03/100426 DC : DRAFT JAN 2003
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN ISO 10993-18 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
17-11-2005
23-11-2012
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 General principles
6 Characterisation 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 characterisation 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 summarising the stepwise
generation of chemical characterisation data
for use in toxicological risk assessment
A.1 General
A.2 Procedure
Annex B (informative) Information sources for chemical characterisation
B.1 General
B.2 Generic name of material
B.3 Other nomenclature and structure formulae of polymeric
chemicals
B.3.1 General
B.3.2 IUPAC nomenclature and structure formulae of
polymeric chemicals
B.3.3 CAS registry number, USAN, and other registry name
and/or number
B.4 General information concerning chemical nature of materials
B.5 Information from the material supplier
B.6 Chemical analysis
B.6.1 Non-specific chemical analysis relevant to exposure
assessment
B.6.2 Qualitative analysis
B.6.3 Quantitative analysis of specific toxic chemicals
for exposure assessment
B.7 National and international material and/or product standards
B.8 Material master file
Annex C (informative) Principles for judging toxicological equivalency
Bibliography
BS EN ISO 10993-18
| Committee |
CH/194
|
| DocumentType |
Draft
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| 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 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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