ISO 8362-2:2024

ISO 8362-2:2024

March 2024
International standard Current

Injection containers and accessories - Part 2: Closures for injection vials

This document specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362-1 and ISO 8362-4.The dimensional requirements are not applicable to barrier-coated closures.Closures specified in this document are intended for single use only.NOTE            The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.

View the extract
Main informations

Collections

International ISO standards

Publication date

March 2024

Number of pages

6 p.

Reference

ISO 8362-2:2024

ICS Codes

11.040.20   Transfusion, infusion and injection equipment

Print number

1
Sumary
Injection containers and accessories - Part 2: Closures for injection vials

This document specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362-1 and ISO 8362-4.

The dimensional requirements are not applicable to barrier-coated closures.

Closures specified in this document are intended for single use only.

NOTE            The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.

Replaced standards (2)
ISO 8362-2:2015
October 2015
International standard Cancelled
Injection containers and accessories - Part 2 : closures for injection vials

ISO 8362-2:2015 specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362‑1 and ISO 8362‑4. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in ISO 8362-2:2015 are intended for single use only.

ISO 8362-2/A1:2022
August 2022
International standard Cancelled
Amendment 1 to standard ISO 8362-2:2015

ZOOM ON ... the Requirements department
To comply with a standard, you need to quickly understand its issues in order to determine its impact on your activity.

The Requirements department helps you quickly locate within the normative text:
- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.

The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.

With Requirements, quickly access the main part of the normative text!

With Requirements, quickly access the main part of the normative text!
Need to identify, monitor and decipher standards?

COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.

Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!

Request your free, no-obligation live demo

I discover COBAZ