UNI EN ISO 10993-18 : 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
26-08-2022
01-01-2009
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 General principles
6 Characterization procedure
6.1 General
6.2 Step 1 - Qualitative information
6.3 Step 2 - Material equivalence
6.4 Step 3 - Quantitative information
6.5 Step 4 - Quantitative risk assessment
6.6 Step 5 - Estimated clinical exposure to chemicals
present
7 Chemical characterization parameters and methods
7.1 General
7.2 Polymers
7.3 Metals and alloys
7.4 Ceramics
7.5 Natural macromolecules
8 Reporting of data obtained
Annex A (normative) Flowchart summarizing the stepwise
generation of chemical characterization data for
use in toxicological risk assessment
Annex B (informative) Information sources for chemical
characterization
Annex C (informative) Principles for judging toxicological
equivalency
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
Bibliography
Describes a framework for the identification of a material and the identification and quantification of its chemical constituents.
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| SN EN ISO 10993-18 : 2009 | Identical |
| BS EN ISO 10993-18:2009 | Identical |
| NS EN ISO 10993-18 : 2009 | Identical |
| NF EN ISO 10993-18 : 2009 | Identical |
| DIN EN ISO 10993-18:2009-08 | Identical |
| EN ISO 10993-18:2009 | Identical |
| ISO 10993-18:2005 | Identical |
| NBN EN ISO 10993-18 : 2009 | Identical |
| ONORM EN ISO 10993-18 : 2009 | Identical |
| UNE-EN ISO 10993-18:2009 | Identical |
| I.S. EN ISO 10993-18:2009 | Identical |
| NEN EN ISO 10993-18 : 2009 | Identical |
| EN 12442-3 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS |
| ISO 5725-1:1994 | Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions |
| ISO 5832-1:2016 | Implants for surgery — Metallic materials — Part 1: Wrought stainless steel |
| ISO 10993-13:2010 | Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| EN 455-3:2015 | Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
| ISO 10993-14:2001 | Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 10993-9:2009 | Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products |
| EN 12442-1 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| EN 12442-2 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING |
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