BS ISO 11040-7:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Prefilled syringes Packaging systems for sterilized subassembled syringes ready for filling
Hardcopy , PDF
04-06-2024
English
30-04-2015
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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.
| Committee |
CH/212
|
| DevelopmentNote |
Supersedes 13/30254718 DC. (04/2015)
|
| DocumentType |
Standard
|
| Pages |
38
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
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.
| 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 |
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