13/30261812 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS ISO 10555-6 - INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS
Hardcopy , PDF
English
30-04-2015
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements of the implantable subcutaneous implanted
port and catheter
5 Magnetic Resonance Imaging (MRI) compatibility
6 Information to be supplied by the manufacturer
7 Identification Marking
Annex A (normative) - Test method for freedom from air
leakage
Annex B (informative) - Determination of flushing volume
Annex C (informative) - Guidance on further characterization
testing: Needle penetration and withdrawal
Annex D (normative) - Test method for freedom from leakage
after multiple punctures
Annex E (normative) - Peak Tensile Force
Bibliography
BS ISO 10555-6
| Committee |
CH/84
|
| DocumentType |
Draft
|
| Pages |
22
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| ISO 5832-1:2016 | Implants for surgery — Metallic materials — Part 1: Wrought stainless steel |
| ISO 11135-1:2007 | Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 9584:1993 | Implants for surgery — Non-destructive testing — Radiographic examination of cast metallic surgical implants |
| ISO 6474-1:2010 | Implants for surgery — Ceramic materials — Part 1: Ceramic materials based on high purity alumina |
| ASTM F 2052 : 2015 : REDLINE | Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment |
| ASTM F 2213 : 2017 : REDLINE | Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment |
| ISO 7864:2016 | Sterile hypodermic needles for single use — Requirements and test methods |
| ISO 5832-2:1999 | Implants for surgery — Metallic materials — Part 2: Unalloyed titanium |
| ISO 10555-1:2013 | Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements |
| ISO 48:2010 | Rubber, vulcanized or thermoplastic — Determination of hardness (hardness between 10 IRHD and 100 IRHD) |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
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