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INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS (ISO 10555-6:2015)
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Available format(s): Hardcopy, PDF
Language(s): English
Published date: 01-01-2017
Publisher: German Institute for Standardisation (Deutsches Institut für Normung)
National forewordNational Annex NA (informative) - BibliographyEuropean forewordAnnex ZA (informative) - Relationship between this European Standard and the Essential Requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered Foreword1 Scope2 Normative references3 Terms and definitions4 Requirements of the implantable subcutaneous implanted port and catheter5 Magnetic Resonance Imaging (MRI) compatibility6 Information to be supplied by the manufacturerAnnex A (normative) - Test method for freedom from air leakageAnnex B (informative) - Determination of flushing volumeAnnex C (informative) - Guidance on further characterization testing - Needle penetration and withdrawalAnnex D (normative) - Test method for freedom from leakage after multiple puncturesAnnex E (normative) - Peak tensile forceBibliography
Describes 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.
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