13/30276989 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN ISO 11070 - STERILE, SINGLE-USE INTRAVASCULAR CATHETER INTRODUCERS
Hardcopy , PDF
30-11-2014
English
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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Superseded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 |
| 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 |
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