EN ISO 10993-15:2000

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)

Migrated from Progress Sheet (TC Comment) (2000-07-10): This doc should be processed under the VA (//votinh with ISO Lead) Are still ++ waiting for TC delegated resolution; (GLG 1996-10-11) ++ SPP update 1997-09-30. ++ New Tc forecast BP BLI 99-10-25 ++ Contact Mr Vyze ext 850 when processing this project through each stage

Biologische Beurteilung von Medizinprodukten - Teil 15: Qualitativer und quantitativer Nachweis von Abbauprodukten aus Metallen und Legierungen (ISO 10993-15:2000)

Dieser Teil von ISO 10993 dient als Orientierung für die Festlegung der allgemeinen Anforderungen, die bei der Konzeption von Prüfungen zur Erbringung des qualitativen und quantitativen Nachweises von Abbauprodukten von fertigen Medizinprodukten aus Metall oder entsprechenden Materialproben im Fertigzustand für sofortigen Einsatz im klinischen Bereich gestellt werden. Er behandelt nur solche Abbauprodukte, die durch eine elektrochemische Veränderung des fertigen Metallproduktes in einem Kurzzeitversuch in vitro erzeugt werden.

Evaluation biologique des dispositifs médicaux - Partie 15: Identification et quantification des produits de dégradation issus des métaux et alliages (ISO 10993-15:2000)

IEC 61076-3-119:2017 établit les spécifications et les exigences d’essai pour les connecteurs rectangulaires, libres et fixes protégés à 10 voies, avec couplage push-pull, pour la transmission de données avec des fréquences allant jusqu’à 100 MHz et pour une utilisation dans les environnements industriels.
Ce document spécifie les connecteurs libres et fixes avec des contacts ronds, adaptés aux terminaisons de vis ou de sertissage. D’autres techniques de terminaison, telles que les connexions de soudure ou de panneau imprimé sont sur accord entre le fabricant et l’utilisateur. Les connecteurs libres et fixes disposent d’un mécanisme de verrouillage push-pull pour la protection IP65 et IP67 selon IEC 60529.
Selon ce document, les connecteurs sont sans rupture de capacité COC conformément à 3.9 de l’IEC 61984:2008, donc ils ne sont pas destinés à être engagés ou désengagés dans une utilisation normale lorsqu’ils vivent ou sont sous charge, si ce n’est autrement spécifié par le fabricant.
Mots clés : Connecteurs, Connecteurs rectangulaires, Connecteurs 10 voies, Couplage Push-Pull

Biološko ovrednotenje medicinskih pripomočkov - 15. del: Identifikacija in ugotavljanje količine razgradnih produktov iz kovin in zlitin (ISO 10993-15:2000)

General Information

• Status: Withdrawn
• Publication Date: 30-Nov-2000
• Withdrawal Date: 09-Jun-2009
• ICS: 11.100 - Laboratory medicine
• Technical Committee: CEN/TC 206 - Biocompatibility of medical and dental materials and devices
• Drafting Committee: CEN/TC 206 - Biocompatibility of medical and dental materials and devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 10-Jun-2009
• Completion Date: 10-Jun-2009
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Ref Project: SIST EN ISO 10993-15:2001 - Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)

Relations

• Replaced By: EN ISO 10993-15:2009 - Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-15:2001
01-november-2001
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO,GHQWLILNDFLMDLQ
XJRWDYOMDQMHNROLþLQHUD]JUDGQLKSURGXNWRYL]NRYLQLQ]OLWLQ,62
Biological evaluation of medical devices - Part 15: Identification and quantification of
degradation products from metals and alloys (ISO 10993-15:2000)
Biologische Beurteilung von Medizinprodukten - Teil 15: Qualitativer und quantitativer
Nachweis von Abbauprodukten aus Metallen und Legierungen (ISO 10993-15:2000)
Evaluation biologique des dispositifs médicaux - Partie 15: Identification et quantification
des produits de dégradation issus des métaux et alliages (ISO 10993-15:2000)
Ta slovenski standard je istoveten z: EN ISO 10993-15:2000
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
SIST EN ISO 10993-15:2001 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10993-15:2001

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SIST EN ISO 10993-15:2001
EUROPEAN STANDARD
EN ISO 10993-15
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2000
ICS 11.100
English version
Biological evaluation of medical devices - Part 15: Identification
and quantification of degradation products from metals and
alloys (ISO 10993-15:2000)
Evaluation biologique des dispositifs médicaux - Partie 15: Biologische Beurteilung von Medizinprodukten - Teil 15:
Identification et quantification des produits de dégradation Qualitativer und quantitativer Nachweis von
issus des métaux et alliages (ISO 10993-15:2000) Abbauprodukten aus Metallen und Legierungen (ISO
10993-15:2000)
This European Standard was approved by CEN on 1 December 2000.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2000 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-15:2000 E
worldwide for CEN national Members.

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SIST EN ISO 10993-15:2001
Page 2
EN ISO 10993-15:2000
Foreword
Corrected 2001-03-08
The text of the International Standard ISO 10993-15:2000 has been prepared by Technical
Committee ISO/TC 194 "Biological evaluation of medical devices" in collaboration with
Technical Committee CEN/TC 206 "Biocompatibility of medical and dental materials and
devices" the secretariat of which is held by NEN.
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 June 2001, and conflicting national
standards shall be withdrawn at the latest by June 2001.
This European Standard 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).
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy,
Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United
Kingdom.
Endorsement notice
The text of the International Standard ISO 10993-15:2000 was approved by CEN as a
European Standard without any modification.
NOTE: Normative references to International Standards are listed in annex ZA (normative).

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SIST EN ISO 10993-15:2001
Page 3
EN ISO 10993-15:2000
Annex ZA (normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amen
...