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IEC 60601-1 - Medical Electrical Equipment Safety
International (IEC); adopted as EN 60601-1, ANSI/AAMI ES60601-1, CSA C22.2 No. 60601-1 and nationally
vEdition 3.1 (IEC 60601-1:2005 + A1:2012), the held text; Amendment 2:2020 (Edition 3.2) held as preview only, changes not applied
9 domains
102 controls
The IEC general standard for the basic safety and essential performance of medical electrical equipment and systems, built from the complete Edition 3.1 text (2005 with Amendment 1:2012): 102 sub-clause leaves covering risk management, electrical, mechanical, thermal and radiation hazards, marking and documents, PEMS, construction and ME systems.
Verified
IEC 60601-1 - Medical Electrical Equipment Safety is a compliance framework from International (IEC); adopted as EN 60601-1, ANSI/AAMI ES60601-1, CSA C22.2 No. 60601-1 and nationally with 9 domains and 102 controls that map to 222 other frameworks. The largest domains are Clauses 4 to 5: general requirements and testing – IEC 60601-1 - Medical Electrical Equipment Safety (20 controls), Clauses 6 to 7: classification, identification, marking and documents – IEC 60601-1 - Medical Electrical Equipment Safety (15 controls), Clauses 11 to 13: temperatures, fire, outputs, hazardous situations and fault conditions – IEC 60601-1 - Medical Electrical Equipment Safety (14 controls). Every control below carries what it requires and what an assessor expects to see.
Maintained by Gerard BlokdykControl text last updated
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 (9)
Clause 14: programmable electrical medical systems – IEC 60601-1 - Medical Electrical Equipment Safety
13 controls
Clause 15: construction – IEC 60601-1 - Medical Electrical Equipment Safety
5 controls
| Code | Title |
|---|---|
| iec-60601-1-medical-electrical-equipment-safety::15.1 | 15.1 Arrangements of controls and indicators of ME equipment |
| iec-60601-1-medical-electrical-equipment-safety::15.2 | 15.2 Serviceability |
| iec-60601-1-medical-electrical-equipment-safety::15.3 | 15.3 Mechanical strength |
| iec-60601-1-medical-electrical-equipment-safety::15.4 | 15.4 ME equipment components and general assembly |
| iec-60601-1-medical-electrical-equipment-safety::15.5 | 15.5 Mains supply transformers of ME equipment and transformers providing separation in accordance with 8.5 |
Clause 16: ME systems – IEC 60601-1 - Medical Electrical Equipment Safety
9 controls
| Code | Title |
|---|---|
| iec-60601-1-medical-electrical-equipment-safety::16.1 | 16.1 General requirements for the ME systems |
| iec-60601-1-medical-electrical-equipment-safety::16.2 | 16.2 Accompanying documents of an ME system |
| iec-60601-1-medical-electrical-equipment-safety::16.3 | 16.3 Power supply |
| iec-60601-1-medical-electrical-equipment-safety::16.4 | 16.4 Enclosures |
| iec-60601-1-medical-electrical-equipment-safety::16.5 | 16.5 Separation devices |
| iec-60601-1-medical-electrical-equipment-safety::16.6 | 16.6 Leakage currents |
| iec-60601-1-medical-electrical-equipment-safety::16.7 | 16.7 Protection against mechanical hazards |
| iec-60601-1-medical-electrical-equipment-safety::16.8 | 16.8 Interruption of the power supply to parts of an ME system |
| iec-60601-1-medical-electrical-equipment-safety::16.9 | 16.9 ME system connections and wiring |
Clause 17: electromagnetic compatibility – IEC 60601-1 - Medical Electrical Equipment Safety
1 controls
| Code | Title |
|---|---|
| iec-60601-1-medical-electrical-equipment-safety::17 | 17 Electromagnetic compatibility of ME equipment and ME systems |
Clause 8: protection against electrical hazards – IEC 60601-1 - Medical Electrical Equipment Safety
11 controls
| Code | Title |
|---|---|
| iec-60601-1-medical-electrical-equipment-safety::8.1 | 8.1 Fundamental rule of protection against electric shock |
| iec-60601-1-medical-electrical-equipment-safety::8.10 | 8.10 Components and wiring |
| iec-60601-1-medical-electrical-equipment-safety::8.11 | 8.11 Mains parts , components and layout |
| iec-60601-1-medical-electrical-equipment-safety::8.2 | 8.2 Requirements related to power sources |
| iec-60601-1-medical-electrical-equipment-safety::8.3 | 8.3 Classification of applied parts |
| iec-60601-1-medical-electrical-equipment-safety::8.4 | 8.4 Limitation of voltage, current or energy |
| iec-60601-1-medical-electrical-equipment-safety::8.5 | 8.5 Separation of parts |
| iec-60601-1-medical-electrical-equipment-safety::8.6 | 8.6 Protective earthing, functional earthing and potential equalization of ME equipment |
| iec-60601-1-medical-electrical-equipment-safety::8.7 | 8.7 Leakage currents and patient auxiliary currents |
| iec-60601-1-medical-electrical-equipment-safety::8.8 | 8.8 Insulation |
| iec-60601-1-medical-electrical-equipment-safety::8.9 | 8.9 Creepage distances and air clearances |
Clauses 11 to 13: temperatures, fire, outputs, hazardous situations and fault conditions – IEC 60601-1 - Medical Electrical Equipment Safety
14 controls
| Code | Title |
|---|---|
| iec-60601-1-medical-electrical-equipment-safety::11.1 | 11.1 Excessive temperatures in ME equipment |
| iec-60601-1-medical-electrical-equipment-safety::11.2 | 11.2 Fire prevention |
| iec-60601-1-medical-electrical-equipment-safety::11.3 | 11.3 Constructional requirements for fire enclosures of ME equipment |
| iec-60601-1-medical-electrical-equipment-safety::11.4 | 11.4 ME equipment and ME systems intended for use with flammable anaesthetics |
| iec-60601-1-medical-electrical-equipment-safety::11.5 | 11.5 ME equipment and ME systems intended for use in conjunction with flammable agents |
| iec-60601-1-medical-electrical-equipment-safety::11.6 | 11.6 Overflow, spillage, leakage, ingress of water or particulate matter, cleaning, disinfection, sterilization and compatibility with substances used with the ME equipment |
| iec-60601-1-medical-electrical-equipment-safety::11.7 | 11.7 Biocompatibility of ME equipment and ME systems |
| iec-60601-1-medical-electrical-equipment-safety::11.8 | 11.8 Interruption of the power supply / supply mains to ME equipment |
| iec-60601-1-medical-electrical-equipment-safety::12.1 | 12.1 Accuracy of controls and instruments |
| iec-60601-1-medical-electrical-equipment-safety::12.2 | 12.2 Usability of ME equipment |
| iec-60601-1-medical-electrical-equipment-safety::12.3 | 12.3 Alarm systems |
| iec-60601-1-medical-electrical-equipment-safety::12.4 | 12.4 Protection against hazardous output |
| iec-60601-1-medical-electrical-equipment-safety::13.1 | 13.1 Specific hazardous situations |
| iec-60601-1-medical-electrical-equipment-safety::13.2 | 13.2 Single fault conditions |
Clauses 4 to 5: general requirements and testing – IEC 60601-1 - Medical Electrical Equipment Safety
20 controls
Clauses 6 to 7: classification, identification, marking and documents – IEC 60601-1 - Medical Electrical Equipment Safety
15 controls
Clauses 9 to 10: mechanical and radiation hazards – IEC 60601-1 - Medical Electrical Equipment Safety
14 controls
| Code | Title |
|---|---|
| iec-60601-1-medical-electrical-equipment-safety::10.1 | 10.1 X-Radiation |
| iec-60601-1-medical-electrical-equipment-safety::10.2 | 10.2 Alpha, beta, gamma, neutron and other particle radiation |
| iec-60601-1-medical-electrical-equipment-safety::10.3 | 10.3 Microwave radiation |
| iec-60601-1-medical-electrical-equipment-safety::10.4 | 10.4 Lasers and light emitting diodes (LEDs) |
| iec-60601-1-medical-electrical-equipment-safety::10.5 | 10.5 Other visible electromagnetic radiation |
| iec-60601-1-medical-electrical-equipment-safety::10.6 | 10.6 Infrared radiation |
| iec-60601-1-medical-electrical-equipment-safety::10.7 | 10.7 Ultraviolet radiation |
| iec-60601-1-medical-electrical-equipment-safety::9.2 | 9.2 Mechanical hazards associated with moving parts |
| iec-60601-1-medical-electrical-equipment-safety::9.3 | 9.3 Mechanical hazard associated with surfaces, corners and edges |
| iec-60601-1-medical-electrical-equipment-safety::9.4 | 9.4 Instability hazards |
| iec-60601-1-medical-electrical-equipment-safety::9.5 | 9.5 Expelled parts hazard |
| iec-60601-1-medical-electrical-equipment-safety::9.6 | 9.6 Acoustic energy (including infra- and ultrasound) and vibration |
| iec-60601-1-medical-electrical-equipment-safety::9.7 | 9.7 Pressure vessels and parts subject to pneumatic and hydraulic pressure |
| iec-60601-1-medical-electrical-equipment-safety::9.8 | 9.8 Mechanical hazards associated with support systems |
Your Compliance Coverage
If you comply with IEC 60601-1 - Medical Electrical Equipment Safety, you already cover:
SASB Standards
4%
5 controls mapped
Compare →Protective Security Policy Framework (PSPF) Release 2026
4%
5 controls mapped
Compare →PIC/S Guide to Good Manufacturing Practice for Medicinal Products
4%
5 controls mapped
Compare →+ 219 more: MTCS (Singapore) (4%), ICH Q10 - Pharmaceutical Quality System (4%)
See all 222 mapped frameworks ↓Maps to 222 other frameworks
140 total controls
SASB Standards
5 source controls mapped|7 target controls covered
4%
Protective Security Policy Framework (PSPF) Release 2026
5 source controls mapped|2 target controls covered
4%
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
5 source controls mapped|4 target controls covered
4%
MTCS (Singapore)
5 source controls mapped|3 target controls covered
4%
ICH Q10 - Pharmaceutical Quality System
5 source controls mapped|4 target controls covered
4%
ICH E6(R3) - Good Clinical Practice
5 source controls mapped|4 target controls covered
4%
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
5 source controls mapped|6 target controls covered
4%
Singapore Government Instruction Manual on ICT&SS Management (IM8)
5 source controls mapped|3 target controls covered
4%
ISO/IEC 27557:2022 - Organisational Privacy Risk Management
4 source controls mapped|6 target controls covered
3%
UK AI Regulation Framework
4 source controls mapped|1 target controls covered
3%
PSD2 SCA
4 source controls mapped|2 target controls covered
3%
OSFI B-13
4 source controls mapped|2 target controls covered
3%
Open Banking Security
4 source controls mapped|2 target controls covered
3%
OECD AI Principles
4 source controls mapped|2 target controls covered
3%
OCC Heightened Standards (12 CFR Part 30, Appendix D)
4 source controls mapped|3 target controls covered
3%
O-RAN WG11 Security Specification
4 source controls mapped|4 target controls covered
3%
NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security
4 source controls mapped|2 target controls covered
3%
Monetary Authority of Singapore Technology Risk Management Guidelines
4 source controls mapped|2 target controls covered
3%
Japan AI Guidelines
4 source controls mapped|4 target controls covered
3%
IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.4)
4 source controls mapped|1 target controls covered
3%
IEEE 7000
4 source controls mapped|2 target controls covered
3%
IEEE 1686
4 source controls mapped|2 target controls covered
3%
ICMM Mining Principles (2024 Update)
4 source controls mapped|2 target controls covered
3%
ICAO Annex 17 - Aviation Security (AVSEC)
4 source controls mapped|3 target controls covered
3%
HKMA SPM
4 source controls mapped|2 target controls covered
3%
HKMA Cyber Resilience Assessment Framework (C-RAF)
4 source controls mapped|2 target controls covered
3%
GLI-33 - Gaming Laboratories International Event Wagering Systems
4 source controls mapped|1 target controls covered
3%
GLBA
4 source controls mapped|2 target controls covered
3%
FedRAMP Rev 5
4 source controls mapped|5 target controls covered
3%
PCI SSF
4 source controls mapped|4 target controls covered
3%
PCI PIN Security
4 source controls mapped|4 target controls covered
3%
South Korea ISMS-P
4 source controls mapped|2 target controls covered
3%
Security of Critical Infrastructure Act 2018 (SOCI)
4 source controls mapped|4 target controls covered
3%
IEC 62443
4 source controls mapped|2 target controls covered
3%
PCI P2PE
4 source controls mapped|4 target controls covered
3%
ISO/IEC 23894:2023
4 source controls mapped|6 target controls covered
3%
NIST Cybersecurity Framework 2.0
4 source controls mapped|5 target controls covered
3%
SSAE 18 - Attestation Standards (SOC Reporting)
4 source controls mapped|3 target controls covered
3%
FFIEC IT Examination Handbook
4 source controls mapped|4 target controls covered
3%
NIST SP 1800-32
4 source controls mapped|2 target controls covered
3%
ISO 28001:2007 Supply Chain Security Management
4 source controls mapped|2 target controls covered
3%
ISO 22320:2018
4 source controls mapped|4 target controls covered
3%
IAIS Insurance Core Principles (ICPs)
4 source controls mapped|3 target controls covered
3%
Kuwait National Cybersecurity Framework
4 source controls mapped|2 target controls covered
3%
Aged Care Quality Standards 2019 (repealed edition)
4 source controls mapped|3 target controls covered
3%
ISO 20400:2017 - Sustainable Procurement
4 source controls mapped|3 target controls covered
3%
NIST SP 800-53 Rev 5
4 source controls mapped|4 target controls covered
3%
ISO/IEC 27003:2017
4 source controls mapped|2 target controls covered
3%
IEC 62304:2015 Medical Device Software Lifecycle Processes
4 source controls mapped|6 target controls covered
3%
API 1164
4 source controls mapped|2 target controls covered
3%
Bermuda Monetary Authority (BMA) Cyber Risk Management Code of Conduct
4 source controls mapped|2 target controls covered
3%
Annex 11 to EU GMP - Computerised Systems
4 source controls mapped|4 target controls covered
3%
ISO/IEC 27019:2024
4 source controls mapped|2 target controls covered
3%
ISO 14064 - Greenhouse Gas Accounting and Verification (Parts 1-3)
4 source controls mapped|5 target controls covered
3%
FDA Quality Management System Regulation (QMSR)
4 source controls mapped|4 target controls covered
3%
UK Defence Standard 05-138 - Cyber Security for Defence Suppliers
3 source controls mapped|1 target controls covered
2%
SEC Climate Disclosure Rule
3 source controls mapped|1 target controls covered
2%
Own Risk and Solvency Assessment (ORSA) - NAIC Model Act
3 source controls mapped|1 target controls covered
2%
OECD Recommendation on Artificial Intelligence (2024 Update)
3 source controls mapped|1 target controls covered
2%
NRF Cybersecurity and Data Privacy Framework (National Retail Federation)
3 source controls mapped|2 target controls covered
2%
NIST SP 800-39
3 source controls mapped|2 target controls covered
2%
NIST SP 800-37
3 source controls mapped|2 target controls covered
2%
NIST SP 800-30
3 source controls mapped|3 target controls covered
2%
NIST Privacy Framework
3 source controls mapped|3 target controls covered
2%
New Zealand Information Security Manual (NZISM)
3 source controls mapped|1 target controls covered
2%
NERC CIP
3 source controls mapped|1 target controls covered
2%
Lloyd's of London Cyber Insurance Requirements and Underwriting Standards
3 source controls mapped|1 target controls covered
2%
IRM/AIRMIC/ALARM A Risk Management Standard (2002)
3 source controls mapped|1 target controls covered
2%
Global Cross-Border Privacy Rules (Global CBPR) Forum
3 source controls mapped|1 target controls covered
2%
German Supply Chain Due Diligence Act (LkSG)
3 source controls mapped|1 target controls covered
2%
BS 65000:2014 - Guidance on Organizational Resilience
3 source controls mapped|2 target controls covered
2%
EASA Part-IS - Information Security in Aviation
3 source controls mapped|3 target controls covered
2%
SOC for Cybersecurity - Cybersecurity Risk Management Examination
3 source controls mapped|3 target controls covered
2%
FFIEC Cybersecurity Assessment Tool (CAT)
3 source controls mapped|2 target controls covered
2%
APRA CPS 230 Operational Risk Management
3 source controls mapped|3 target controls covered
2%
Singapore AI Governance Framework
3 source controls mapped|1 target controls covered
2%
APRA SPS 220 Risk Management (Superannuation)
3 source controls mapped|1 target controls covered
2%
FBI CJIS Security Policy
3 source controls mapped|1 target controls covered
2%
Authorised Economic Operator (AEO) Programmes - Global Standards
3 source controls mapped|1 target controls covered
2%
TISAX - Trusted Information Security Assessment Exchange
3 source controls mapped|2 target controls covered
2%
APRA CPS 234
3 source controls mapped|2 target controls covered
2%
Solvency II
3 source controls mapped|3 target controls covered
2%
AS9100D - Aerospace Quality Management System
3 source controls mapped|1 target controls covered
2%
AML/CTF Act 2006 (Australia)
3 source controls mapped|1 target controls covered
2%
UAE Virtual Asset Regulatory Authority (VARA) Regulations
3 source controls mapped|1 target controls covered
2%
Telecommunications Sector Security Reforms (TSSR)
3 source controls mapped|1 target controls covered
2%
Science Based Targets Initiative (SBTi) - Net-Zero Standard
3 source controls mapped|6 target controls covered
2%
ITU Radio Regulations and Space Security Standards
3 source controls mapped|1 target controls covered
2%
TEFCA - Trusted Exchange Framework and Common Agreement
3 source controls mapped|2 target controls covered
2%
SLSA
3 source controls mapped|1 target controls covered
2%
SIG (Shared Assessments)
3 source controls mapped|2 target controls covered
2%
Regulation on the European Health Data Space (EHDS)
3 source controls mapped|3 target controls covered
2%
PTES
3 source controls mapped|1 target controls covered
2%
OWASP SAMM
3 source controls mapped|2 target controls covered
2%
OWASP MASVS
3 source controls mapped|2 target controls covered
2%
OWASP ASVS
3 source controls mapped|2 target controls covered
2%
OpenSSF Scorecard
3 source controls mapped|2 target controls covered
2%
NIST SP 800-92
3 source controls mapped|2 target controls covered
2%
NIST SP 800-88
3 source controls mapped|1 target controls covered
2%
NIST SP 800-63-4
3 source controls mapped|2 target controls covered
2%
NIST SP 800-61 Rev. 3
3 source controls mapped|2 target controls covered
2%
NIST SP 800-146
3 source controls mapped|2 target controls covered
2%
NIST SP 800-145
3 source controls mapped|2 target controls covered
2%
NIST SP 800-144
3 source controls mapped|2 target controls covered
2%
NIST SP 800-137
3 source controls mapped|1 target controls covered
2%
NIST SP 800-123
3 source controls mapped|1 target controls covered
2%
NIST SP 800-115 (Technical Guide to Information Security Testing and Assessment)
3 source controls mapped|2 target controls covered
2%
MITRE D3FEND
3 source controls mapped|2 target controls covered
2%
MITRE ATT&CK
3 source controls mapped|2 target controls covered
2%
ISMAP (Japan)
3 source controls mapped|2 target controls covered
2%
GAMP 5 - Good Automated Manufacturing Practice
3 source controls mapped|2 target controls covered
2%
Florida Digital Bill of Rights (FDBR)
3 source controls mapped|3 target controls covered
2%
ISO/SAE 21434
3 source controls mapped|2 target controls covered
2%
NIST SP 800-190
3 source controls mapped|2 target controls covered
2%
ISO/IEC 27043:2015
3 source controls mapped|2 target controls covered
2%
WHO Global Strategy on Digital Health 2020-2025
3 source controls mapped|2 target controls covered
2%
ISO/IEC 29147:2018
2 source controls mapped|2 target controls covered
1%
WCAG 2.2
2 source controls mapped|1 target controls covered
1%
W3C Verifiable Credentials (VC) Data Model 2.0
2 source controls mapped|1 target controls covered
1%
Vietnam Law on Cybersecurity (No. 116/2025/QH15)
2 source controls mapped|1 target controls covered
1%
USMCA Chapter 19 - Digital Trade (United States-Mexico-Canada Agreement)
2 source controls mapped|1 target controls covered
1%
UK Gambling Commission LCCP and Remote Technical Standards
2 source controls mapped|2 target controls covered
1%
UK GDPR (UK General Data Protection Regulation)
2 source controls mapped|1 target controls covered
1%
Regional Comprehensive Economic Partnership (RCEP) - E-Commerce Chapter
2 source controls mapped|1 target controls covered
1%
UK Bribery Act 2010
2 source controls mapped|3 target controls covered
1%
Trinidad and Tobago Data Protection Act 2011
2 source controls mapped|3 target controls covered
1%
Tanzania Personal Data Protection Act 2022
2 source controls mapped|2 target controls covered
1%
Philippines Cybercrime Prevention Act (RA 10175)
2 source controls mapped|1 target controls covered
1%
PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR)
2 source controls mapped|2 target controls covered
1%
Pakistan Personal Data Protection Bill 2023
2 source controls mapped|2 target controls covered
1%
OWASP Top 10:2025
2 source controls mapped|1 target controls covered
1%
OWASP DevSecOps Maturity Model (DSOMM)
2 source controls mapped|2 target controls covered
1%
NRC 10 CFR 73.54 - Nuclear Facility Cybersecurity
2 source controls mapped|5 target controls covered
1%
Notifiable Data Breaches Scheme (Australia)
2 source controls mapped|1 target controls covered
1%
NIST Special Publication 800-34 Revision 1, Contingency Planning Guide for Federal Information Systems
2 source controls mapped|2 target controls covered
1%
NIST Post-Quantum Cryptography Standards (FIPS 203, 204, 205)
2 source controls mapped|1 target controls covered
1%
Nigeria Data Protection Act 2023 (NDPA)
2 source controls mapped|3 target controls covered
1%
Nebraska Data Privacy Act
2 source controls mapped|3 target controls covered
1%
NATO STANAG 4774 (Confidentiality Metadata Labels) and STANAG 4778 (Metadata Binding)
2 source controls mapped|2 target controls covered
1%
South Korea PIPA
2 source controls mapped|1 target controls covered
1%
ITAR - International Traffic in Arms Regulations
2 source controls mapped|1 target controls covered
1%
Italy Personal Data Protection Code (Legislative Decree No. 196/2003, amended 2018)
2 source controls mapped|1 target controls covered
1%
Israel Protection of Privacy Law (5741-1981)
2 source controls mapped|2 target controls covered
1%
India Account Aggregator Framework (RBI)
2 source controls mapped|1 target controls covered
1%
IATF 16949:2016 - Quality Management System for Automotive Production
2 source controls mapped|2 target controls covered
1%
IATA Operational Safety Audit (IOSA) Standards Manual
2 source controls mapped|1 target controls covered
1%
IAEA Nuclear Security Series - Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
2 source controls mapped|3 target controls covered
1%
FTC GLBA Safeguards Rule (16 CFR Part 314)
2 source controls mapped|1 target controls covered
1%
French Sapin II Law (Law No. 2016-1691)
2 source controls mapped|1 target controls covered
1%
Federal Decree-Law No. 45 of 2021 on the Protection of Personal Data (UAE PDPL)
2 source controls mapped|2 target controls covered
1%
FCC Customer Proprietary Network Information (CPNI) and Data Breach Rules (47 CFR 64.2001-2011)
2 source controls mapped|2 target controls covered
1%
FATF Recommendation 16 - Payment Transparency (Travel Rule)
2 source controls mapped|1 target controls covered
1%
ISO/IEC 27004:2016
2 source controls mapped|3 target controls covered
1%
ASIS SPC.1-2009 - Organizational Resilience Standard
2 source controls mapped|1 target controls covered
1%
ISO/IEC 30111:2019
2 source controls mapped|2 target controls covered
1%
ISO/IEC 29100:2024
2 source controls mapped|3 target controls covered
1%
ISO/IEC 29115:2013 - Entity Authentication Assurance Framework
2 source controls mapped|1 target controls covered
1%
ISO/IEC 27050-1:2019
2 source controls mapped|1 target controls covered
1%
PCI DSS 4.0
2 source controls mapped|1 target controls covered
1%
ISO/IEC 27014:2020
2 source controls mapped|2 target controls covered
1%
ISO/IEC 27011:2024
2 source controls mapped|2 target controls covered
1%
US Foreign Corrupt Practices Act (FCPA)
2 source controls mapped|1 target controls covered
1%
ISO/IEC 23837:2023
2 source controls mapped|1 target controls covered
1%
ISO/IEC 29134:2023
2 source controls mapped|1 target controls covered
1%
ISO/IEC 27400:2022
2 source controls mapped|1 target controls covered
1%
ISO/IEC 27007:2020
2 source controls mapped|1 target controls covered
1%
ISO/IEC 27031:2011
2 source controls mapped|1 target controls covered
1%
SANS Incident Handler's Handbook and PICERL Methodology
2 source controls mapped|2 target controls covered
1%
Barbados Data Protection Act 2019
2 source controls mapped|1 target controls covered
1%
Automotive SPICE (ASPICE) v4.1 - Process Assessment Model
2 source controls mapped|2 target controls covered
1%
Rhode Island Data Transparency and Privacy Protection Act (RIDTPPA)
2 source controls mapped|1 target controls covered
1%
ISO/IEC 25012:2008 - Data Quality Model
2 source controls mapped|2 target controls covered
1%
DAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition)
2 source controls mapped|3 target controls covered
1%
NIST SP 800-124 Revision 2 - Guidelines for Managing the Security of Mobile Devices
2 source controls mapped|3 target controls covered
1%
COBIT 2019
2 source controls mapped|1 target controls covered
1%
US SEC Digital Assets and Crypto Regulatory Framework
2 source controls mapped|2 target controls covered
1%
Azerbaijan Law on Personal Data (2010)
2 source controls mapped|1 target controls covered
1%
Illinois Biometric Information Privacy Act (BIPA)
2 source controls mapped|1 target controls covered
1%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
2 source controls mapped|2 target controls covered
1%
ISO 56002
2 source controls mapped|2 target controls covered
1%
ISO/IEC 17025:2017 - General Requirements for Testing and Calibration
2 source controls mapped|2 target controls covered
1%
ISO 19650 - Organisation and Digitisation of Information about Buildings and Civil Engineering Works (BIM)
2 source controls mapped|3 target controls covered
1%
Switzerland New Federal Act on Data Protection (nFADP/nDSG, 2023)
2 source controls mapped|1 target controls covered
1%
SOC 2
2 source controls mapped|2 target controls covered
1%
FedRAMP High
2 source controls mapped|1 target controls covered
1%
FedRAMP Moderate
2 source controls mapped|1 target controls covered
1%
Singapore Cybersecurity Act 2018
2 source controls mapped|1 target controls covered
1%
Albania Law No. 124/2024 on Personal Data Protection
2 source controls mapped|2 target controls covered
1%
ISO 8000 - Data Quality
2 source controls mapped|2 target controls covered
1%
UK Open Banking Standard
2 source controls mapped|1 target controls covered
1%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
2 source controls mapped|1 target controls covered
1%
Sweden Data Protection Act (Dataskyddslag, 2018:218)
2 source controls mapped|1 target controls covered
1%
AICPA Privacy Management Framework (PMF)
2 source controls mapped|2 target controls covered
1%
ISO 41001:2018 - Facility Management Systems
2 source controls mapped|2 target controls covered
1%
IEC 62351 - Power Systems Communication Security
2 source controls mapped|1 target controls covered
1%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
2 source controls mapped|1 target controls covered
1%
Belgium Data Protection Act (Wet van 30 juli 2018, Loi du 30 juillet 2018)
2 source controls mapped|1 target controls covered
1%
DFARS 252.204-7012 - Safeguarding Covered Defense Information
2 source controls mapped|1 target controls covered
1%
UK Telecommunications (Security) Act 2021
2 source controls mapped|1 target controls covered
1%
ISO 26262:2018 - Functional Safety for Road Vehicles
2 source controls mapped|1 target controls covered
1%
Connecticut Data Privacy Act (CTDPA)
2 source controls mapped|1 target controls covered
1%
NAIC Insurance Data Security Model Law (MDL-668)
2 source controls mapped|2 target controls covered
1%
ISO 13485:2016
1 source controls mapped|1 target controls covered
1%
OECD Guidelines for Multinational Enterprises on Responsible Business Conduct (2023 Update)
1 source controls mapped|1 target controls covered
1%
NIST AI 600-1: Generative AI Profile
1 source controls mapped|1 target controls covered
1%
GHG Protocol
1 source controls mapped|1 target controls covered
1%
ISO 26000:2010
1 source controls mapped|2 target controls covered
1%
BREEAM - Building Research Establishment Environmental Assessment Method
1 source controls mapped|3 target controls covered
1%
ISO/IEC 27010:2015
1 source controls mapped|1 target controls covered
1%
PAS 1192-5:2015 - Security-Minded Approach to BIM and Digital Built Environments
1 source controls mapped|1 target controls covered
1%
Oman National Cybersecurity Framework
1 source controls mapped|1 target controls covered
1%
Ghana Cybersecurity Act
1 source controls mapped|1 target controls covered
1%
FISMA
1 source controls mapped|1 target controls covered
1%
21 CFR Part 211 - Current Good Manufacturing Practice
1 source controls mapped|3 target controls covered
1%
Belgium CyberFundamentals
1 source controls mapped|1 target controls covered
1%
NSA Guidance for Transition to Quantum-Resistant Cryptography
1 source controls mapped|1 target controls covered
1%
BSI IT-Grundschutz
1 source controls mapped|1 target controls covered
1%
NATO AQAP 2110 - Quality Assurance Requirements for Design, Development, and Production
1 source controls mapped|1 target controls covered
1%
MDS2 (Medical Device)
1 source controls mapped|3 target controls covered
1%
HITECH Act
1 source controls mapped|3 target controls covered
1%
COSO Internal Control - Integrated Framework (2013)
1 source controls mapped|2 target controls covered
1%
UNESCO Recommendation on the Ethics of AI
1 source controls mapped|1 target controls covered
1%
Coverage is not the same as your position
This page shows what IEC 60601-1 - Medical Electrical Equipment Safety overlaps with in general. Where your organisation actually stands, against the standard you are going for and the certifications you already hold, is a different question. Same graph and the same recorded refutations, scoped to you rather than to a pair.
The Compliance Position Diagnostic, $5,000 fixed, ten business daysWhat is IEC 60601-1 - Medical Electrical Equipment Safety and who does it apply to?
IEC 60601-1 - Medical Electrical Equipment Safety is a compliance framework from International (IEC); adopted as EN 60601-1, ANSI/AAMI ES60601-1, CSA C22.2 No. 60601-1 and nationally with 9 domains and 102 controls. The IEC general standard for the basic safety and essential performance of medical electrical equipment and systems, built from the complete Edition 3.1 text (2005 with Amendment 1:2012): 102 sub-clause leaves covering risk management, electrical, mechanical, thermal and radiation hazards, marking and documents, PEMS, construction and ME systems. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
What does IEC 60601-1 - Medical Electrical Equipment Safety actually require?
IEC 60601-1 - Medical Electrical Equipment Safety has 102 controls organised across 9 domains. The largest domains are Clauses 4 to 5: general requirements and testing – IEC 60601-1 - Medical Electrical Equipment Safety (20 controls), Clauses 6 to 7: classification, identification, marking and documents – IEC 60601-1 - Medical Electrical Equipment Safety (15 controls), Clauses 11 to 13: temperatures, fire, outputs, hazardous situations and fault conditions – IEC 60601-1 - Medical Electrical Equipment Safety (14 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
If I already comply with another framework, how much of IEC 60601-1 - Medical Electrical Equipment Safety do I already cover?
IEC 60601-1 - Medical Electrical Equipment Safety maps to 222 other compliance frameworks. The top mapping partners are SASB Standards (4% coverage), Protective Security Policy Framework (PSPF) Release 2026 (4% coverage), PIC/S Guide to Good Manufacturing Practice for Medicinal Products (4% coverage). Use our comparison tool to explore control-level mappings between frameworks.
How do I implement IEC 60601-1 - Medical Electrical Equipment Safety?
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 102 controls and track your progress.
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