• There are no items in your cart

DIN ISO 11040-4 E : 2017

Current
Current

The latest, up-to-date edition.

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)

English

Published date

01-01-2017

National foreword
National Annex (informative) - Bibliography
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Syringe barrel
6 Sterilized subassembled syringes ready for filling
7 Packaging
8 Labelling
Annex A (informative) - Examples of types of sterilized
        subassembled syringes ready for filling
Annex B (informative) - Head designs
Annex C (normative) - Test methods for syringe barrels
Annex D (informative) - Sample preparation for endotoxin
        and particulate determination
Annex E (informative) - Glide force test method to evaluate
        syringe lubrication
Annex F (informative) - Needle penetration test
Annex G (normative) - Test methods for closure systems
Annex H (informative) - Dye solution tightness test
Bibliography

Pertains to: - tubing-glass barrels (single-chamber design) for injection preparations, and - sterilized subassembled syringes ready for filling.

DocumentType
Standard
Pages
59
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current

Standards Relationship
ISO 11040-4:2015 Identical

DIN EN ISO 80369-7 E : 2017 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)
DIN EN ISO 80369-7:2017-10 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)

ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates
ISO 7619-1:2010 Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness)
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 178 E : 2013 PLASTICS - DETERMINATION OF FLEXURAL PROPERTIES (ISO 178:2010 + AMD.1:2013)
DIN ISO 11040-5 E : 2013 PREFILLED SYRINGES - PART 5: PLUNGER STOPPERS FOR INJECTABLES (ISO 11040-5:2012)
ISO 527-2:2012 Plastics — Determination of tensile properties — Part 2: Test conditions for moulding and extrusion plastics
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
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 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)

View more information
US$176.32
Excluding Tax where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.