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ISO 11418-3:2016

Containers and accessories for pharmaceutical preparations -- Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms

General information

Valid from 14.11.2016
ICS Groups
11.040.20 Transfusion, infusion and injection equipment 11.120.99 Other standards related to pharmaceutics
Directives or regulations
None

Standard history

Status
Date
Type
Name
16.11.2017
Amendment
ISO 11418-3:2016/Amd 1:2017
14.11.2016
Main
ISO 11418-3:2016
Main
ISO 11418-3:2005
ISO 11418-3:2016 specifies the design, dimensions, material and requirements of screw-neck glass bottles (veral) for pharmaceutical preparations in solid and liquid dosage forms. Screw-neck glass bottles are applicable to primary packs used in direct contact with a drug.
It is applicable to screw-neck glass bottles (veral) used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations in solid and liquid dosage forms which are not intended for parenteral use.

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Standard monitoring
English (PDF 717 KB)

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Amendment

ISO 11418-3:2016/Amd 1:2017

ISO 11418-3:2016 - Amendment
Newest version Valid from 16.11.2017
Main

EVS-EN ISO 80369-1:2018

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EVS-EN 60601-2-24:2015

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EVS-EN 60601-2-40:2019

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English