Customer Support: +1 416-401-8730

Login to i2i Subscription Intertek.com
  • There are no items in your cart
Please enter a keyword to search
Advanced search

DIN EN ISO 10993-14 E : 2009

Current
Current

The latest, up-to-date edition.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2009

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Test procedures
  4.1 Principle
  4.2 Testing of dental devices
  4.3 General testing techniques
  4.4 Extreme solution test
  4.5 Simulation solution test
5 Analysis of filtrate
  5.1 General
  5.2 Choice of chemicals or elements to be analysed
  5.3 Sensitivity of the analysis method
6 Test report
Bibliography
Annex ZA (informative) Relationship between this European
         Standard and the Essential Requirements of EU Directive
         93/42/EEC on Medical Devices
Annex ZB (informative) Relationship between this European
         Standard and the Essential Requirements of EU Directive
         90/385/EEC on Active Implantable Medical Devices
National Annex NA (informative) Bibliography

Defines two methods of obtaining solutions of degradation products from ceramics (including glasses) for the purposes of quantification.

DocumentType
Standard
Pages
21
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current

DIN EN ISO 10993-10 E : 2003 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010)
DIN EN ISO 10993-15 E : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS
DIN EN ISO 10993-10:2003-02 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010)

ISO 5017:2013 Dense shaped refractory products — Determination of bulk density, apparent porosity and true porosity
ISO 3310-1:2016 Test sieves Technical requirements and testing Part 1: Test sieves of metal wire cloth
ISO 6872:2015 Dentistry Ceramic materials
EN ISO 10993-9:2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 6474:1994 Implants for surgery Ceramic materials based on high purity alumina
ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
EN ISO 3696:1995 Water for analytical laboratory use - Specification and test methods (ISO 3696:1987)
DIN ISO 6474 E : 2001 IMPLANTS FOR SURGERY - CERAMIC MATERIALS BASED ON HIGH PURITY ALUMINA
DIN ISO 3696:1991-06 WATER FOR ANALYTICAL LABORATORY USE - SPECIFICATION AND TEST METHODS
EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)

View more information
US$98.87
Excluding Tax where applicable
USD
CAD
CHF
CNY
DKK
EUR
GBP
HKD
IDR
INR
JPY
KRW
MXN
NOK
NZD
SEK
SGD
USD
ZAR
Hardcopy - English
PDF - English
01
02
03
04
05
06
07
08
09
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

Learn more on subscription solutions

or

Get in touch with us