DIN ISO 11418-2:2018
Containers and accessories for pharmaceutical preparations - Part 2: Screw-neck glass bottles for syrups (ISO 11418-2:2016 + Amd.1:2017)

Standard No.

DIN ISO 11418-2:2018

Release Date

2018

Published By

German Institute for Standardization

Status

Be replaced

Replace By

DIN ISO 11418-2 A1 E:2018-02

Latest

DIN ISO 11418-2:2018-07

Replace

DIN ISO 11418-2:2017 DIN ISO 11418-2/A1:2018

Scope

This document specifies the design, dimensions, material and requirements of screw-neck glass bottles for pharmaceutical preparations in liquid form (syrups). Screw-neck glass bottles are applicable to primary packs used in direct contact with a drug. This document is applicable to screw-neck glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.

DIN ISO 11418-2:2018 Referenced Document

• DIN EN ISO 1101:2017 Geometrical product specifications (GPS) - Geometrical tolerancing - Tolerances of form, orientation, location and run-out (ISO 1101:2017); German version EN ISO 1101:2017
• DIN EN ISO 7459:2004 Glass containers - Thermal shock resistance and thermal shock endurance - Test methods (ISO 7459:2004); German version EN ISO 7459:2004
• DIN EN ISO 8113:2004 Glass containers - Resistance to vertical load - Test method (ISO 8113:2004); German version EN ISO 8113:2004
• DIN ISO 4802-1:2017 Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 1: Determination by titration method and classification (ISO 4802-1:2016)
• DIN ISO 4802-2:2017 Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 2: Determination by flame spectrometry and classification (ISO 4802-2:2016)
• DIN ISO 719:1989 Glass; hydrolytic resistance of glass grains at 98 °C; method of test and classification; identical with ISO 719:1985
• DIN ISO 720:1989 Glass; Hydrolytic resistance of glass grains at 121 °C; method of test and classification; identical with ISO 720:1985
• ISO 1101:2017 Geometrical product specifications (GPS) - Geometrical tolerancing - Tolerances of form, orientation, location and run-out
• ISO 4802-1:2016 Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 1: Determination by titration method and classification
• ISO 4802-2:2016 Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 2: Determination by flame spectrometry and classification
• ISO 719:1985 Glass; Hydrolytic resistance of glass grains at 98 degrees C; Method of test and classification
• ISO 720:1985 Glass; Hydrolytic resistance of glass grains at 121 degrees C; Method of test and classification
• ISO 7459:2004 Glass containers - Thermal shock resistance and thermal shock endurance - Test methods
• ISO 8113:2004 Glass containers - Resistance to vertical load - Test method

DIN ISO 11418-2:2018 history

• 2018 DIN ISO 11418-2:2018-07 Containers and accessories for pharmaceutical preparations - Part 2: Screw-neck glass bottles for syrups (ISO 11418-2:2016 + Amd.1:2017)
• 1970 DIN ISO 11418-2 A1 E:2018-02
• 2018 DIN ISO 11418-2:2018 Containers and accessories for pharmaceutical preparations - Part 2: Screw-neck glass bottles for syrups (ISO 11418-2:2016 + Amd.1:2017)
• 2017 DIN ISO 11418-2:2017 Containers and accessories for pharmaceutical preparations - Part 2: Screw-neck glass bottles for syrups (ISO 11418-2:2016)
• 2005 DIN ISO 11418-2:2005 Containers and accessories for pharmaceutical preparations - Part 2: Screw-neck glass bottles for syrups (ISO 11418-2:2005); text in German and English
• 0000 DIN ISO 11418-2:2004
• 0000 DIN ISO 11418-2:1996