13/30276989 DC : 0

Superseded

View Superseded by

BS EN ISO 11070 - STERILE, SINGLE-USE INTRAVASCULAR CATHETER INTRODUCERS

Available format(s)

Hardcopy , PDF

Superseded date

30-11-2014

Language(s)

English

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Additional requirements for introducer needles
6 Additional requirements for introducer catheters
7 Additional requirements for sheath introducers
8 Additional requirements for guide wires
9 Additional requirements for dilators
10 Additional requirements for kits containing combinations
   of devices specified in this International Standard
Annex A (informative) - Guidance on materials and design
Annex B (normative) - Test method for corrosion resistance
Annex C (normative) - Method for determining peak tensile
        force of introducer catheters, sheath introducers and
        dilators
Annex D (normative) - Test method for liquid leakage from
        sheath introducers under pressure
Annex E (normative) - Test method for liquid leakage through
        haemostasis valves of sheath introducers
Annex F (normative) - Test method for fracture of guide wires
Annex G (normative) - Test method for resistance of guide wires
        to damage by flexing
Annex H (normative) - Method for determining peak tensile
        force of guide wires
Bibliography

BS EN ISO 11070

Committee	CH/84
DocumentType	Draft
Pages	36
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN ISO 11070 : 2014

DIN 13273-7:2003-08	CATHETER FOR MEDICAL USE - PART 7: DETERMINATION OF THE X-RAY ATTENUATION OF CATHETERS - REQUIREMENTS AND TESTING
ISO 11135:2014	Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 9626:2016	Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
ISO 7886-1:2017	Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
ISO 8601:2004	Data elements and interchange formats Information interchange Representation of dates and times
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 10555-1:2013	Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
ISO 11134:1994	Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
ISO 11137:1995	Sterilization of health care products Requirements for validation and routine control Radiation sterilization
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 10555-5:2013	Intravascular catheters — Sterile and single-use catheters — Part 5: Over-needle peripheral catheters
ASTM F 640 : 2012 : REDLINE	Standard Test Methods for Determining Radiopacity for Medical Use
ISO 10555-4:2013	Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters