iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
CEN

EN ISO 9713:2022

(Main)

Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2022)

Neurosurgical implants - Self-closing intracranial aneurysm clips (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.

Neurochirurgische Implantate - Selbstschließende intrakranielle Aneurysmen-Clips (ISO 9713:2022)

Dieses Dokument legt Kenngrößen von selbstschließenden Aneurysmen-Clips, die für permanente intrakranielle Implantationen bestimmt sind, und die Anforderungen für ihre Kennzeichnung, Verpackung, Sterilisation sowie für Etikettierung und begleitende Dokumentation fest. Zusätzlich enthält diese Norm ein Verfahren für die Messung der Schließkraft.
Dieses Dokument ist nicht anwendbar für formbare Clips oder für Clips, die für die Dauer eines chirurgischen Eingriffs bestimmt sind und vor Wundverschluss entfernt werden (temporäre Clips).
ANMERKUNG   In diesem Dokument bezieht sich der Begriff „Implantat“, wenn nicht anderweitig festgelegt, auf die selbstschließenden intrakraniellen Aneurysmen-Clips.

Implants neurochirurgicaux - Clips intracrâniens pour anévrisme à autofermeture (ISO 9713:2022)

Le présent document établit les caractéristiques des clips pour anévrisme à autofermeture destinés à une implantation intracrânienne permanente et spécifie les exigences pour leur marquage, emballage, stérilisation et étiquetage, ainsi que pour la documentation d’accompagnement. En outre, il donne une méthode pour mesurer la force de fermeture.
Le présent document ne couvre ni les clips malléables, ni les clips prévus pour être utilisés en cours d’opération et retirés avant la fermeture de la plaie (clips temporaires).
NOTE       Dans le présent document, sauf indication contraire, le terme «implant» désigne les clips intracrâniens pour anévrisme à autofermeture.

Nevrokirurški vsadki (implantati) - Samozapiralne sponke za uporabo pri intrakranialnih anevrizmah (ISO 9713:2022)

Ta dokument določa lastnosti samozapiralnih sponk za uporabo pri intrakranialnih anevrizmah, namenjenih za trajno intrakranialno vsaditev, in določa zahteve za njihovo označevanje, pakiranje, sterilizacijo ter za označevanje in spremno dokumentacijo. Poleg tega navaja tudi metodo za merjenje zapiralne sile. Ta dokument se ne uporablja za upogljive sponke ali sponke, ki so namenjene za uporabo med operacijo in jih kirurg pred zaprtjem rane odstrani (začasne sponke). OPOMBA: V tem dokumentu, če ni drugače določeno, se izraz »vsadek« navezuje na samozapiralne sponke za uporabo pri intrakranialnih anevrizmah.

General Information

Status
Published
Publication Date
25-Jan-2022
Withdrawal Date
30-Jul-2022
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
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
26-Jan-2022
Completion Date
26-Jan-2022
Ref Project
SIST EN ISO 9713:2022 - Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2022)

Relations

Replaces
EN ISO 9713:2009 - Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)
Effective Date
08-Jun-2022

Buy Standard

EN ISO 9713:2022EN ISO 9713:2022
PreviousNext
Standard
EN ISO 9713:2022
English language
17 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 9713:2022
01-junij-2022
Nadomešča:
SIST EN ISO 9713:2009
Nevrokirurški vsadki (implantati) - Samozapiralne sponke za uporabo pri
intrakranialnih anevrizmah (ISO 9713:2022)
Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2022)
Neurochirurgische Implantate - Selbstschließende intrakranielle Aneurysmen-Clips (ISO
9713:2022)
Implants neurochirurgicaux - Clips intracrâniens pour anévrisme à autofermeture (ISO
9713:2022)
Ta slovenski standard je istoveten z: EN ISO 9713:2022
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 9713:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 9713:2022

---------------------- Page: 2 ----------------------
SIST EN ISO 9713:2022


EN ISO 9713
EUROPEAN STANDARD

NORME EUROPÉENNE

January 2022
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 9713:2009
English Version

Neurosurgical implants - Self-closing intracranial
aneurysm clips (ISO 9713:2022)
Implants neurochirurgicaux - Clips intracrâniens pour Neurochirurgische Implantate - Selbstschließende
anévrisme à autofermeture (ISO 9713:2022) intrakranielle Aneurysmen-Clips (ISO 9713:2022)
This European Standard was approved by CEN on 12 December 2021.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9713:2022 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
SIST EN ISO 9713:2022
EN ISO 9713:2022 (E)
Contents Page
European foreword . 3

2

---------------------- Page: 4 ----------------------
SIST EN ISO 9713:2022
EN ISO 9713:2022 (E)
European foreword
This document (EN ISO 9713:2022) 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 July 2022, and conflicting national standards shall be
withdrawn at the latest by July 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 9713:2009.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 9713:2022 has been approved by CEN as EN ISO 9713:2022 without any modification.

3

---------------------- Page: 5 ----------------------
SIST EN ISO 9713:2022

---------------------- Page: 6 ----------------------
SIST EN ISO 9713:2022
I
...

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 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 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
CEN
EN ISO 5832-7:2019(Main)
Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy (ISO 5832-7:2016)
SIST EN ISO 5832-7:2019

ISO 5832-7:2016 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.

  • Standard
    11 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 5832-1:2019(Main)
Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-1:2016)
SIST EN ISO 5832-1:2019

ISO 5832-1:2016 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 part of ISO 5832.
NOTE 2       The alloy described in this part of ISO 5832 corresponds to UNS S31673 referred to in ASTM F138/ASTM F139 and to alloy code 1.4441 given in the withdrawn DIN 17443.

  • Standard
    14 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 16054:2019(Main)
Implants for surgery - Minimum data sets for surgical implants (ISO 16054:2019)
SIST EN ISO 16054:2019

This document defines minimum data sets for implants to facilitate recording and international exchange of data for the purposes of implant tracking systems. This data can also be used to support retrieval analysis and implant registry.
This document is applicable to the manufacturers and distributors of medical devices intended for implant via a surgical procedure and to those hospitals and other medical facilities which carry out implant or explant procedures. It specifies requirements for data items to be recorded by the manufacturers and distributors of implants and by hospitals and other medical facilities at both the time of implant event and at the time of any subsequent explant event.
This document is intended to define a minimum data set to be recorded for all implant and explant events, as well as providing for the timely retrieval of minimum implant data related to specific subsets of patients who have received specific identified devices or devices within a specified range of lot, batch or serial codes, for the purpose of patient follow up.
It is not the intent of this document to provide a means of data recovery which is related to specific medical practitioners, medical facilities or manufacturers for purposes other than patient follow up or product recall in the event of unforeseen device malfunction.

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