14/30251609 DC : 0

Superseded

BS EN ISO 12417-1 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS

Available format(s)

Hardcopy , PDF

Superseded date

31-10-2015

Language(s)

English

Publisher

British Standards Institution

1 Scope
2 Normative references
3 Terms and definitions
4 Intended Performance
5 Design attributes
6 Materials
7 Design evaluation
8 Manufacturing
9 Sterilization
10 Packaging
11 Information supplied by the Manufacturer
Annex A (informative) - Definitions of potential
        clinical and technical events
Annex B (informative) - Local information
        regarding submission issues for VDDCPs
Bibliography
Annex ZA (informative) - Relationship between
         this European Standard and the Essential
         Requirements of EU Directive 93/42/EEC
         on Medical Devices

BS EN ISO 12417-1.

Committee	CH/150/2
DocumentType	Draft
Pages	61
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN ISO 12417-1:2015

ISO 11070:2014	Sterile single-use intravascular introducers, dilators and guidewires
ISO/IEC 17025:2005	General requirements for the competence of testing and calibration laboratories
ISO 25539-2:2012	Cardiovascular implants Endovascular devices Part 2: Vascular stents
ISO 15223-2:2010	Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
CFR 21(PTS200-299) : 0	FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 200-299
ISO 14160:2011	Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
ISO 16054:2000	Implants for surgery Minimum data sets for surgical implants
ISO 13960:2010	Cardiovascular implants and extracorporeal systems Plasmafilters
ISO 5840:2005	Cardiovascular implants Cardiac valve prostheses
EN 556-2:2015	Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices
ISO 10555-2:1996	Sterile, single-use intravascular catheters Part 2: Angiographic catheters
ISO 7198:2016	Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
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
CFR 21(PTS800-1299) : 0	FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
ISO 25539-1:2017	Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
ISO 14630:2012	Non-active surgical implants General requirements
ISO 5841-2:2014	Implants for surgery Cardiac pacemakers Part 2: Reporting of clinical performance of populations of pulse generators or leads
ISO/TR 14283:2004	Implants for surgery Fundamental principles
ISO/TS 17137:2014	Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants
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
ISO 13781:2017	Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing
ISO 7199:2016	Cardiovascular implants and artificial organs Blood-gas exchangers (oxygenators)
ASTM F 2213 : 2017 : REDLINE	Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
ISO 10555-3:2013	Intravascular catheters — Sterile and single-use catheters — Part 3: Central venous catheters
ISO 10555-1:2013	Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
ISO 15814:1999	Implants for surgery Copolymers and blends based on polylactide In vitro degradation testing
ISO 25539-3:2011	Cardiovascular implants Endovascular devices Part 3: Vena cava filters
ISO 14155:2011	Clinical investigation of medical devices for human subjects Good clinical practice
ISO 16428:2005	Implants for surgery — Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
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 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
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 10555-4:2013	Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters
ISO 16429:2004	Implants for surgery — Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods