I.S. EN ISO 10555-1:2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS (ISO 10555-1:2013/AMD 1:2017)
Hardcopy , PDF
English
01-01-2013
07-12-2023
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.
Dates of withdrawal of national standards are available from NSAI.
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Superseded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 |
| Standards | Relationship |
| NBN EN ISO 10555-1 : 2013 | Identical |
| DIN EN ISO 10555-1:2013-11 | Identical |
| ISO 10555-1:2013 | Identical |
| BS EN ISO 10555-1 : 2013 | Identical |
| EN ISO 10555-1:2013 | Equivalent |
| ONORM EN ISO 10555-1 : 2018 | Identical |
| UNE-EN ISO 10555-1:2013 | Identical |
| NF EN ISO 10555-1 : 2013 AMD 1 2017 | Identical |
| NS EN ISO 10555-1 : 2013 AMD 1 2017 | Identical |
| NEN EN ISO 10555-1 : 2013 AMD 1 2018 | Identical |
| 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 11607-2:2006 | Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes |
| 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/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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