DIN ISO 11040-4:2007-10
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
Available format(s)
Hardcopy , PDF
Language(s)
German
Published date
01-01-2007
Superseded date
07-03-2021
Superseded by
€146.26
Excluding VAT
| DevelopmentNote |
Supersedes DIN 58358-4. (08/2002)
|
| DocumentType |
Standard
|
| Pages |
14
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 11040-4:2015 | Identical |
| DIN ISO 11040-5:2013-12 | PREFILLED SYRINGES - PART 5: PLUNGER STOPPERS FOR INJECTABLES (ISO 11040-5:2012) |
| DIN HDBK 231 : 4ED 2012 |
| ISO 8871-1:2003 | Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavates |
| DIN ISO 4802-2:2016-08 (Draft) | GLASSWARE - HYDROLYTIC RESISTANCE OF THE INTERIOR SURFACES OF GLASS CONTAINERS - PART 2: DETERMINATION BY FLAME SPECTROMETRY AND CLASSIFICATION (ISO 4802-2:2016) |
| DIN EN ISO 7864:2015-01 (Draft) | STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS (ISO 7864:2016) |
| DIN EN ISO 14644-1:2016-06 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 1: CLASSIFICATION OF AIR CLEANLINESS BY PARTICLE CONCENTRATION (ISO 14644-1:2015) |
| ISO 7619-1:2010 | Rubber, vulcanized or thermoplastic — Determination of indentation hardness — Part 1: Durometer method (Shore hardness) |
| DIN EN ISO 10993-7:2009-02 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008) |
| ISO 720:1985 | 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 | 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) |
| DIN 13097-4:2009-08 | HYPODERMIC NEEDLES - PART 4: POINT GEOMETRY, REQUIREMENTS AND TESTING |
| ISO 11040-5:2012 | Prefilled syringes — Part 5: Plunger stoppers for injectables |
| ISO 11608-5:2012 | Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions |
| ISO 14937:2009 | 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 | Prefilled syringes — Part 7: Packaging systems for sterilized subassembled syringes ready for filling |
| DIN ISO 3951-1:2016-06 | 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 23908:2013-10 | 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) |
| ISO 527-2:2012 | Plastics — Determination of tensile properties — Part 2: Test conditions for moulding and extrusion plastics |
| DIN EN ISO 7886-1:2015-10 (Draft) | STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE |
| ISO 2039-2:1987 | 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 |
| 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 | 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 2039-2:1987); German version EN ISO 2039-2:1999 |
| 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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