ISO (E). PDF disclaimer. This PDF file may contain embedded typefaces. In accordance with Adobe’s licensing policy, this file may. DIN ISO norm. • Reduced glass particles, airlines, inclusions and scratches for improved camera inspection. • Outstanding chemical resistance, neutrality. ISO. Fourth edition. Injection equipment for medical use —. Part 1: Ampoules for injectables. Matériel d’injection à usage médical —.
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Aluminium caps for transfusion, infusion and injection bottles – general requirements and test methods. Injection containers for injectables and accessories. Quality assurance – general topics. Annex 11 – Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource generic products. Glass cylinders for pen-injectors for medical use. Good manufacturing practices for sterile pharmaceutical products.
Requirements for dosage form containers.
A list is given below of the standards on packaging issued kso the International Organization for Standardization ISOas of 10 Octoberstarting with the four main standards, after which they are listed in numerical order. Glass barrels for injectables. Carrying out the inspection. Requirements in The international pharmacopoeia.
The international pharmacopoeia – 50 years on.
ISO – Injection equipment for medical use — Part 1: Ampoules for injectables
Elastomeric parts for aqueous parenteral preparations. Screw-neck vials made of glass tubing for liquid dosage forms. Appendix 2 – Labels 1. Annex 9 – Guidelines on packaging for pharmaceutical products.
Comparator products for equivalence assessment of interchangeable multisource generic products. Basic tests for pharmaceutical substances and dosage forms. Requests for analysis of drug samples. Aseptic processing and sterilization by filtration. Quality management and quality systems elements.
Guidelines for quality improvement. Quality control – reference materials. Aluminium caps for injection vials. Good manufacturing practices in pharmaceutical production. Special types of closure. Repacking, relabelling and dispensing. Materials and setting-up of equipment, instruments and other devices. Injection vials made of moulded glass.
Infusion equipment for medical use. Tuberculosis programme – fixed-dose combinations. Quality control – specifications and tests.
BS EN ISO – Injection equipment for medical use. Ampoules for injectables
Needles – requirements and test methods. Model isi of analysis for use in trade and procurement. Closures for injection vials. Monographs for The international pharmacopoeia. Information on general publications. Pen-injectors for medical use. Drug quality assurance terminology.
Quality systems – model for quality assurance in production, installation and servicing. Equipment for drug control laboratories. Freeze-drying closures for infusion bottles. Glass cylinders for dental local anaesthetic cartridges. Guidelines for processed materials. Plungers and discs for pen-injectors for medical use.
BS EN ISO 9187-1:1999
Harmonization of regulatory requirements. International Infrared Reference Spectra.
Evaluation of test results. Caps made of aluminium-plastics combinations for injection vials. Annex 6 – Good manufacturing practices for sterile pharmaceutical products. Annex 8 – Quality systems requirements for national good manufacturing practice inspectorates. Appendix 4 – International standards on packaging.