16/30282706 DC : 0
NA
Status of Standard is Unknown
BS ISO 11608-6 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 6: ON-BODY DELIVERY SYSTEMS
Hardcopy , PDF
English
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Other performance testing
7 Inspection
8 Test report
9 Information to be supplied by the manufacturer
10 Instructions for use
Annex A (informative) - Decision Tree 1 - On-body
delivery system
Annex B (informative) - Decision Tree 2 - Applicability
of ISO 11608 Parts
Annex C (informative) - Medicinal product compatibility
and stability
Annex D (normative) - Particulate testing
Annex E (informative) - Biological evaluation in
accordance with ISO 10993 series
Annex F (informative) - Pharmaceutical and medicinal
product compatibility requirements for medicinal
product contacting surfaces - Regulations, guidance,
standards or compendia material (4.10)
Annex G (informative) - Test methods
Annex H (informative) - Information to ISO/DIS 11608-6
readers (Preliminary Annex for DIS version,
containing a test matrix)
Bibliography
BS ISO 11608-6.
| Committee |
CH/84
|
| DocumentType |
Draft
|
| Pages |
53
|
| PublisherName |
British Standards Institution
|
| Status |
NA
|
| ISO 11608-4:2006 | Pen-injectors for medical use — Part 4: Requirements and test methods for electronic and electromechanical pen-injectors |
| ISO 10993-13:2010 | Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices |
| 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 |
| ISO 11608-2:2012 | Needle-based injection systems for medical use — Requirements and test methods — Part 2: Needles |
| ISO 10993-18:2005 | Biological evaluation of medical devices — Part 18: Chemical characterization of materials |
| ISO 10993-11:2017 | Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
| IEC 60529:1989+AMD1:1999+AMD2:2013 CSV | Degrees of protection provided by enclosures (IP Code) |
| ISO 10993-12:2012 | Biological evaluation of medical devices — Part 12: Sample preparation and reference materials |
| ISO 10993-7:2008 | Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| ISO 8536-4:2010 | Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| ISO 10555-1:2013 | Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements |
| ISO 10993-9:2009 | Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products |
| 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 10555-5:2013 | Intravascular catheters — Sterile and single-use catheters — Part 5: Over-needle peripheral catheters |
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