BS ISO 11040-6:2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 Plastic barrels for injectables
Hardcopy , PDF
English
30-04-2012
23-01-2019
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
Bibliography
Describes the materials, dimensions and requirements for plastic barrels (singlechamber design) for injection preparations, which are to be subsequently filled and assembled on standardized processing equipment.
| Committee |
CH/212
|
| DevelopmentNote |
Supersedes 10/30212297 DC. (04/2012)
|
| DocumentType |
Standard
|
| Pages |
20
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 11040-6:2012 | Identical |
| ISO 11040-4:2015 | Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling |
| ISO 11040-5:2012 | Prefilled syringes — Part 5: Plunger stoppers for injectables |
| 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 80369-7:2016 | Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications |
| 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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