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IEC 60601-1 — Medical Electrical Equipment Safety
International
vEdition 3.2 (2020)
6 domains
20 controls
IEC 60601-1 is the international standard for the safety and essential performance of medical electrical equipment. It establishes general requirements for basic safety and essential performance applicable to all medical electrical equipment and medical electrical systems. The standard covers electrical hazards, mechanical hazards, radiation hazards, EMC, and software requirements (through IEC 62304 reference).
Verified
Framework summaries on this platform are AI-assisted interpretations for educational and compliance planning purposes. They do not reproduce or replace the official standards. Refer to the authoritative source for the definitive text. Framework names and trademarks belong to their respective organisations.
Framework Domains (6)
Clause 1-3: Scope, References, and Terminology
3 controls
| Code | Title |
|---|---|
| 60601-1.1 | Scope, object, and related standards |
| 60601-1.2 | Normative references |
| 60601-1.3 | Terminology and definitions |
Clause 11-14: Temperatures, Accuracy, Faults, and PEMS
4 controls
| Code | Title |
|---|---|
| 60601-1.11 | Protection against excessive temperatures and other hazards |
| 60601-1.12 | Accuracy of controls and instruments |
| 60601-1.13 | Hazardous situations and fault conditions |
| 60601-1.14 | Programmable electrical medical systems (PEMS) |
Clause 15-17: Construction, ME Systems, and EMC
3 controls
| Code | Title |
|---|---|
| 60601-1.15 | Construction of ME equipment |
| 60601-1.16 | ME systems |
| 60601-1.17 | Electromagnetic compatibility (EMC) |
Clause 4-5: General Requirements and Testing
4 controls
| Code | Title |
|---|---|
| 60601-1.4.1 | General requirements |
| 60601-1.4.2 | Risk management process |
| 60601-1.5.1 | General requirements for testing |
| 60601-1.5.2 | Test conditions and environment |
Clause 6-7: Classification, Identification and Marking
3 controls
| Code | Title |
|---|---|
| 60601-1.6 | Classification of ME equipment and systems |
| 60601-1.7.1 | Equipment identification and marking |
| 60601-1.7.2 | Documents and instructions for use |
Clause 8-10: Protection Against Hazards
3 controls
| Code | Title |
|---|---|
| 60601-1.10 | Protection against radiation hazards |
| 60601-1.8 | Protection against electrical hazards |
| 60601-1.9 | Protection against mechanical hazards |
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3 source controls mapped|4 target controls covered
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3 source controls mapped|4 target controls covered
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3 source controls mapped|3 target controls covered
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3 source controls mapped|4 target controls covered
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15%
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15%
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3 source controls mapped|2 target controls covered
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3 source controls mapped|2 target controls covered
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3 source controls mapped|2 target controls covered
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3 source controls mapped|2 target controls covered
15%
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3 source controls mapped|2 target controls covered
15%
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3 source controls mapped|2 target controls covered
15%
NIST SP 800-150
3 source controls mapped|2 target controls covered
15%
AWS Well-Architected Security Pillar
3 source controls mapped|2 target controls covered
15%
NIST SP 800-161
3 source controls mapped|2 target controls covered
15%
MITRE ATT&CK
3 source controls mapped|2 target controls covered
15%
NIST SP 800-146
3 source controls mapped|2 target controls covered
15%
EU Cyber Resilience Act
3 source controls mapped|2 target controls covered
15%
BSIMM
3 source controls mapped|2 target controls covered
15%
MTCS (Singapore)
3 source controls mapped|2 target controls covered
15%
NIST SP 800-183
3 source controls mapped|2 target controls covered
15%
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3 source controls mapped|2 target controls covered
15%
OWASP SAMM
3 source controls mapped|2 target controls covered
15%
ISO 27017
3 source controls mapped|2 target controls covered
15%
NIST SP 800-160
3 source controls mapped|2 target controls covered
15%
NIST SP 800-115
3 source controls mapped|2 target controls covered
15%
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3 source controls mapped|2 target controls covered
15%
NIST SP 800-145
3 source controls mapped|2 target controls covered
15%
SLSA
3 source controls mapped|2 target controls covered
15%
NIST SP 800-181
3 source controls mapped|2 target controls covered
15%
NIST SP 800-218
3 source controls mapped|2 target controls covered
15%
California IoT Security Law
3 source controls mapped|2 target controls covered
15%
NIST SP 800-137
3 source controls mapped|2 target controls covered
15%
UK PSTI Act
3 source controls mapped|2 target controls covered
15%
NIST SP 800-88
3 source controls mapped|2 target controls covered
15%
SSDF (NIST)
3 source controls mapped|2 target controls covered
15%
APRA SPS 220 Risk Management (Superannuation)
3 source controls mapped|3 target controls covered
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APRA CPS 220 Risk Management
3 source controls mapped|3 target controls covered
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3 source controls mapped|1 target controls covered
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COSO ERM
3 source controls mapped|3 target controls covered
15%
ISO 31000
3 source controls mapped|3 target controls covered
15%
AML/CTF Act 2006 (Australia)
3 source controls mapped|1 target controls covered
15%
NIST SP 800-30
3 source controls mapped|3 target controls covered
15%
NIST SP 800-37
3 source controls mapped|3 target controls covered
15%
ISO 27005
3 source controls mapped|3 target controls covered
15%
APRA CPS 230 Operational Risk Management
3 source controls mapped|3 target controls covered
15%
Global Cross-Border Privacy Rules (Global CBPR) Forum
3 source controls mapped|1 target controls covered
15%
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3 source controls mapped|3 target controls covered
15%
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3 source controls mapped|1 target controls covered
15%
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3 source controls mapped|1 target controls covered
15%
NIST Privacy Framework Version 1.0
3 source controls mapped|2 target controls covered
15%
FFIEC Cybersecurity Assessment Tool (CAT)
3 source controls mapped|2 target controls covered
15%
IRM Enterprise Risk Management Framework (Institute of Risk Management)
3 source controls mapped|2 target controls covered
15%
NIST Privacy Framework 1.0
3 source controls mapped|3 target controls covered
15%
EASA Part-IS — Information Security in Aviation
3 source controls mapped|3 target controls covered
15%
WCO Authorised Economic Operator (AEO) Framework
3 source controls mapped|2 target controls covered
15%
NRF Cybersecurity and Data Privacy Framework (National Retail Federation)
3 source controls mapped|5 target controls covered
15%
WCO SAFE Framework of Standards to Secure and Facilitate Global Trade (2021)
3 source controls mapped|2 target controls covered
15%
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3 source controls mapped|2 target controls covered
15%
EU Critical Raw Materials Act (Regulation (EU) 2024/1252)
3 source controls mapped|2 target controls covered
15%
EU Chips Act (Regulation (EU) 2023/1781)
3 source controls mapped|2 target controls covered
15%
German Supply Chain Due Diligence Act (LkSG)
3 source controls mapped|1 target controls covered
15%
SOC for Cybersecurity — Cybersecurity Risk Management Examination
3 source controls mapped|3 target controls covered
15%
SEC Cybersecurity Disclosure Rules
3 source controls mapped|2 target controls covered
15%
OECD AI Principles (2024 Update)
3 source controls mapped|1 target controls covered
15%
NIST SP 800-39
3 source controls mapped|3 target controls covered
15%
UAE Virtual Asset Regulatory Authority (VARA) Regulations
3 source controls mapped|1 target controls covered
15%
SEC Climate Disclosure Rule
3 source controls mapped|3 target controls covered
15%
Canada Artificial Intelligence and Data Act (AIDA)
3 source controls mapped|1 target controls covered
15%
Own Risk and Solvency Assessment (ORSA) — NAIC Model Act
3 source controls mapped|2 target controls covered
15%
Lloyd's of London Cyber Insurance Requirements and Underwriting Standards
3 source controls mapped|1 target controls covered
15%
Authorised Economic Operator (AEO) Programmes — Global Standards
3 source controls mapped|1 target controls covered
15%
UK Defence Standard 05-138 — Cyber Security for Defence Suppliers
3 source controls mapped|1 target controls covered
15%
Singapore Model AI Governance Framework (2nd Edition)
3 source controls mapped|1 target controls covered
15%
Critical Infrastructure Risk Management Program (CIRMP) Rules 2023
3 source controls mapped|2 target controls covered
15%
EU SFDR (Sustainable Finance Disclosure Regulation)
2 source controls mapped|4 target controls covered
10%
US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule
2 source controls mapped|7 target controls covered
10%
HIPAA Security Rule
2 source controls mapped|7 target controls covered
10%
ISO/IEC 29100:2024
2 source controls mapped|3 target controls covered
10%
US Foreign Corrupt Practices Act (FCPA)
2 source controls mapped|1 target controls covered
10%
21 CFR Part 58 — Good Laboratory Practice (GLP)
2 source controls mapped|2 target controls covered
10%
BRCGS Global Standard for Food Safety Issue 9
2 source controls mapped|3 target controls covered
10%
ISO/IEC 27400:2022
2 source controls mapped|3 target controls covered
10%
ISO/IEC 27011:2024
2 source controls mapped|3 target controls covered
10%
3GPP 5G Security Architecture (TS 33.501)
2 source controls mapped|2 target controls covered
10%
ISO/IEC 29134:2023
2 source controls mapped|3 target controls covered
10%
ISO/IEC 27014:2020
2 source controls mapped|3 target controls covered
10%
EMV 3-D Secure (3DS2) — Payment Authentication Protocol
2 source controls mapped|3 target controls covered
10%
ISO/IEC 29147:2018
2 source controls mapped|3 target controls covered
10%
ISO/IEC 27004:2016
2 source controls mapped|3 target controls covered
10%
ISO/IEC 29115:2023 — Entity Authentication Assurance Framework
2 source controls mapped|1 target controls covered
10%
ISO/IEC 27031:2011
2 source controls mapped|1 target controls covered
10%
ISO/IEC 27007:2020
2 source controls mapped|1 target controls covered
10%
ISO/IEC 30111:2019
2 source controls mapped|3 target controls covered
10%
ISO/IEC 27050 — Electronic Discovery (Parts 1-4)
2 source controls mapped|1 target controls covered
10%
SQF Code Edition 9 — Safe Quality Food
2 source controls mapped|1 target controls covered
10%
ASIS SPC.1-2009 — Organizational Resilience Standard
2 source controls mapped|1 target controls covered
10%
NIST SP 800-124 Rev 2 — Mobile Device Security
2 source controls mapped|3 target controls covered
10%
APRA Prudential Standard CPS 234 — Information Security (Australia)
2 source controls mapped|1 target controls covered
10%
ETSI QKD Standards — Quantum Key Distribution (ETSI ISG QKD)
2 source controls mapped|3 target controls covered
10%
ISO 56002
2 source controls mapped|4 target controls covered
10%
UK Open Banking Standard
2 source controls mapped|1 target controls covered
10%
EU Union Customs Code (UCC) — Data Protection and Security Provisions (Regulation 952/2013)
2 source controls mapped|2 target controls covered
10%
Serbia Law on Personal Data Protection (2018)
2 source controls mapped|4 target controls covered
10%
Netherlands GDPR Implementation Act (UAVG — Uitvoeringswet AVG, 2018)
2 source controls mapped|5 target controls covered
10%
Kuwait Data Privacy Protection Regulation (KDPPR, 2021 — CMA Directive)
2 source controls mapped|3 target controls covered
10%
Vietnam Law on Cybersecurity (No. 24/2018/QH14)
2 source controls mapped|5 target controls covered
10%
Luxembourg Law of 1 August 2018 on Data Protection (GDPR Implementation)
2 source controls mapped|5 target controls covered
10%
Portugal Law No. 58/2019 — Data Protection Implementation Act
2 source controls mapped|6 target controls covered
10%
North Macedonia Law on Personal Data Protection (2020)
2 source controls mapped|5 target controls covered
10%
Hungary Act CXII of 2011 on Informational Self-Determination and Freedom of Information (Info Act)
2 source controls mapped|4 target controls covered
10%
Uruguay Personal Data Protection Act (Law No. 18.331)
2 source controls mapped|5 target controls covered
10%
South Korea Credit Information Act
2 source controls mapped|1 target controls covered
10%
UK Gambling Commission — Cyber Resilience Requirements
2 source controls mapped|3 target controls covered
10%
NATO STANAG 4774/4778 — Confidentiality Metadata Labels
2 source controls mapped|3 target controls covered
10%
Virginia Consumer Data Protection Act (VCDPA)
2 source controls mapped|1 target controls covered
10%
IRS Publication 1075 — Tax Information Security Guidelines
2 source controls mapped|1 target controls covered
10%
UK Bribery Act 2010
2 source controls mapped|3 target controls covered
10%
ISO 19650 — Organisation and Digitisation of Information about Buildings and Civil Engineering Works (BIM)
2 source controls mapped|3 target controls covered
10%
SOC 2
2 source controls mapped|2 target controls covered
10%
Digital Economy Partnership Agreement (DEPA)
2 source controls mapped|2 target controls covered
10%
Italy Personal Data Protection Code (Legislative Decree No. 196/2003, amended 2018)
2 source controls mapped|1 target controls covered
10%
FTC GLBA Safeguards Rule (16 CFR Part 314)
2 source controls mapped|2 target controls covered
10%
FCC Customer Proprietary Network Information (CPNI) and Data Breach Rules (47 CFR 64.2001-2011)
2 source controls mapped|3 target controls covered
10%
IFRS 17 — Insurance Contracts
2 source controls mapped|2 target controls covered
10%
CIRCIA (Cyber Incident Reporting for Critical Infrastructure Act)
2 source controls mapped|3 target controls covered
10%
UK Construction (Design and Management) Regulations 2015 (CDM 2015)
2 source controls mapped|3 target controls covered
10%
Denmark Data Protection Act (Databeskyttelsesloven, 2018)
2 source controls mapped|4 target controls covered
10%
AICPA Privacy Management Framework (PMF)
2 source controls mapped|2 target controls covered
10%
NIST Post-Quantum Cryptography Standards (FIPS 203, 204, 205)
2 source controls mapped|1 target controls covered
10%
IAEA Nuclear Security Series — Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
2 source controls mapped|3 target controls covered
10%
DAMA-DMBOK2 — Data Management Body of Knowledge (2nd Edition)
2 source controls mapped|3 target controls covered
10%
ISO 41001:2018 — Facility Management Systems
2 source controls mapped|3 target controls covered
10%
ISO 39001:2012 — Road Traffic Safety Management
2 source controls mapped|3 target controls covered
10%
ISO 37002:2021 — Whistleblowing Management Systems
2 source controls mapped|3 target controls covered
10%
ISO 50001:2018 — Energy Management Systems
2 source controls mapped|3 target controls covered
10%
ISO 22313:2020 — Guidance on Business Continuity Management Systems
2 source controls mapped|3 target controls covered
10%
Regional Comprehensive Economic Partnership (RCEP) — E-Commerce Chapter
2 source controls mapped|2 target controls covered
10%
EU AI Liability Directive
2 source controls mapped|4 target controls covered
10%
EU Audiovisual Media Services Directive (AVMSD, Directive 2018/1808)
2 source controls mapped|2 target controls covered
10%
Cook Islands Electronic Transactions Act & Privacy Provisions (2003)
2 source controls mapped|3 target controls covered
10%
US Americans with Disabilities Act (ADA) — Title III Digital Accessibility
2 source controls mapped|3 target controls covered
10%
EU Network Code on Cybersecurity for the Electricity Sector
2 source controls mapped|3 target controls covered
10%
EU Machinery Regulation (Regulation (EU) 2023/1230)
2 source controls mapped|4 target controls covered
10%
EU General Product Safety Regulation (GPSR, Regulation 2023/988)
2 source controls mapped|5 target controls covered
10%
Laos Law on Prevention and Combating Cybercrime (2015)
2 source controls mapped|4 target controls covered
10%
Paraguay Law on Protection of Personal Data (Law No. 6534/2020)
2 source controls mapped|4 target controls covered
10%
Jordan Draft Personal Data Protection Law (2022)
2 source controls mapped|4 target controls covered
10%
EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
2 source controls mapped|2 target controls covered
10%
EU Web Accessibility Directive (Directive 2016/2102)
2 source controls mapped|3 target controls covered
10%
Lebanon Electronic Transactions and Personal Data Protection Law (Law No. 81/2018)
2 source controls mapped|2 target controls covered
10%
Tunisia Organic Law on Personal Data Protection (Law No. 2004-63)
2 source controls mapped|2 target controls covered
10%
Senegal Law on Personal Data Protection (Law No. 2008-12)
2 source controls mapped|3 target controls covered
10%
Morocco Data Protection Law (09-08)
2 source controls mapped|4 target controls covered
10%
Ethiopia Personal Data Protection Proclamation (No. 1321/2024)
2 source controls mapped|4 target controls covered
10%
Kazakhstan Law on Personal Data and Their Protection (No. 94-V)
2 source controls mapped|4 target controls covered
10%
Poland Act on Personal Data Protection (Ustawa o ochronie danych osobowych, 2018)
2 source controls mapped|5 target controls covered
10%
Latvia Personal Data Processing Law (Fizisko personu datu apstrades likums, 2018)
2 source controls mapped|7 target controls covered
10%
Finland Data Protection Act (Tietosuojalaki, 1050/2018)
2 source controls mapped|5 target controls covered
10%
Estonia Personal Data Protection Act (Isikuandmete kaitse seadus, 2019)
2 source controls mapped|4 target controls covered
10%
Russia Federal Law on Personal Data (152-FZ)
2 source controls mapped|4 target controls covered
10%
Croatia Act on Implementation of the GDPR (Official Gazette 42/2018)
2 source controls mapped|3 target controls covered
10%
Greece Law 4624/2019 — Hellenic Data Protection Authority (HDPA) Implementation Act
2 source controls mapped|2 target controls covered
10%
Botswana Data Protection Act (2024)
2 source controls mapped|5 target controls covered
10%
Fiji Data Protection Bill (2020)
2 source controls mapped|5 target controls covered
10%
Zimbabwe Data Protection Act (2021)
2 source controls mapped|4 target controls covered
10%
Uganda Data Protection and Privacy Act (2019)
2 source controls mapped|4 target controls covered
10%
Brunei Personal Data Protection Order 2024 (PDPO)
2 source controls mapped|6 target controls covered
10%
Singapore Payment Services Act (PSA) — Digital Payment Token Regulation
2 source controls mapped|5 target controls covered
10%
Singapore Protection from Online Falsehoods and Manipulation Act (POFMA, 2019)
2 source controls mapped|3 target controls covered
10%
Australia Online Safety Act 2021
2 source controls mapped|4 target controls covered
10%
IEC 62351 — Power Systems Communication Security
2 source controls mapped|1 target controls covered
10%
Tanzania Personal Data Protection Act (Draft)
2 source controls mapped|4 target controls covered
10%
Trinidad and Tobago Data Protection Act 2011
2 source controls mapped|4 target controls covered
10%
Jamaica Data Protection Act 2020
2 source controls mapped|3 target controls covered
10%
Mauritius Data Protection Act 2017
2 source controls mapped|2 target controls covered
10%
Kenya Data Protection Act 2019
2 source controls mapped|3 target controls covered
10%
Ghana Data Protection Act 2012 (Act 843)
2 source controls mapped|2 target controls covered
10%
Cayman Islands Data Protection Act 2017 (DPA)
2 source controls mapped|4 target controls covered
10%
Czech Republic Act on Personal Data Processing (Act No. 110/2019 Sb.)
2 source controls mapped|4 target controls covered
10%
ISO 22739:2024 — Blockchain and Distributed Ledger Technologies Vocabulary
2 source controls mapped|3 target controls covered
10%
Nigeria Data Protection Act 2023 (NDPA)
2 source controls mapped|2 target controls covered
10%
IATA Operational Safety Audit (IOSA) Standards Manual
2 source controls mapped|1 target controls covered
10%
South Korea Korea Internet Self-Governance Organisation (KISO) Code of Ethics
2 source controls mapped|5 target controls covered
10%
ISO 26262:2018 — Functional Safety for Road Vehicles
2 source controls mapped|1 target controls covered
10%
RFC 2350 — Expectations for Computer Security Incident Response (BCP 21)
2 source controls mapped|3 target controls covered
10%
SANS Incident Handler's Handbook and PICERL Methodology
2 source controls mapped|2 target controls covered
10%
Pakistan Personal Data Protection Bill 2023
2 source controls mapped|3 target controls covered
10%
PCAOB AS 2201 — Audit of Internal Control Over Financial Reporting (ICFR)
2 source controls mapped|3 target controls covered
10%
CISA ICS-CERT Advisories and Industrial Control Systems Security Guidelines
2 source controls mapped|2 target controls covered
10%
ITAR — International Traffic in Arms Regulations
2 source controls mapped|2 target controls covered
10%
Automotive SPICE (ASPICE) v4.0 — Process Assessment Model
2 source controls mapped|2 target controls covered
10%
DO-178C / ED-12C — Software Considerations in Airborne Systems
2 source controls mapped|3 target controls covered
10%
Israel Protection of Privacy Law (5741-1981)
2 source controls mapped|3 target controls covered
10%
Bermuda Personal Information Protection Act 2016 (PIPA)
2 source controls mapped|2 target controls covered
10%
ISO/IEC 27006:2024
2 source controls mapped|3 target controls covered
10%
ICAO Annex 17 — Aviation Security (AVSEC)
2 source controls mapped|3 target controls covered
10%
US NRC 10 CFR 73.54 — Cyber Security for Nuclear Power Plants
2 source controls mapped|3 target controls covered
10%
EN 50126/50128/50129 — Railway RAMS and Safety
2 source controls mapped|3 target controls covered
10%
Belgium Data Protection Act (Wet van 30 juli 2018, Loi du 30 juillet 2018)
2 source controls mapped|2 target controls covered
10%
Tennessee Information Protection Act (TIPA)
2 source controls mapped|1 target controls covered
10%
Chile Personal Data Protection Law (Law No. 21.719)
2 source controls mapped|3 target controls covered
10%
China Personal Information Protection Law (PIPL)
2 source controls mapped|3 target controls covered
10%
WCAG 2.2
2 source controls mapped|1 target controls covered
10%
NIST SP 800-34 Rev 1 — Contingency Planning Guide
2 source controls mapped|3 target controls covered
10%
US Children's Online Privacy Protection Act (COPPA) and COPPA 2.0 Proposed Updates
2 source controls mapped|1 target controls covered
10%
COBIT 2019
2 source controls mapped|1 target controls covered
10%
Armenia Law on Protection of Personal Data (2015)
2 source controls mapped|3 target controls covered
10%
USMCA Chapter 19 — Digital Trade (United States-Mexico-Canada Agreement)
2 source controls mapped|1 target controls covered
10%
EU NIS2 Directive — Transport Sector Requirements
2 source controls mapped|2 target controls covered
10%
eIDAS 2.0 — EU Digital Identity Regulation
2 source controls mapped|3 target controls covered
10%
RICS Professional Standards — Data and Technology in Property
2 source controls mapped|1 target controls covered
10%
Switzerland New Federal Act on Data Protection (nFADP/nDSG, 2023)
2 source controls mapped|1 target controls covered
10%
EDM Council CDMC — Cloud Data Management Capabilities Framework
2 source controls mapped|3 target controls covered
10%
HL7 FHIR Security Framework
2 source controls mapped|1 target controls covered
10%
South Korea PIPA
2 source controls mapped|1 target controls covered
10%
UK Building Safety Act 2022
2 source controls mapped|2 target controls covered
10%
EU Data Act
2 source controls mapped|2 target controls covered
10%
UK GDPR (UK General Data Protection Regulation)
2 source controls mapped|1 target controls covered
10%
W3C Verifiable Credentials (VC) Data Model 2.0
2 source controls mapped|2 target controls covered
10%
Singapore Cybersecurity Act 2018
2 source controls mapped|1 target controls covered
10%
Cyber Security Act 2024 (Australia)
2 source controls mapped|1 target controls covered
10%
Bosnia and Herzegovina Law on Protection of Personal Data (2006, amended 2011)
2 source controls mapped|3 target controls covered
10%
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)
2 source controls mapped|3 target controls covered
10%
Angola Personal Data Protection Law (Law No. 22/11)
2 source controls mapped|4 target controls covered
10%
Barbados Data Protection Act 2019
2 source controls mapped|1 target controls covered
10%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
2 source controls mapped|1 target controls covered
10%
Sri Lanka Personal Data Protection Act (No. 9 of 2022)
2 source controls mapped|1 target controls covered
10%
SWIFT Customer Security Programme (CSP)
2 source controls mapped|2 target controls covered
10%
French Sapin II Law (Law No. 2016-1691)
2 source controls mapped|1 target controls covered
10%
South Africa Promotion of Access to Information Act (PAIA)
2 source controls mapped|1 target controls covered
10%
Sweden Data Protection Act (Dataskyddslag, 2018:218)
2 source controls mapped|1 target controls covered
10%
Philippines Cybercrime Prevention Act (RA 10175)
2 source controls mapped|1 target controls covered
10%
ISO/IEC 25012:2008 — Data Quality Model
2 source controls mapped|2 target controls covered
10%
SSAE 18 SOC 1 — Report on Controls at a Service Organisation (ICFR)
2 source controls mapped|1 target controls covered
10%
ECSS Software Engineering Standards (ESA)
2 source controls mapped|3 target controls covered
10%
Online Safety Act 2021 (Australia)
2 source controls mapped|3 target controls covered
10%
ESA ECSS-E-ST-40C — Space Software Engineering Standard
2 source controls mapped|3 target controls covered
10%
Azerbaijan Law on Personal Data (2010)
2 source controls mapped|1 target controls covered
10%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
2 source controls mapped|2 target controls covered
10%
OWASP DevSecOps Maturity Model (DSOMM)
2 source controls mapped|3 target controls covered
10%
PCI DSS v4.0
2 source controls mapped|3 target controls covered
10%
China Cybersecurity Law (CSL)
2 source controls mapped|1 target controls covered
10%
India Account Aggregator Framework (RBI)
2 source controls mapped|1 target controls covered
10%
IATF 16949:2016 — Quality Management System for Automotive Production
2 source controls mapped|2 target controls covered
10%
Singapore Payment Services Act 2019 (PSA) — Digital Payment Token Provisions
2 source controls mapped|1 target controls covered
10%
MiFID II / MiFIR
2 source controls mapped|1 target controls covered
10%
OECD Guidelines for Multinational Enterprises on Responsible Business Conduct (2023 Update)
1 source controls mapped|1 target controls covered
5%
ISO 26000:2010
1 source controls mapped|2 target controls covered
5%
CDP Corporate Questionnaire
1 source controls mapped|3 target controls covered
5%
Science Based Targets Initiative (SBTi) — Net-Zero Standard
1 source controls mapped|3 target controls covered
5%
GHG Protocol
1 source controls mapped|3 target controls covered
5%
HITECH Act
1 source controls mapped|3 target controls covered
5%
MDS2 (Medical Device)
1 source controls mapped|3 target controls covered
5%
NATO AQAP 2110 — Quality Assurance Requirements for Design, Development, and Production
1 source controls mapped|1 target controls covered
5%
WELL Building Standard v2 (International WELL Building Institute)
1 source controls mapped|1 target controls covered
5%
Washington My Health My Data Act (MHMD)
1 source controls mapped|1 target controls covered
5%
UNESCO Recommendation on the Ethics of AI
1 source controls mapped|1 target controls covered
5%
ISO/IEC 27010:2015
1 source controls mapped|1 target controls covered
5%
China Data Security Law (DSL)
1 source controls mapped|1 target controls covered
5%
NIST SP 800-172
1 source controls mapped|1 target controls covered
5%
CMMC 2.0
1 source controls mapped|1 target controls covered
5%
COSO Internal Control — Integrated Framework (2013)
1 source controls mapped|1 target controls covered
5%
Voluntary Principles on Security and Human Rights (VPs)
1 source controls mapped|1 target controls covered
5%
NIST SP 800-53A
1 source controls mapped|1 target controls covered
5%
FISMA
1 source controls mapped|1 target controls covered
5%
ISO 27001:2022
1 source controls mapped|1 target controls covered
5%
CISA Zero Trust Maturity Model
1 source controls mapped|1 target controls covered
5%
NIST SP 800-171
1 source controls mapped|1 target controls covered
5%
Cyber Essentials Plus
1 source controls mapped|1 target controls covered
5%
ANSSI Cybersecurity Framework
1 source controls mapped|1 target controls covered
5%
DISA Security Technical Implementation Guides (STIGs)
1 source controls mapped|1 target controls covered
5%
Belgium CyberFundamentals
1 source controls mapped|1 target controls covered
5%
DoD Zero Trust Reference Architecture
1 source controls mapped|1 target controls covered
5%
Saudi NCA ECC
1 source controls mapped|1 target controls covered
5%
Ghana Cybersecurity Act
1 source controls mapped|1 target controls covered
5%
NSA Quantum-Resistant (QR) Cryptography Migration Guidance
1 source controls mapped|1 target controls covered
5%
Spain ENS
1 source controls mapped|1 target controls covered
5%
BSI IT-Grundschutz
1 source controls mapped|1 target controls covered
5%
Frequently Asked Questions
What is IEC 60601-1 — Medical Electrical Equipment Safety?
IEC 60601-1 — Medical Electrical Equipment Safety is a compliance framework from International with 6 domains and 20 controls. IEC 60601-1 is the international standard for the safety and essential performance of medical electrical equipment. It establishes general requirements for basic safety and essential performance applicable to all medical electrical equipment and medical electrical systems. The standard covers electrical hazards, mechanical hazards, radiation hazards, EMC, and software requirements (through IEC 62304 reference). It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
How many controls does IEC 60601-1 — Medical Electrical Equipment Safety have?
IEC 60601-1 — Medical Electrical Equipment Safety has 20 controls organised across 6 domains. The largest domains are Clause 11-14: Temperatures, Accuracy, Faults, and PEMS (4 controls), Clause 4-5: General Requirements and Testing (4 controls), Clause 1-3: Scope, References, and Terminology (3 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
What frameworks does IEC 60601-1 — Medical Electrical Equipment Safety map to?
IEC 60601-1 — Medical Electrical Equipment Safety maps to 499 other compliance frameworks. The top mapping partners are FAA Cybersecurity Framework for Aviation (30% coverage), EU Taxonomy Regulation (Regulation 2020/852) (25% coverage), EU Taxonomy Regulation (25% coverage). Use our comparison tool to explore control-level mappings between frameworks.
How do I get started with IEC 60601-1 — Medical Electrical Equipment Safety compliance?
Start your IEC 60601-1 — Medical Electrical Equipment Safety compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about IEC 60601-1 — Medical Electrical Equipment Safety requirements, and cross-framework mapping helps you leverage existing controls from other frameworks you may already comply with. Create a free account to access all 20 controls and track your progress.
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