iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
SIST

SIST EN ISO 5840-2:2021/oprA1:2024

(Amendment)

Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes - Amendment 1 (ISO 5840-2:2021/DAM 1:2024)

Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes - Amendment 1 (ISO 5840-2:2021/DAM 1:2024)

Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 2: Chirurgisch implantierter Herzklappenersatz - Änderung 1 (ISO 5840-2:2021/DAM 1:2024)

Implants cardiovasculaires - Prothèses valvulaires - Partie 2: Prothèse valvulaires implantées chirurgicalement - Amendement 1 (ISO 5840-2:2021/DAM 1:2024)

Vsadki (implantati) za srce in ožilje - Proteze za srčno zaklopko - 2. del: Kirurško vsajeni (implantirani) nadomestki srčne zaklopke (ISO 5840-2:2021/DAM 1:2024)

General Information

Status
Not Published
Public Enquiry End Date
29-Apr-2024
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
VAZ - Healthcare
Current Stage
4020 - Public enquire (PE) (Adopted Project)
Start Date
26-Feb-2024
Due Date
15-Jul-2024
Ref Project
EN ISO 5840-2:2021/prA1 - Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes - Amendment 1 (ISO 5840-2:2021/DAM 1:2024)

Relations

Amends
SIST EN ISO 5840-2:2021 - Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2021)
Effective Date
22-Nov-2023

Buy Standard

EN ISO 5840-2:2021/oprA1:2024EN ISO 5840-2:2021/oprA1:2024
PreviousNext
Draft
EN ISO 5840-2:2021/oprA1:2024
English language
5 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 5840-2:2021/oprA1:2024
01-april-2024
Vsadki (implantati) za srce in ožilje - Proteze za srčno zaklopko - 2. del: Kirurško
vsajeni (implantirani) nadomestki srčne zaklopke (ISO 5840-2:2021/DAM 1:2024)
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart
valve substitutes - Amendment 1 (ISO 5840-2:2021/DAM 1:2024)
Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 2: Chirurgisch implantierter
Herzklappenersatz - Änderung 1 (ISO 5840-2:2021/DAM 1:2024)
Implants cardiovasculaires - Prothèses valvulaires - Partie 2: Prothèse valvulaires
implantées chirurgicalement - Amendement 1 (ISO 5840-2:2021/DAM 1:2024)
Ta slovenski standard je istoveten z: EN ISO 5840-2:2021/prA1
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 5840-2:2021/oprA1:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 5840-2:2021/oprA1:2024

---------------------- Page: 2 ----------------------
SIST EN ISO 5840-2:2021/oprA1:2024
DRAFT
Amendment
ISO 5840-2:2021/
DAM 1
ISO/TC 150/SC 2
Cardiovascular implants — Cardiac
Secretariat: ANSI
valve prostheses —
Voting begins on:
Part 2:
2024-02-07
Surgically implanted heart valve
Voting terminates on:
substitutes 2024-05-01
AMENDMENT 1
Implants cardiovasculaires — Prothèses valvulaires —
Partie 2: Prothèse valvulaires implantées chirurgicalement
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 5840-2:2021/DAM 1:2024(en)
© ISO 2024

---------------------- Page: 3 ----------------------
SIST EN ISO 5840-2:2021/oprA1:2024
DRAFT
ISO 5840-2:2021/DAM 1:2024(en)
Amendment
ISO 5840-2:2021/
DAM 1
ISO/TC 150/SC 2
Cardiovascular implants — Cardiac
Secretariat: ANSI
valve prostheses —
Voting begins on:
Part 2:
Surgically implanted heart valve
Voting terminates on:
substitutes
AMENDMENT 1
Implants cardiovasculaires — Prothèses valvulaires —
Partie 2: Prothèse valvulaires implantées chirurgicalement
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 5840-2:2021/DAM 1:2023(en)
© ISO 2023
© ISO 2024 – All rights reserved
ii

---------------------- Page: 4 ----------------------
SIST EN ISO 5840-2:2021/oprA1:2024
ISO 5840-2:2021/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 committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental
...

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

SIST
SIST EN ISO 12417-1:2024(Main)
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2024)
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
SIST
SIST EN ISO 14708-3:2023(Main)
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO 14708-3:2017)
EN ISO 14708-3:2022

ISO 14708-3:2008 is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system.
ISO 14708-3:2008 is also applicable to all non-implantable parts and accessories of the devices.
The tests that are specified in ISO 14708-3:2008 are type tests intended to be carried out on a sample of a device to show compliance, and are not intended to be used for the routine testing of manufactured products.

  • Standard
    63 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 21917:2023(Main)
Anaesthetic and respiratory equipment - Voice prostheses (ISO 21917:2021)
EN ISO 21917:2022

This document specifies performance requirements for voice prostheses including requirements for marking, packaging and information to be provided by the manufacturer as well as test methods for the evaluation of physical characteristics of voice prostheses.
NOTE      There is guidance or rationale for this list item contained in A.2.

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

This document specifies the characteristics of, and corresponding test methods for, wrought cobaltnickel 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
SIST
SIST EN ISO 9713:2022(Main)
Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2022)
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
SIST
SIST EN ISO 5832-3:2022(Main)
Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:2021)
EN ISO 5832-3:2021

This document specifies the characteristics of, and corresponding test methods for, the wrought
titanium alloy known as titanium 6-aluminium 4-vanadium alloy (Ti-6Al-4V 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 might not
necessarily comply with the specifications given in this document.

  • Standard
    16 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 5840-1:2021(Main)
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2021)
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
SIST
SIST EN ISO 5840-3:2021(Main)
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2021)
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
SIST
SIST EN ISO 5840-2:2021(Main)
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2021)
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
SIST
SIST EN ISO 25539-2:2020(Main)
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020)
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 devices.
NOTE 3 Absorbable implants are within the scope of ISO/TS 17137.
Although coated stents and coated stent systems are within the scope of this document, this document
is not comprehensive with respect to coatings.
NOTE 4 Some coating properties are within the scope of ISO 17327-1.
This document does not address the requirements for, and the evaluation of, viable tissues and nonviable
biologic materials used in the construction of vascular stents.

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