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10/30212297 DC : 0

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BS ISO 11040-6 - PREFILLED SYRINGES - PART 6: PLASTIC BARRELS FOR INJECTABLES
Available format(s)

Hardcopy , PDF

Superseded date

30-04-2012

Language(s)

English

Foreword
Introduction
1 Scope
2 Normative references
3 Dimensions and designation
4 Requirements
5 Tolerance on graduated capacity
6 Packaging and labelling
Annex A (informative) - Head designs
Annex B (informative) - Guidance on materials
Annex C (informative) - Test for the determination
        of particulate contamination
Bibliography

Committee
CH/212
DocumentType
Draft
Pages
19
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

ISO 11040-4:2015 Prefilled syringes Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
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 11040-7:2015 Prefilled syringes Part 7: Packaging systems for sterilized subassembled syringes ready for filling
ASTM D 7210 : 2013 : REDLINE Standard Practice for Extraction of Additives in Polyolefin Plastics
ISO 3826-1:2013 Plastics collapsible containers for human blood and blood components Part 1: Conventional containers
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 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
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 13926-2:2011 Pen systems Part 2: Plunger stoppers for pen-injectors for medical use
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
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 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
ISO 15747:2010 Plastic containers for intravenous injections
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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