Customer Support: 131 242

  • There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Dismiss alert

DIN ISO 8536-6:2017-09

Current
Current

The latest, up-to-date edition.

INFUSION EQUIPMENT FOR MEDICAL USE - PART 6: FREEZE DRYING CLOSURES FOR INFUSION BOTTLES (ISO 8536-6:2016)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2017

National foreword
National Annex (informative) - Bibliography
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Shape and dimensions
5 Designation
6 Material
7 Requirements
8 Labelling
Annex A (normative) - Determination of fragments
Annex B (normative) - Determination of spike penetration
        force
Annex C (normative) - Spike retention/sealability
Annex D (normative) - Closure piercing device
Annex E (informative) - Determination of residual
        moisture
Bibliography

Describes the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, that is used in connection with the freeze-drying (or lyophilization) of drugs and biological materials.

DocumentType
Standard
Pages
23
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current

Standards Relationship
ISO 8536-6:2016 Identical

DIN EN ISO 8871-5:2017-03 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 5: FUNCTIONAL REQUIREMENTS AND TESTING (ISO 8871-5:2016)

ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates
ISO 7619-1:2010 Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness)
ISO 15510:2014 Stainless steels Chemical composition
ISO 8536-3:2009 Infusion equipment for medical use Part 3: Aluminium caps for infusion bottles
ISO 2230:2002 Rubber products — Guidelines for storage
DIN ISO 48:2016-09 Rubber, vulcanized or thermoplastic - Determination of hardness (hardness between 10 IRHD and 100 IRHD) (ISO 48:2010)
DIN EN ISO 8871-1:2004-11 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 1: EXTRACTABLE IN AQUEOUS AUTOCLAVATES
DIN EN ISO 8871-5 E : 2017 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 5: FUNCTIONAL REQUIREMENTS AND TESTING (ISO 8871-5:2016)
ISO 15378:2017 Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
DIN EN ISO 8871-4:2006-09 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006)
ISO 8871-5:2016 Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing
ISO 48:2010 Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD)
ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 4: Biological requirements and test methods
ISO 8536-1:2011 Infusion equipment for medical use Part 1: Infusion glass bottles

View more information
$178.44
Including GST where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

Need help?
Call us on 131 242, then click here to start a Screen Sharing session
so we can help right away! Learn more