17/30357741 DC : 0
NA
Status of Standard is Unknown
BS ISO 11040-6 - PREFILLED SYRINGES - PART 6: PLASTIC BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING
Hardcopy , PDF
English
1 Scope
2 Normative references
3 Terms and definitions
4 General Requirements
5 Dimensions and Designation
6 Requirements
7 Graduation
8 Packaging and labelling
Annex A (informative) - Examples of types of sterilized
subassembled Annex A syringes ready for
filling
Annex B (informative) - Head designs
Annex C (normative) - Test methods for syringe
barrels
Annex D (informative) - Sample preparation for
endotoxin and particulate determination
Annex E (informative) - Evaluation of syringe
lubrication by glide force test method
Annex F (informative) - Needle penetration test
Annex G (normative) - Test methods for closure systems
Annex H (informative) - Dye solution tightness test
Annex I (informative) - Guidance on materials
Bibliography
BS ISO 11040-6.
| Committee |
CH/212 IVDS
|
| DocumentType |
Draft
|
| Pages |
63
|
| PublisherName |
British Standards Institution
|
| Status |
NA
|
| ISO 8871-1:2003 | Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavates |
| ISO 11040-4:2015 | Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling |
| ISO 80369-20:2015 | Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods |
| ISO 9626:2016 | Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods |
| ISO 11040-5:2012 | Prefilled syringes — Part 5: Plunger stoppers for injectables |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| 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 10993-7:2008 | Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals |
| ISO 13926-2:2011 | Pen systems — Part 2: Plunger stoppers for pen-injectors for medical use |
| ISO 7864:2016 | Sterile hypodermic needles for single use — Requirements and test methods |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| ISO 80369-1:2010 | Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements |
| ISO 80369-7:2016 | Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications |
| 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 |
| ISO/IEC Guide 98-3:2008 | Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) |
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