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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Needles – requirements and test methods. Quality control – specifications and tests. Aseptic processing and sterilization by filtration. International Standard ISO Quality management and quality systems elements. Nomenclature and computerized systems. Annex 11 – Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource generic products.
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 uso in numerical order.
BS EN ISO – Injection equipment for medical use. Ampoules for injectables
Elastomeric parts for aqueous parenteral preparations. Basic tests for pharmaceutical substances and dosage forms.
Dissolution test requirements for individual monographs. Glass cylinders for dental local anaesthetic cartridges. Reusable all-glass or metal-and-glass syringes for medical use.
ISO – Injection equipment for medical use — Part 1: Ampoules for injectables
Requests for jso of drug samples. Caps made of aluminium-plastics combinations for infusion bottles and injection vials – requirements and test methods. Glass barrels for injectables. Quality systems – model for quality assurance in production, installation and servicing. Preparation for the inspection. Hazard analysis and critical control point system.
BS EN ISO 9187-1:1999
Internal audit and periodic review. Good manufacturing practices for sterile pharmaceutical products. Injection caps made of aluminium-plastics combinations without overlapping plastics part.
Special types of closure. Annex 9 – Guidelines on packaging for pharmaceutical products. Guidelines for processed materials. International Nonproprietary Names for pharmaceutical substances. Freeze-drying closures for injection vials. Harmonization of regulatory requirements. Quality systems – model for quality assurance in final inspection and test. Glass cylinders for pen-injectors for medical use.
Comparator products for equivalence assessment of interchangeable multisource generic products. Design, performance requirements and tests. Requirements for dosage form containers.
Injection containers for injectables and accessories. Appendix 1 – Model analytical test report for active pharmaceutical ingredients, excipients and pharmaceutical products. Annex 6 – Good manufacturing practices for sterile pharmaceutical products. Guidelines for good storage practices. General aspects of packaging. Injection vials made of glass tubing.
Calibration, validation and verification of equipment, instruments and other devices. Quality control – pharmaceutical control laboratories. Transfusion equipment for medical use.