Name: UNI EN ISO 25539-3 : 2012
Brand: UNI

CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS

Published date

04-12-2012

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Intended performance
6 Design attributes
7 Materials
8 Design evaluation
9 Post-market surveillance
10 Manufacturing
11 Sterilization
12 Packaging
Annex A (informative) - Attributes of endovascular devices
        - Vena cava filters - Technical and clinical
        considerations
Annex B (informative) - Descriptions of potential device
        effects of failure and failure modes and descriptions
        of detrimental clinical effects
Annex C (informative) - Bench and analytical tests
Annex D (informative) - Test methods
Annex E (informative) - Examples of terms for clinical use
        of vena cava filters
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC

Defines requirements for vena cava filters, based upon current medical knowledge.

Committee	CT 44
DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Current

Standards	Relationship
EN ISO 25539-3:2011	Identical
ISO 25539-3:2011	Identical

ISO 11070:2014	Sterile single-use intravascular introducers, dilators and guidewires
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 10555-2:1996	Sterile, single-use intravascular catheters Part 2: Angiographic catheters
ASTM F 2503 : 2013 : REDLINE	Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
ISO 17475:2005	Corrosion of metals and alloys Electrochemical test methods Guidelines for conducting potentiostatic and potentiodynamic polarization measurements
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
ISO 14937:2009	Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO/TR 14969:2004	Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
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 14630:2012	Non-active surgical implants General requirements
ASTM F 2052 : 2015 : REDLINE	Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
ISO/TS 15539:2000	Cardiovascular implants Endovascular prostheses
ASTM F 2213 : 2017 : REDLINE	Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
ISO/TS 12417:2011	Cardiovascular implants and extracorporeal systems Vascular device-drug combination products
EN 12006-3:1998+A1:2009	Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices
ISO 10555-3:2013	Intravascular catheters — Sterile and single-use catheters — Part 3: Central venous catheters
CFR 21(PTS1-99) : 0	FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99
ISO 10555-1:2013	Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
ISO 14155:2011	Clinical investigation of medical devices for human subjects Good clinical practice
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
ASTM D 638 : 2014 : REDLINE	Standard Test Method for Tensile Properties of Plastics
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