15/30304642 DC : 0
NA
NA
Status of Standard is Unknown
BS ISO 11040-8 - PREFILLED SYRINGES - PART 8: REQUIREMENTS AND TEST METHODS FOR FINISHED PRIFILLED SYRINGES
Available format(s)
Hardcopy , PDF
Language(s)
English
Publisher
€22.71
Excluding VAT
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 User requirements
5 System characterization
6 Physical system characterization
7 Pharmaceutical requirements
8 Documentation
Bibliography
BS ISO 11040-8.
| Committee |
CH/212
|
| DocumentType |
Draft
|
| Pages |
18
|
| PublisherName |
British Standards Institution
|
| Status |
NA
|
| ISO 11137-1:2006 | Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 11040-4:2015 | Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling |
| ISO 11608-4:2006 | Pen-injectors for medical use — Part 4: Requirements and test methods for electronic and electromechanical pen-injectors |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| 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 11608-5:2012 | Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions |
| ISO 11608-1:2014 | Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| ISO 11608-2:2012 | Needle-based injection systems for medical use — Requirements and test methods — Part 2: Needles |
| ISO 7886-1:2017 | Sterile hypodermic syringes for single use — Part 1: Syringes for manual use |
| ISO 11608-3:2012 | Needle-based injection systems for medical use — Requirements and test methods — Part 3: Finished containers |
| ISO 13408-1:2008 | Aseptic processing of health care products — Part 1: General requirements |
| 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 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 11040-6:2012 | Prefilled syringes — Part 6: Plastic barrels for injectables |
| ISO 23908:2011 | Sharps injury protection — Requirements and test methods — Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| 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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