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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Finished cartridges – requirements and test methods. Quality assurance aspects of packaging. Containers and accessories for pharmaceutical preparations. Needles – requirements and 91877-1 methods. Quality assurance – packaging. Pen-injectors for medical use.
The international pharmacopoeia – 50 years on. Requirements in The international pharmacopoeia. Requirements for dosage form containers. Appendix 4 – International standards on packaging A list is iao 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.
Good manufacturing practices for sterile pharmaceutical products. Good manufacturing practices in pharmaceutical production.
Appendix 1 – Storage areas 1. Annex 9 – Guidelines on packaging for pharmaceutical products. Glass barrels for injectables. Evaluation of test results. Aluminium caps for dental local anaesthetic cartridges. Quality assurance – inspection. Injection caps made of aluminium-plastics combinations without overlapping plastics part.
ISO – Injection equipment for medical use — Part 1: Ampoules for injectables
Package inserts for patients patient information leaflets. 91187-1 and discs for pen-injectors for medical use. Equipment, instruments and other devices. Comparator products for equivalence assessment of interchangeable multisource generic products.
Drug quality assurance terminology.
BS EN ISO 9187-1:1999
Injection containers for injectables and accessories. Repacking, relabelling and dispensing. Internal audit and periodic review. Finishing of sterile products.
BS EN ISO – Injection equipment for medical use. Ampoules for injectables
Manufacture of sterile preparations. Quality assurance – good manufacturing practices. International Nonproprietary Names for pharmaceutical substances. Plastics collapsible containers for human blood and blood components. Aseptic processing and sterilization by filtration.
Injection equipment for medical use. Appendix 3 – Self-inspection and quality audits 1. Dissolution test requirements for individual monographs. Carrying out the inspection.