• There are no items in your cart

BS ISO 11040-7:2015

Current
Current

The latest, up-to-date edition.

Prefilled syringes Packaging systems for sterilized subassembled syringes ready for filling
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

04-30-2015

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements for the packaging system
5 Information to be provided by the manufacturer
6 Marking of the tub
7 Packaging of tubs in trading units/bundles
Annex A (informative) - Design of nests
Annex B (informative) - Determination of nest deflection
Annex C (informative) - Design of tubs
Annex D (informative) - Schematic illustrations of
        examples for the orientation of tubs within the
        protective bag
Annex E (informative) - Design and dimensions of
        the protective bag
Annex F (informative) - Test method to determine the
        distance between the edge of the protective bag
        to the rear end of the tub
Bibliography

Describes the packaging system that is used to deliver sterilized subassembled syringes ready for filling in tubs and nests.

This part of ISO11040 specifies the packaging system that is used to deliver sterilized subassembled syringes ready for filling in tubs and nests.

Downstream processes (processes after filling such as in house/outside transport, reprocessing) can result in specific requirements on the packaging system used to deliver sterilized subassembled syringes ready for filling. However, these requirements are not within the scope of this part of ISO11040.

NOTE1 Glass barrels and sterilized subassembled syringes ready for filling, plungers, and plastic barrels for injectables are specified in ISO11040-4, ISO11040-5, and ISO11040-6.

NOTE2 ISO11607-2 addresses validation requirements of sealing and packaging processes for medical devices.

Committee
CH/212
DevelopmentNote
Supersedes 13/30254718 DC. (04/2015)
DocumentType
Standard
Pages
38
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
ISO 11040-7:2015 Identical

ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO/TS 11139:2006 Sterilization of health care products Vocabulary
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)
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

View more information
US$277.90
Excluding Tax 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.