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ISO/WD 10993-11 – Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
September 26, 2023
This document reached stage 20.60 on 2023-09-26, TC/SC: ISO/TC 194
ISO 10993-17:2023 – Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents
September 13, 2023
This document reached stage 60.60 on 2023-09-13, TC/SC: ISO/TC 194, ICS: 11.100.20
ISO 10993-17:2002 – Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
September 13, 2023
This document reached stage 95.99 on 2023-09-13, TC/SC: ISO/TC 194, ICS: 11.100.20
ISO 10993-4:2017/CD Amd 1 – Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1
September 11, 2023
This document reached stage 30.60 on 2023-09-11, TC/SC: ISO/TC 194, ICS: 11.100.20
ISO/CD 10993-1 – Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
September 4, 2023
This document reached stage 30.60 on 2023-09-04, TC/SC: ISO/TC 194, ICS: 11.100; 11.100.20
ISO/CD 14155 – Clinical investigation of medical devices for human subjects — Good clinical practice
August 30, 2023
This document reached stage 30.20 on 2023-08-30, TC/SC: ISO/TC 194, ICS: 11.100.20
ISO/CD 10993-7.2 – Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
August 30, 2023
This document reached stage 30.20 on 2023-08-30, TC/SC: ISO/TC 194, ICS: 11.100.20
ISO/TS 11796:2023 – Biological evaluation of medical devices — Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
July 27, 2023
This document reached stage 60.60 on 2023-07-27, TC/SC: ISO/TC 194, ICS: 11.100.20
ISO/AWI 21762 – Medical devices utilizing human tissues and their derivatives — Application of risk management
July 24, 2023
This document reached stage 20.00 on 2023-07-24, TC/SC: ISO/TC 194
ISO/CD 8250 – Cleanliness of medical devices — Process design and test methods
July 11, 2023
This document reached stage 30.20 on 2023-07-11, TC/SC: ISO/TC 194, ICS: 11.040.01
ISO/CD 10993-6 – Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
June 19, 2023
This document reached stage 30.60 on 2023-06-19, TC/SC: ISO/TC 194, ICS: 11.100.20
ISO/TS 10993-19:2020 – Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
June 6, 2023
This document reached stage 90.93 on 2023-06-06, TC/SC: ISO/TC 194, ICS: 11.100.20
ISO/CD 10993-3 – Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive and developmental toxicity
May 3, 2023
This document reached stage 30.98 on 2023-05-03, TC/SC: ISO/TC 194, ICS: 11.100.20
ISO 10993-3:2014 – Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
May 3, 2023
This document reached stage 90.93 on 2023-05-03, TC/SC: ISO/TC 194, ICS: 11.100.20
ISO 10993-4:2017 – Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
April 19, 2023
This document reached stage 90.93 on 2023-04-19, TC/SC: ISO/TC 194, ICS: 11.100.20
ISO 10993-11:2017 – Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
April 18, 2023
This document reached stage 90.92 on 2023-04-18, TC/SC: ISO/TC 194, ICS: 11.100.20
ISO/AWI 10993-4 – Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1
April 18, 2023
This document reached stage 20.00 on 2023-04-18, TC/SC: ISO/TC 194
ISO/TR 10993-55:2023 – Biological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicity
February 6, 2023
This document reached stage 60.60 on 2023-02-06, TC/SC: ISO/TC 194, ICS: 11.100.20
ISO 14155:2020 – Clinical investigation of medical devices for human subjects — Good clinical practice
December 12, 2022
This document reached stage 90.92 on 2022-12-12, TC/SC: ISO/TC 194, ICS: 11.100.20
ISO/CD TR 37137-2 – Biological evaluation of absorbable medical devices — Part 2: Standard guide for absorbable metals
December 12, 2022
This document reached stage 30.98 on 2022-12-12, TC/SC: ISO/TC 194, ICS: 11.040.40

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