ISO 9187-1 PDF
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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Guidelines for quality improvement. Quality management and quality systems elements. Aseptic processing and sterilization by filtration. Monographs for The international pharmacopoeia.
ISO – Injection equipment for medical use — Part 1: Ampoules for injectables
Plungers and discs for dental local anaesthetic cartridges. Injection vials made of glass tubing. Good manufacturing practices for sterile pharmaceutical products. Needles – requirements and test methods. Glass transfusion bottles, closures and caps. The international pharmacopoeia – 50 years on. Lso systems – model for quality assurance in design, development, production, installation and servicing. Glass cylinders for dental local anaesthetic cartridges. Quality control – specifications and tests.
Equipment, instruments and other devices. Quality systems – model for quality assurance in production, installation and servicing. Requirements in The international pharmacopoeia.
Freeze-drying closures for infusion bottles. Information on general publications.
Quality systems – model for quality assurance in final inspection and test. Annex 7 – Guidelines on pre-approval inspections. Annex 3 – Good practices for national pharmaceutical control laboratories. Appendix 1 – Storage areas 1.
BS EN ISO 9187-1:1999
Repacking, relabelling and dispensing. Good practices for national pharmaceutical control laboratories. Quality control – pharmaceutical control laboratories. Screw-neck vials made of glass tubing for liquid dosage forms. Basic tests for pharmaceutical substances and dosage forms. Disposable hanging devices for transfusion and infusion bottles – requirements and test methods. Quality control – reference materials.
Measures to combat counterfeit drugs. Protection of the environment. Caps made of aluminium-plastics combinations for infusion bottles. Annex 4 – Considerations for requesting analysis of drug samples 1. Annex 8 – Quality systems requirements for national good manufacturing practice inspectorates. 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.
Elastomeric parts for aqueous parenteral preparations. International Standard ISO Screw-neck bottles vials for solid and liquid dosage forms. International Nonproprietary Names for pharmaceutical substances. Materials and setting-up of equipment, instruments and other devices. Harmonization of regulatory requirements. Preparation for the inspection. Glass barrels for injectables.
Injection containers for injectables and accessories. Screw-neck bottles for syrups. Tuberculosis programme – fixed-dose combinations.
Freeze-drying closures for injection vials. Injection caps made of aluminium-plastics combinations without overlapping plastics part.
Closures for injection vials. Infusion sets for single use, gravity feed. Requirements for dosage form containers.