BS ISO 11040-6 - PREFILLED SYRINGES - PART 6: PLASTIC BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING

Available format(s)

Hardcopy , PDF

Language(s)

English

Publisher

British Standards Institution

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)