BS EN ISO 10555-6:2017
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Intravascular catheters. Sterile and single-use catheters – Subcutaneous implanted ports
| Published By | Publication Date | Number of Pages |
| BSI | 2017 | 28 |
ISO 10555-6:2015 specifies requirements, performance, and user safety issues related to subcutaneous implanted ports and catheters for intravascular long-term use supplied in sterile condition and intended for single use. ISO 10555-6:2015 does not specify requirements, performance, and user safety issues related to non-coring needles.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 6 | Annex ZA (informative)Relationship between this European Standard and the Essential Requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered |
| 10 | Foreword |
| 11 | 1 Scope 2 Normative references 3 Terms and definitions |
| 13 | 4 Requirements of the implantable subcutaneous implanted port and catheter 4.1 General |
| 14 | 4.2 Biocompatibility 4.3 Distance markings 4.4 Nominal dimensions of the subcutaneous implanted port 4.5 Physical requirements 4.5.1 Radio-detectability 4.5.2 Surface finish 4.5.3 Freedom from leakage 4.5.4 Flushing volume |
| 15 | 4.5.5 Characteristics of the septum 4.5.6 Characteristics of the connection or the catheter 4.6 Flow rate 4.6.1 Subcutaneous implanted ports not indicated for power injection 4.6.2 Subcutaneous implanted ports indicated for power injection |
| 16 | 4.7 Burst pressure of the subcutaneous implanted port and catheter 4.7.1 Subcutaneous implanted ports not indicated for power injection 4.7.2 Subcutaneous implanted ports indicated for power injection 5 Magnetic Resonance Imaging (MRI) compatibility 6 Information to be supplied by the manufacturer 6.1 Marking on the device 6.2 Primary packaging |
| 17 | 6.3 Labels for traceability 6.4 Instruction for use |
| 18 | Annex A (normative) Test method for freedom from air leakage |
| 20 | Annex B (informative) Determination of flushing volume |
| 22 | Annex C (informative) Guidance on further characterization testing: Needle penetration and withdrawal |
| 24 | Annex D (normative) Test method for freedom from leakage after multiple punctures |
| 25 | Annex E (normative) Peak tensile force |
| 26 | Bibliography |
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BS EN ISO 10555-6:2017+A1:2019
Intravascular catheters. Sterile and single-use catheters – Subcutaneous implanted ports Published By Publication Date Number…
