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11/30228364 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Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 EN ISO 10555-1 - INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS
Available format(s)

Hardcopy , PDF

Superseded date

07-31-2013

Language(s)

English

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Designation of nominal size
6 Information to be supplied by manufacturer
Annex A (normative) - Test method for
        corrosion resistance
Annex B (normative) - Method for determining
        force at break
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 ZA (informative) - Relationship between this
         International Standard and the Essential
         Requirements of EU Directive
Bibliography

BS EN ISO 10555-1

Committee
CH/84
DocumentType
Draft
Pages
35
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
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 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 11134:1994 Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements

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