ISO 8362-5 PDF

September 2, 2019 posted by

Récipients et accessoires pour produits injectables —. Partie 5: Bouchons à lyophilisation pour flacons d’injection. STANDARD. ISO. ISO. Second edition. Injection containers and accessories —. Part 5: Freeze drying closures for injection vials. Récipients et accessoires. Injection containers and accessories – Part 5: Freeze drying closures for injection vials (ISO ).

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Pen-injectors for medical use.

BS EN ISO 8362-5:2016

Closures for injection vials. Plastics collapsible containers for human blood and isso components. Calibration, validation and verification of equipment, instruments and other devices.

Injection vials made of glass tubing. Appendix 2 – Labels 1. Glass cylinders for pen-injectors for medical use. It is designed to cover every economic sector and virtually every activity of the humankind where technical standards may be used. Then you can isl reading Kindle books on your smartphone, tablet, or computer – no Kindle device required.


Aseptic processing and sterilization by filtration. Jso of sterile products. Write a product review. Shopbop Designer Fashion Brands. Visit our Help Pages. NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be strongly affected by the nature and performance of the primary packaging.

Requests for analysis of drug samples. Injection vials made of moulded glass. Glass barrels for injectables.

SRPS EN ISO 8362-5:2017

Glass transfusion bottles, closures and caps. Injection equipment for medical use. Nomenclature and computerized systems. International Infrared Reference Spectra. Manufacture of sterile preparations.

Repacking, relabelling and dispensing. Annex 5 – Basic elements of good manufacturing practices in pharmaceutical production. Quality systems – model for quality assurance in production, installation and servicing. Disposable hanging devices for transfusion and infusion bottles – requirements and test methods. Guidelines for good ios practices. Design, performance requirements and tests.

The dimensional requirements are not applicable to barrier-coated closures. Plungers and discs for pen-injectors for medical use.

Quality control – specifications and tests. Caps made of aluminium-plastics combinations for infusion bottles and injection vials – requirements and test methods. Aluminium caps for dental local anaesthetic cartridges. Quality assurance – inspection.


Universal Medicap

Information on reference materials for pharmacopoeial analysis. We recommend that you check the website of the publishers of the international document before making a purchase. Annex 7 – Guidelines on pre-approval inspections. Needles – requirements and test methods.

Model certificate of analysis for use in trade and procurement.

Requirements for 83622-5 form containers. Enter your mobile number or email address below and we’ll send you a link to download the free Kindle App.

Finished cartridges – requirements and test methods. Sterile single-use syringes, with or without needle, for insulin. International Chemical Reference Substances. Information on general publications.