Sampling procedures for inspection by variables -- Part 3: Double sampling schemes indexed by acceptance quality limit (AQL) for lot-bylot inspection— 122 стр.
Sampling procedures for inspection by variables -- Part 2: General specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection of independent quality characteristics— 96 стр.
Skimmed milk, whey and buttermilk - Determination of fat content - Gravimetric method (Reference method) (ISO 7208:2008); German version EN ISO 7208:2008— 22 стр.
Corrosion of metals and alloys - Determination of AC corrosion - Protection criteria (ISO 18086:2015); German and English version prEN ISO 18086:2017— 50 стр.
Uncertainty of measurement -- Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) -- Supplement 2: Extension to any number of output quantities— 84 стр.
Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 2: Determination by flame spectrometry and classification (ISO 4802-2:2016)— 20 стр.
Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 1: Determination by titration method and classification (ISO 4802-1:2016)— 24 стр.
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— 213 стр.
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); Text in German and English— 195 стр.
Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010); German version EN ISO 80369-1:2010— 29 стр.
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); German version EN ISO 23908:2013— 20 стр.
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); German version EN ISO 17665-1:2006— 51 стр.
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015); German version EN ISO 15378:2015— 85 стр.
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 14937:2009)— 54 стр.
Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015); German version EN ISO 14644-1:2015— 54 стр.
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012); German version EN ISO 11608-5:2012— 24 стр.
Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012); German version EN ISO 11608-2:2012— 25 стр.
Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007); German version EN ISO 11140-4:2007— 43 стр.
Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007); German version EN ISO 11140-3:2009— 30 стр.
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014); German version EN ISO 11140-1:2014— 43 стр.
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006); German version EN ISO 11137-3:2006— 25 стр.
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013); German version EN ISO 11137-2:2015— 92 стр.
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)— 54 стр.
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 11135-1:2007); German version EN ISO 11135-1:2007— 52 стр.
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008); German version EN ISO 10993-7:2008— 108 стр.
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009— 35 стр.
Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016); German version EN ISO 9626:2016— 35 стр.
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates (ISO 8871-1:2003); German version EN ISO 8871-1:2004, text in German and English— 32 стр.
Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:1993, including Technical Corrigendum 1:1995); German version EN ISO 7886-1:1996— 20 стр.
Plastics - Determination of tensile properties - Part 2: Test conditions for moulding and extrusion plastics (ISO 527-2:2012); German version EN ISO 527-2:2012— 18 стр.
Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986); German version EN 20594-1:1993— 9 стр.
Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings; German version EN 1707:1996— 11 стр.
Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO/DIS 80369-1:2015); German and English version prEN ISO 80369-1:2015
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)
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to Good Manufacturing Practice (GMP) (ISO/DIS 15378:2016); German and English version prEN ISO 15378:2016— 85 стр.
Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration (ISO 14644-14:2016)
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO/DIS 11137-3:2015); German and English version prEN ISO 11137-3:2015
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008); Corrigendum 1 to English translation of DIN EN ISO 10993-7:2009-02— 3 стр.
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO/DIS 10993-1:2017); German and English version prEN ISO 10993-1:2017
Sampling procedures for inspection by variables -- Part 5: Sequential sampling plans indexed by acceptance quality limit (AQL) for inspection by variables (known standard deviation)— 44 стр.
Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling (ISO 11040-4:2015); Text in German and English— 68 стр.
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016, Corrected version 2016-12-01); German version EN ISO 80369-7:2017— 65 стр.
