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10/30196945 DC : 0

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

BS ISO 25539-3 - CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS

Available format(s)

Hardcopy , PDF

Superseded date

31-03-2012

Superseded by

BS EN ISO 25539-3:2011

Language(s)

English

€56.09
Excluding VAT

1 Scope
2 Normative references
3 Definitions
4 General requirements
5 Intended performance
6 Design attributes
7 Materials
8 Design evaluation
9 Post market surveillance
10 Manufacturing
11 Sterilisation
12 Packaging
Annex A (informative) - Attributes of endovascular
        devices - vena cava filters - Technical and
        clinical considerations
Annex B (informative) - Definitions of Potential Failure
        Modes and Effects of Failure
Annex C (informative) - Bench and analytical tests
Annex D (informative) - Test methods
Annex E (informative) - Examples of some terms for
        clinical use of vena cava filters
Bibliography

Committee
CH/150/2
DocumentType
Draft
Pages
124
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

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
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 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
ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied

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