ISO 9187-1 PDFJune 20, 2020
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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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.
Quality systems – model for quality assurance in design, development, production, installation and servicing. International Standard ISO Quality systems – model for quality assurance in production, installation and servicing. Quality systems – model for quality assurance in final inspection and test.
ISO – Injection equipment for medical use — Part 1: Ampoules for injectables
Quality management and quality systems elements. Guidelines for processed materials. Guidelines for quality improvement. Reusable all-glass or metal-and-glass syringes for medical use.
Design, performance requirements and tests. Transfusion equipment for medical use. Glass transfusion bottles, closures and caps. Plastics collapsible containers for human blood and blood components. Injection containers for injectables and accessories. Injection vials made of glass tubing. Closures for injection vials. Aluminium caps for injection vials. Injection vials made of moulded glass.
Freeze-drying closures for injection vials. Caps made of aluminium-plastics combinations for injection vials. Injection caps made of aluminium-plastics combinations without overlapping plastics part.
Infusion equipment for medical use. Infusion sets for single use, gravity feed. Freeze-drying closures for infusion bottles. Caps made of aluminium-plastics combinations for infusion bottles. Sterile single-use syringes, with or without needle, for insulin. Elastomeric parts for aqueous parenteral preparations. Aluminium caps for transfusion, infusion and injection bottles – general requirements and test methods.
Injection equipment for medical use.
BS EN ISO 9187-1:1999
Caps made of aluminium-plastics combinations for infusion bottles and injection vials – requirements and test methods. Glass cylinders for dental local anaesthetic cartridges. Plungers and discs for dental local anaesthetic cartridges. Aluminium caps for dental local anaesthetic cartridges.
Glass barrels for injectables. Containers and accessories for pharmaceutical preparations. Screw-neck bottles for syrups. Screw-neck bottles vials for solid and liquid dosage forms. Screw-neck vials made of glass tubing for liquid dosage forms.
Pen-injectors for medical use. Requirements and test methods. Needles – requirements and test methods. Finished cartridges – requirements and test methods. Glass cylinders for pen-injectors for medical use. Plungers and discs for pen-injectors for medical use. Disposable hanging devices for transfusion and infusion bottles – requirements and test methods. 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.
Quality control – specifications and tests. The international pharmacopoeia – 50 years on. Monographs for The international pharmacopoeia. Dissolution test requirements for individual monographs. Basic tests for pharmaceutical substances and dosage forms.
Quality control – reference materials. International Chemical Reference Substances. International Infrared Reference Spectra. Information on reference materials for pharmacopoeial analysis. Quality control – pharmaceutical control laboratories. Good practices for national pharmaceutical control laboratories.
Equipment for drug control laboratories. Requests for analysis of drug samples. Quality assurance – good manufacturing practices. Good manufacturing practices in pharmaceutical production.
Good manufacturing practices for sterile pharmaceutical products.
Guidelines for good storage practices. Hazard analysis and critical control point system. Quality assurance – inspection. Quality systems for national GMP inspectorates. Quality assurance – packaging. General aspects of packaging. Glass containers for pharmaceutical use and rubber closures for containers of pharmaceuticals.
Quality assurance – general topics. Starting materials for pharmaceutical products: Model certificate of analysis for use in trade and procurement. Screening tests for antimalarials and antituberculosis drugs.
Tuberculosis programme – fixed-dose combinations. Comparator products for equivalence assessment of interchangeable multisource generic products. Measures to combat counterfeit drugs.
Information on general publications. Nomenclature and computerized systems. International Nonproprietary Names for pharmaceutical substances. Drug quality assurance terminology. Harmonization of regulatory requirements. Annex 3 – Good practices for national pharmaceutical control laboratories. Equipment, instruments and other devices. Materials and setting-up of equipment, instruments and other devices. Calibration, validation and verification of equipment, instruments and other devices.
BS EN ISO – Injection equipment for medical use. Ampoules for injectables
Evaluation of test results. Appendix 1 – Model analytical test report for active pharmaceutical ingredients, excipients and pharmaceutical products. Appendix 2 – Equipment for a first-stage and medium-size pharmaceutical control laboratory. Annex 4 – Considerations for requesting analysis of drug samples 1.
Annex 5 – Basic elements of good manufacturing practices in pharmaceutical production. Annex 6 – Good manufacturing practices for sterile pharmaceutical products. Manufacture of sterile preparations. Aseptic processing and sterilization by filtration.
Finishing of sterile products. Annex 7 – Guidelines on pre-approval inspections. Preparation for the inspection. Carrying out the inspection. Sample collection and testing. Annex 8 – Quality systems requirements for national good manufacturing practice inspectorates.