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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The international pharmacopoeia – 50 years on. Appendix 4 – International standards on packaging. Requirements for dosage form containers. Elastomeric parts for aqueous parenteral preparations.
Caps made of aluminium-plastics combinations for injection vials.
Pen-injectors for medical use. Ido inserts for patients patient information leaflets. Quality control – pharmaceutical control laboratories. Injection vials made of moulded glass. Appendix 2 – Equipment for a first-stage and medium-size pharmaceutical control laboratory. Caps made of aluminium-plastics combinations for infusion bottles. Equipment for drug control laboratories. Quality assurance – inspection.
Model certificate of analysis for use in trade and procurement. Evaluation of test results. Freeze-drying closures for injection vials.
917-1 3 – Self-inspection and quality audits 1. International Nonproprietary Names for pharmaceutical substances. Plungers and discs for pen-injectors isp medical use. Infusion equipment for medical use. Plungers and discs for dental local anaesthetic cartridges. Appendix 4 – International standards on packaging A list is given below of the standards on packaging issued by the International Organization for Standardization ISOas of 10 Octoberstarting with the four main standards, after which they are listed in numerical order.
Good manufacturing practices for sterile pharmaceutical products. Quality control – reference materials.
Harmonization of regulatory requirements. Injection equipment for medical use. Appendix 2 – Labels 1. Annex 6 – Good manufacturing practices for sterile pharmaceutical products. International Standard ISO Closures for injection vials. 987-1 for analysis of drug samples. Protection of the environment. Screw-neck bottles vials for solid and liquid dosage forms. Sample collection and testing. Tuberculosis programme – fixed-dose combinations. Plastics collapsible containers for human blood and blood components.
Glass transfusion bottles, closures and caps. Measures to combat counterfeit drugs.
Starting materials for pharmaceutical products: Design, performance requirements and tests. Glass containers for pharmaceutical use and rubber closures for containers of pharmaceuticals. Annex 10 – Model certificate of jso. Quality systems for national GMP inspectorates. Sterile single-use syringes, with or without needle, for insulin.
Containers and accessories for pharmaceutical preparations.
Quality assurance – general topics. Equipment, instruments and other devices. Packaging materials and closures. Carrying out the inspection. Quality assurance – good manufacturing practices. General aspects of packaging. Disposable hanging devices for transfusion and infusion bottles – requirements and test methods.
Needles – requirements 9187–1 test methods. Aseptic processing and sterilization by filtration.
Guidelines for good storage practices. Manufacture of sterile preparations. Screening tests for antimalarials and antituberculosis drugs.