BS ISO 11608-6 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 6: ON-BODY DELIVERY SYSTEMS

Available format(s)

Hardcopy , PDF

Language(s)

English

Publisher

British Standards Institution

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