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26,520 current ISO publications, 5,220 drafts and 1,738 FDA-recognized standards, with every replaced edition traced to its successor. Below the search is a sample assessment you can download.
Results for 10993-1
30+ shown| Designation | Status | Source |
|---|---|---|
| ISO 10993-18 Second edition 2020-01 Amendment 1 2022-05 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process [Including Amendment 1 (2022)]. | Recognized 2026-09-07 | US · FDA 2-298 |
| ISO 10993-1 Sixth edition 2025-11 Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process | Recognized 2026-05-25 | US · FDA 2-313 |
| ISO 10993-12 Fifth edition 2021-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials [Including AMENDMENT 1 (2025) | Recognized 2026-05-25 | US · FDA 2-314 |
| 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 | Current 2025-11-18 | INTL · ISO |
| ISO 10993-17:2023/Amd 1:2025 Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents — Amendment 1 | Current 2025-11-18 | INTL · ISO |
| ISO 10993-12:2021/Amd 1:2025 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials — Amendment 1 | Current 2025-08-13 | INTL · ISO |
| ISO 10993-17 Second edition 2023-09 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents | Recognized 2023-12-18 | US · FDA 2-303 |
| ISO 10993-17:2023 Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents | Current 2023-09-13 | INTL · ISO |
| ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization | Recognized 2022-12-19 | US · FDA 2-296 |
| ISO 10993-12 Fifth edition 2021-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials | Recognized 2022-12-19 | US · FDA 2-289 |
| ISO 10993-18:2020/Amd 1:2022 Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process — Amendment 1: Determination of the uncertainty factor | Current 2022-05-11 | INTL · ISO |
| ISO 10993-10:2021 Biological evaluation of medical devices — Part 10: Tests for skin sensitization | Current 2021-11-16 | INTL · ISO |
| ISO 10993-12:2021 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials Replaced by ISO/PWI 10993-12 | Current 2021-01-20 | INTL · ISO |
| ISO 10993-15 Second edition 2019-11 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys | Recognized 2020-12-21 | US · FDA 2-288 |
| ISO 10993-18:2020 Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process | Current 2020-01-13 | INTL · ISO |
| ISO 10993-15:2019 Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys | Current 2019-11-26 | INTL · ISO |
| ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | Recognized 2019-01-14 | US · FDA 2-258 |
| ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Recognized 2018-09-17 | US · FDA 2-255 |
| ISO 10993-16 Third edition 2017-05 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables | Recognized 2018-06-07 | US · FDA 2-249 |
| ISO 10993-13 Second edition 2010-06-15 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices | Recognized 2016-07-26 | US · FDA 2-169 |
| ISO 10993-14 First edition 2001-11-15 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics | Recognized 2016-07-26 | US · FDA 2-170 |
| ISO 10993-17 First edition 2002-12-01 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances | Recognized 2016-07-26 | US · FDA 2-237 |
| ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity Replaced by ISO/DIS 10993-11.2 | Under review 2017-09-14 | INTL · ISO |
| ISO 10993-16:2017 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables Replaced by ISO/FDIS 10993-16 | Under review 2017-05-16 | INTL · ISO |
| ISO 10993-13:2010 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices Replaced by ISO/AWI 10993-13, ISO/PWI 10993-13 | Under review 2010-06-04 | INTL · ISO |
| ISO 10993-14:2001 Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics Replaced by ISO/PWI 10993-14, ISO/AWI 10993-14 | Under review 2001-11-22 | INTL · ISO |
| ISO/AWI 10993-13 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices | Draft | INTL · ISO |
| ISO/AWI 10993-14 Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics | Draft | INTL · ISO |
| ISO/DIS 10993-11.2 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity | Draft | INTL · ISO |
| ISO/FDIS 10993-16 Biological evaluation of medical devices — Part 16: Toxicokinetic evaluation for degradation products and leachables | Draft | INTL · ISO |
In a workspace, one click adds any of these to your watchlist. Contains ISO Open Data, licensed under ODC-By 1.0 (iso.org/open-data).
Sample assessment
automated upper-arm blood-pressure monitor
Reusable, non-invasive, battery-powered oscillometric monitor with an inflatable arm cuff and a companion app over Bluetooth. Home and clinical use, adults. Sold in the US and EU.
EU · Regulation (EU) 2017/745 (MDR)
Class IIa (Annex VIII, Rule 10 — active device for diagnosis/monitoring)
US · 21 CFR 870.1130 — non-invasive blood pressure measurement system
Class II, 510(k)
| Standard | Title | Why it applies |
|---|---|---|
| IEC 60601-1 | Medical electrical equipment — basic safety and essential performance | Electrically powered device |
| IEC 60601-1-2 | Electromagnetic disturbances (EMC) | Electronics + Bluetooth radio |
| IEC 60601-1-11 | Home healthcare environment | Intended for home use |
| IEC 80601-2-30 | Automated non-invasive sphygmomanometers | Particular standard for this device type |
| ISO 81060-2 | Clinical investigation of intermittent automated measurement type | Clinical validation of accuracy |
| ISO 14971 | Application of risk management to medical devices | All medical devices |
| IEC 62304 | Medical device software — life cycle processes | Embedded firmware + app |
| IEC 62366-1 | Usability engineering | Lay users at home |
| ISO 10993-1 | Biological evaluation — evaluation and testing | Cuff in contact with intact skin |
| ISO 15223-1 | Symbols for labels and information | Labeling |
Sample output for an illustrative product, not advice for any real device. In a workspace the Advisor asks about your product first, shows the reason and confidence for every item, and a named reviewer signs off each decision.
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