2015-01 (Draft)
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STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS (ISO 7864:2016)
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DIN EN ISO 14644-1:2016-06
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CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 1: CLASSIFICATION OF AIR CLEANLINESS BY PARTICLE CONCENTRATION (ISO 14644-1:2015)
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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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DIN EN ISO 10993-7:2009-02
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Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
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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
|
Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
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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
|
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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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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
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|
DIN EN ISO 23908:2013-10
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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 (ISO 23908:2011)
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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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DIN EN ISO 7886-1:2015-10 (Draft)
|
STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE
|
|
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
|
Glass; Hydrolytic resistance of glass grains at 121 ?C; method of test and classification; identical with ISO 720:1985
|
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DIN EN ISO 180:2013-08
|
PLASTICS - DETERMINATION OF IZOD IMPACT STRENGTH (ISO 180:2000 + AMD.1:2006 + AMD.2:2013)
|
|
DIN EN ISO 17665-1:2006-11
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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 (ISO 17665-1:2006)
|
|
DIN EN ISO 9626:2015-03 (Draft)
|
STAINLESS STEEL NEEDLE TUBING FOR THE MANUFACTURE OF MEDICAL DEVICES - REQUIREMENTS AND TEST METHODS (ISO 9626:2016)
|
|
ISO 180:2000
|
Plastics Determination of Izod impact strength
|
|
DIN EN ISO 15378:2016-03
|
PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) (ISO 15378:2017)
|
|
DIN EN ISO 11135-1:2007-08
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
|
|
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 1707:1997-01
|
CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - LOCK FITTINGS
|
|
DIN EN 20594-1:1995-01
|
CONICAL FITTINGS WITH A 6 % (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS
|
|
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 2039-2:2000-01
|
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
|
|
DIN EN ISO 11608-5:2013-01
|
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012)
|
|
DIN EN ISO 11608-2:2012-12
|
Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012)
|
|
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 ISO 4802-1:2016-08 (Draft)
|
GLASSWARE - HYDROLYTIC RESISTANCE OF THE INTERIOR SURFACES OF GLASS CONTAINERS - PART 1: DETERMINATION BY TITRATION METHOD AND CLASSIFICATION (ISO 4802-1:2016)
|
|
DIN EN ISO 80369-1:2015-09 (Draft)
|
SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS
|
|
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
|
|
DIN ISO 11040-5:2013-12
|
PREFILLED SYRINGES - PART 5: PLUNGER STOPPERS FOR INJECTABLES (ISO 11040-5:2012)
|
|
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
|
|
ISO/IEC Guide 98-3:2008
|
Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
|
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