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Results for 60601-1
23 shown| Designation | Status | Source |
|---|---|---|
| IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Note: This standard is recognized with relevant US national differences applied, see references #1 and #2 in the Relevant FDA Guidance and/or Supportive Publication section below. | Recognized 2023-04-03 | US · FDA 19-49 |
| IEC 60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment | Recognized 2021-06-07 | US · FDA 12-336 |
| IEC 60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers | Recognized 2020-12-21 | US · FDA 19-37 |
| IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment | Recognized 2020-12-21 | US · FDA 19-38 |
| IEC 60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment | Recognized 2020-12-21 | US · FDA 19-39 |
| IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | Recognized 2020-12-21 | US · FDA 19-36 |
| IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | Recognized 2020-12-21 | US · FDA 5-132 |
| IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems | Recognized 2020-12-21 | US · FDA 5-131 |
| IEC 60601-1-12:2014/Amd 1:2020 Medical Electrical Equipment — Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the emergency medical services environment — Amendment 1 | Current 2020-09-23 | INTL · ISO |
| IEC 60601-1-8:2006/Amd 2:2020 Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems — Amendment 2 | Current 2020-09-23 | INTL · ISO |
| IEC 60601-1-10:2007/Amd 2:2020 Medical electrical equipment — Part 1-10: General requirements for basic safety and essential performance — Collateral standard: Requirements for the development of physiologic closed-loop controllers — Amendment 2 Replaced by IEC/AWI 60601-1-10 | Current 2020-09-21 | INTL · ISO |
| IEC 60601-1-11:2015/Amd 1:2020 Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment — Amendment 1 | Current 2020-09-21 | INTL · ISO |
| IEC 60601-1-12:2014 Medical Electrical Equipment — Part 1-12: General requirements for basic safety and essential performance — Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the emergency medical services environment | Current 2015-11-18 | INTL · ISO |
| IEC 60601-1-11:2015 Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment | Current 2015-01-21 | INTL · ISO |
| IEC 60601-1-10:2007/Amd 1:2013 Medical electrical equipment — Part 1-10: General requirements for basic safety and essential performance — Collateral standard: Requirements for the development of physiologic closed-loop controllers — Amendment 1 Replaced by IEC/AWI 60601-1-10 | Current 2013-11-29 | INTL · ISO |
| IEC 60601-1-8:2006/Amd 1:2012 Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems — Amendment 1 Replaced by IEC/CD 60601-1-8 | Current 2012-12-03 | INTL · ISO |
| IEC 60601-1-8:2006 Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems Replaced by IEC/CD 60601-1-8 | Current 2006-11-13 | INTL · ISO |
| IEC 60601-1-10:2007 Medical electrical equipment — Part 1-10: General requirements for basic safety and essential performance — Collateral standard: Requirements for the development of physiologic closed-loop controllers Replaced by IEC/AWI 60601-1-10 | Under review 2007-11-29 | INTL · ISO |
| IEC/AWI 60601-1-10 Medical electrical equipment — Part 1-10: General requirements for basic safety and essential performance — Collateral standard: Requirements for the development of physiologic closed-loop controllers | Draft | INTL · ISO |
| IEC 60601-1-11:2010/Cor 1:2011 Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment — Technical Corrigendum 1 Replaced by IEC 60601-1-11:2015 | Withdrawn 2011-05-06 | INTL · ISO |
| IEC 60601-1-11:2010 Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment Replaced by IEC 60601-1-11:2015 | Withdrawn 2010-05-04 | INTL · ISO |
| IEC 60601-1-8:2003/Amd 1:2006 Medical electrical equipment — Part 1-8: General requirements for safety — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems — Amendment 1 Replaced by IEC 60601-1-8:2006 | Withdrawn 2006-03-20 | INTL · ISO |
| IEC 60601-1-8:2003 Medical electrical equipment — Part 1-8: General requirements for safety — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems Replaced by IEC 60601-1-8:2006 | Withdrawn 2003-12-01 | 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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