INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS (ISO 10555-6:2015)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2017

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

National foreword
National Annex NA (informative) - Bibliography
European foreword
Annex ZA (informative) - Relationship between this
         European Standard and the Essential Requirements
         of Directive 93/42/EEC [OJ L 169] aimed to
         be covered
Foreword
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
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

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.

DocumentType	Standard
Pages	27
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Current

Standards	Relationship
EN ISO 10555-6:2017	Identical
ISO 10555-6:2015	Identical

ISO 5832-1:2016	Implants for surgery — Metallic materials — Part 1: Wrought stainless steel
DIN EN ISO 5832-2 E : 2012	IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 2: UNALLOYED TITANIUM (ISO 5832-2:1999)
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 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 10555-3:2013	Intravascular catheters — Sterile and single-use catheters — Part 3: Central venous catheters
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 594-1:1986	Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
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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DIN EN ISO 10555-6 E : 2017

Current

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

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