DIN 13097-4 Hypodermic needles - Part 4: Point geometry, requirements and testing*， 2019-06-01 Update
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1
ISO 11040-5 Prefilled syringes - Part 5: Plunger stoppers for injectables
ISO 11040-7 Prefilled syringes - Part 7: Packaging systems for sterilized subassembled syringes ready for filling
ISO 11135-1 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization; Technical Corrigendum 1
ISO 11140 Sterilization of health care products — Chemical indicators — Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers*， 2022-11-22 Update
ISO 11608-2 Needle-based injection systems for medical use — Requirements and test methods — Part 2: Double-ended pen needles*， 2022-04-07 Update
ISO 11608-5 Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions*， 2022-04-07 Update
ISO 14644-1 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration*， 2015-12-01 Update
ISO 14937 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 15378 Primary packaging materials for medicinal products*， 2024-01-01 Update
ISO 17665-1 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 178 Surface chemical analysis — Secondary ion mass spectrometry — Linearity of intensity scale in single ion counting time-of-flight mass analysers*， 2019-04-01 Update
ISO 180 Plastics. Determination of Izod impact strength*， 2023-06-07 Update
ISO 2039-2 Plastics; Determination of hardness; Part 2 : Rockwell hardness
ISO 23908 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 2859-1 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection; Technical Corrigendum 1
ISO 3951 Sampling procedures and charts for inspection by variables for percent nonconforming
ISO 527-2 Plastics - Determination of tensile properties - Part 2: Test conditions for moulding and extrusion plastics
ISO 554 Standard atmospheres for conditioning and/or testing; Specifications
ISO 594-1 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment; Part 1 : General requirements
ISO 594-2 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
ISO 720:1985 Glass; Hydrolytic resistance of glass grains at 121 degrees C; Method of test and classification
ISO 7619-1 Rubber, vulcanized or thermoplastic - Determination of indentation hardness - Part 1: Durometer method (Shore hardness)
ISO 7864 Sterile hypodermic needles for single use - Requirements and test methods*， 2016-08-01 Update
ISO 7886-1:1993 Sterile hypodermic syringes for single use; part 1: syringes for manual use
ISO 80369-1 Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements*， 2018-11-05 Update
ISO 80369-7 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications*， 2021-04-30 Update
ISO 8871-1 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates
ISO 9626 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods*， 2016-08-01 Update
ISO/IEC Guide 98-3 Uncertainty of measurement - Guide to the expression of uncertainty in measurement (GUM:1995). Extension to any number of output quantities
BS ISO 11040-4:2015 history
2020BS ISO 11040-4:2015+A1:2020 Prefilled syringes. Glass barrels for injectables and sterilized subassembled syringes ready for filling
2015BS ISO 11040-4:2015 Prefilled syringes. Glass barrels for injectables and sterilized subassembled syringes ready for filling