医疗健康
(76 项标准)行业: 医疗健康
ISO/IEC 27001:2022
Information security, cybersecurity and privacy protection — Information security management systems — Requirements
SOC 2 Type II
Service Organization Control - Trust Services Criteria
GDPR
General Data Protection Regulation — EU Regulation (EU) 2016/679
HIPAA
Health Insurance Portability and Accountability Act — US Public Law 104-191
PCI DSS 4.0.1
Payment Card Industry Data Security Standard
CCPA/CPRA
California Consumer Privacy Act & California Privacy Rights Act
LGPD
Lei Geral de Proteção de Dados Pessoais — Brazil's General Data Protection Law (Law No. 13,709/2018)
PIPL
Personal Information Protection Law — 中华人民共和国个人信息保护法
ISO 13485:2016
Medical devices — Quality management systems — Requirements for regulatory purposes
ISO/IEC 27017:2015
Code of practice for information security controls based on ISO/IEC 27002 for cloud services
ISO/IEC 27018:2025
Code of practice for protection of personally identifiable information (PII) in public clouds acting as PII processors
ISO/IEC 27701:2025
Extension to ISO/IEC 27001 and ISO/IEC 27002 for privacy information management
ISO/IEC 42001:2023
Information technology — Artificial intelligence — Management system
ISO 9001:2015
Quality management systems — Requirements
ISO 14001:2026
Environmental management systems — Requirements with guidance for use
ISO 45001:2018
Occupational health and safety management systems — Requirements
ISO 31000:2018
Risk management — Guidelines
ISO 14971:2019
Medical devices — Application of risk management to medical devices
IEC 60601-1 Ed.3.2 (2020)
Medical electrical equipment — General requirements for basic safety and essential performance
IEC 62366-1:2015+AMD1:2020
Medical devices — Application of usability engineering to medical devices
ISO 50001:2018
Energy management systems — Requirements with guidance for use
EU AI Act
Regulation (EU) 2024/1689 — Artificial Intelligence Act
ISO 22301:2019
Security and resilience — Business continuity management systems — Requirements
EU MDR 2017/745
European Medical Devices Regulation — Regulation (EU) 2017/745
FDA 510(k)
Premarket Notification — US Medical Device Clearance Program
NIST CSF 2.0
Cybersecurity Framework 2.0 — Framework for Improving Critical Infrastructure Cybersecurity
NIS2 Directive
Directive (EU) 2022/2555 — Measures for a High Common Level of Cybersecurity Across the Union
SOX
Sarbanes-Oxley Act of 2002 — U.S. Public Company Accounting Reform and Investor Protection Act
GMP (cGMP)
Good Manufacturing Practice — WHO Guidelines & FDA 21 CFR 210/211
IEC 62304:2006+A1:2015
Medical device software — Software life cycle processes
ISO/IEC 17025:2017
General requirements for the competence of testing and calibration laboratories
CSA STAR
Cloud Security Alliance Security, Trust, Assurance and Risk Program
Cyber Essentials
UK Government-Backed Cyber Security Certification Scheme
ISO 15189:2022
Medical laboratories — Requirements for quality and competence
ISO/IEC 27002:2022
Information security, cybersecurity and privacy protection — Information security controls
ISO 37301:2021
Compliance management systems — Requirements with guidance for use
ISO 35001:2019
Biorisk management for laboratories and other related organisations
ISO 8601-1:2019 / ISO 8601-2:2019
Date and time — Representations for information interchange
ISO 7101:2023
Healthcare organization management — Management systems for quality in healthcare organizations — Requirements
ISO 10993-1:2025
Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
ISO 80369-1:2025
Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements
ISO 14708-7:2019
Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear and auditory brainstem implant systems
ISO 20658:2023
Requirements for the collection and transport of samples for medical laboratory examinations
ISO 6763:2024
Healthcare organization management — Pandemic response — Guidance on social distancing and source control
ISO 22367:2026
Medical laboratories — Application of risk management to medical laboratories
ISO 15011-2:2009
Health and safety in welding and allied processes — Laboratory method for sampling fume and gases — Part 2: Determination of the emission rates of carbon monoxide (CO), carbon dioxide (CO2), nitrogen monoxide (NO) and nitrogen dioxide (NO2) during arc welding, cutting and gouging
ISO 18562-1:2024
Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process
ISO 10993-18:2020
Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
ISO 22442-1:2020
Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
ISO 11980:2025
Ophthalmic optics — Contact lenses and contact lens care products — Requirements and guidance for clinical investigations
ISO 10416:2008
Petroleum and natural gas industries — Drilling fluids — Laboratory testing
ISO 11781:2025
Molecular biomarker analysis — Requirements and guidance for single-laboratory validation of qualitative real-time polymerase chain reaction (PCR) methods
ISO 9829:2025
Healthcare organization management — Pandemic response (respiratory) — Contact tracing
ISO 22403:2020
Plastics — Assessment of the intrinsic biodegradability of materials exposed to marine inocula under mesophilic aerobic laboratory conditions — Test methods and requirements
ISO 7405:2025
Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
ISO 80369-2:2024
Small-bore connectors for liquids and gases in healthcare applications — Part 2: Connectors for respiratory applications
ISO 5741:2023
Healthcare organization management — Pandemic response — Temporary medical facility
ISO 6974-4:2000
Natural gas — Determination of composition with defined uncertainty by gas chromatography — Part 4: Determination of nitrogen, carbon dioxide and C1 to C5 and C6+ hydrocarbons for a laboratory and on-line measuring system using two columns
ISO 19001:2013
In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
ISO 13022:2012
Medical products containing viable human cells — Application of risk management and requirements for processing practices
ISO 11137-1:2025
Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 15193:2026
In vitro diagnostic medical devices — Requirements for reference measurement procedures
ISO 15194:2026
In vitro diagnostic medical devices — Requirements for certified reference materials and the content of supporting documentation
ISO 15883-6:2026
Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-critical medical devices and health care equipment
ISO 15883-7:2025
Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment
ISO 20364:2026
Healthcare organization management — Pandemic response — Requirements for surging diagnostic demand
ISO 15883-2:2024
Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices
PDPA (Singapore)
Personal Data Protection Act 2012 — Singapore Data Protection Law
APPI
Act on the Protection of Personal Information — 個人情報の保護に関する法律
PIPEDA
Personal Information Protection and Electronic Documents Act — Canadian Federal Privacy Law
HITRUST CSF
HITRUST Common Security Framework — Healthcare-Focused Certifiable Security & Privacy Framework
NIST AI RMF 1.0
AI Risk Management Framework — NIST AI 100-1
Colorado ADMT Act
Consumer Protections for Automated Decision-Making Technology — SB24-205 as amended by SB26-189
India DPDP Act
Digital Personal Data Protection Act 2023 and DPDP Rules 2025
NIST SP 800-53
Security and Privacy Controls for Information Systems and Organizations — NIST SP 800-53 Rev. 5 (Release 5.2.0)
MLPS 2.0
Cybersecurity Multi-Level Protection Scheme — GB/T 22239-2019 Information Security Technology, Baseline for Classified Protection of Cybersecurity