11/30228364 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 10555-1 - INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS
Hardcopy , PDF
English
31-07-2013
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Superseded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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