10/30196945 DC : 0

Superseded

View Superseded by

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

Available format(s)

Hardcopy , PDF

Superseded date

03-31-2012

Language(s)

English

Publisher

British Standards Institution

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Status	Superseded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	BS EN ISO 25539-3:2011

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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
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EN 12006-3:1998+A1:2009	Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices
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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
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ASTM D 638 : 2014 : REDLINE	Standard Test Method for Tensile Properties of Plastics
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ISO 15223:2000	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied