13/30254718 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS ISO 11040-7 - PREFILLED SYRINGES - PART 7: PACKAGING SYSTEMS FOR STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING
Hardcopy , PDF
30-04-2015
English
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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
Bibliography
BS ISO 11040-7
| Committee |
CH/212
|
| DocumentType |
Draft
|
| Pages |
34
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| 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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