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CEN

prEN ISO 14630

(Main)

Non-active surgical implants - General requirements (ISO/DIS 14630:2022)

Non-active surgical implants - General requirements (ISO/DIS 14630:2022)

Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO/DIS 14630:2022)

Implants chirurgicaux non actifs - Exigences générales (ISO/DIS 14630:2022)

Neaktivni kirurški vsadki (implantati) - Splošne zahteve (ISO/DIS 14630:2022)

General Information

Status
Not Published
Publication Date
11-Apr-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
Current Stage
4060 - Closure of enquiry - Enquiry
Start Date
09-Dec-2022
Completion Date
09-Dec-2022
Directive
2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
Mandate
M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
Ref Project
oSIST prEN ISO 14630:2022 - Non-active surgical implants - General requirements (ISO/DIS 14630:2022)

Relations

Revises
EN ISO 14630:2012 - Non-active surgical implants - General requirements (ISO 14630:2012)
Effective Date
10-Oct-2018

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SLOVENSKI STANDARD
oSIST prEN ISO 14630:2022
01-november-2022
Neaktivni kirurški vsadki (implantati) - Splošne zahteve (ISO/DIS 14630:2022)
Non-active surgical implants - General requirements (ISO/DIS 14630:2022)
Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO/DIS 14630:2022)
Implants chirurgicaux non actifs - Exigences générales (ISO/DIS 14630:2022)
Ta slovenski standard je istoveten z: prEN ISO 14630
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 14630:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 14630:2022

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oSIST prEN ISO 14630:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14630
ISO/TC 150 Secretariat: DIN
Voting begins on: Voting terminates on:
2022-09-16 2022-12-09
Non-active surgical implants — General requirements
Implants chirurgicaux non actifs — Exigences générales
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 14630:2022(E)
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. © ISO 2022

---------------------- Page: 3 ----------------------
oSIST prEN ISO 14630:2022
ISO/DIS 14630:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14630
ISO/TC 150 Secretariat: DIN
Voting begins on: Voting terminates on:

Non-active surgical implants — General requirements
Implants chirurgicaux non actifs — Exigences générales
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2022
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 14630:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
  © ISO 2022 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

---------------------- Page: 4 ----------------------
oSIST prEN ISO 14630:2022
ISO/DIS 14630:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions .
...

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