ISO 10993-1 |
Evaluation and testing within a risk management system |
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ISO 10993-2 |
Animal welfare requirements |
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ISO 10993-3 |
Tests for genotoxicity, carcinogenicity and reproductive toxicity |
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ISO 10993-4 |
Selection of tests for interactions with blood |
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ISO 10993-5 |
Tests for in vitro cytotoxicity |
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ISO 10993-6 |
Tests for local effects after implantation |
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ISO 10993-7 |
Ethylene oxide sterilization residuals |
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ISO 10993-8 |
Selection and qualification of reference materials for biological tests |
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ISO 10993-9 |
Framework for identification and quantification of potential degradation products |
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ISO 10993-10 |
Tests for skin sensitization |
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ISO 10993-11 |
Tests for systemic toxicity |
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ISO 10993-12 |
Sample preparation and reference materials |
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ISO 10993-13 |
Identification and quantification of degradation products from polymeric medical devices |
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ISO 10993-14 |
Identification and quantification of degradation products from ceramics |
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ISO 10993-15 |
Identification and quantification of degradation products from metals and alloys |
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ISO 10993-16 |
Toxicokinetic study design for degradation products and leachables |
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ISO 10993-17 |
Establishment of allowable limits for leachable substances |
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ISO 10993-18 |
Chemical characterization of materials |
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ISO 10993-19 |
Physico-chemical, morphological and topographical characterization of materials |
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ISO 10993-20 |
Principles and methods for immunotoxicology testing of medical devices |
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ISO 10993-21 |
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ISO/TR 10993-22 |
Guidance on nanomaterials |
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ISO 10993-23 |
Tests for irritation |
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Source: www.beuth.de/en |
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Bioburden
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (EN ISO 11737-1)
Contact us to structure your Biocompatibility tests series, evaluate reports, and/or update your Biocompatibility files.