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About being in a medical institution

About being in a medical institution, Total:415 items.

The international standard classification for "About being in a medical institution" includes: Sociology. Services. Company organization and management. Administration. Transport , Medical Sciences and health care facilities in general , Occupational safety. Industrial hygiene , Quality , Finances. Banking. Monetary systems. Insurance , Health care technology (Vocabularies) , Sewage water , Services for companies .

The Chinese standard classification for "About being in a medical institution" includes: Software engineering , Sanitation in general , Standardization and quality management , Labor sanitation , Medical science , Computer application , Finance and Insurance , Environmental sanitation , Pollutants discharge in general .


Group Standards of the People's Republic of China

  • T/CARDTCM 005-2020 Standards for the Construction of Traditional Chinese Medicine Rehabilitation Physiotherapy Institutions
  • T/CHAS 20-3-6-2022 Pharmacy administration and Pharmacy practice in Healthcare institutions—— Part 3-6: Pharmaceutical supply services——Medical institution preparation
  • T/CHAA 013-2021 Good practice guideline for nutritional meal service personnel in hospital
  • T/JCQX 002-2024 Specification for cleaning service in healthcare settings
  • T/XSMIA 0001-2024 Star rating for the management of social medical institutions
  • T/CIATCM 041-2019 Basic datasets for electronic medical records of Traditional Chinese Medicine section in primary medical and health care institution
  • T/CIATCM 048-2019 Functional specification of basic medical management information system in Traditional Chinese Medicine section in primary medical and health care institution
  • T/WSJD 55-2024 Guidelines for Radiation Health Supervision in Medical Institutions
  • T/CIATCM 051-2019 Basic datasets for the platform of preventive treatment of diseases in Traditional Chinese Medicine section in primary medical and health care institution
  • T/GZYX 002-2024 Evaluation specification for private medical institutions integrity management
  • T/CAS 842-2024 Evaluation of quality management maturity of medical equipment in medical institutions
  • T/CIATCM 050-2019 Functional specification of the information system for preventive treatment of diseases in Traditional Chinese Medicine section in primary medical and health care institution
  • T/SZSMDA 003-2022 Specifications for setting up blood transfusion departments of medical institutions in Shenzhen
  • T/GDACM 0110-2022 Specification of Decocting Chinese Materia Medica using Decocting Machine in Medical Institutions
  • T/CIATCM 049-2019 Basic datasets for the health Information of basic medical care information system in Traditional Chinese Medicine section in primary medical and health care institution
  • T/CIATCM 091-2020 Guidelines on construction of the health information for electronic medical records in Traditional Chinese Medicine section in community setting of health services
  • T/SHWSHQ 10-2022 Safety management specifications for medical gas systems in medical and health institutions
  • T/WSJD 9-2020 Technical guidelines for on-line monitoring of sterilization effect of small pressure steam sterilizers in medical institutions
  • T/FDSA 0057-2024 Dataset of remote dynamic mechanical ventilation for medical institutions
  • T/SMHISA 006-2022 Palliative care service specifications in integrated medical and elderly care institutions
  • T/CIATCM 040-2019 Functional specification of electronic medical records in Traditional Chinese Medicine section in primary medical and health care institution
  • T/WSJD 23.1-2022 Guidelines for On-line Monitoring of Medical Waste in Medical and Health Institutions Part I General Principles
  • T/ACEF 033-2022 Guidelines for safe disposal of medical waste in COVID-19's small and medium sized medical institutions
  • T/CNMIA 0002-2022 Social Credit Evaluation of Social Medical Institutions
  • T/GDWJ 020-2023 Service specification of medical nursing assistant in medical institution
  • T/CIATCM 052-2019 Functional specification of teleconsultation information system in Traditional Chinese Medicine section in primary medical and health care institution
  • T/QPYH 0001-2019 Metrological Management Standards for Medical Institutions
  • T/GXAS 871-2024 Specification for management of medical nursing assistants of medical institutions
  • T/CIATCM 092-2020 Guidelines on construction of the health information for electronic medical records in Traditional Chinese Medicine section in community setting of health services
  • T/CACM 1579-2024 Acceptance specification of prepared slices of Chinese crude drugs in medical institutions
  • T/CIATCM 093-2020 Guidelines on construction of teleconsultation system in Traditional Chinese Medicine section in primary medical and health care institution
  • T/CNSS 003-2020 Standardization of the establishment and management of human milk banks in medical institutions
  • T/CIATCM 043-2019 Guidlines on construction of the platform of health information in Traditional Chinese Medicine section in primary medical and health care institutions
  • T/CIATCM 044-2019 Functional specification of the information system for knowledge in Traditional Chinese Medicine section in primary medical and health care institution
  • T/NAHIEM 92-2023 General rules for the use of cosmetics in medical institutions
  • T/COSHA 48-2024 Specifications for Safety Production Materials Management in Medical Institutions
  • T/CAS 843-2024 Evaluation of quality management maturity of medical consumables in medical institutions
  • T/CAGR 013-2024 Traditional Chinese medicine therapy in sanatorium General introduction
  • T/CIATCM 046-2019 Data element dictionary for the platform of health information in Traditional Chinese Medicine section in primary medical and health care institution
  • T/CACM 1476-2023 Specification for manipulation of pediatric tuina in medical institutions
  • T/JNWX 17-2024 Medical organization property service standard
  • T/CASME 1404-2022 Specification for evaluation of medical textiles washing services in medical institutions
  • T/CIATCM 053-2019 Basic datasets for teleconsultation in Traditional Chinese Medicine section in primary medical and health care institution
  • T/CIATCM 042-2019 Specification of electronic medical records sharing in Traditional Chinese Medicine section in primary medical and health care institution
  • T/CIATCM 094-2020 Data interface technical specification in Traditional Chinese Medicine section in primary medical and health care institution
  • T/CIATCM 055-2019 Functional specification of the information system for distance learning in Traditional Chinese Medicine section in primary medical and health care institution
  • T/CAGR 014-2024 Prevention and health care technology of traditional Chinese medicinein sanatorium
  • T/CMEAS 005-2023 Technical specifications for smart security prevention and control in medical institutions
  • T/GZAEPI 003-2022 Specification for operation and maintenance management of sewage treatment in medical organization
  • T/GZBC 37-2020 Data governance standard of medical institutions
  • T/CMEAS 012-2023 High-alert drug risk management specifications for medical institutions
  • T/NAHIEM 75-2023 Quality standards for medical institutions to provide integrated medical and nursing care services
  • T/CITS 162-2024 Specifications for remote intelligent blood management in medical institutions
  • T/XSMIA 0001-2021 Star rating for the management of social medical institutions
  • T/CASME 1404-2024 Specification for evaluation of medical textiles washing services in medical institutions
  • T/WSJD 63-2024 Guidelines for use of disinfectant wipes in healthcare facilities
  • T/CIATCM 045-2019 Basic datasets for the Information of knowledge base in Traditional Chinese Medicine section in primary medical and health care institution
  • T/HNAEPI 008-2023 Technical specifications for online monitoring and management platform of wastewater in medical institutions
  • T/CIATCM 054-2019 Guidelines on construction of information system for distance learning in Traditional Chinese Medicine section in primary medical and health care institution
  • T/WSJD 11-2020 Guidelines for performance testing and evaluation of medical sterilizers in medical and health institutions
  • T/GDWJ 021-2024 Construction specification for smart hospital campus of medical institutions
  • T/FNASS 09-2021 Standards for medical care services for the elderly in elderly care institutions
  • T/CNMIA 0001-2018 Credit Rating of Non-public Medical Institutions in China
  • T/DE 3-2021 Security technical requirements for hybrid cloud in medical institutions
  • T/STIC 130023-2024 Service Standards for Non-Public Medical Aesthetic Institutions
  • T/NAHIEM 56-2022 Construction Standards for Radiotherapy Centers of Medical Institutions
  • T/CNMIA 0009-2023 Evaluation on medical quality and service ability of social assisted reproductive healthcare institutions
  • T/CRHA 161-2025 Management regulations for unaccompanied care services in medical institutions

Jiangsu Provincial Standard of the People's Republic of China

  • DB3209/T 1240-2023 Guidelines for Pharmacovigilance in Medical Institutions
  • DB32/T 5131-2025 Service Specifications for Comprehensive Geriatric Assessment in Healthcare Institutions
  • DB3202/T 1074-2024 Guidelines for the ban on smoking in medical and health institutions
  • DB32/T 4414-2022 Regulations on Radiological Protection Management of Medical Institutions
  • DB3203/T 1081-2025 Specifications for video data security construction in medical institutions
  • DB3211/T 1090-2024 Standards for anti-terrorism work in medical institutions
  • DB3212/T 1065-2021 Standards for Quality Evaluation of Medical Devices Used in Medical Institutions
  • DB32/T 5063-2025 Outpatient service standards for tertiary medical institutions
  • DB32/T 4777-2024 Medical service standards for medical and nursing institutions
  • DB3205/T 1167-2024 Medical institution data classification and grading specifications
  • DB32/T 3549-2019 Specifications for setting up facilities and equipment for temporary storage of medical waste in medical and health institutions
  • DB32/T 4269-2022 Technical specification for sludge treatment in medical institutions
  • DB32/T 3545.4-2021 Technical Management of Blood Purification Therapy Part 4: Medical Quality Management Standards for Blood Purification Medical Institutions
  • DB32/T 3547-2019 Technical specifications for wastewater treatment and online monitoring in medical institutions
  • DB3205/T 1083-2023 Data security management specifications for medical institutions
  • DB32/T 3548-2019 Guidelines for the Construction of Online Traceability Management Information System for Medical Waste in Medical Institutions
  • DB32/T 4199-2022 Department setting specifications of tumor radiaotherapy in medical institutions
  • DB32/T 4553-2023 Guidelines of adverse events monitoring for hospital medical device

Professional Standard - Hygiene

  • WS/T 808-2022 Standard for logo design of primary health care facilities
  • WS/T 591-2018 Regulation for prevention and control of healthcare associated infection in outpatient department and emergency department in healthcare facilities
  • WS/T 393-2012 Development and implementation of clinical pathways for medical institutions
  • WS 308-2019 Fire safety management for medical institutions
  • WS 307-2009 Standard of symbols for medical institutions
  • WS 308-2009 Management of fire safety for mdical institutions
  • WS 670-2021 Basic dataset of healthcare-associated infection surveillance
  • WS/T 367-2012 Regulation of disinfection technique in healthcare settings
  • WS/T 527-2016 Names of general medical sites

Fujian Provincial Standard of the People's Republic of China

  • DB35/T 2046-2021 Specifications for the Construction of Internet Hospitals in Public Medical Institutions
  • DB3502/T 183-2025 Guidelines for the implementation and application of unique identification of medical devices in medical institutions
  • DB3502/T 119-2024 Cleaning and disinfection specification for medical institution site
  • DB35/T 2153-2023 Mutual recognition and sharing of data transmission and application requirements for inspection and test results in medical institutions

Zhejiang Provincial Standard of the People's Republic of China

  • DB33/T 738-2016 Comprehensive energy consumption and power consumption quota of medical institutions
  • DB3311/T 237-2023 Technical specifications for artificial breeding of horsemouth
  • DB33/T 738-2021 Energy consumption quota and calculation method of medical institutions
  • DB33/T 2568-2023 Medical Security Management and Service Standards for Designated Medical Institutions

Tianjin Provincial Standard of the People's Republic of China

  • DB12/ 597-2015 Regulations on Medical Waste Treatment in Medical and Health Institutions
  • DB12/T 597-2025 Specification for the Management of Medical Waste in Healthcare Institutions
  • DB12/T 751-2017 Specifications for the construction of blood transfusion departments (blood banks) in medical institutions

Anhui Provincial Standard of the People's Republic of China

  • DB3404/T 2-2020 Hand Hygiene Specifications for Nursing Staff in Medical Institutions
  • DB34/T 4425-2023 Guidelines for the construction of therapeutic drug monitoring laboratories in medical institutions
  • DB34/T 4790-2024 Specifications for the Construction of Internet Hospitals in Medical Institutions
  • DB34/T 5124-2025 Medical waste management regulations for medical and health institutions
  • DB34/T 4621-2023 Pre-job training guide for rehabilitation treatment technicians in medical institutions
  • DB34/T 4622-2023 Service specifications for rehabilitation therapists in medical institutions
  • DB3418/T 039-2024 Management Specifications for Medical Visits in Nursing Homes

Shandong Provincial Standard of the People's Republic of China

  • DB37/T 4373-2021 Standard for evaluation of medical services agreement between contracted medical institution and medical insurance administration
  • DB37/T 4236-2020 Newly added medical insurance agreement designated medical institution management specifications
  • DB37/T 2673-2019 Energy Consumption Rating Standards for Medical Institutions
  • DB37/T 4379-2021 Standard for medical security service of designated medical institution

Yunnan Provincial Standard of the People's Republic of China

Hunan Provincial Standard of the People's Republic of China

  • DB43/T 2921-2024 Standards for the management of telemedicine care services in integrated medical and nursing care institutions
  • DB43/T 612-2021 Energy consumption quota for medical institutions

Ningxia Provincial Standard of the People's Republic of China

  • DB64/T 2121-2025 Safety risk prevention and control standards for medical and health institutions
  • DB64/T 2122-2025 Specifications for mutual recognition of medical institution inspection and test results
  • DB64/T 1902-2023 Energy consumption quota for medical institutions
  • DB64/T 1986-2024 Standards for evaluation of the construction of age-friendly medical institutions

Liaoning Provincial Standard of the People's Republic of China

  • DB21/T 4099-2024 Administrative Regulations for Environmental Management of Medical Insurance Administrative Institutions
  • DB21/T 3683-2022 Regulations on Hygienic Management of Medical Waste in Medical and Health Institutions
  • DB21/T 4099-2025 Environmental management standards for medical insurance agencies

Hebei Provincial Standard of the People's Republic of China

  • DB13/T 6072-2025 Technical Specifications for Pharmacovigilance in Medical Institutions
  • DB1301/T 490-2023 Standards for hospice care services in medical institutions
  • DB1301/T 506-2024 Rules for filling veterinary prescriptions in animal clinics
  • DB13/T 2961-2019 Specifications for the construction of integrity measurement in medical institutions

Heilongjiang Provincial Standard of the People's Republic of China

  • DB23/T 1992-2017 Standardize the quality of combined medical and elderly care services for medical institutions
  • DB23/T 3911-2024 Specification for sanitary management of medical waste in medical and health institutions

Shanxi Provincial Standard of the People's Republic of China

  • DB14/T 1738-2024 Evaluation Standards for Training Institutions of Health Care Assistants
  • DB14/T 2252-2020 Specifications for temperature control management of refrigerated medicines in medical institutions
  • DB14/T 1737-2024 Training Service Standards for Medical Care Attendants Institutions
  • DB14/T 2003-2020 Energy consumption quotas for health care institutions
  • DB14/T 2996-2024 Requirements for setting up moxibustion treatment venues in medical institutions

未注明发布机构

Beijing Provincial Standard of the People's Republic of China

  • DB11/T 1578-2025 Safety management requirements for hazardous chemicals in medical institutions
  • DB11/T 859-2012 Mortuary funeral service specification for medical institutions
  • DB11/T 1864-2021 Technical Guidelines for Clinical Nutrition in Medical Institutions
  • DB11/T 1259-2015 Cleaner Production Evaluation Index System for Medical Institutions
  • DB11/T 1964-2022 Technical specifications for the assessment of elderly-friendly medical institutions
  • DB11/T 1863-2021 Cleaning Service Specifications for Medical Institutions
  • DB11/T 1794-2020 Technical specifications for clinical blood use in medical institutions
  • DB11/T 2363-2024 Guidelines for End-of-Life Care Services in Medical Institutions

石家庄市市场监督管理局

Guangdong Provincial Standard of the People's Republic of China

  • DB4403/T 541-2024 Technical Specifications for the Monitoring and Reporting of Adverse Events of Medical Devices in Healthcare Institutions
  • DB4403/T 332-2023 Technical specifications for palliative care in medical institutions
  • DB4403/T 334-2023 Standards for treating diseases with traditional Chinese medicine in medical institutions

Shanghai Provincial Standard of the People's Republic of China

  • DB31/T 1153-2019 Medical institution performance excellence evaluation criteria
  • DB31/T 1430-2023 Service standards for drug addiction identification in medical institutions
  • DB31/T 1344-2022 Specifications for classification and disposal of medical waste in animal diagnosis and treatment institutions
  • DB31/T 1274-2021 Complaint Handling Specifications for Medical Institutions
  • DB31/T 1063-2017 Hygienic requirements for sewage treatment in small medical institutions
  • DB31/T 553-2012 Guidelines for Rational Energy Use in Buildings of Municipal Medical Institutions
  • DB31/T 1473-2024 Intellectual property management regulations for medical and health institutions
  • DB31/T 1227-2020 Specifications for the establishment of blood transfusion departments in medical institutions

National Health Commission of the People's Republic of China

  • WS/T 845-2024 Standards for bed transfer between the elderly care area and the medical area in medical and nursing institutions
  • WS/T 307-2024 Medical Institution Logo Standard (Replaces WS 307-2009)

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

  • GB 18466-2005 Discharge standard of water pollutants for medical organization
  • GB 18466-2001 Requirements for medical organization sewage discharge

Henan Provincial Standard of the People's Republic of China

  • DB41/T 2805-2025 Guidelines for the Construction of Radiation Diagnosis and Treatment Facilities in Medical Institutions
  • DB41/ 2555-2023 Water pollutant discharge standards for medical institutions
  • DB41/T 1960.2-2021 Institutional Energy Consumption Quotas Part 2: Healthcare Facilities
  • DB41/T 2402-2023 Management specification for the use of medical molecular sieve oxygen-generating equipment in medical institutions

Jilin Provincial Standard of the People's Republic of China

  • DB22/T 3469-2023 Standards for writing nursing documents in medical institutions
  • DB22/T 2365-2015 Regulations on the Management of Medical Institutions for Advanced Study Students
  • DB22/T 468-2009 Standards for management of health supervision files in medical institutions
  • DB22/T 468-2018 Standards for management of health supervision files in medical institutions

Inner Mongolia Provincial Standard of the People's Republic of China

  • DB15/ 509.4-2012 Fire Safety Management in Public Places Medical Institutions
  • DB15/T 972-2024 Specifications for property management services of medical institutions
  • DB1505/T 21-2024 Medical insurance agency fund work specifications
  • DB1505/T 20-2024 Medical insurance designated medical institution agreement management regulations

Guizhou Provincial Standard of the People's Republic of China

Hubei Provincial Standard of the People's Republic of China

  • DB42/T 1079.3-2021 Hubei Provincial Energy Consumption Quotas for Public Institutions Part 3: Medical Institutions
  • DB4201/T 689-2023 Technical Guidelines for Sludge Disposal in Medical Institutions (Trial)
  • DB4203/T 248-2024 Management Norms for Statistical Work in Medical Institutions
  • DB4203/T 241-2024 Standards for services for inpatient rehabilitation patients in medical institutions

Shaanxi Provincial Standard of the People's Republic of China

  • DB61/T 1381-2020 Standards for Medical Care Services in Elderly Care Institutions

Xizang Provincial Standard of the People's Republic of China

  • DB54/T 0216-2020 Regulations on Medical and Health Care Services of Child Welfare Institutions
  • DB54/T 0200-2020 Regulations on medical care services in pension institutions

Professional Standard - Business

  • SB/T 11037-2013 Service specification pharmaceutical commerce enterprises of medical institutions

Jiangxi Provincial Standard of the People's Republic of China

  • DB36/T 1980-2024 Construction specifications for elderly-friendly medical institutions
  • DB36/T 1981-2024 Service management specifications for outpatient services for the elderly in medical institutions
  • DB36/T 1644-2022 Specifications for the construction of nutritional and healthy canteens in medical institutions

Gansu Provincial Standard of the People's Republic of China

  • DB62/T 4735-2023 Technical specifications for medical waste disposal in animal diagnosis and treatment institutions

Sichuan Provincial Standard of the People's Republic of China

  • DB5117/T 59-2022 Anti-terrorism prevention norms for medical and health institutions

Professional Standard - Agriculture

  • NY/T 4669-2025 Technical Specifications for Classification and Collection of Medical Waste from Animal Clinics

Chongqing Provincial Standard of the People's Republic of China

  • DB50/T 1787-2025 Standards for hospice care services in medical and nursing institutions

Ministry of Housing and Urban-Rural Development of the People's Replublic of China

  • GB 51459-2024 Technical standards for wastewater treatment projects in medical institutions

Compressed Gas Association (U.S.)

  • CGA E-10-2018 A guide to maintaining medical gas and vacuum systems in healthcare facilities

Canadian Standards Association (CSA)

North Atlantic Treaty Organization Standards Agency

  • STANAG 2061-2001 PROCEDURES FOR DISPOSITION OF ALLIED PATIENTS BY MEDICAL INSTALLATIONS

International Organization for Standardization (ISO)

  • ISO 5741:2023 Healthcare organization management — Pandemic response — Temporary medical facility
  • ISO 7101:2023 Healthcare organization management — Management systems for quality in healthcare organizations — Requirements
  • ISO/TS 17371:2023 Healthcare organization management
  • ISO 22886:2020 Healthcare organization management — Vocabulary
  • ISO 23447:2023 Healthcare organization management — Hand hygiene performance
  • ISO 14971:2019 Plus Redline Medical devices - Application of risk management to medical devices

Association Francaise de Normalisation

  • NF S98-136:2009 Sterilisation of medical devices - Risk management related to the preparation of sterile medical devices within health establishments.
  • XP ISO/TS 22421:2021 Sterilization of healthcare products - Common requirements for sterilizers used for terminal sterilization of medical devices in healthcare settings
  • GA S99-174:2006 Use of medical devices - Interpretation guide for NF S99-172 - Risk management relative to the use of materials and medical devices in anaesthesia and intensive care in health establishments
  • NF EN IEC 60336:2021 Appareils électromédicaux - Gaines équipées pour diagnostic médical - Dimensions des foyers et caractéristiques connexes
  • NF EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
  • NF EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices
  • NF S99-211/A11*NF EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices
  • NF S98-116-1*NF EN ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1 : critical and semi-critical medical devices
  • GA S99-173:2004 Use of medical devices - Interpretation guide for NF S99-172 - Risk management relative to the use of echographs in health care establishments

SCC

  • LIA Z136.3-2018 Safe Use of Lasers in Health Care Facilities
  • LIA Z136.3-2005 Safe Use of Lasers in Health Care Facilities
  • LIA Z136.3-2011 Safe Use of Lasers in Health Care Facilities
  • AAMI TIR12:2010 Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
  • AAMI TIR31:2008 Process Challenge Devices/Test Packs for Use in Health Care Facilities
  • AAMI ST90:2017 Processing of health care products - Quality management systems for processing in health care facilities
  • AAMI ST65-2000 Processing of Reusable Surgical Textiles for Use in Health Care Facilities
  • AAMI/ISO 14971:2019 Medical devices - Application of risk management to medical devices
  • AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
  • AAMI/ISO 17664-1:2022 Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 1: Critical and semi-critical medical devices

IX-EU/EC

  • 2013/473/EU-2013 COMMISSION RECOMMENDATION on the audits and assessments performed by notified bodies in the field of medical devices (Text with EEA relevance)
  • MEDDEV 2.5/9-2004 IMPLICATIONS OF THE MEDICAL DEVICES DIRECTIVES (93/42/EEC) IN RELATION TO MEDICAL DEVICES CONTAINING NATURAL RUBBER LATEX: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES (Rev 1)
  • TEST/92/42-1996 List of Bodies Notified under Directive 92/42/EEC Hot-Water Boilers
  • TEST/93/42-1996 List of Bodies Notified under Directive 93/42/EEC Medical Devices
  • MEDDEV 2.10-2 ATT 4-2001 Special Rules of Accreditation for Certification Bodies of Quality Systems Scope "Sterile Medical Devices" (Rev 1)
  • MEDDEV 2.1/3-2001 GUIDELINES RELATING TO THE APPLICATION OF : THE COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES
  • NO 920/2013-2013 COMMISSION IMPLEMENTING REGULATION on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices (Text with EEA relevance)

Standard Association of Australia (SAA)

  • AS 1071:2015 Placement and presentation of hand hygiene materials in relation to the basin in healthcare settings
  • AS 4083:1992 Emergency responses for health care facilities
  • AS 5182:2018 Vendor Credentialing for Healthcare Facilities
  • AS 2945:1998 Batch-type washer/disinfectors for health care facilities
  • AS 4187:1998 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities
  • AS ISO 14971:2020 Medical devices — Application of risk management to medical devices
  • AS 4485.1:2021 Security for healthcare facilities, Part 1: General requirements
  • AS 4485.2:2021 Security for healthcare facilities, Part 2: Procedures guide

AT-ON

Ente Nazionale Italiano di Unificazione

American National Standards Institute (ANSI)

  • AAMI TIR45:2023 Guidance on the use of AGILE practices in the development of medical device software
  • AAMI TIR45-2012(2018) Guidance on the use of AGILE practices in the development of medical device software
  • AAMI TIR18:2010 Guidance on electromagnetic compatibility of medical devices in healthcare facilities
  • ANSI/AAMI ST58-2013(2018) Application of chemical sterilization and high-level disinfection in medical institutions
  • ANSI/IES RP-29-22 LIGHTING HOSPITAL AND HEALTHCARE FACILITIES
  • AAMI TIR12:2004 Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
  • ANSI/AAMI ST90-2017 Processing of health care products—Quality management systems for processing in health care facilities
  • AAMI TIR31:2003 Process challenge devices/test packs for use in health care facilities
  • ANSI/AAMI ST65-2008(2018) Processing of reusable surgical textiles for use in healthcare settings
  • ANSI/TIA-1179-A-2017 Healthcare Facility Telecommunications Infrastructure Standard
  • ANSI/ADA AAMI ST40-2004(2013) Table Dry Heat (Heated Air) Sterilization and Sterility Assurance in Healthcare Facilities
  • ANSI/AAMI ST40-2004(2018) Dry heat (heated air) sterilization of dials and sterility assurance in healthcare settings
  • AAMI TIR12:1994 Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers, 1ed
  • ANSI/AAMI/ISO 14971:2019 Medical devices— Application of risk management to medical devices
  • ANSI/AAMI/ISO 17664-1:2022 Processing of health care products -Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices
  • ANSI/AAMI ST35-2003 Safe Handling and Biological Decontamination of Reusable Medical Devices in Health Care Facilities and in Nonclinical Settings

U.S. Military Regulations and Norms

Institute of Electrical and Electronics Engineers (IEEE)

Korean Agency for Technology and Standards (KATS)

  • KS P 3106-2006(2016) Centrifuge for medical use
  • KS X ISO TR 21730-2020 Health informatics-Use of mobile wireless communication and computing technology in healthcare facilities-Recommendations for the management of unintentional electromagnetic interference with medical devices
  • KS P ISO 17664-1-2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices

Bureau of Indian Standards

  • IS 18742-1-2024 Processing of Health Care Products-Information to be Provided by the Medical Device Manufacturer for the Processing of Medical Devices - Part 1 Critical and Semi-Critical Medical Devices
  • IS 18742-2-2024 Processing of Health Care Products - Information to be Provided by the Medical Device Manufacturer for the Processing of Medical Devices - Part 2 Non-Critical Medical Devices
  • IS 18287-2023 Sterilization Of Health Care Products Common Requirements For Sterilizers For Terminal Sterilization Of Medical Devices In Health Care Facilities

Gosstandart of Russia

  • GOST R 59588-2021 Providing safety for medical institutions. Providing security for the facilities of medical institutions. General requirements
  • GOST R 52976-2008 Health informatics. First database structure of medical statistics of medical entity for electronic exchange of these data. General requirements
  • GOST R 52978-2008 Health informatics. Database structure of medical entity for electronic exchange of these data. General requirements
  • GOST R 55635-2020 Medical-social expertise. Requirements to the personnel establishments of medical-social expertise
  • GOST R 55635-2013 Medical-social expertise. Requirements to the personnel establishments of medical-social expertise
  • GOST R 59901-2021 Medical-social expertise. Expert and rehabilitation diagnostics using special diagnostic equipment in federal institutions of medical and social expertise
  • GOST R 59902-2021 Medical-social expertise. Standards for the placement of federal institutions of medical and social expertise
  • GOST ISO 14971-2021 Medical devices. Application of risk management to medical devices

Swedish Institute for Standards

  • ASTM E1959-11 Standard Guide for Requests for Proposals Regarding Medical Transcription Services for Healthcare Institutions
  • SIS-ISO/TS 22421:2021 Sterilization of health care products - Common requirements for sterilizers forterminal sterilization of medical devices in health care facilities (ISO/TS 22421:2021)

British Standards Institution (BSI)

  • BS ISO 5741:2023 Healthcare organization management. Pandemic response. Temporary medical facility
  • 25/30489493 DC BS ISO 20364 Healthcare organization management. Guidance for healthcare organizations’ response to the surging diagnostic demands in a pandemic
  • BS EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
  • BS PD ISO/TR 21730:2005 Health informatics. Use of mobile wireless communication and computing technology in healthcare facilities. Recommendations for the management of unintentional electromagnetic interference with medical devices
  • BS EN ISO 14971:2019+A11:2021 Medical devices - Application of risk management to medical devices
  • BS EN ISO 14971:2019 Medical devices. Application of risk management to medical devices
  • BS EN 12967-3:2007 Health informatics. Service architecture. Computational viewpoint
  • BS EN 13718-1:2014+A1:2020 Medical vehicles and their equipment. Air ambulances. Requirements for medical devices used in air ambulances
  • 22/30430346 DC BS ISO 5741. Pandemic response. Temporary medical facility
  • BS EN 13718-1:2014 Medical vehicles and their equipment. Air ambulances. Requirements for medical devices used in air ambulances
  • BS EN 13718-1:2008 Medical vehicles and their equipment - Part 1:Air ambulances - Requirements for medical devices used in air ambulances
  • PD ISO/TS 22421:2021 Sterilization of health care products. Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
  • BS EN 62366:2008+A1:2015 Medical devices. Application of usability engineering to medical devices
  • BS EN IEC 60336:2021 Medical electrical equipment. X-ray tube assemblies for medical diagnosis. Focal spot dimensions and related characteristics
  • BS DD ENV 12967-1:1998 Medical informatics. Healthcare Information System Architecture (HISA)-Healthcare middleware layer

GB-REG

NATO - North Atlantic Treaty Organization

Association for Electrical, Electronic & Information Technologies (VDE)

EU/EC - European Union/Commission Legislative Documents

  • MEDDEV 2.1/3-1998 GUIDELINES RELATING TO THE DEMARCATION BETWEEN - DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES - DIRECTIVE 93/42/EEC ON MEDICAL DEVICES AND -DIRECTIVE 65/65/EEC RELATING TO MEDICINAL PRODUCTS AND RELATED DIRECTIVES (Rev 5.1)
  • MEDDEV 2.10-2 ATT 1-2001 DESIGNATION AND MONITORING OF NOTIFIED BODIES WITHIN THE FRAMEWORK OF EC DIRECTIVES ON MEDICAL DEVICES (Rev 1)
  • MEDDEV 2.1/4-1994 GUIDELINES RELATING TO THE APPLICATION OF: THE COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES
  • MEDDEV 2.1/2-1994 GUIDELINES RELATING TO THE APPLICATION OF : THE COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES (Rev 2)

TIA - Telecommunications Industry Association

  • TIA-1179-A-2017 Healthcare Facility Telecommunications Infrastructure Standard

US-FCR

Federal Institute for Occupational Safety and Health

  • TRGS 525:1998-05 Technical rules for hazardous substances TRGS 525 Handling of hazardous substances in facilities providing health care services

Association of German Mechanical Engineers

  • VDI 5706 Blatt-1 E:2022-11 Management of hygienically relevant surfaces in medical facilities – Classification and design of hygienically relevant surfaces – Classification Einsprüche bis 2023-02-28
  • VDI 2301-1993 Reduction of emissions; incineration of waste from hospitals and other health care facilities

Canadian General Standards Board (CGSB)

  • CAN/CGSB 38.12-1993 Cotton pants for male staff in hospitals and establishments (nurses' aides, maintenance workers and others)

American Society for Testing and Materials (ASTM)

  • ASTM F2312-24 Standard Terminology Relating to Tissue Engineered Medical Products
  • ASTM F2312-11(2020) Standard Terminology Relating to Tissue Engineered Medical Products
  • ASTM F3352/F3352M-23b Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
  • ASTM F2407/F2407M-23a Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
  • ASTM E2118-00 Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures

American Water Works Association (AWWA)

  • AWWA JAW71380 Journal AWWA — Cross-Sector Emergency Planning for Water Providers and Healthcare Facilities

CN-DB 1

  • DB14/T 1738-2018 Evaluation standards for medical nurse training institutions
  • DB14/T 1737-2018 Service specifications for medical caregiver training institutions

Kingdom of Bahrain Testing and Metrology Directorate

  • BH GSO ASTM F2407:2023 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
  • BH GSO ISO 14971:2017 Medical devices -- Application of risk management to medical devices
  • BH GSO ISO/TS 22421:2023 Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities

GCC Standardization Organization

  • GSO ASTM F2407:2022 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
  • GSO ISO/TS 22421:2023 Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities

Danish Standards Foundation

  • DANSK DS/EN ISO 14971:2012 Medical devices – Application of risk management to medical devices
  • DANSK DS/ISO 14971:2020 Medical devices – Application of risk management to medical devices
  • DS/EN ISO 14971:2013 Medical devices - Application of risk management to medical devices
  • DANSK DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
  • DANSK DS/EN IEC 60336:2021 Medical electrical equipment – X-ray tube assemblies for medical diagnosis – Focal spot dimensions and related characteristics
  • DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
  • DANSK DS/EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
  • DANSK DS/ISO 17664-1:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices

Spanish Association for Standardization (UNE)

  • UNE-EN ISO 14971:2020/A11:2022 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
  • UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
  • UNE-EN 62366:2009 Medical devices- Application of usability engineering to medical devices
  • UNE-EN IEC 60336:2021 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics (Endorsed by Asociación Española de Normalización in March of 2021.)
  • AENOR UNE-EN 62366:2009 Medical devices - Application of usability engineering to medical devices
  • UNE-EN IEC 60336:2021/AC:2022-07 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics (Endorsed by Asociación Española de Normalización in August of 2022.)
  • AENOR UNE-EN 62366/A1:2009 Medical devices - Application of usability engineering to medical devices
  • UNE-EN ISO 17664-1:2022 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)

Comitato Elettrotecnico Italiano

The Directorate General of Specifications and Metrology (DGSM)

South African Bureau of Standard

  • SANS 18308:2007 Health informatics - Requirements for an electronic health record architecture

German Institute for Standardization

  • DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
  • DIN EN ISO 17664-2:2023 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021); German and English version prEN ISO 17664-2:2023
  • DIN EN ISO 17664-1 E:2021 Draft Document - Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO/FDIS 17664-1:2020); German and English v...
  • DIN EN ISO 17664-2:2024-04 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021); German version EN ISO 17664-2:2023
  • DIN EN ISO 14971 E:2018-08 Application of medical device risk management in medical devices (draft)
  • DIN CEN ISO/TS 18530:2016*DIN SPEC 13229:2016 Medical service relationship logo

CENELEC - European Committee for Electrotechnical Standardization

  • EN 62366:2008 Medical devices - Application of usability engineering to medical devices

International Electrotechnical Commission (IEC)

  • IEC 62366:2007 Medical devices - Application of usability engineering to medical devices

European Committee for Standardization (CEN)

  • EN ISO 17664-2:2023 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021)
  • CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices
  • EN ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)

PL-PKN