16/30282706 DC : 0
NA
Status of Standard is Unknown
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
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