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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Annex 6 – Good manufacturing practices for sterile pharmaceutical products. Annex 10 – Model certificate of analysis. Glass barrels for injectables.
BS EN ISO 9187-1:1999
Glass cylinders for dental local anaesthetic cartridges. Dissolution test requirements for individual monographs. Annex 11 – Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource generic products. Monographs for The international pharmacopoeia. Infusion equipment for medical iiso.
BS EN ISO – Injection equipment for medical use. Ampoules for injectables
Nomenclature and computerized systems. International Infrared Reference Spectra. Packaging materials and closures.
Freeze-drying closures for infusion bottles. Quality assurance – good manufacturing practices. Plungers and discs for dental local anaesthetic izo.
Basic tests for pharmaceutical substances and dosage forms. Preparation for the inspection. Requirements in The international pharmacopoeia.
Quality control – pharmaceutical control laboratories. Annex 3 – Good practices for national pharmaceutical control laboratories. Aluminium caps for dental local anaesthetic cartridges. Appendix 2 – Equipment for a first-stage and medium-size pharmaceutical control laboratory. Appendix 1 – Model analytical test report for active pharmaceutical ingredients, excipients and pharmaceutical products. International Nonproprietary Names for ido substances. Protection of the environment.
Starting materials for pharmaceutical products: Equipment for drug control laboratories. Screw-neck bottles for syrups. International Standard ISO Screw-neck bottles vials for solid and liquid dosage forms. Annex 8 – Quality uso requirements for national good manufacturing practice inspectorates. International Chemical Reference Substances. Annex 7 – Guidelines on pre-approval inspections. The international pharmacopoeia – 50 years on. Repacking, relabelling and dispensing.
Aluminium caps for injection vials. Materials and setting-up of equipment, instruments and other devices. Finishing of sterile products. Requirements for dosage form containers.
ISO – Injection equipment for medical use — Part 1: Ampoules for injectables
A list is given below of the standards on packaging issued by the International Organization for Standardization ISOas of 10 Octoberstarting sio the four main standards, after which they are listed in numerical order. Caps made of aluminium-plastics combinations for injection vials.
Appendix 3 – Self-inspection and quality audits 1. Requests for analysis of drug samples. Plungers and discs for pen-injectors for medical is. Requirements and test methods. Finished cartridges – requirements and test methods. Special types of closure.
Glass containers for pharmaceutical use and rubber closures for containers of pharmaceuticals. Quality systems – model for quality assurance in final inspection and test. Plastics collapsible containers for human 91887-1 and blood components. Guidelines for good storage practices.