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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Quality control – pharmaceutical control laboratories. Plungers and discs for dental local anaesthetic cartridges. Annex 6 – Good manufacturing practices for sterile pharmaceutical products.
Annex 5 – Basic elements of good manufacturing practices in pharmaceutical production.
Screw-neck bottles vials for solid and liquid dosage forms. Good manufacturing practices in pharmaceutical production.
Quality systems – isi for quality assurance in production, installation and servicing. Package inserts for patients patient information leaflets.
Annex 7 – Guidelines on pre-approval inspections. Appendix 4 – International standards on packaging.
ISO – Injection equipment for medical use — Part 1: Ampoules for injectables
Quality assurance – inspection. Annex 4 – Considerations for requesting analysis of drug samples 1. Iiso vials made of glass tubing. Elastomeric parts for aqueous parenteral preparations. Appendix 2 – Equipment for a first-stage and medium-size pharmaceutical control laboratory.

Annex 3 – Good practices for national pharmaceutical control laboratories. Screening tests for antimalarials and antituberculosis drugs. Internal audit and periodic review. Glass containers for pharmaceutical use and rubber closures for containers of pharmaceuticals. Quality assurance – packaging.
BS EN ISO 9187-1:1999
Monographs for The international pharmacopoeia. Appendix 1 – Model analytical test report for active pharmaceutical ingredients, excipients and pharmaceutical products. Plastics 91187-1 containers for human blood and blood components.

Aluminium caps for transfusion, infusion and injection bottles – general requirements and test methods. Measures to combat counterfeit drugs. Quality assurance – good manufacturing practices.
Appendix 2 – Labels 1. Design, performance requirements and tests. Quality assurance aspects of packaging. Glass barrels for isso. Harmonization of regulatory requirements. Needles – requirements and test methods. International Infrared Reference Spectra. Annex 8 – Quality systems requirements for national good manufacturing practice inspectorates.
BS EN ISO – Injection equipment for medical use. Ampoules for injectables
Closures for injection vials. Injection caps made of 91871- combinations without overlapping plastics part. Good manufacturing practices for sterile pharmaceutical products. Reusable all-glass or metal-and-glass syringes for medical use.
