ISO 11040-4:2015
Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling

Standard No.

ISO 11040-4:2015

Release Date

2015

Published By

International Organization for Standardization (ISO)

Status

Be replaced

Replace By

ISO 11040-4:2015/Amd 1:2020

Latest

ISO 11040-4:2015/Amd 1:2020

Scope

This part of ISO 11040 applies to — tubing-glass barrels (single-chamber design) for injection preparations, and — sterilized subassembled syringes ready for filling. It specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods. This part of ISO 11040 also specifies those components that are part of the sterilized subassembled syringe ready for filling. Glass barrels and sterilized subassembled syringes ready for filling in accordance with this part of Components to complete the subassembled syringe, such as plunger and rod, are not specified in this part of ISO 11040. NOTE Attention is drawn to applicable national or regional regulations such as Ph. Eur., USP, or JP. Where relevant, specific references to Ph. Eur., USP, and JP have been given in specific clauses or subclauses of this part

ISO 11040-4:2015 Referenced Document

• DIN 13097-4:2009 Hypodermic needles - Part 4: Point geometry, requirements and testing
• ISO 178:2010 Plastics - Determination of flexural properties
• ISO 180:2000 Plastics - Determination of Izod impact strength
• ISO 2039-2:1987 Plastics; Determination of hardness; Part 2 : Rockwell hardness
• ISO 2859-1:1999 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
• ISO 3951-1:2013 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 3951-2:2013 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
• ISO 3951-3:2007 Sampling procedures for inspection by variables - Part 3: Double sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
• ISO 3951-4:2011 Sampling procedures for inspection by variables - Part 4: Procedures for assessment of declared quality levels
• ISO 527-2:2012 Plastics - Determination of tensile properties - Part 2: Test conditions for moulding and extrusion plastics
• ISO 554:1976 Standard atmospheres for conditioning and/or testing; Specifications
• ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment; 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 720:1985 Glass; Hydrolytic resistance of glass grains at 121 degrees C; Method of test and classification
• ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)

ISO 11040-4:2015 history

• 2020 ISO 11040-4:2015/Amd 1:2020 Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling — Amendment 1
• 2015 ISO 11040-4:2015 Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
• 2007 ISO 11040-4:2007 Prefilled syringes - Part 4: Glass barrels for injectables
• 1996 ISO 11040-4:1996 Prefilled syringes - Part 4: Glass barrels for injectables