Biocompatibility

23 standards in this category.

Standard	Title	Scope	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