EN ISO 9187-1:2010
Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2010)

Standard No.
EN ISO 9187-1:2010
Release Date
2010
Published By
European Committee for Standardization (CEN)
Latest
EN ISO 9187-1:2010
Replace
DIN EN ISO 9187-1:2008 DIN EN ISO 9187-1:2010
Scope
This part of ISO 9187 specifies materials, dimensions, capacities, performance and packaging requirements for three forms of glass ampoule (forms B, C and D) for injectable pharmaceutical products

EN ISO 9187-1:2010 Referenced Document

  • ISO 2859-1 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection; Technical Corrigendum 1
  • ISO 4802-1 Glassware
  • ISO 4802-2 Glassware
  • ISO 720 Glass — Hydrolytic resistance of glass grains at 121 °C — Method of test and classification

EN ISO 9187-1:2010 history

  • 2010 EN ISO 9187-1:2010 Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2010)
  • 2008 EN ISO 9187-1:2008 Injection equipment for medical use - Part 1: Ampoules for injectables
  • 2003 EN ISO 9187-1:2003 Injection equipment for medical use - Part 1: Ampoules for injectables ISO 9187-1:2000
  • 1999 EN ISO 9187-1:1999 Injection Equipment for Medical Use - Part 1: Ampoules for Injectables (Incorporating Corrigenda May 1999 and October 1999)

EN ISO 9187-1:2010 Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2010) has been changed from DIN EN ISO 9187-1:2008 Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2006); German and English version EN ISO 9187-1:2008.




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