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EVS-EN ISO 10993-15:2001

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys

General information
Withdrawn from 07.08.2009
Base Documents
ISO 10993-15:2000; EN ISO 10993-15:2000
ICS Groups
11.100 Laboratory medicine
Directives or regulations
None

Standard history

Status
Date
Type
Name
07.08.2009
Main
EVS-EN ISO 10993-15:2009
Main
EVS-EN ISO 10993-15:2001
This part of the standard provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or corresponding materials samples finished as ready for clinical use. It is applicable only those degradation products generated by chemical alteration of the finished metallic device in an in vitro accelerated degradation test.
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Standard monitoring
English

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English

Contact

standard@evs.ee
+372 605 5060
Akadeemia tee 21/6, Tallinn, 12618, Estonia
Reg. code 80120020
Eesti Standardimis- ja Akrediteerimiskeskus MTÜ
E-N 8:30-17:00 R 8:30-16:00

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