Projektu virzības (STK griezumā) https:/www.lvs.lv/projects WI FAKE-93464. ISO/AWI TS 37137-2 - Biological evaluation for absorbable medical devices — Part 2: Evaluation and testing of medical devices for soft tissue repair Projekts sasniedzis stadiju 10.99 datumā 24.02.2026. Nākamā stadija 20.00. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/479229 479229 Tue, 24 Feb 2026 02:24:14 +0200 WI FAKE-93462. ISO/AWI TS 26420 - Biological evaluation of medical devices — Guidance on the impact of bioaccumulation and intermittent contact in the application of ISO 10993-1 Projekts sasniedzis stadiju 10.99 datumā 27.01.2026. Nākamā stadija 20.00. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/478758 478758 Tue, 27 Jan 2026 08:26:05 +0200 WI FAKE-93388. ISO/PWI 10993-23 - Biological evaluation of medical devices — Part 23: Tests for irritation Nākamā stadija 00.00. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/477690 477690 Thu, 20 Nov 2025 03:06:50 +0200 WI FAKE-93387. ISO/PWI 10993-10 - Biological evaluation of medical devices — Part 10: Tests for skin sensitization Nākamā stadija 00.00. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/477689 477689 Thu, 20 Nov 2025 03:06:49 +0200 WI FAKE-93386. ISO/PWI 10993-5 - Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity Nākamā stadija 00.00. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/477688 477688 Thu, 20 Nov 2025 03:06:49 +0200 WI FAKE-93385. ISO/PWI TS 26399 - Biological evaluation of medical devices – Guidance on the application of ISO 10993-1 throughout the medical device life cycle Nākamā stadija 00.00. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/477687 477687 Thu, 20 Nov 2025 03:06:49 +0200 WI FAKE-93384. ISO/PWI TR 26398 - Biological evaluation of medical devices - Information on the use of clinical data in the application of ISO 10993-1 Nākamā stadija 00.00. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/477686 477686 Thu, 20 Nov 2025 03:06:48 +0200 WI FAKE-93383. ISO/PWI TR 26397 - Biological evaluation of medical devices – Information on reasonably foreseeable misuse in the application of ISO 10993-1 Nākamā stadija 00.00. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/477685 477685 Thu, 20 Nov 2025 03:06:48 +0200 WI FAKE-93382. ISO/PWI TR 26376 - Biological evaluation of medical devices – Information on biological equivalence in the application of ISO 10993-1 Nākamā stadija 00.00. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/477684 477684 Thu, 20 Nov 2025 03:06:48 +0200 WI FAKE-92777. ISO/AWI TS 26177 - Biological evaluation of medical devices – Guidance on risk estimation in the application of ISO 10993-1” Projekts sasniedzis stadiju 10.99 datumā 03.11.2025. Nākamā stadija 20.00. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/476131 476131 Tue, 02 Sep 2025 03:31:32 +0300 WI FAKE-91724. ISO/AWI TS 25364-4 - Analytical chemistry matters associated with ISO 10993-18 — Part 4: Critical aspects of extract viability in extractables and leachables testing using non-targeted analysis (NTA) Projekts sasniedzis stadiju 10.99 datumā 17.09.2025. Nākamā stadija 20.00. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/473610 473610 Fri, 28 Mar 2025 08:20:05 +0200 WI FAKE-91188. ISO/CD 25695 - Medical devices utilizing bioengineered biological substances — Application of risk management Projekts sasniedzis stadiju 30.00 datumā 20.03.2026. Nākamā stadija 30.20. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/472287 472287 Wed, 08 Jan 2025 03:39:41 +0200 WI FAKE-90932. ISO/CD TS 25364-3 - Analytical chemistry matters associated with ISO 10993-18 — Part 3: Instrumental and human requirements for evaluating organic medical device extractables and leachables via Non-Targeted Analysis (NTA) Projekts sasniedzis stadiju 30.20 datumā 14.02.2025. Nākamā stadija 30.60. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/471490 471490 Fri, 15 Nov 2024 02:03:38 +0200 WI FAKE-90931. ISO/CD TS 25364-2 - Analytical chemistry matters associated with ISO 10993-18 — Part 2: Quantification of medical device extractables and leachables using Non-Targeted Analysis (NTA) Projekts sasniedzis stadiju 30.20 datumā 25.02.2025. Nākamā stadija 30.60. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/471489 471489 Fri, 15 Nov 2024 02:03:38 +0200 WI FAKE-90930. ISO/CD TS 25364-1 - Chemical characterization of medical devices — Part 1: Identification of organic extractables in Non-Targeted Analysis (NTA) Projekts sasniedzis stadiju 30.60 datumā 14.04.2025. Nākamā stadija 50.00. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/471488 471488 Fri, 15 Nov 2024 02:03:37 +0200 WI FAKE-90746. ISO/AWI 22442-3 - 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 Nākamā stadija 10.99. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/471085 471085 Wed, 30 Oct 2024 01:37:57 +0200 WI FAKE-90745. ISO/WD TR 21582 - Pyrogenicity — Principles and methods for pyrogen testing of medical devices Projekts sasniedzis stadiju 20.00 datumā 02.01.2025. Nākamā stadija 20.20. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/471084 471084 Wed, 30 Oct 2024 01:37:56 +0200 WI FAKE-90744. ISO/DIS 10993-4 - Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood Projekts sasniedzis stadiju 30.99 datumā 07.04.2026. Nākamā stadija 40.00. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100, 11.100.20 https:/www.lvs.lv/projects/project/471083 471083 Wed, 30 Oct 2024 01:37:56 +0200 WI FAKE-90743. ISO/AWI 10993-14 - Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics Nākamā stadija 10.99. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/471082 471082 Wed, 30 Oct 2024 01:37:56 +0200 WI FAKE-90742. ISO/AWI 10993-13 - Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices Nākamā stadija 10.99. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/471081 471081 Wed, 30 Oct 2024 01:37:55 +0200 WI FAKE-90037. ISO/WD TS 25364 - Discovery, Identification and Quantification of Medical Device Extractables and Leachables via Non-Target Analysis (NTA) — Analytical Chemistry Matters Associated with ISO 10993-18 Projekts sasniedzis stadiju 10.99 datumā 14.11.2024. Nākamā stadija 20.98. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/469349 469349 Wed, 10 Jul 2024 02:00:57 +0300 WI FAKE-89238. ISO/AWI 8250 - Cleanliness of medical devices — Process design and test methods Projekts sasniedzis stadiju 10.99 datumā 21.08.2024. Nākamā stadija 20.00. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/467491 467491 Sat, 23 Mar 2024 01:49:15 +0200 WI FAKE-88206. ISO/DIS 10993-16 - Biological evaluation of medical devices — Part 16: Toxicokinetic evaluation for degradation products and leachables Projekts sasniedzis stadiju 40.20 datumā 08.12.2025. Nākamā stadija 40.60. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/465013 465013 Wed, 01 Nov 2023 01:46:09 +0200 WI FAKE-88205. ISO 10993-12:2021/Amd 1:2025 - Biological evaluation of medical devices — Part 12: Sample preparation and reference materials — Amendment 1 Projekts sasniedzis stadiju 60.60 datumā 13.08.2025. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/465012 465012 Wed, 01 Nov 2023 01:46:08 +0200 WI FAKE-88204. ISO/CD TR 24850 - Sources of hazard information for medical device constituents Projekts sasniedzis stadiju 30.00 datumā 15.04.2026. Nākamā stadija 30.20. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/465011 465011 Wed, 01 Nov 2023 01:46:08 +0200 WI FAKE-88203. ISO/NP TS 24830 - Application of in-silico/read-across approaches for identifying a medical device constituent analogue Projekts sasniedzis stadiju 10.00 datumā 10.04.2026. Nākamā stadija 10.20. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/465010 465010 Wed, 01 Nov 2023 01:46:08 +0200 WI FAKE-88202. ISO/CD TS 21726 - Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents Projekts sasniedzis stadiju 30.20 datumā 21.02.2026. Nākamā stadija 30.60. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/465009 465009 Wed, 01 Nov 2023 01:46:08 +0200 WI FAKE-88201. ISO 10993-17:2023/Amd 1:2025 - Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents — Amendment 1 Projekts sasniedzis stadiju 60.60 datumā 18.11.2025. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/465008 465008 Wed, 01 Nov 2023 01:46:07 +0200 WI FAKE-88200. ISO 10993-23:2021/Amd 1:2025 - Biological evaluation of medical devices — Part 23: Tests for irritation — Amendment 1: Additional in vitro reconstructed human epidermis models Projekts sasniedzis stadiju 60.60 datumā 01.05.2025. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/465007 465007 Wed, 01 Nov 2023 01:46:07 +0200 WI FAKE-88199. ISO/FDIS 10993-3 - Biological evaluation of medical devices — Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity Projekts sasniedzis stadiju 50.00 datumā 30.10.2025. Nākamā stadija 50.20. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/465006 465006 Wed, 01 Nov 2023 01:46:07 +0200 WI FAKE-86868. ISO/DIS 21762 - Medical devices utilizing non-viable human materials — Risk management Projekts sasniedzis stadiju 40.20 datumā 16.09.2025. Nākamā stadija 40.60. Atbildīgā komiteja: ISO/TC 194. ICS: 11.040.99 https:/www.lvs.lv/projects/project/384799 384799 Sat, 29 Apr 2023 07:24:39 +0300 WI FAKE-86862. ISO 10993-4:2017/Amd 1:2025 - Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1 Projekts sasniedzis stadiju 60.60 datumā 08.01.2025. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/384784 384784 Fri, 28 Apr 2023 07:30:34 +0300 WI FAKE-86799. ISO/DIS 10993-11.2 - Biological evaluation of medical devices — Part 11: Tests for systemic toxicity Projekts sasniedzis stadiju 40.00 datumā 17.04.2026. Nākamā stadija 40.20. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/384646 384646 Wed, 19 Apr 2023 08:03:54 +0300 WI FAKE-86796. ISO/AWI 10993-4 - Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1 Projekts sasniedzis stadiju 20.00 datumā 18.04.2023. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/384643 384643 Wed, 19 Apr 2023 08:03:53 +0300 WI FAKE-86248. ISO/PWI TS 10993-22 - Biological evaluation of medical devices — Part 22: Guidance on nanomaterials Projekts sasniedzis stadiju 00.00 datumā 13.12.2022. Nākamā stadija 00.98. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/383214 383214 Wed, 14 Dec 2022 07:44:56 +0200 WI FAKE-86247. ISO/CD TS 20324 - Generation of medical device extracts for chemical analysis to support toxicological risk assessment Projekts sasniedzis stadiju 30.20 datumā 04.09.2025. Nākamā stadija 30.60. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/383213 383213 Wed, 14 Dec 2022 07:44:55 +0200 WI FAKE-86246. ISO/DIS 10993-2 - Biological evaluation of medical devices — Part 2: Animal welfare requirements Projekts sasniedzis stadiju 40.60 datumā 04.02.2025. Nākamā stadija 40.99. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/383212 383212 Wed, 14 Dec 2022 07:44:55 +0200 WI FAKE-85514. ISO/DIS 18969 - Clinical evaluation of medical devices Projekts sasniedzis stadiju 40.20 datumā 15.12.2025. Nākamā stadija 40.60. Atbildīgā komiteja: ISO/TC 194. ICS: 11.040.01 https:/www.lvs.lv/projects/project/381794 381794 Tue, 23 Aug 2022 05:30:36 +0300 WI FAKE-85211. ISO/PWI 10993-5 - Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity Projekts sasniedzis stadiju 00.00 datumā 16.06.2022. Nākamā stadija 00.98. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/381148 381148 Fri, 17 Jun 2022 06:18:33 +0300 WI FAKE-84824. ISO 10993-7:2026 - Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals Projekts sasniedzis stadiju 60.60 datumā 20.04.2026. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/380311 380311 Fri, 18 Mar 2022 13:46:20 +0200 WI FAKE-84512. ISO 10993-1:2025 - Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process Projekts sasniedzis stadiju 60.60 datumā 18.11.2025. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100, 11.100.20 https:/www.lvs.lv/projects/project/373511 373511 Thu, 13 Jan 2022 04:17:39 +0200 WI FAKE-83976. ISO 10993-6:2026 - Biological evaluation of medical devices — Part 6: Tests for local effects after implantation Projekts sasniedzis stadiju 60.00 datumā 20.12.2025. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/372228 372228 Fri, 22 Oct 2021 04:16:30 +0300 WI FAKE-83973. ISO/NP TS 11967 - Biological evaluation of medical devices — Guidance on commissioning scientifically robust chemical characterization testing in accordance with ISO 10993-18 Projekts sasniedzis stadiju 10.00 datumā 23.03.2026. Nākamā stadija 10.20. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/372225 372225 Fri, 22 Oct 2021 04:16:30 +0300 WI FAKE-83972. ISO/PWI 10993-12 - Biological evaluation of medical devices — Part 12: Sample preparation and reference materials Projekts sasniedzis stadiju 00.00 datumā 21.10.2021. Nākamā stadija 00.98. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/372224 372224 Fri, 22 Oct 2021 04:16:29 +0300 WI FAKE-83971. ISO/PWI TS 11966 - Pyrogenicity Projekts sasniedzis stadiju 00.00 datumā 21.10.2021. Nākamā stadija 00.98. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/372223 372223 Fri, 22 Oct 2021 04:16:29 +0300 WI FAKE-83970. ISO/PWI 10993-4 - Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood Projekts sasniedzis stadiju 00.00 datumā 21.10.2021. Nākamā stadija 00.98. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/372222 372222 Fri, 22 Oct 2021 04:16:29 +0300 WI FAKE-83969. ISO/PWI 10993-14 - Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics Projekts sasniedzis stadiju 00.00 datumā 21.10.2021. Nākamā stadija 00.98. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/372221 372221 Fri, 22 Oct 2021 04:16:29 +0300 WI FAKE-83968. ISO 14155:2026 - Clinical investigation of medical devices for human subjects — Good clinical practice Projekts sasniedzis stadiju 60.60 datumā 23.03.2026. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/372220 372220 Fri, 22 Oct 2021 04:16:29 +0300 WI FAKE-83916. 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 Projekts sasniedzis stadiju 60.60 datumā 27.07.2023. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/372052 372052 Fri, 15 Oct 2021 08:09:14 +0300 WI FAKE-83711. ISO/PWI 10993-20 - Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices Projekts sasniedzis stadiju 00.00 datumā 12.12.2022. Nākamā stadija 00.98. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/371675 371675 Wed, 15 Sep 2021 04:09:11 +0300 WI FAKE-83418. ISO/PWI 6337 - Mathematical models for the evaluation of toxicokinetics Projekts sasniedzis stadiju 00.00 datumā 12.07.2021. Nākamā stadija 00.98. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/370920 370920 Tue, 13 Jul 2021 03:52:10 +0300 WI FAKE-83092. ISO/CD 8250 - Cleanliness of medical devices — Process design and test methods Projekts sasniedzis stadiju 30.99 datumā 27.10.2023. Nākamā stadija 30.98. Atbildīgā komiteja: ISO/TC 194. ICS: 11.040.01 https:/www.lvs.lv/projects/project/370108 370108 Fri, 28 May 2021 04:27:57 +0300 WI A00008:10:078866. ISO 10993-2:2022 - Biological evaluation of medical devices — Part 2: Animal welfare requirements Projekts sasniedzis stadiju 60.60 datumā 03.11.2022. Nākamā stadija 90.92. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/361738 361738 Mon, 01 Jul 2019 09:44:21 +0300 WI A00008:10:075769. ISO 10993-12:2021 - Biological evaluation of medical devices — Part 12: Sample preparation and reference materials Projekts sasniedzis stadiju 60.60 datumā 20.01.2021. Nākamā stadija 90.20. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/355886 355886 Wed, 09 May 2018 11:05:40 +0300 WI A00008:10:075279. ISO 10993-10:2021 - Biological evaluation of medical devices — Part 10: Tests for skin sensitization Projekts sasniedzis stadiju 60.60 datumā 16.11.2021. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/354914 354914 Fri, 09 Feb 2018 12:11:35 +0200 WI A00008:10:075323. ISO 10993-17:2023 - Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents Projekts sasniedzis stadiju 60.60 datumā 13.09.2023. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/354870 354870 Fri, 09 Feb 2018 12:11:26 +0200 WI A00008:10:075138. ISO/TS 10993-19:2020 - Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials Projekts sasniedzis stadiju 90.93 datumā 06.06.2023. Nākamā stadija 90.20. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/354192 354192 Wed, 13 Dec 2017 11:11:01 +0200 WI A00008:10:072766. ISO 10993-7:2008/Amd 1:2019 - Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants Projekts sasniedzis stadiju 60.60 datumā 09.12.2019. Nākamā stadija 95.99. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/352277 352277 Wed, 12 Jul 2017 12:22:23 +0300 WI A00008:10:073582. ISO/TS 37137-1:2021 - Biological evaluation of absorbable medical devices — Part 1: General requirements Projekts sasniedzis stadiju 90.60 datumā 04.06.2024. Nākamā stadija 90.93. Atbildīgā komiteja: ISO/TC 194. ICS: 11.040.40 https:/www.lvs.lv/projects/project/351434 351434 Wed, 12 Jul 2017 12:19:44 +0300 WI A00008:10:074151. ISO 10993-23:2021 - Biological evaluation of medical devices — Part 23: Tests for irritation Projekts sasniedzis stadiju 60.60 datumā 20.01.2021. Nākamā stadija 90.20. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/351117 351117 Wed, 12 Jul 2017 12:18:49 +0300 WI A00008:10:071862. ISO/TR 10993-55:2023 - Biological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicity Projekts sasniedzis stadiju 60.60 datumā 06.02.2023. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/344372 344372 Sun, 10 Jul 2016 11:54:13 +0300 WI A00008:10:071690. ISO 14155:2020 - Clinical investigation of medical devices for human subjects — Good clinical practice Projekts sasniedzis stadiju 90.92 datumā 12.12.2022. Nākamā stadija 95.99. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/343980 343980 Mon, 20 Jun 2016 14:59:22 +0300 WI A00008:10:071514. ISO/TS 21726:2019 - Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents Projekts sasniedzis stadiju 90.60 datumā 03.09.2025. Nākamā stadija 90.92. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/343777 343777 Mon, 06 Jun 2016 15:58:04 +0300 WI A00008:10:071146. ISO/NP TR 37137-1 - Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants — Part 1: Title missing Atbildīgā komiteja: ISO/TC 194. ICS: 11.040.40 https:/www.lvs.lv/projects/project/343457 343457 Thu, 12 May 2016 12:17:03 +0300 WI A00008:10:071147. ISO/CD TR 37137-2 - Biological evaluation of absorbable medical devices — Part 2: Standard guide for absorbable metals Atbildīgā komiteja: ISO/TC 194. ICS: 11.040.40 https:/www.lvs.lv/projects/project/343456 343456 Thu, 12 May 2016 12:17:03 +0300 WI A00008:10:071150. ISO/TR 21582:2021 - Pyrogenicity — Principles and methods for pyrogen testing of medical devices Projekts sasniedzis stadiju 60.60 datumā 12.07.2021. Nākamā stadija 90.92. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/343453 343453 Thu, 12 May 2016 12:17:03 +0300 WI A00008:10:068426. ISO 10993-11:2017 - Biological evaluation of medical devices — Part 11: Tests for systemic toxicity Projekts sasniedzis stadiju 90.92 datumā 18.04.2023. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/336701 336701 Mon, 14 Sep 2015 21:13:48 +0300 WI A00008:10:045651. ISO/AWI TS 29741 - Biological evaluation of medical devices — Development of tolerable intake values for Di(2-ethylhexyl)phthalate (DEHP) Projekts sasniedzis stadiju 20.00 datumā 11.01.2007. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/335827 335827 Mon, 14 Sep 2015 21:11:19 +0300 WI A00008:10:035976. ISO/DIS 10993-6 - Biological evaluation of medical devices — Part 6: Tests for local effects after implantation Projekts sasniedzis stadiju 40.60 datumā 25.05.2005. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/335522 335522 Mon, 14 Sep 2015 21:10:29 +0300 WI A00008:10:069217. ISO/TR 15499:2016 - Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process Projekts sasniedzis stadiju 99.60 datumā 22.10.2018. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/335456 335456 Mon, 14 Sep 2015 21:10:18 +0300 WI A00008:10:068936. ISO 10993-1:2018 - Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process Projekts sasniedzis stadiju 90.92 datumā 21.08.2021. Nākamā stadija 95.99. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/334746 334746 Mon, 14 Sep 2015 21:08:18 +0300 WI A00008:10:068937. ISO 10993-15:2019 - Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys Projekts sasniedzis stadiju 90.20 datumā 15.10.2024. Nākamā stadija 90.60. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/334745 334745 Mon, 14 Sep 2015 21:08:17 +0300 WI A00008:10:068938. ISO/NP TS 10993-20 - Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/334744 334744 Mon, 14 Sep 2015 21:08:17 +0300 WI A00008:10:023736. ISO 14155:1996 - Medicīnisko ierīču klīniski pētījumi Projekts sasniedzis stadiju 99.60 datumā 26.02.2003. Atbildīgā komiteja: ISO/TC 194. ICS: 11.120.01, 11.040.01, 11.100 https:/www.lvs.lv/projects/project/328144 328144 Tue, 16 Nov 1999 00:00:00 +0200 WI A00008:10:025333. ISO 10993-1:1997 - Biological evaluation of medical devices — Part 1: Evaluation and testing Projekts sasniedzis stadiju 99.60 datumā 28.07.2003. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100 https:/www.lvs.lv/projects/project/324480 324480 Thu, 16 Oct 2014 01:10:10 +0300 WI A00008:10:018966. ISO 10993-6:1994 - Biological evaluation of medical devices — Part 6: Tests for local effects after implantation Projekts sasniedzis stadiju 99.60 datumā 04.04.2007. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/324328 324328 Thu, 16 Oct 2014 01:09:47 +0300 WI A00008:10:064238. ISO/DTR 17137-2 - Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants — Part 2: Guidance on biological evaluation of absorbable implants Atbildīgā komiteja: ISO/TC 194. ICS: 11.040.40 https:/www.lvs.lv/projects/project/323126 323126 Thu, 16 Oct 2014 01:06:30 +0300 WI A00008:10:063448. ISO 10993-4:2017 - Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood Projekts sasniedzis stadiju 90.60 datumā 29.10.2024. Nākamā stadija 90.92. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/323082 323082 Thu, 16 Oct 2014 01:06:23 +0300 WI A00008:10:045368. ISO/CD 10993-3 - Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/273580 273580 Wed, 15 Oct 2014 23:43:49 +0300 WI A00008:10:063449. ISO/CD 10993-5 - Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/256361 256361 Wed, 15 Oct 2014 23:10:03 +0300 WI A00008:10:039204. ISO 10993-12:2002/DAmd 1 - Biological evaluation of medical devices — Part 12: Sample preparation and reference materials — Amendment 1 Projekts sasniedzis stadiju 40.60 datumā 25.05.2005. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/256048 256048 Wed, 15 Oct 2014 23:09:23 +0300 WI A00008:10:036404. ISO/WD 10993-1 - Biological evaluation of medical devices — Part 1: Evaluation and testing Projekts sasniedzis stadiju 20.00 datumā 18.10.2001. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100 https:/www.lvs.lv/projects/project/256005 256005 Wed, 15 Oct 2014 23:09:17 +0300 WI A00008:10:036403. ISO/TS 20993:2006 - Biological evaluation of medical devices — Guidance on a risk-management process Projekts sasniedzis stadiju 99.60 datumā 08.10.2012. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/256004 256004 Wed, 15 Oct 2014 23:09:17 +0300 WI A00008:10:035981. ISO/NP TS 21729 - Terminology in the field of clinical activities related to the assessment of medical devices Atbildīgā komiteja: ISO/TC 194. ICS: 01.040.11, 11.100.01 https:/www.lvs.lv/projects/project/255789 255789 Wed, 15 Oct 2014 23:08:47 +0300 WI A00008:10:035980. ISO/WD TS 10993-21 - Biological evaluation of medical devices — Part 21: Guidelines for the preparation of standards for the biological evaluation of medical devices Projekts sasniedzis stadiju 20.00 datumā 28.06.2001. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100 https:/www.lvs.lv/projects/project/255788 255788 Wed, 15 Oct 2014 23:08:47 +0300 WI A00008:10:065918. ISO/TR 10993-22:2017 - Biological evaluation of medical devices — Part 22: Guidance on nanomaterials Projekts sasniedzis stadiju 60.60 datumā 14.07.2017. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/228283 228283 Wed, 15 Oct 2014 22:12:43 +0300 WI A00008:10:065052. ISO/TR 10993-33:2015 - Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3 Projekts sasniedzis stadiju 60.60 datumā 06.03.2015. Nākamā stadija 90.92. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/227792 227792 Wed, 15 Oct 2014 22:11:37 +0300 WI A00008:10:064780. ISO/WD TS 29741 - Biological evaluation of medical devices — Development of tolerable intake values for Di(2-ethylhexyl)phthalate (DEHP) Projekts sasniedzis stadiju 20.00 datumā 28.04.2014. Atbildīgā komiteja: ISO/TC 194. https:/www.lvs.lv/projects/project/227577 227577 Wed, 15 Oct 2014 22:11:08 +0300 WI A00008:10:064763. ISO/WD 10993-7 - Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals Projekts sasniedzis stadiju 20.00 datumā 15.04.2014. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/227562 227562 Wed, 15 Oct 2014 22:11:06 +0300 WI A00008:10:064751. ISO/NP TS 10993-19 - Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/227552 227552 Wed, 15 Oct 2014 22:11:05 +0300 WI A00008:10:064750. ISO 10993-18:2020 - Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process Projekts sasniedzis stadiju 90.60 datumā 05.06.2025. Nākamā stadija 90.93. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/227551 227551 Wed, 15 Oct 2014 22:11:05 +0300 WI A00008:10:064744. ISO/PWI 10993-17 - Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances Projekts sasniedzis stadiju 00.60 datumā 18.06.2014. Nākamā stadija 00.98. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/227546 227546 Wed, 15 Oct 2014 22:11:04 +0300 WI A00008:10:064582. ISO 10993-16:2017 - Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables Projekts sasniedzis stadiju 90.93 datumā 05.09.2022. Nākamā stadija 90.92. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/227422 227422 Wed, 15 Oct 2014 22:10:47 +0300 WI A00008:10:064581. ISO/PWI 10993-13 - Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices Projekts sasniedzis stadiju 00.00 datumā 09.07.2013. Nākamā stadija 00.98. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/227421 227421 Wed, 15 Oct 2014 22:10:47 +0300 WI A00008:10:064580. ISO 10993-9:2019 - Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products Projekts sasniedzis stadiju 90.20 datumā 15.10.2024. Nākamā stadija 90.60. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/227420 227420 Wed, 15 Oct 2014 22:10:46 +0300 WI A00008:10:061089. ISO 10993-6:2016 - Biological evaluation of medical devices — Part 6: Tests for local effects after implantation Projekts sasniedzis stadiju 90.92 datumā 16.03.2022. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/224885 224885 Wed, 15 Oct 2014 22:04:55 +0300 WI A00008:10:055614. ISO 10993-3:2014 - Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity Projekts sasniedzis stadiju 90.93 datumā 03.05.2023. Nākamā stadija 90.92. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/222658 222658 Wed, 15 Oct 2014 21:59:47 +0300 WI A00008:10:050994. ISO/WD 10993-4 - Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood Projekts sasniedzis stadiju 20.00 datumā 06.05.2008. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/221061 221061 Wed, 15 Oct 2014 21:56:11 +0300 WI A00008:10:042997. ISO/CD 10993-1 - Biological evaluation of medical devices — Part 1: Evaluation and testing Projekts sasniedzis stadiju 20.00 datumā 06.10.2005. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/219850 219850 Wed, 15 Oct 2014 21:53:23 +0300 WI A00008:10:041177. ISO/WD 14155-2 - Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans Projekts sasniedzis stadiju 20.20 datumā 28.11.2005. Atbildīgā komiteja: ISO/TC 194. ICS: 11.100.20 https:/www.lvs.lv/projects/project/218896 218896 Wed, 15 Oct 2014 21:51:18 +0300