iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
CEN

EN ISO 5840-3:2021/prA1

(Amendment)

Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques - Amendment 1 (ISO 5840 3:2021/DAM 1:2024)

Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques - Amendment 1 (ISO 5840 3:2021/DAM 1:2024)

Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 3: Durch Minimal-Invasive Methoden Implantierter Herzklappenersatz - Änderung 1 (ISO 5840 3:2021/DAM 1:2024)

Implants cardiovasculaires - Prothèses valvulaires - Partie 3: Valves cardiaques de substitution implantées par des techniques transcathéter - Amendement 1 (ISO 5840 3:2021/DAM 1:2024)

Vsadki (implantati) za srce in ožilje - Proteze za srčno zaklopko - 3. del: Nadomestki srčne zaklopke, vsajeni (implantirani) s transkatetrsko metodo - Dopolnilo A1 (ISO 5840 3:2021/DAM 1:2024)

General Information

Status
Not Published
Publication Date
03-Sep-2025
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
CEN/TC 285 - Non-active surgical implants
Current Stage
4060 - Closure of enquiry - Enquiry
Start Date
30-Apr-2024
Completion Date
30-Apr-2024
Ref Project
SIST EN ISO 5840-3:2021/oprA1:2024 - Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques - Amendment 1 (ISO 5840 3:2021/DAM 1:2024)

Relations

Amends
EN ISO 5840-3:2021 - Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2021)
Effective Date
22-Nov-2023

Buy Standard

EN ISO 5840-3:2021/oprA1:2024EN ISO 5840-3:2021/oprA1:2024
PreviousNext
Draft
EN ISO 5840-3:2021/oprA1:2024
English language
6 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 5840-3:2021/oprA1:2024
01-april-2024
Vsadki (implantati) za srce in ožilje - Proteze za srčno zaklopko - 3. del:
Nadomestki srčne zaklopke, vsajeni (implantirani) s transkatetrsko metodo -
Dopolnilo A1 (ISO 5840 3:2021/DAM 1:2024)
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes
implanted by transcatheter techniques - Amendment 1 (ISO 5840 3:2021/DAM 1:2024)
Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 3: Durch Minimal-Invasive
Methoden Implantierter Herzklappenersatz - Änderung 1 (ISO 5840 3:2021/DAM 1:2024)
Implants cardiovasculaires - Prothèses valvulaires - Partie 3: Valves cardiaques de
substitution implantées par des techniques transcathéter - Amendement 1 (ISO 5840
3:2021/DAM 1:2024)
Ta slovenski standard je istoveten z: EN ISO 5840-3:2021/prA1
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 5840-3:2021/oprA1:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 5840-3:2021/oprA1:2024

---------------------- Page: 2 ----------------------
SIST EN ISO 5840-3:2021/oprA1:2024
DRAFT
Amendment
ISO 5840-3:2021/
DAM 1
ISO/TC 150/SC 2
Cardiovascular implants — Cardiac
Secretariat: ANSI
valve prostheses —
Voting begins on:
Part 3:
2024-02-06
Heart valve substitutes implanted
Voting terminates on:
by transcatheter techniques 2024-04-30
AMENDMENT 1
Implants cardiovasculaires — Prothèses valvulaires —
Partie 3: Valves cardiaques de substitution implantées par des
techniques transcathéter
AMENDEMENT 1
ICS: 11.040.40
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO 5840-3:2021/DAM 1:2024(en)
© ISO 2024

---------------------- Page: 3 ----------------------
SIST EN ISO 5840-3:2021/oprA1:2024
DRAFT
ISO 5840-3:2021/DAM 1:2024(en)
Amendment
ISO 5840-3:2021/
DAM 1
ISO/TC 150/SC 2
Cardiovascular implants — Cardiac
Secretariat: ANSI
valve prostheses —
Voting begins on:
Part 3:
Heart valve substitutes implanted
Voting terminates on:
by transcatheter techniques
AMENDMENT 1
Implants cardiovasculaires — Prothèses valvulaires —
Partie 3: Valves cardiaques de substitution implantées par des
techniques transcathéter
AMENDEMENT 1
ICS: 11.040.40
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO 5840-3:2021/DAM 1:2023(en)
© ISO 2023
© ISO 2024 – All rights reserved
ii

---------------------- Page: 4 ----------------------
SIST EN ISO 5840-3:2021/oprA1:2024
ISO 5840-3:2021/DAM 1:2023(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committ
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

CEN
EN ISO 5832-7:2024(Main)
Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy (ISO 5832-7:2024)
SIST EN ISO 5832-7:2024

This document specifies the characteristics of, and corresponding test methods for, forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy for use in the manufacture of surgical implants.
NOTE            The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this document.

  • Standard
    11 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    8 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 5832-1:2024(Main)
Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-1:2024)
SIST EN ISO 5832-1:2024

This document specifies the characteristics of, and corresponding test methods for, wrought stainless steel for use in the manufacture of surgical implants.
NOTE 1       The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this document.
NOTE 2       The alloy described in this document corresponds to UNS S31673 in ASTM F138 and ASTM F139.

  • Standard
    14 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    11 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 12417-1:2024(Main)
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2024)
SIST EN ISO 12417-1:2024

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).

  • Standard
    57 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 5832-6:2022(Main)
Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy (ISO 5832-6:2022)
SIST EN ISO 5832-6:2022

This document specifies the characteristics of, and corresponding test methods for, wrought cobalt-nickel chromium-molybdenum alloy for use in the manufacture of surgical implants.
NOTE      The tensile properties of a sample obtained from a finished product made of this alloy do not necessarily comply with those specified in this document.

  • Standard
    11 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 9713:2022(Main)
Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2022)
SIST EN ISO 9713:2022

This document establishes the characteristics of self-closing aneurysm clips intended for permanent intracranial implantation and specifies requirements for their marking, packaging, sterilization and for labelling and accompanying documentation. In addition, it gives a method for the measurement of closing force.
This document is not applicable to malleable clips, or clips intended to be used during the course of surgery and removed before wound closure (temporary clips).
NOTE       In this document when not otherwise established, the term “implant” refers to the self-closing intracranial aneurysm clips.

  • Standard
    17 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 16061:2021(Main)
Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021)
SIST EN ISO 16061:2021

This document specifies the general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are supplied after refurbishment.
NOTE     In this document, unless otherwise specified, the term "instrument" refers to an instrument for use in association with non-active surgical implants.
This document also applies to instruments which can be connected to power-driven systems, but it does not apply to the power-driven systems themselves.
With regard to safety, this document gives the requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the instrument manufacturer, hereafter referred to as the manufacturer.
This document is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants.

  • Standard
    23 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 5840-2:2021(Main)
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2021)
SIST EN ISO 5840-2:2021

This document is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E for examples of surgical heart valve substitutes and their components.
This document is applicable to both newly developed and modified surgical heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted.
This document establishes an approach for verifying/validating the design and manufacture of a surgical heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests can include those to assess the physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of their materials and components. The tests can also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute.
This document defines operational conditions and performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.
For some heart valve substitutes (e.g. sutureless), the requirements of both this document and ISO 5840-3:2021 can be relevant and are considered as applicable to the specific device design and are based on the results of the risk analysis.

  • Standard
    60 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 5840-3:2021(Main)
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2021)
SIST EN ISO 5840-3:2021

This document is applicable to all devices intended for implantation as a transcatheter heart valve substitute.
This document is applicable to transcatheter heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted.
This document establishes an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be derived from the risk assessment. The tests can include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.
This document defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.
This document includes considerations for implantation of a transcatheter heart valve substitute inside a pre-existing prosthetic device (e.g. valve-in-valve and valve-in-ring configurations).

  • Standard
    66 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 5840-1:2021(Main)
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2021)
SIST EN ISO 5840-1:2021

This document is applicable to heart valve substitutes intended for implantation and provides general requirements. Subsequent parts of the ISO 5840 series provide specific requirements.
This document is applicable to newly developed and modified heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted.
ISO 5840-1 outlines an approach for verifying/validating the design and manufacture of a heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests can include those to assess the physical, chemical, biological, and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.
ISO 5840-1 defines operational conditions for heart valve substitutes.
ISO 5840-1 furthermore defines terms that are also applicable to ISO 5840-2 and ISO 5840-3.
ISO 5840-1 does not provide requirements specific to homografts, tissue engineered heart valves (e.g. valves intended to regenerate in vivo), and heart valve substitutes designed for implantation in circulatory support devices. Some of the provisions of ISO 5840-1 can be applied to valves made from human tissue that is rendered non-viable.
NOTE     A rationale for the provisions of ISO 5840-1 is given in Annex A.

  • Standard
    87 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 25539-2:2020(Main)
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020)
SIST EN ISO 25539-2:2020

This document specifies requirements for the evaluation of stent systems (vascular stents and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in Annex D. This document is supplemental to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
NOTE 1  Due to the variations in the design of implants covered by this document, and in some cases due to the emergence of novel types of such implants, acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of this document will be necessary.
This document is applicable to vascular stents and vascular scaffolds (e.g. absorbable vascular scaffolds) used to treat vascular stenoses or other vascular abnormalities or pathologies. Some of the requirements are specific to endovascular treatment of arterial stenoses. Although uses of stent systems other than treatment of arterial stenoses (e.g. venous stenting) are within the scope of this document, comprehensive requirements and testing are not described for these uses. Similarly, specific stent configurations (e.g. bifurcation stents) are within the scope, but comprehensive requirements and testing are not described for these devices.
Stents used in combination with an endovascular prosthesis to complete the treatment of a lesion, including bridging stents (e.g. stents placed in the renal arteries after deployment of a fenestrated endovascular prosthesis), are within the scope of this document, but test methods are not described for the combination. ISO 25539-1 also provides information relevant to the preclinical in vivo and clinical evaluations of such stents.
Vascular stents that have surface modifications, such as drug and/or other coatings, are within the scope of this document. Stents covered with materials that significantly modify the permeability of the uncovered stent (e.g. by covering the stent-free-surface area) are within the scope of ISO 25539-1. The stent design or intended use might dictate the need to address functional requirements identified in both ISO 25539-1 and this document (e.g. stents used in combination with endovascular prostheses, stents used to treat aortic aneurysms).
Balloons integral to the stent system are within the scope of this document. This document provides requirements beyond the requirements of ISO 10555-4, which are specific to the use of balloons with vascular stents.
This document is not applicable to procedures and devices used prior to the introduction of the vascular stent, such as balloon angioplasty devices.
Tacking devices intended to spot treat post-angioplasty dissections, coil supporting devices, and flow diverters are within the scope of this document, but comprehensive requirements and testing are not described for these devices.
Although drug-eluting stents are within the scope of this document, this document is not comprehensive with respect to the drug-eluting properties of these devices.
NOTE 2  Vascular device-drug combination products are within the scope of ISO 12417-1.
Although absorbable stents and stents with absorbable coatings are within the scope of this document, this document is not comprehensive with respect to the absorbable properties of these d

  • Standard
    124 pages
    English language
    sale 10% off
    e-Library read for
    1 day