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IEC 60601-1 - Medical Electrical Equipment Safety

Self-Assess
International
vEdition 3.2 (2020)
20 domains
41 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).

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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 (20)

Clause 1-3: Scope, References, and Terminology

3 controls
Controls in the Clause 1-3: Scope, References, and Terminology domain of IEC 60601-1 - Medical Electrical Equipment Safety — 3 controls
CodeTitle
60601-1.1Scope, object, and related standards
60601-1.2Normative references
60601-1.3Terminology and definitions

Clause 11-14: Temperatures, Accuracy, Faults, and PEMS

4 controls
Controls in the Clause 11-14: Temperatures, Accuracy, Faults, and PEMS domain of IEC 60601-1 - Medical Electrical Equipment Safety — 4 controls
CodeTitle
60601-1.11Protection against excessive temperatures and other hazards
60601-1.12Accuracy of controls and instruments
60601-1.13Hazardous situations and fault conditions
60601-1.14Programmable electrical medical systems (PEMS)

Clause 15-17: Construction, ME Systems, and EMC

3 controls
Controls in the Clause 15-17: Construction, ME Systems, and EMC domain of IEC 60601-1 - Medical Electrical Equipment Safety — 3 controls
CodeTitle
60601-1.15Construction of ME equipment
60601-1.16ME systems
60601-1.17Electromagnetic compatibility (EMC)

Clause 4-5: General Requirements and Testing

4 controls
Controls in the Clause 4-5: General Requirements and Testing domain of IEC 60601-1 - Medical Electrical Equipment Safety — 4 controls
CodeTitle
60601-1.4.1General requirements
60601-1.4.2Risk management process
60601-1.5.1General requirements for testing
60601-1.5.2Test conditions and environment

Clause 6-7: Classification, Identification and Marking

3 controls
Controls in the Clause 6-7: Classification, Identification and Marking domain of IEC 60601-1 - Medical Electrical Equipment Safety — 3 controls
CodeTitle
60601-1.6Classification of ME equipment and systems
60601-1.7.1Equipment identification and marking
60601-1.7.2Documents and instructions for use

Clause 8-10: Protection Against Hazards

3 controls
Controls in the Clause 8-10: Protection Against Hazards domain of IEC 60601-1 - Medical Electrical Equipment Safety — 3 controls
CodeTitle
60601-1.10Protection against radiation hazards
60601-1.8Protection against electrical hazards
60601-1.9Protection against mechanical hazards

Collateral - Alarms

1 controls
Controls in the Collateral - Alarms domain of IEC 60601-1 - Medical Electrical Equipment Safety — 1 controls
CodeTitle
60601-1-8Alarm Systems

Collateral - EMC

1 controls
Controls in the Collateral - EMC domain of IEC 60601-1 - Medical Electrical Equipment Safety — 1 controls
CodeTitle
60601-1-2Electromagnetic Compatibility

Collateral - Environment

2 controls
Controls in the Collateral - Environment domain of IEC 60601-1 - Medical Electrical Equipment Safety — 2 controls
CodeTitle
60601-1-11Home Healthcare Environment
60601-1-12Emergency Medical Services Environment

Collateral - Usability

1 controls
Controls in the Collateral - Usability domain of IEC 60601-1 - Medical Electrical Equipment Safety — 1 controls
CodeTitle
60601-1-6Usability Engineering

Construction

1 controls
Controls in the Construction domain of IEC 60601-1 - Medical Electrical Equipment Safety — 1 controls
CodeTitle
60601-1-15Construction and Components

Electrical

3 controls
Controls in the Electrical domain of IEC 60601-1 - Medical Electrical Equipment Safety — 3 controls
CodeTitle
60601-1-10Protective Earth Connection
60601-1-8Alarm Systems
60601-1-9Leakage Current Testing

Energy

2 controls
Controls in the Energy domain of IEC 60601-1 - Medical Electrical Equipment Safety — 2 controls
CodeTitle
60601-1-11Home Healthcare Environment
60601-1-12Emergency Medical Services Environment

General Requirements

3 controls
Controls in the General Requirements domain of IEC 60601-1 - Medical Electrical Equipment Safety — 3 controls
CodeTitle
60601-1-4.2Risk Management Process
60601-1-4.3Essential Performance
60601-1-4.5Equivalent Safety

Information

1 controls
Controls in the Information domain of IEC 60601-1 - Medical Electrical Equipment Safety — 1 controls
CodeTitle
60601-1-16Marking, Labelling and Documents

Lifecycle

1 controls
Controls in the Lifecycle domain of IEC 60601-1 - Medical Electrical Equipment Safety — 1 controls
CodeTitle
60601-1-PMSPost-Market Surveillance Feedback

Mechanical

1 controls
Controls in the Mechanical domain of IEC 60601-1 - Medical Electrical Equipment Safety — 1 controls
CodeTitle
60601-1-7Mechanical Hazards

Production

1 controls
Controls in the Production domain of IEC 60601-1 - Medical Electrical Equipment Safety — 1 controls
CodeTitle
60601-1-PRODProduction and Routine Testing

Security

1 controls
Controls in the Security domain of IEC 60601-1 - Medical Electrical Equipment Safety — 1 controls
CodeTitle
60601-1-CYBCybersecurity for Networked Equipment

Software

2 controls
Controls in the Software domain of IEC 60601-1 - Medical Electrical Equipment Safety — 2 controls
CodeTitle
60601-1-13Software Lifecycle (IEC 62304)
60601-1-14Programmable Electrical Medical System (PEMS)

Your Compliance Coverage

If you comply with IEC 60601-1 - Medical Electrical Equipment Safety, you already cover:

NIST AI Risk Management Framework (AI RMF 1.0)

13%

5 controls mapped

Compare →

PIC/S Guide to Good Manufacturing Practice for Medicinal Products

13%

5 controls mapped

Compare →

ICH Q10 - Pharmaceutical Quality System

13%

5 controls mapped

Compare →

+ 223 more: ICH E6(R3) - Good Clinical Practice (13%), ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence (13%)

See all 226 mapped frameworks ↓

Maps to 226 other frameworks

38 total controls
NIST AI Risk Management Framework (AI RMF 1.0)
5 source controls mapped|4 target controls covered
13%
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
5 source controls mapped|4 target controls covered
13%
ICH Q10 - Pharmaceutical Quality System
5 source controls mapped|4 target controls covered
13%
ICH E6(R3) - Good Clinical Practice
5 source controls mapped|4 target controls covered
13%
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
5 source controls mapped|8 target controls covered
13%
Protective Security Policy Framework (PSPF) Release 2024
5 source controls mapped|2 target controls covered
13%
MTCS (Singapore)
5 source controls mapped|3 target controls covered
13%
SASB Standards
4 source controls mapped|2 target controls covered
11%
ICMM Mining Principles (2024 Update)
4 source controls mapped|2 target controls covered
11%
ISO 14064 - Greenhouse Gas Accounting and Verification (Parts 1-3)
4 source controls mapped|5 target controls covered
11%
FDA Quality Management System Regulation (QMSR)
4 source controls mapped|4 target controls covered
11%
Aged Care Quality Standards (Australia)
4 source controls mapped|3 target controls covered
11%
UK AI Regulation Framework
4 source controls mapped|1 target controls covered
11%
OECD AI Principles
4 source controls mapped|2 target controls covered
11%
NIS2 Directive
4 source controls mapped|2 target controls covered
11%
Japan AI Guidelines
4 source controls mapped|4 target controls covered
11%
IEEE 7000
4 source controls mapped|2 target controls covered
11%
IEEE 1686
4 source controls mapped|2 target controls covered
11%
IEC 62443
4 source controls mapped|2 target controls covered
11%
NIST SP 800-53 Rev 5
4 source controls mapped|4 target controls covered
11%
API 1164
4 source controls mapped|2 target controls covered
11%
NIST SP 1800-32
4 source controls mapped|2 target controls covered
11%
ISO 27019
4 source controls mapped|2 target controls covered
11%
ISO/IEC 38500:2024 - Governance of IT
4 source controls mapped|4 target controls covered
11%
PSD2 SCA
4 source controls mapped|2 target controls covered
11%
OSFI B-13
4 source controls mapped|2 target controls covered
11%
Open Banking Security
4 source controls mapped|2 target controls covered
11%
OCC Heightened Standards (12 CFR Part 30, Appendix D)
4 source controls mapped|3 target controls covered
11%
O-RAN WG11 Security Specification
4 source controls mapped|4 target controls covered
11%
NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security
4 source controls mapped|2 target controls covered
11%
Monetary Authority of Singapore Technology Risk Management Guidelines
4 source controls mapped|2 target controls covered
11%
IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)
4 source controls mapped|1 target controls covered
11%
ICAO Annex 17 - Aviation Security (AVSEC)
4 source controls mapped|3 target controls covered
11%
HKMA SPM
4 source controls mapped|2 target controls covered
11%
HKMA Cyber Resilience Assessment Framework (C-RAF)
4 source controls mapped|2 target controls covered
11%
GLI-33 - Gaming Laboratories International Event Wagering Systems
4 source controls mapped|1 target controls covered
11%
GLBA
4 source controls mapped|2 target controls covered
11%
FedRAMP Rev 5
4 source controls mapped|3 target controls covered
11%
ISO/IEC 27557:2022 - Organisational Privacy Risk Management
4 source controls mapped|7 target controls covered
11%
ISO/IEC 23837 - Security Requirements for Quantum Key Distribution
4 source controls mapped|3 target controls covered
11%
NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements
4 source controls mapped|5 target controls covered
11%
Annex 11 to EU GMP - Computerised Systems
4 source controls mapped|4 target controls covered
11%
ISO 20400:2017 - Sustainable Procurement
4 source controls mapped|3 target controls covered
11%
PCI PIN Security
4 source controls mapped|4 target controls covered
11%
IEC 62304:2015 Medical Device Software Lifecycle Processes
4 source controls mapped|6 target controls covered
11%
NIST Cybersecurity Framework 2.0
4 source controls mapped|5 target controls covered
11%
Bermuda Monetary Authority (BMA) Cyber Risk Management Code of Conduct
4 source controls mapped|2 target controls covered
11%
IAIS Insurance Core Principles (ICPs)
4 source controls mapped|3 target controls covered
11%
ISO/IEC 23894:2023
4 source controls mapped|6 target controls covered
11%
ISO 22320:2018
4 source controls mapped|4 target controls covered
11%
PCI P2PE
4 source controls mapped|4 target controls covered
11%
PCI SSF
4 source controls mapped|4 target controls covered
11%
APRA CPS 234
4 source controls mapped|4 target controls covered
11%
FFIEC IT Examination Handbook
4 source controls mapped|4 target controls covered
11%
ISO 37000:2021 - Governance of Organizations
4 source controls mapped|4 target controls covered
11%
AS9100D - Aerospace Quality Management System
4 source controls mapped|4 target controls covered
11%
ISO/IEC 27003:2017
4 source controls mapped|4 target controls covered
11%
SSAE 18 - Attestation Standards (SOC Reporting)
4 source controls mapped|3 target controls covered
11%
ISO 28001:2007 Supply Chain Security Management
4 source controls mapped|2 target controls covered
11%
ITU Radio Regulations and Space Security Standards
3 source controls mapped|1 target controls covered
8%
TEFCA - Trusted Exchange Framework and Common Agreement
3 source controls mapped|2 target controls covered
8%
Regulation on the European Health Data Space (EHDS)
3 source controls mapped|3 target controls covered
8%
GAMP 5 - Good Automated Manufacturing Practice
3 source controls mapped|2 target controls covered
8%
Florida Digital Bill of Rights (FDBR)
3 source controls mapped|1 target controls covered
8%
ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories
3 source controls mapped|5 target controls covered
8%
SLSA
3 source controls mapped|1 target controls covered
8%
SIG (Shared Assessments)
3 source controls mapped|2 target controls covered
8%
PTES
3 source controls mapped|1 target controls covered
8%
OWASP SAMM
3 source controls mapped|2 target controls covered
8%
OWASP MASVS
3 source controls mapped|2 target controls covered
8%
OWASP ASVS
3 source controls mapped|2 target controls covered
8%
OpenSSF Scorecard
3 source controls mapped|2 target controls covered
8%
NIST SP 800-92
3 source controls mapped|2 target controls covered
8%
NIST SP 800-88
3 source controls mapped|1 target controls covered
8%
NIST SP 800-63-4
3 source controls mapped|2 target controls covered
8%
NIST SP 800-61
3 source controls mapped|2 target controls covered
8%
NIST SP 800-146
3 source controls mapped|2 target controls covered
8%
NIST SP 800-145
3 source controls mapped|2 target controls covered
8%
NIST SP 800-144
3 source controls mapped|2 target controls covered
8%
NIST SP 800-137
3 source controls mapped|1 target controls covered
8%
NIST SP 800-123
3 source controls mapped|1 target controls covered
8%
NIST SP 800-115 (Technical Guide to Information Security Testing and Assessment)
3 source controls mapped|2 target controls covered
8%
MITRE D3FEND
3 source controls mapped|2 target controls covered
8%
MITRE ATT&CK
3 source controls mapped|2 target controls covered
8%
ISMAP (Japan)
3 source controls mapped|2 target controls covered
8%
21 CFR Part 211 - Current Good Manufacturing Practice
3 source controls mapped|4 target controls covered
8%
ISO 27043
3 source controls mapped|2 target controls covered
8%
ISO 27018
3 source controls mapped|2 target controls covered
8%
NIST SP 800-190
3 source controls mapped|2 target controls covered
8%
ISO/SAE 21434
3 source controls mapped|2 target controls covered
8%
AWS Well-Architected Security Pillar
3 source controls mapped|2 target controls covered
8%
ISO 27017
3 source controls mapped|2 target controls covered
8%
Azure Security Benchmark
3 source controls mapped|2 target controls covered
8%
UK Defence Standard 05-138 - Cyber Security for Defence Suppliers
3 source controls mapped|1 target controls covered
8%
SEC Climate Disclosure Rule
3 source controls mapped|1 target controls covered
8%
Own Risk and Solvency Assessment (ORSA) - NAIC Model Act
3 source controls mapped|1 target controls covered
8%
OECD Recommendation on Artificial Intelligence (2024 Update)
3 source controls mapped|1 target controls covered
8%
NRF Cybersecurity and Data Privacy Framework (National Retail Federation)
3 source controls mapped|2 target controls covered
8%
NIST SP 800-39
3 source controls mapped|2 target controls covered
8%
NIST SP 800-37
3 source controls mapped|2 target controls covered
8%
NIST SP 800-30
3 source controls mapped|3 target controls covered
8%
NIST Privacy Framework
3 source controls mapped|3 target controls covered
8%
NIS2 Directive Implementing Acts
3 source controls mapped|1 target controls covered
8%
New Zealand Information Security Manual (NZISM)
3 source controls mapped|1 target controls covered
8%
NERC CIP
3 source controls mapped|1 target controls covered
8%
Lloyd's of London Cyber Insurance Requirements and Underwriting Standards
3 source controls mapped|1 target controls covered
8%
IRM Enterprise Risk Management Framework (Institute of Risk Management)
3 source controls mapped|1 target controls covered
8%
Global Cross-Border Privacy Rules (Global CBPR) Forum
3 source controls mapped|1 target controls covered
8%
German Supply Chain Due Diligence Act (LkSG)
3 source controls mapped|1 target controls covered
8%
APRA SPS 220 Risk Management (Superannuation)
3 source controls mapped|3 target controls covered
8%
ISO 31000
3 source controls mapped|3 target controls covered
8%
AML/CTF Act 2006 (Australia)
3 source controls mapped|1 target controls covered
8%
ISO 27005
3 source controls mapped|3 target controls covered
8%
APRA CPS 230 Operational Risk Management
3 source controls mapped|3 target controls covered
8%
BS 65000:2014 - Guidance on Organizational Resilience
3 source controls mapped|2 target controls covered
8%
FFIEC Cybersecurity Assessment Tool (CAT)
3 source controls mapped|2 target controls covered
8%
EASA Part-IS - Information Security in Aviation
3 source controls mapped|3 target controls covered
8%
AS9100D:2016 - Quality Management Systems for Aviation, Space, and Defence
3 source controls mapped|2 target controls covered
8%
Canada Artificial Intelligence and Data Act (AIDA)
3 source controls mapped|1 target controls covered
8%
FBI CJIS Security Policy
3 source controls mapped|1 target controls covered
8%
Authorised Economic Operator (AEO) Programmes - Global Standards
3 source controls mapped|1 target controls covered
8%
NAIC Insurance Data Security Model Law (MDL-668)
2 source controls mapped|2 target controls covered
5%
WCAG 2.2
2 source controls mapped|1 target controls covered
5%
W3C Verifiable Credentials (VC) Data Model 2.0
2 source controls mapped|1 target controls covered
5%
Vietnam Law on Cybersecurity (No. 24/2018/QH14)
2 source controls mapped|1 target controls covered
5%
USMCA Chapter 19 - Digital Trade (United States-Mexico-Canada Agreement)
2 source controls mapped|1 target controls covered
5%
UK Gambling Commission - Cyber Resilience Requirements
2 source controls mapped|2 target controls covered
5%
UK GDPR (UK General Data Protection Regulation)
2 source controls mapped|1 target controls covered
5%
Regional Comprehensive Economic Partnership (RCEP) - E-Commerce Chapter
2 source controls mapped|1 target controls covered
5%
UK Bribery Act 2010
2 source controls mapped|1 target controls covered
5%
Trinidad and Tobago Data Protection Act 2011
2 source controls mapped|3 target controls covered
5%
Tanzania Personal Data Protection Act (Draft)
2 source controls mapped|2 target controls covered
5%
Philippines Cybercrime Prevention Act (RA 10175)
2 source controls mapped|1 target controls covered
5%
PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR)
2 source controls mapped|2 target controls covered
5%
Pakistan Personal Data Protection Bill 2023
2 source controls mapped|2 target controls covered
5%
OWASP Top 10:2025
2 source controls mapped|1 target controls covered
5%
OWASP DevSecOps Maturity Model (DSOMM)
2 source controls mapped|2 target controls covered
5%
NRC 10 CFR 73.54 - Nuclear Facility Cybersecurity
2 source controls mapped|2 target controls covered
5%
Notifiable Data Breaches Scheme (Australia)
2 source controls mapped|1 target controls covered
5%
NIST Special Publication 800-34 Revision 1, Contingency Planning Guide for Federal Information Systems
2 source controls mapped|2 target controls covered
5%
NIST Post-Quantum Cryptography Standards (FIPS 203, 204, 205)
2 source controls mapped|1 target controls covered
5%
Nigeria Data Protection Act 2023 (NDPA)
2 source controls mapped|3 target controls covered
5%
Nebraska Data Privacy Act
2 source controls mapped|3 target controls covered
5%
NATO STANAG 4774 (Confidentiality Metadata Labels) and STANAG 4778 (Metadata Binding)
2 source controls mapped|2 target controls covered
5%
South Korea PIPA
2 source controls mapped|1 target controls covered
5%
ITAR - International Traffic in Arms Regulations
2 source controls mapped|1 target controls covered
5%
Italy Personal Data Protection Code (Legislative Decree No. 196/2003, amended 2018)
2 source controls mapped|1 target controls covered
5%
Israel Protection of Privacy Law (5741-1981)
2 source controls mapped|2 target controls covered
5%
India Account Aggregator Framework (RBI)
2 source controls mapped|1 target controls covered
5%
IATF 16949:2016 - Quality Management System for Automotive Production
2 source controls mapped|2 target controls covered
5%
IATA Operational Safety Audit (IOSA) Standards Manual
2 source controls mapped|1 target controls covered
5%
IAEA Nuclear Security Series - Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
2 source controls mapped|3 target controls covered
5%
FTC GLBA Safeguards Rule (16 CFR Part 314)
2 source controls mapped|1 target controls covered
5%
French Sapin II Law (Law No. 2016-1691)
2 source controls mapped|1 target controls covered
5%
Federal Decree-Law No. 45 of 2021 on the Protection of Personal Data (UAE PDPL)
2 source controls mapped|2 target controls covered
5%
FCC Customer Proprietary Network Information (CPNI) and Data Breach Rules (47 CFR 64.2001-2011)
2 source controls mapped|2 target controls covered
5%
FATF Recommendation 16 - Virtual Asset Travel Rule
2 source controls mapped|1 target controls covered
5%
ISO/IEC 29100:2024
2 source controls mapped|3 target controls covered
5%
21 CFR Part 58 - Good Laboratory Practice (GLP)
2 source controls mapped|2 target controls covered
5%
BRCGS Global Standard for Food Safety Issue 9
2 source controls mapped|3 target controls covered
5%
ISO/IEC 27400:2022
2 source controls mapped|3 target controls covered
5%
ISO/IEC 27011:2024
2 source controls mapped|3 target controls covered
5%
ISO 19011
2 source controls mapped|2 target controls covered
5%
ISO/IEC 29134:2023
2 source controls mapped|3 target controls covered
5%
ISO/IEC 27014:2020
2 source controls mapped|3 target controls covered
5%
ISO/IEC 29147:2018
2 source controls mapped|3 target controls covered
5%
ISO/IEC 27004:2016
2 source controls mapped|3 target controls covered
5%
ISO/IEC 29115:2023 - Entity Authentication Assurance Framework
2 source controls mapped|1 target controls covered
5%
ISO/IEC 27031:2011
2 source controls mapped|1 target controls covered
5%
ISO/IEC 27007:2020
2 source controls mapped|1 target controls covered
5%
ISO 31000:2018
2 source controls mapped|1 target controls covered
5%
ISO/IEC 30111:2019
2 source controls mapped|3 target controls covered
5%
ISO/IEC 27050 - Electronic Discovery (Parts 1-4)
2 source controls mapped|1 target controls covered
5%
ASIS SPC.1-2009 - Organizational Resilience Standard
2 source controls mapped|1 target controls covered
5%
NIST SP 800-124 Revision 2 - Guidelines for Managing the Security of Mobile Devices
2 source controls mapped|3 target controls covered
5%
ISO 56002
2 source controls mapped|4 target controls covered
5%
ISO 19650 - Organisation and Digitisation of Information about Buildings and Civil Engineering Works (BIM)
2 source controls mapped|3 target controls covered
5%
SOC 2
2 source controls mapped|2 target controls covered
5%
AICPA Privacy Management Framework (PMF)
2 source controls mapped|2 target controls covered
5%
DAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition)
2 source controls mapped|3 target controls covered
5%
ISO 41001:2018 - Facility Management Systems
2 source controls mapped|3 target controls covered
5%
ISO 39001:2012 - Road Traffic Safety Management
2 source controls mapped|3 target controls covered
5%
ISO 37002:2021 - Whistleblowing Management Systems
2 source controls mapped|3 target controls covered
5%
ISO 22313:2020 - Guidance on Business Continuity Management Systems
2 source controls mapped|3 target controls covered
5%
IEC 62351 - Power Systems Communication Security
2 source controls mapped|1 target controls covered
5%
ISO 22739:2024 - Blockchain and Distributed Ledger Technologies Vocabulary
2 source controls mapped|3 target controls covered
5%
ISO 26262:2018 - Functional Safety for Road Vehicles
2 source controls mapped|1 target controls covered
5%
SANS Incident Handler's Handbook and PICERL Methodology
2 source controls mapped|2 target controls covered
5%
Automotive SPICE (ASPICE) v4.0 - Process Assessment Model
2 source controls mapped|2 target controls covered
5%
Rhode Island Data Transparency and Privacy Protection Act (RIDTPPA)
2 source controls mapped|1 target controls covered
5%
ISO/IEC 27006:2024
2 source controls mapped|3 target controls covered
5%
Belgium Data Protection Act (Wet van 30 juli 2018, Loi du 30 juillet 2018)
2 source controls mapped|2 target controls covered
5%
COBIT 2019
2 source controls mapped|1 target controls covered
5%
Illinois Biometric Information Privacy Act (BIPA)
2 source controls mapped|3 target controls covered
5%
FedRAMP High
2 source controls mapped|1 target controls covered
5%
NIST SP 800-53 Revision 5.1 HIGH
2 source controls mapped|1 target controls covered
5%
FedRAMP Moderate
2 source controls mapped|1 target controls covered
5%
NIST SP 800-53 Rev 5 MODERATE
2 source controls mapped|1 target controls covered
5%
NIST SP 800-53 Rev 5 LOW
2 source controls mapped|1 target controls covered
5%
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)
2 source controls mapped|2 target controls covered
5%
ISO 8000 - Data Quality
2 source controls mapped|2 target controls covered
5%
Barbados Data Protection Act 2019
2 source controls mapped|1 target controls covered
5%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
2 source controls mapped|1 target controls covered
5%
ISO/IEC 25012:2008 - Data Quality Model
2 source controls mapped|2 target controls covered
5%
Azerbaijan Law on Personal Data (2010)
2 source controls mapped|1 target controls covered
5%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
2 source controls mapped|1 target controls covered
5%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
2 source controls mapped|2 target controls covered
5%
Science Based Targets Initiative (SBTi) - Net-Zero Standard
1 source controls mapped|1 target controls covered
3%
OECD Guidelines for Multinational Enterprises on Responsible Business Conduct (2023 Update)
1 source controls mapped|1 target controls covered
3%
NIST AI 600-1: Generative AI Profile
1 source controls mapped|1 target controls covered
3%
GHG Protocol
1 source controls mapped|1 target controls covered
3%
ISO 26000:2010
1 source controls mapped|2 target controls covered
3%
BREEAM - Building Research Establishment Environmental Assessment Method
1 source controls mapped|3 target controls covered
3%
NATO AQAP 2110 - Quality Assurance Requirements for Design, Development, and Production
1 source controls mapped|1 target controls covered
3%
MDS2 (Medical Device)
1 source controls mapped|3 target controls covered
3%
HITECH Act
1 source controls mapped|3 target controls covered
3%
COSO Internal Control - Integrated Framework (2013)
1 source controls mapped|2 target controls covered
3%
ISO/IEC 27010:2015
1 source controls mapped|1 target controls covered
3%
PAS 1192-5:2015 - Security-Minded Approach to BIM and Digital Built Environments
1 source controls mapped|1 target controls covered
3%
Oman National Cybersecurity Framework
1 source controls mapped|1 target controls covered
3%
Ghana Cybersecurity Act
1 source controls mapped|1 target controls covered
3%
FISMA
1 source controls mapped|1 target controls covered
3%
Belgium CyberFundamentals
1 source controls mapped|1 target controls covered
3%
NSA Guidance for Transition to Quantum-Resistant Cryptography
1 source controls mapped|1 target controls covered
3%
BSI IT-Grundschutz
1 source controls mapped|1 target controls covered
3%
ISO 13485:2016
1 source controls mapped|1 target controls covered
3%
Compare IEC 60601-1 - Medical Electrical Equipment Safety with NIST AI Risk Management Framework (AI RMF 1.0)

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 20 domains and 41 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 41 controls organised across 20 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 226 other compliance frameworks. The top mapping partners are NIST AI Risk Management Framework (AI RMF 1.0) (13% coverage), PIC/S Guide to Good Manufacturing Practice for Medicinal Products (13% coverage), ICH Q10 - Pharmaceutical Quality System (13% 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 41 controls and track your progress.

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