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I.S. EN ISO 10555-1:2013

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS (ISO 10555-1:2013/AMD 1:2017)
Available format(s)

Hardcopy , PDF

Superseded date

12-07-2023

Language(s)

English

Published date

01-01-2013

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

National Foreword
European Foreword
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Designation of nominal size
6 Information to be supplied by the manufacturer
Annex A (normative) - Test method for corrosion
        resistance
Annex B (normative) - Method for determining peak
        tensile force
Annex C (normative) - Test method for liquid leakage
        under pressure
Annex D (normative) - Test method for air leakage
        into hub assembly during aspiration
Annex E (normative) - Determination of flowrate
        through catheter
Annex F (normative) - Test for burst pressure under
        static conditions
Annex G (normative) - Power injection test for
        flowrate and device pressure(only for products
        indicated for power injection)
Annex H (informative) - Units of measurement systems
        other than those specified in this part of
        ISO 10555, which may additionally be used
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential Requirements
         of EU Directive 93/42/EEC amended by Directive
         2007/47/EEC

Describes general requirements for intravascular catheters, supplied in the sterile condition and intended for single use, for any application.

DevelopmentNote
Supersedes I.S. EN ISO 10555-2. (10/2013)
DocumentType
Standard
Pages
54
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy
Supersedes

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ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems Vascular device-drug combination products
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 3105:1994 Glass capillary kinematic viscometers — Specifications and operating instructions
ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
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
ASTM F 640 : 2012 : REDLINE Standard Test Methods for Determining Radiopacity for Medical Use

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