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UNE-EN ISO 10555-4:2014

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2013)

Available format(s)

Hardcopy , PDF

Superseded date

17-07-2024

Superseded by

UNE-EN ISO 10555-4:2024

Language(s)

Spanish, Castilian, English

Published date

19-02-2014

€81.60
Excluding VAT

Foreword
1 Scope
2 Normative references
3 Definitions
4 Requirements
Annex A (normative) Test for freedom from leakage and
         damage on inflation
Annex B (informative) Guidance on the selection of balloon
         materials
Annex C (informative) Bibliography

Defines requirements for sterile, single use balloon dilatation catheters.

Committee
CTN 111
DocumentType
Standard
Pages
22
PublisherName
Asociacion Espanola de Normalizacion
Status
Superseded
SupersededBy
Supersedes

ISO 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires
ISO 25539-2:2012 Cardiovascular implants Endovascular devices Part 2: Vascular stents
ISO 14630:2012 Non-active surgical implants — General requirements
ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems Vascular device-drug combination products
ISO 10555-1:2013 Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
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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