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13/30261812 DC : 0

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BS ISO 10555-6 - INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS
Available format(s)

Hardcopy , PDF

Superseded date

30-04-2015

Language(s)

English

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Superseded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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