DIN EN ISO 8362-2:2016
Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2015); German version EN ISO 8362-2:2015

Standard No.

DIN EN ISO 8362-2:2016

Release Date

2016

Published By

German Institute for Standardization

Status

Be replaced 2022-12

Replace By

DIN EN ISO 8362-2:2022

Latest

DIN EN ISO 8362-2:2023-10

Replace

DIN EN ISO 8362-2:2010 DIN EN ISO 8362-2:2014

DIN EN ISO 8362-2:2016 Referenced Document

• DIN EN ISO 15378:2012 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2011); German version EN ISO 15378:2011
• DIN EN ISO 8871-1:2004 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates (ISO 8871-1:2003); German version EN ISO 8871-1:2004, text in German and English
• DIN EN ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006); English version of DIN EN ISO 8871-4:2006-09
• DIN EN ISO 8871-5:2014 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2005); German version EN ISO 8871-5:2014
• DIN ISO 3302-1:1999 Rubber - Tolerances for products - Part 1: Dimensional tolerances (ISO 3302-1:1996)
• DIN ISO 48:2009 Rubber, vulcanized or thermoplastic - Determination of hardness (hardness between 10 IRHD and 100 IRHD) (ISO 48:2007);English version of DIN ISO 48:2009-10
• DIN ISO 7619-1:2012 Rubber, vulcanized or thermoplastic - Determination of indentation hardness - Part 1: Durometer method (Shore hardness) (ISO 7619-1:2010)
• ISO 2230:2002 Rubber products - Guidelines for storage
• ISO 3302-1:2014 Rubber - Tolerances for products - Part 1: Dimensional tolerances
• ISO 3302-2:2008 Rubber - Tolerances for products - Part 2: Geometrical tolerances
• ISO 48:2010 Rubber, vulcanized or thermoplastic - Determination of hardness (hardness between 10 IRHD and 100 IRHD)
• ISO 7619-1:2010 Rubber, vulcanized or thermoplastic - Determination of indentation hardness - Part 1: Durometer method (Shore hardness)

DIN EN ISO 8362-2:2016 history

• 2023 DIN EN ISO 8362-2:2023-10 Injection containers and accessories - Part 2: Closures for injection vials (ISO/DIS 8362-2:2023); German and English version prEN ISO 8362-2:2023 / Note: Date of issue 2023-08-25*Intended as replacement for DIN EN ISO 8362-2 (2022-12).
• 2022 DIN EN ISO 8362-2:2022-12 Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2015 + Amd 1:2022); German version EN ISO 8362-2:2015 + A1:2022
• 2022 DIN EN ISO 8362-2:2022 Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2015 + Amd 1:2022) (includes Amendment A1:2022)
• 2016 DIN EN ISO 8362-2:2016 Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2015); German version EN ISO 8362-2:2015
• 2010 DIN EN ISO 8362-2:2010 Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2008); German version EN ISO 8362-2:2010