EN ISO 12417-1:2015

Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015)

ISO 12417-1:2015 specifies requirements for vascular device-drug combination products (VDDCPs) based upon current technical and medical knowledge. VDDCPs are medical devices with various clinical indications for use in the human vascular blood system. A VDDCP incorporates, as an integral part, substance(s) which, if used separately, can be considered to be a medicinal substance or product (drug substance, drug product) but the action of the medicinal substance is ancillary to that of the device and supports the primary mode of action (PMOA) of the device. With regard to safety, this part of ISO 12417 outlines requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information supplied by the manufacturer. For implanted products, this International Standard should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. This International Standard should also be considered as a supplement to relevant device-specific standards, such as the ISO 25539‑series specifying requirements for endovascular devices. Requirements listed in this part of ISO 12417 also address VDDCPs that are not permanent implants.
NOTE          Due to variations in the design of combination products covered by this part of ISO 12417 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 part of ISO 12417 might be necessary.
Delivery systems or parts of the delivery system are included in the scope of this part of ISO 12417, if they comprise an integral component of the vascular device and if they are drug-covered (e.g. drug-covered balloon catheters and drug-covered guidewires).
Devices whose PMOA is to provide a conduit for delivery of a drug, are excluded from the scope of this part of ISO 12417 (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).
Procedures and devices used prior to and following the introduction of the VDDCP (e.g. balloon angioplasty devices) are excluded from the scope of this part of ISO 12417 if they do not affect the drug-related aspects of the device.
ISO 12417-1:2015 is not comprehensive with respect to the pharmacological evaluation of VDDCPs. Some information on the requirements of different national and regional authorities is given in Annex B.
Absorbable components of VDDCPs (e.g. coatings) are addressed by this part of ISO 12417 in their connection with drug-related aspects of the device. Degradation and other time-dependent aspects of absorbable implants and coatings are not completely addressed by this part of ISO 12417.
NOTE          See also ISO/TS 17137 and ASTM F3036-13.
ISO 12417-1:2015 does not address issues associated with viable or non-viable biological materials such as tissues, cells, or proteins.
ISO 12417-1:2015 does not address issues associated with active surgical implants (i.e. implants that require power not generated by the human body or gravity).

Kardiovaskuläre Implantate und extrakorporale Systeme - Vaskuläre Medizinprodukt/Arzneimittel-Kombinationsprodukte - Teil 1: Allgemeine Anforderungen (ISO 12417-1:2015)

1.1   Diese Internationale Norm legt Anforderungen an vaskuläre Medizinprodukt/Arzneimittel-Kombinations-produkte (VDDCPs) basierend auf dem aktuellen technischen und medizinischen Kenntnisstand fest. VDDCPs sind Medizinprodukte mit unterschiedlichen klinischen Indikationen für den Einsatz im menschlichen vaskulären Blutsystem. Ein VDDCP enthält als integralen Bestandteil eine oder mehrere Substanz(en), die bei getrennter Anwendung als medizinisch wirksame Substanz oder medizinisch wirksames Produkt (medizini-scher Wirkstoff, Arzneimittel) angesehen werden können, deren Wirkung jedoch der des Medizinproduktes untergeordnet ist und dessen primären Wirkmechanismus (PMOA) unterstützt. Im Hinblick auf die Sicherheit umreißt diese Internationale Norm Anforderungen an die beabsichtigte Funktion, an Konstruktionsmerkmale, Materialien, Designprüfung, Herstellung, Sterilisation, Verpackung und die vom Hersteller bereitzustellenden Informationen. In Bezug auf implantierte Produkte sollte diese Internationale Norm als Ergänzung zu ISO 14630 angesehen werden, in der allgemeine Anforderungen an die Funktion von nichtaktiven chirurgi-schen Implantaten festgelegt sind. Außerdem sollte die vorliegende Internationale Norm als Ergänzung zu den einschlägigen Normen zu speziellen Medizinprodukten, wie z. B. zur Normenreihe ISO 25539, die Anfor-derungen an endovaskuläre Medizinprodukte enthält, angesehen werden. Die in der vorliegenden Internatio-nalen Norm aufgeführten Anforderungen gelten auch für VDDCPs, bei denen es sich nicht um dauerhafte Implantate handelt.
Aufgrund von Abweichungen im Design der von der vorliegenden Internationalen Norm behandelten Kombi-nationsprodukte und aufgrund der relativ neuen Entwicklungen bei einigen dieser Kombinationsprodukte stehen annehmbare genormte In-vitro-Testergebnisse und Ergebnisse klinischer Studien nicht immer zur Verfügung. Daher kann bei Vorliegen weiterer wissenschaftlicher und klinischer Daten eine entsprechende Überarbeitung dieser Norm erforderlich werden.
1.2   Versorgungssysteme oder Teile des Versorgungssystems fallen in den Anwendungsbereich dieser Norm, sofern sie einen integralen Bestandteil des vaskulären Medizinproduktes bilden und wirkstoffbeschich-tet sind (z. B. wirkstoffbeschichtete Ballonkatheter und wirkstoffbeschichtete Führungsdrähte).
1.3   Medizinprodukte, deren PMOA darin besteht, eine Leitung für die Zufuhr eines Arzneimittels bereitzu-stellen (wie z. B. Infusionskatheter) sind nicht Gegenstand der vorliegenden Internationalen Norm, es sei denn, sie enthalten eine Arzneimittelkomponente, die eine die Wirkung des Medizinproduktteils ergänzende Wirkung haben soll (z. B. ein mit einem Antimikrobiotikum beschichteter Infusionskatheter).
1.4   Die vor und nach Einsetzen des VDDCP angewendeten Verfahren und Medizinprodukte (z. B. angio-plastische Ballons) sind nicht Gegenstand der vorliegenden Norm, es sei denn, sie haben Einfluss auf die arzneimittelbezogenen Aspekte des Medizinproduktes.
1.5   Diese Internationale Norm behandelt die pharmakologische Bewertung von VDDCPs nicht erschöp-fend. Einige Informationen zu den Anforderungen unterschiedlicher nationaler und regionaler Behörden finden sich in Anhang B dieser Internationalen Norm.
1.6   Absorbierbare Bestandteile von VDDCPs (z. B. Beschichtungen) werden von dieser Internationalen Norm in ihrer Verbindung zu arzneimittelbezogenen Aspekten des Medizinproduktes behandelt. Der Abbau und andere zeitabhängige Aspekte von absorbierbaren Implantaten und Beschichtungen werden in dieser Internationalen Norm nicht behandelt.
ANMERKUNG   Der Prozess der Ausarbeitung der Technischen Spezifikation ISO/TS 17137, Cardiovascular absorbable implants und von ASTM WK35909, Standard Guide to Testing Absorbable Stents and Stent Grafts ist noch nicht abgeschlossen.

Implants cardiovasculaires et circuits extra-corporels - Produits de combinaison médicament-dispositif vasculaire - Partie 1: Exigences générales (ISO 12417-1:2015)

ISO 12417-1:2015 spécifie les exigences relatives aux produits de combinaison médicament-dispositif vasculaire (VDDCP) sur la base des connaissances techniques et médicales actuelles. Les VDDCP sont des dispositifs médicaux ayant diverses indications cliniques, conçus pour être utilisés dans le système vasculaire sanguin chez l'homme. Un VDDCP intègre une ou plusieurs substances qui, si elles sont utilisées séparément, peuvent être considérées comme étant une substance ou un produit médicamenteux (substance pharmaceutique, médicament), mais dont l'action est auxiliaire à celle du dispositif et vient en appui du mode d'action principal de ce dernier. En matière de sécurité, la présente partie de l'ISO 12417 définit les exigences relatives aux performances prévues, aux caractéristiques de conception, aux matériaux, à l'évaluation de la conception, à la fabrication, à la stérilisation, à l'emballage et aux informations fournies par le fabricant. Pour les produits implantés, il convient de considérer la présente Norme internationale comme un complément à l'ISO 14630, qui spécifie les exigences générales relatives aux performances des implants chirurgicaux non actifs. Il convient également de la considérer comme un complément aux normes spécifiques aux dispositifs connexes, notamment la série ISO 25539 qui spécifie les exigences relatives aux dispositifs endovasculaires. Les exigences énumérées dans la présente partie de l'ISO 12417 concernent également les VDDCP qui ne sont pas implantés à titre permanent.
NOTE          En raison des variantes de conception parmi les produits de combinaison traités par la présente partie de l'ISO 12417 et en raison du caractère relativement récent de la mise au point de certains de ces produits, il n'y a pas toujours de résultats d'essai in vitro normalisé acceptables, ni de résultats d'étude clinique disponibles. Lorsque de nouvelles données scientifiques et cliniques seront disponibles, il pourrait être nécessaire de procéder à une révision appropriée de la présente partie de l'ISO 12417.
Les dispositifs de délivrance ou parties du dispositif de délivrance relèvent du domaine d'application de la présente partie de l'ISO 12417 s'ils font partie intégrante du dispositif vasculaire et s'ils sont revêtus de médicament (par exemple, cathéters à ballonnet revêtus de médicament ou fils guides revêtus de médicament).
Les dispositifs dont le mode d'action principal est la fourniture d'un conduit pour l'administration d'un médicament sont exclus du domaine d'application de la présente partie de l'ISO 12417 (par exemple, cathéters de perfusion), à moins qu'ils ne contiennent un composant médicamenteux dont l'action est auxiliaire à celle du dispositif (par exemple, cathéter de perfusion à revêtement antimicrobien).
Les modes opératoires et les dispositifs utilisés avant et après l'introduction du VDDCP (par exemple, les dispositifs d'angioplastie transluminale percutanée) sont exclus du domaine d'application de la présente partie de l'ISO 12417 s'ils n'affectent pas les aspects médicamenteux du dispositif.
ISO 12417-1:2015 ne détaille pas l'évaluation pharmacologique des VDDCP. Certaines informations relatives aux exigences des différents organismes nationaux et régionaux sont données dans l'Annexe B.
Les composants biorésorbables des VDDCP (par exemple, les revêtements) sont abordés dans la présente partie de l'ISO 12417 en ce qui concerne leur rapport avec les aspects médicamenteux du dispositif. La dégradation et

Vsadki (implantati) za srce in ožilje ter zunajtelesni pretočni sistemi - Žilni medicinski kombinirani proizvodi/zdravila - 1. del: Splošne zahteve (ISO 12417-1:2015)

1.1    Ta standard določa zahteve za žilne medicinske kombinirane proizvode/zdravila (VDDCP), ki temeljijo na trenutnem tehničnem in medicinskem znanju. Žilni medicinski kombinirani proizvodi/zdravila so medicinski pripomočki z različnimi kliničnimi indikacijami namenjeni uporabi v človeškem žilnem sistemu. Sestavni del žilnega medicinskega kombiniranega proizvoda/zdravila so snovi, ki se lahko obravnavajo kot medicinski proizvodi (zdravila), če se uporabljajo posebej, vendar je delovanje medicinske učinkovine sekundarno v primerjavi s pripomočkom in podpira primarni način delovanja pripomočka. V zvezi z varnostjo ta standard podaja zahteve za predvidene lastnosti, obliko, materiale, vrednotenje oblike, izdelavo, sterilizacijo, pakiranje in informacije, ki jih zagotovi proizvajalec. Za izdelke, namenjene vsaditvi, se ta standard šteje za dodatek k standardu ISO 14630, ki določa splošne zahteve za lastnosti neaktivnih kirurških vsadkov. Ta standard se šteje tudi kot dodatek k ustreznim standardom za določene pripomočke, kot je skupina standardov ISO 25539, ki določajo zahteve za znotrajžilne pripomočke. Zahteve, navedene v tem standardu, se nanašajo tudi na žilne medicinske kombinirane proizvode/zdravila, ki niso nujno trajni vsadki.  OPOMBA Zaradi razlik v zasnovi izdelkov, ki so zajeti v tem standardu, in ker so nekateri od teh izdelkov bili razviti nedavno, sprejemljivi standardizirani preskusi in vitro in klinični rezultati niso vedno na voljo. S pojavom novih znanstvenih in kliničnih podatkov bodo potrebne ustrezne revizije tega standarda.  1.2    Sistemi za dovajanje ali deli sistemov za dovajanje so zajeti v tem standardu, če so ključna komponenta žilnega pripomočka in če so prevlečeni z zdravilom (npr. balonski katetri in vodilne žice, prevlečene z zdravilom).  1.3    Črpalke in infuzijski katetri, ki niso prekriti z zdravilom in katerih glavna naloga je dovajanje zdravila, niso zajeti v tem standardu.  1.4    Postopki in pripomočki, ki se uporabljajo pred in po vsaditvi žilnega medicinskega kombiniranega proizvoda/zdravila (npr. pripomočka za angioplastiko) niso zajeti v ta standard, če ne vplivajo na vidike pripomočka, ki so povezani z zdravili.  1.5    Ta standard ni izčrpen na področju farmakološkega vrednotenja žilnih medicinskih kombiniranih proizvodov/zdravil. Nekateri podatki glede zahtev različnih nacionalnih in regionalnih organov so podani v dodatku B tega standarda.  1.6    Bioresorbilne komponente žilnih medicinskih kombiniranih proizvodov/zdravil (npr. prevleke) so v tem standardu obravnavane v povezavi z vidiki pripomočka, ki so povezani z zdravili.  Razgradnja in drugi časovno odvisni vidiki bioresorbilnih vsadkov ter prevlek niso obravnavani v tem delu standarda ISO 12417.  1.7    Ta standard ne obravnava vprašanj, povezanih z živim tkivom in neživimi biološkimi materiali.

General Information

• Status: Withdrawn
• Publication Date: 13-Oct-2015
• Withdrawal Date: 20-Feb-2024
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: CEN/TC 285 - Non-active surgical implants
• Drafting Committee: CEN/TC 285 - Non-active surgical implants
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 12417-1:2015 - Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015)

Relations

• Replaced By: EN ISO 12417-1:2024 - Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2024)
• Effective Date: 19-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2015
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Cardiovascular implants and extracorporeal systems - Vascular device-drug combination
products - Part 1: General requirements (ISO 12417-1:2015)
Kardiovaskuläre Implantate und extrakorporale Systeme - Vaskuläre
Medizinprodukt/Arzneimittel-Kombinationsprodukte - Teil 1: Allgemeine Anforderungen
(ISO 12417-1:2015)
Implants cardiovasculaires et circuits extra-corporels - Produits de combinaison
médicament-dispositif vasculaire - Partie 1: Exigences générales (ISO 12417-1:2015)
Ta slovenski standard je istoveten z: EN ISO 12417-1:2015
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 12417-1
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2015
EUROPÄISCHE NORM
ICS 11.040.40
English Version
Cardiovascular implants and extracorporeal systems -
Vascular device-drug combination products - Part 1:
General requirements (ISO 12417-1:2015)
Implants cardiovasculaires et circuits extra-corporels - Kardiovaskuläre Implantate und extrakorporale
Produits de combinaison médicament-dispositif Systeme - Vaskuläre Medizinprodukt/Arzneimittel-
vasculaire - Partie 1: Exigences générales (ISO 12417- Kombinationsprodukte - Teil 1: Allgemeine
1:2015) Anforderungen (ISO 12417-1:2015)
This European Standard was approved by CEN on 8 August 2015.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 12417-1:2015 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices . 4

European foreword
This document (EN ISO 12417-1:2015) has been prepared by Technical Committee ISO/TC 150
“Implants for surgery” in collaboration with Technical Committee CEN/TC 285 “Non-active surgical
implants” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by April 2016, and conflicting national standards shall be
withdrawn at the latest by April 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 12417-1:2015 has been approved by CEN as EN ISO 12417-1:2015 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices
This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide a means of conforming to Essential
Requirements of the New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and
has been implemented as a national standard in at least one Member State, compliance with the clauses
of this standard confers, within the limits of the scope of this standard, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
This standard provides a process for managing risks associated with medical devices. Because this
standard describes an ongoing process applicable in part or in all to the Essential Requirements of
Directive 93/42/EEC on medical devices, it is not meaningful to link individual clauses of the standard
to specific corresponding Essential Requirements.
Compliance with all the requirement clauses in this standard will ensure that general aspects of medical
devices related to patient risk and safety have been addressed. For particular medical devices or for
particular safety aspects, additional specific requirements may need to be complied with in order to
meet the essential requirements. With respect to users of medical devices and third persons, additional
specific requirements from other EU Directives may need to be complied with in order to meet Essential
Requirement 1. Relevant harmonized standards may also be used for these purposes.
The risk management processes described in this standard could establish the need for collection of
clinical or other experimental data for risk-benefit evaluation purposes. It does not describe how this
has to be carried out. Relevant harmonized standards may be used for this purpose.
WARNING — Other requirements and other EU Directives may be applicable to a product falling within
the scope of this standard.
Table ZA.1— Correspondence between this European Standard
and Directive 93/42/EEC amended by Directive 2007/47/EEC
Essential Requirements (ERs) Clause(s)/sub-clause(s) Qualifying remarks
of Directive 93/42/EEC of this EN ISO 12417-1
7.1 Clause 5
Clause 8
7.2 Clause 8
9.3
Clause 10
7.3 7.2.4.3
7.2.4.3.2
7.2.4.3.2 g)
7.2.4.3.5
Essential Requirements (ERs) Clause(s)/sub-clause(s) Qualifying remarks
of Directive 93/42/EEC of this EN ISO 12417-1
7.4 7.2.4.3
7.2.4.3.4
7.2.4.3.10
7.2.4.3.12
7.2.4.3.13
7.5 7.2.4.3.4
7.2.4.3.10
7.2.4.3.11
7.2.4.3.16
9.3
7.6 5.2.3 f)
8.1 Clause 9
Clause 10
8.3 5.1
(Design) 7.2.4.2
8.3 Clause 8
(Manufacturing, Packaging) Clause 9
10.1
10.2
11.2 m)
8.4 9.1.1
8.5 8.1
9.2
8.6 9.2
Clause 10
8.7 Clause 11 EN ISO 14630:2012, 11.2 f)
9.1 5.1 a) See specific standards product
requirements for the device part
5.2.3 e)
7.2.4.3.10
9.2 5.1
(Risk of injury) 7.2.4.1
9.2 5.2.2 f)
(Magnetic fields) 5.2.3 g)
7.2.4.3.7
9.2 5.2.1 e)
(Aging) 5.2.2 a)
7.1
7.2.4.3.10
9.3 11.2.1 l)
Essential Requirements (ERs) Clause(s)/sub-clause(s) Qualifying remarks
of Directive 93/42/EEC of this EN ISO 12417-1
13.1 11.2.1 i)
11.3
13.2 Clause 11
13.3 a) 11.2.1 b)
13.3 b) 11.2.1 a), c), d)
13.3 c) 11.2.1 f)
13.3 d) 11.2.1 e)
13.3 e) 11.2.1 h)
13.3 f) 11.2.1 g)
13.3 i) 11.2.1 k)
13.3 j) 11.2.1 i)
13.3 k) 11.2.1 j)
13.3 l) 11.2.1 l)
13.3 m) 11.2.1 f)
13.4 11.3 a), d)
13.5 Clause 11
13.6 a) 11.3
13.6 b) 11.3 e), g), j), k), r)
13.6 c) N/A See EN ISO 14630, 11.3 f)
13.6 e) 11.2 b), e), i), j), k), m)
13.6 f) 11.3 j)
13.6 g) 11.3 o), q)
13.6 l) 11.3 j)
13.6 m) 11.3 a), b), c), f)
13.6 n) 11.3 k)
13.6 q) 11.3 t)
INTERNATIONAL ISO
STANDARD 12417-1
First edition
2015-10-01
Cardiovascular implants and
extracorporeal systems — Vascular
device-drug combination products —
Part 1:
General requirements
Implants cardiovasculaires et circuits extra-corporels — Produits de
combinaison médicament-dispositif vasculaire —
Partie 1: Exigences générales
Reference number
ISO 12417-1:2015(E)
©
ISO 2015
ISO 12417-1:2015(E)
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
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ISO 12417-1:2015(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Intended performance . 6
4.1 General . 6
4.2 Classification . 6
4.3 Intended clinical location . 6
5 Design attributes . 6
5.1 General . 6
5.2 Drug-containing part of the VDDCP (DCP) . 7
5.2.1 General. 7
5.2.2 Matrix . 7
5.2.3 Active pharmaceutical ingredient (API) . 7
6 Materials . 8
7 Design evaluation . 8
7.1 General .
...