ISO/TR 12417-2:2017

Withdrawn

Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

07-07-2022

Language(s)

English

Published date

11-21-2017

Publisher

International Organization for Standardization

ISO/TR 12417-2:2017 provides region-specific information for

- local submissions and approvals for vascular device-drug combination products (VDDCPs) in countries and regions around the world;

- changes related to the drug containing part and how they are evaluated by the different local regions.

For implanted products, this document is considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.

ISO/TR 12417-2:2017 is considered also as a supplement to ISO 12417‑1, and any relevant device-specific standards, such as the ISO 25539 series specifying requirements for endovascular devices. Requirements listed in this document also address VDDCPs that are not necessarily permanent implants.

DocumentType	Technical Report
Pages	29
PublisherName	International Organization for Standardization
Status	Withdrawn
SupersededBy	ISO/TR 12417-2:2022

Standards	Relationship
IS 17751 : Part 2 : 2022	Identical

MEDDEV 2.7-1 : REV 4 2016	CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC AND 90/385/EEC
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 16054:2000	Implants for surgery Minimum data sets for surgical implants
ISO 13960:2010	Cardiovascular implants and extracorporeal systems Plasmafilters
MEDDEV 2.12-1 : REV 8 : 2013	GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM
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 7198:2016	Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
MEDDEV 2.1-3 : REV 3 : 2015	BORDERLINE PRODUCTS, DRUG-DELIVERY PRODUCTS AND MEDICAL DEVICES INCORPORATING, AS INTEGRAL PART, AN ANCILLARY MEDICINAL SUBSTANCE OR AN ANCILLARY HUMAN BLOOD DERIVATIVE
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
CFR 21(PTS800-1299) : 0	FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
ISO 5840-1:2015	Cardiovascular implants Cardiac valve prostheses Part 1: General requirements
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 12417-1:2015	Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: 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 13781:2017	Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing
MEDDEV 2.12-2 : REV 2012	POST MARKET CLINICAL FOLLOW-UP STUDIES - A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
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 25539-3:2011	Cardiovascular implants Endovascular devices Part 3: Vena cava filters
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 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