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BS EN ISO 12417-1:2024

BS EN ISO 12417-1:2024

$198.66

Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products – General requirements

Published By Publication Date Number of Pages
BSI 2024 58
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This document specifies requirements for vascular device-drug combination products (VDDCPs). With regard to safety, this document outlines requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. For implanted products, this document is intended to be used as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. This document is intended to be used as a supplement to 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 permanent implants. NOTE 1        Due to variations in the design of combination products covered by this document and due to the relatively recent development of some of these combination products, acceptable standardized in vitro test results and clinical study results are not always available. As further scientific and clinical data become available, appropriate revision of this document can be necessary. This document applies to delivery systems or parts of the delivery system that are an integral component of the vascular device and that are drug-covered (e.g. drug-covered balloon catheters and drug-covered guidewires). This document does not apply to devices whose PMOA provide a conduit for delivery of a drug (e.g. infusion catheters), unless they contain a drug component that is intended to have an ancillary action to the device part (e.g. antimicrobial coated infusion catheter). This document does not apply to procedures and devices used prior to and following the introduction of the VDDCP (e.g. balloon angioplasty devices) that do not affect the drug-related aspects of the device. This document does not provide a comprehensive pharmacological evaluation of VDDCPs. NOTE 2        Some information about the requirements of certain national and regional authorities is given in Annex B. The connection of absorbable components of VDDCPs (e.g. coatings) with drug-related aspects of the device are addressed in this document. This document does not provide an exhaustive list of the degradation and other time-dependent aspects of absorbable implants and coatings. NOTE 3        For more information on absorbable coatings, refer to ISO/TS 17137 and ASTM F3036-13. This document does not address issues associated with viable or non-viable biological materials such as tissues, cells or proteins. This document does not address issues associated with active surgical implants (i.e. implants that require power not generated by the human body or gravity).

PDF Catalog

PDF Pages PDF Title
2 undefined
7 Foreword
8 Introduction
9 1 Scope
10 2 Normative references
3 Terms and definitions
14 4 Intended performance
4.1 General
4.2 Classification
15 4.3 Intended clinical location
5 Design attributes
5.1 General
5.2 Drug-containing part of the VDDCP
5.2.1 General
16 5.2.2 Matrix
5.2.3 Active pharmaceutical ingredient
17 6 Materials
7 Design evaluation
7.1 General
18 7.2 Pre-clinical evaluation
7.2.1 Sampling
7.2.2 Conditioning of test samples
19 7.2.3 Pre-clinical in vitro test reports and additional information
7.2.4 Pre-clinical in vitro evaluation
25 7.2.5 Preclinical in vivo evaluation
30 7.3 Clinical evaluation
7.3.1 Purpose
7.3.2 Specific aims
7.3.3 Clinical investigation plan
31 7.3.4 Data acquisition
33 7.3.5 Final report
34 7.4 Post-market surveillance
8 Manufacturing
8.1 General
8.2 Raw material reporting and analysis of the API
35 8.3 Raw material analysis and reporting for excipients
8.4 VDDCP batch release testing
36 9 Sterilization
9.1 Products supplied sterile ā€” Testing to support ā€œSterileā€ labelling
9.2 Products supplied non-sterile
9.3 Sterilization residuals
10 Packaging
10.1 General
10.2 Considerations for VDDCPs
10.3 Impact of changes in storage and shipping temperatures on VDDCP
37 11 Information supplied by the manufacturer
11.1 General
11.2 Labelling
11.2.1 VDDCP label(s)
11.2.2 Record label
38 11.3 Instructions for use
39 Annex A (informative) Description of potential clinical and technical events
44 Annex B (informative) Local information regarding submission issues for VDDCPs
50 Bibliography

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BS EN ISO 12417-1:2024
$198.66