生物相容性
本类别共 23 条标准。
| 标准编号 | 标题 | 适用范围 | GSPR |
|---|---|---|---|
| EN ISO 10993-1:2020 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | Framework for biological evaluation of medical devices within risk management | 10, 10.1, 10.2, 10.3 |
| EN ISO 10993-3:2014 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity | Genotoxicity, carcinogenicity and reproductive toxicity testing | 10, 10.1, 10.4, 10.4.1 |
| EN ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | In vitro cytotoxicity testing methods | 10, 10.1, 10.4, 10.4.1 |
| EN ISO 10993-7:2008 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals | Allowable limits for EO residuals in EO-sterilised medical devices | 10, 10.1, 10.4, 10.4.2 |
| EN ISO 10993-11:2018 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Systemic toxicity testing | 10, 10.6 |
| EN ISO 22442-1:2020 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management | Risk management for medical devices utilizing animal tissues | 12, 13, 13.1, 13.2 |
| EN ISO 22442-2:2020 | Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling | Controls on sourcing, collection and handling of animal tissues | 12, 13, 13.1, 13.2 |
| EN ISO 22442-3:2020 | Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents | Virus/TSE agent elimination validation for animal-derived medical devices | 12, 13, 13.1, 13.2 |
| ISO 10993-1:2018 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process | Biocompatibility evaluation framework | 10, 10.1, 10.4 |
| ISO 10993-4:2017 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood | Biological evaluation of medical devices -- Selection of tests for interactions ... | 10 |
| ISO 10993-6:2016 | Biological evaluation of medical devices - Part 6: Tests for local effects after implantation | Biological evaluation of medical devices -- Tests for local effects after implan... | 10 |
| ISO 10993-9:2019 | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products | Biological evaluation of medical devices -- Framework for identification and qua... | 10 |
| ISO 10993-10:2021 | Biological evaluation of medical devices - Part 10: Tests for skin sensitization | Biological evaluation of medical devices -- Tests for skin sensitization. | 10 |
| ISO 10993-13:2010 | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices | Biological evaluation of medical devices -- Identification and quantification of... | 10 |
| ISO 10993-14:2001 | Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics | Biological evaluation of medical devices -- Identification and quantification of... | 10 |
| ISO 10993-15:2019 | Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys | Biological evaluation of medical devices -- Identification and quantification of... | 10 |
| ISO 10993-16:2017 | Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables | Biological evaluation of medical devices -- Toxicokinetic study design for degra... | 10 |
| ISO 10993-2:2022 | Biological evaluation of medical devices - Part 2: Animal welfare requirements | Animal welfare requirements for biological evaluation. | 10, 10.4 |
| ISO 10993-8:2000 | Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests | Reference materials for biological tests. | 10, 10.4 |
| ISO 10993-19:2020 | Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials | Material characterization for biological evaluation. | 10, 10.4 |
| ISO 10993-20:2006 | Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices | Immunotoxicology testing of medical devices. | 10, 10.4 |
| ISO/TS 10993-21:2022 | Biological evaluation of medical devices - Part 21: Experimental assessment of irritation potential in skin sensitization assays | Irritation assessment in skin sensitization assays. | 10, 10.4 |
| ISO 10993-22:2017 | Biological evaluation of medical devices - Part 22: Guidance on nanomaterials | Biological evaluation of nanomaterials. | 10, 10.4 |