Medical and Health Products

Medical and Health Products, Total:157 items.

The international standard classification for "Medical and Health Products" includes: Other standards related to sterilization and disinfection , Medical Sciences and health care facilities in general , Character sets and information coding .

The Chinese standard classification for "Medical and Health Products" includes: Public medical equipment , Sanitation in general , Data encryption , Computer application .

未注明发布机构

PD ISO/TS 5777:2024 Health informatics — The architecture of internet healthcare service network
DIN CEN ISO/TS 19256:2017*DIN SPEC 13236:2017 Health informatics - Requirements for medicinal product dictionary systems for health care
CAN/CSA-ISO 17664:2018 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices
ANSI/AAMI/ISO 13408-7:2012(2018) Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products

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

GB/T 19971-2005 Sterilization of health care products-Vocabulary
GB/T 20367-2006 Sterilization of health care products - Requirement for validation and routine control of moist heat sterilization in health care facilities
GB/T 19971-2015 Sterilization of health care products―Vocabulary

Group Standards of the People's Republic of China

T/CNMIA 0041-2023 Smart Medical International Health Complex evaluation Standard
T/YAIMH 006-2019 Internet + Medical and Health Science Popularization Management Standards
T/CI 292-2024 Security requirements for medical health big data
T/JSIA 0004-2024 Specification for healthcare big data quality management
T/SDBDA 46-2023 Health and Medical Big Data Security Management Guide
T/ZJHIA 14-2024 Specification for classification and grading of medical and health data
T/CHATA 017-2022 Guidelines for health education of tuberculosis in designated medical institution
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/CHIA 13-2018 Medical and Healthcare IoT-Fusion Model for Sensed Information of Human Body
T/GDNS 002-2023 Health medical data compliance circulation standard
T/GDNS 007-2023 Medical and Health Personal Information Protection Specifications
T/SHIA 8-2020 Sharing application Guide forHealth care Big data of Sichuan
T/CI 130-2023 Ethical requirements for sharing healthcare data
T/GZBC 36-2020 Technical specification for desensitization of medical data

Jiangxi Provincial Standard of the People's Republic of China

DB36/T 1644-2022 Specifications for the construction of nutritional and healthy canteens in medical institutions

Sichuan Provincial Standard of the People's Republic of China

DB51/T 2989-2023 Sichuan Province Health and Medical Big Data Application Guide

国家食品药品监督管理局

YY/T 0567.7-2016 Aseptic processing of health care products. Part 7: Alternative processes for medical devices and combination products

Guizhou Provincial Standard of the People's Republic of China

DB52/T 1694-2022 Management specifications for the construction of nutritional and healthy canteens in medical institutions

国家市场监督管理总局、中国国家标准化管理委员会

GB/T 39725-2020 Information security technology—Guide for health data security
GB/T 40028.2-2021 Smart city—Smart medical—Part 2：Mobile health

Professional Standard - Hygiene

WS/T 363.16-2023 Health Information Data Meta Catalog Part 16: Drugs and Medical Devices

Guangxi Provincial Standard of the People's Republic of China

DB45/T 2660-2023 Maternal mental health diagnosis and treatment service standards

International Organization for Standardization (ISO)

ISO/TS 19256:2016 Health informatics - Requirements for medicinal product dictionary systems for health care
ISO/TR 25257:2009 Health informatics - Business requirements for an international coding system for medicinal products
ISO/TS 16791:2020 Health informatics — Requirements for international machine-readable coding of medicinal product package identifiers
ISO/PRF 29585 Health informatics – Framework for healthcare and related data reporting
ISO 13683:1997 Sterilization of health care products - Requirements for validation and routine control of moist heat sterilization in health care facilities
ISO/CD TS 5788:2023 Health informatics — Internet Healthcare Service Pattern
ISO 29585:2023 Health informatics — Framework for healthcare and related data reporting
ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
ISO/IEEE 11073-20702:2018 Health informatics — Point-of-care medical device communication — Part 20702: Medical devices communication profile for web services
ISO 17664-2:2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices
ISO/CD TS 5777:2023 Health Informatics — The architecture of Internet healthcare service network
ISO 13408-2:2003 Aseptic processing of health care products - Part 2: Filtration

Standard Association of Australia （SAA）

MP 94-2003 Product numbering standards for electronic health supply chains
AS 5023 Set:2006 Health supply chain messaging Set

ES-UNE

UNE-CEN ISO/TS 19256:2017 Health informatics - Requirements for medicinal product dictionary systems for health care (ISO/TS 19256:2016) (Endorsed by Asociación Española de Normalización in May of 2017.)
UNE 179002:2018 Health services. Quality management system for health care transport organization.

Korean Agency for Technology and Standards (KATS)

KS X ISO TR 25257:2014 Health informatics — Business requirements for an international coding system for medicinal products
KS X ISO TR 25257:2016 Health informatics — Business requirements for an international coding system for medicinal products
KS X ISO TR 25257:2010 Health informatics-Business requirements for an international coding system for medicinal products
KS X ISO TS 22220-2022 Health informatics — Identification of subjects of health care
KS X ISO TS 27527:2014 Health informatics — Provider identification
KS X ISO TS 27527:2017 Health informatics — Provider identification
KS P ISO 13408-2:2010 Aseptic processing of health care products-Part 2:Filtration

RU-GOST R

GOST R ISO 11137-3-2008 Sterilization of health care products. Radiation. Part 3. Guidance on dosimetric aspects
GOST R ISO 11137-2-2008 Sterilization of health care products. Radiation. Part 2. Establishing the sterilization dose
GOST R ISO 18472-2009 Sterilization of health care products. Biological and chemical indicators. Test equipment
GOST R ISO 11140-1-2009 Sterilization of health care products. Chemical indicators. Part 1. General requirements
GOST ISO/TS 22220-2013 Health informatics. Identification of subjects of health care
GOST R ISO 11140-2-2001 Sterilization of health care products. Chemical indicators. Part 2. Test equipment and methods
GOST R 57305-2016 Health informatics. Requirements for international machine-readable coding of medicinal product package identifiers
GOST R ISO 11140-5-2008 Sterilization of health care products. Chemical indicators. Part 5. Class 2 indicators for air removal test sheets and packs
GOST R ISO 11137-1-2008 Sterilization of health care products. Radiation. Part 1. Requirements for development, validation and routine control of a sterilization process for medical devices

British Standards Institution (BSI)

PD CEN ISO/TS 19256:2017 Health informatics. Requirements for medicinal product dictionary systems for health care
BS PD CEN ISO/TS 19256:2017 Health informatics. Requirements for medicinal product dictionary systems for health care
BS DD ISO/TS 22220:2011 Health informatics. Identification of subjects of health care
DD ISO/TS 22220:2011 Health informatics. Identification of subjects of health care
BS CWA 16642:2013 Health care services. Quality criteria for health check
PD ISO/TR 18638:2017 Health informatics. Guidance on health information privacy education in healthcare organizations
PAS 29:1999 Disposable pulp products for use in healthcare
BS ISO 29585:2023 Health informatics. Framework for healthcare and related data reporting
PD ISO/TS 22077-2:2015 Health informatics. Medical waveform format. Electrocardiography
BS DD ISO/TS 11073-92001:2007 Health informatics - Medical waveform format - Encoding rules
BS ISO 22077-1:2015 Health informatics. Medical waveform format. Encoding rules
BS ISO 22077-1:2022 Health informatics. Medical waveform format. Encoding rules
DD ENV 13608-1:2000 Health informatics. Security for healthcare communication. Concepts and terminology
PD CR 13694:1999 Health informatics. Safety and security related software quality standards for healthcare (SSQS)
BS EN ISO 21549-5:2016 Health informatics. Patient healthcard data. Identification data
BS EN ISO 21549-2:2014 Health informatics. Patient healthcard data. Common objects
BS DD CEN/TS 15260:2006 Health informatics - Classification of safety risks from health informatics products
BS EN ISO 21549-5:2008 Health informatics - Patient healthcard data - Identification data
PD ISO/TS 22077-3:2015 Health informatics. Medical waveform format. Long term electrocardiography
BS EN ISO 21549-6:2008 Health informatics - Patient healthcard data - Administrative data
22/30430505 DC BS ISO 29585. Health informatics. Framework for healthcare and related data reporting
DD ENV 13608-3:2000 Health informatics. Security for healthcare communication. Secure data channels
DD ENV 13608-2:2000 Health informatics. Security for healthcare communication. Secure data objects

European Committee for Standardization (CEN)

EN ISO/TS 19256:2017 Health informatics - Requirements for medicinal product dictionary systems for health care
CEN ISO/TS 19256:2017 Health informatics - Requirements for medicinal product dictionary systems for health care (ISO/TS 19256:2016)
prCEN ISO/TS 19293 rev Health informatics — Requirements for a record of a dispense of a medicinal product
EN ISO/TS 19293:2018 Health Informatics - Requirements for a record of the dispense of a medicinal product
PD CEN/TS 15260:2006 Health informatics - Classification of safety risks from health informatics products

SCC

AAMI ST90:2017 Processing of health care products - Quality management systems for processing in health care facilities
BS DD ISO/TS 22220:2009 Health informatics. Identification of subjects of health care
BS PD ISO/TR 18638:2017 Health informatics. Guidance on health information privacy education in healthcare organizations
SN-CWA 16642:2013 Health care services - Quality criteria for health checks
DANSK DS/ISO/TR 18638:2017 Health informatics – Guidance on health information privacy education in healthcare organizations
DANSK DS/CEN ISO/TS 19256:2017 Health informatics – Requirements for medicinal product dictionary systems for health care (ISO/TS 19256:2016)
DIN CEN ISO/TS 19256:2017 Health informatics - Requirements for medicinal product dictionary systems for health care (ISO/TS 19256:2016); English version CEN ISO/TS 19256:2017
SN-CEN ISO/TS 19256:2017 Health informatics - Requirements for medicinal product dictionary systems for health care (ISO/TS 19256:2016)
SN-CR 14301:2002 Health informatics — Framework for security protection of healthcare communication
DANSK DS/CEN/CR 14301:2002 Health informatics - Framework for security protection of healthcare communication
ETSI TR 103 477:2020 eHEALTH; Standardization use cases for eHealth
DANSK DS/ISO 29585:2023 Health informatics – Framework for healthcare and related data reporting
NS-EN 12381:2005 Health informatics — Time standards for healthcare specific problems
DANSK DS/EN 12381:2005 Health informatics – Time standards for healthcare specific problems
UNE 179002:2008 Health services. Quality management system for health care transport organization.
SN-CEN/TR 15300:2006 Health informatics — Framework for formal modelling of healthcare security policies
AAMI/ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.
SN-CR 13694:1999 Health Informatics — Safety and Security Related Software Quality Standards for Healthcare (SSQS)
BS PD CR 13694:1999 Health informatics. Safety and security related software quality standards for healthcare (SSQS)
DANSK DS/ISO/TS 5777:2024 Health informatics – The architecture of internet healthcare service network
DANSK DS/CEN/CR 13694:2000 Health Informatics – Safety and Security Related Software Quality Standards for Healthcare (SSQS)
BS PD CEN ISO/TS 11137-4:2023 Sterilization of health care products. Radiation-Guidance on process control
BS PD ISO/TS 5777:2024 Health informatics. The architecture of internet healthcare service network
BS EN ISO 17664:2017 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices
CSA 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
AAMI/ISO 17664-2:2022 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
AENOR UNE-CEN/TS 15260 EX:2007 Healthcare IT. Safety risk classification for healthcare IT products.
DANSK DS/EN ISO 17664:2017 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017)
AAMI ST98:2022 Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices
DANSK DS/ISO 17664-2:2021 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

Danish Standards Foundation

DS/ISO/TS 22421:2021 Sterilization of health care products – Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
DS/EN 12381:2005 Health informatics - Time standards for healthcare specific problems
DS/CEN/CR 14301:2002 Health informatics - Framework for security protection of healthcare communication
DS/CEN/TR 15300:2007 Health informatics - Framework for formal modelling of healthcare security policies
DS/ISO 13131:2021 Health informatics – Telehealth services – Quality planning guidelines

IEEE - The Institute of Electrical and Electronics Engineers@ Inc.

IEEE P11073-10101/D8-2019 Standard for Health Informatics—Point-of-Care Medical Device Communication—Nomenclature

German Institute for Standardization

DIN CEN ISO/TS 19256:2017-06*DIN SPEC 13236:2017-06 Health informatics - Requirements for medicinal product dictionary systems for health care (ISO/TS 19256:2016); English version CEN ISO/TS 19256:2017
DIN EN ISO 11615:2013 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2012); German version EN ISO 11615:2012
DIN EN 12435:2006 Health Informatics - Expression of results of measurements in health sciences; English version EN 12435:2006
DIN CEN/TS 15260:2007 Health informatics - Classification of safety risks from health informatics products; German and English version CEN/TS 15260:2006

Association Francaise de Normalisation

XP S98-224*XP ISO/TS 22421:2021 Sterilization of health care products - Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
NF S97-524:2005 Health informatics - Time standards for healthcare specific problems.
NF EN ISO 27269:2022 Health Informatics - International summary of the patient's medical record
NF EN ISO 13408-7:2015 Aseptic processing of healthcare products - Part 7: alternative processes for medical devices and combination products
NF EN ISO 12381:2019 Health Informatics - Explicit tense expressions used in healthcare
NF S97-540*NF EN 12435:2006 Health informatics - Expression of results of measurements in health sciences
NF S98-116-2*NF ISO 17664-2:2021 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
XP ISO/TS 22421:2021 Sterilization of healthcare products - Common requirements for sterilizers used for terminal sterilization of medical devices in healthcare settings

National Fire Protection Association (NFPA)

NFPA FPH SECTION 7-5-2003 Fire Service Occupational Safety, Medical, and Health Issues

US-AAMI

ANSI/AAMI/ISO TIR17665-3:2014 Sterilization of health care products - Moist heat - Guidance on the designation of a medical product to a product family and processing category for steam sterilization

GSO

GSO ISO/TS 16791:2015 Health informatics -- Requirements for international machine-readable coding of medicinal product package identifiers
GSO ISO 13408-7:2015 Aseptic processing of health care products -- Part 7: Alternative processes for medical devices and combination products
ISO/TS 5777:2024 Health informatics — The architecture of internet healthcare service network
GSO 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
BH GSO 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

NATO - North Atlantic Treaty Organization

AJMEDP-4-2011 ALLIED JOINT MEDICAL FORCE HEALTH PROTECTION DOCTRINE

GB-REG

REG NASA NPD 8900.5 REV B-2011 NASA Health and Medical Policy for Human Space Exploration
REG NASA NPR 7120-2011 NASA Health and Medical Technical Authority (HMTA) Implementation

AENOR

UNE-EN 12381:2005 Health informatics - Time standards for healthcare specific problems

National Aeronautics and Space Administration (NASA)

NASA NPD 8900.5 REV A-2006 NASA HEALTH AND MEDICAL POLICY FOR HUMAN SPACE EXPLORATION

Lithuanian Standards Office

LST EN 12381-2005 Health informatics - Time standards for healthcare specific problems

VDI - Verein Deutscher Ingenieure

VDI 4075 Blatt 5-2012 Produktionsintegrierter Umweltschutz (PIUS) - Gesundheitswesen

US-CFR-file

CFR 42-424.530-2014 Public Health. Part424:Conditions for Medicare payment. Section424.530:Denial of enrollment in the Medicare program.

Institute of Electrical and Electronics Engineers (IEEE)

IEEE P11073-10101/D1, June 2018 IEEE Draft Standard for Health Informatics—Point-of-Care Medical Device Communication—Part 10101: Nomenclature
IEEE P11073-10201/D2.1.10 October 2018 IEEE Draft Standard for Health Informatics - Point-of-Care Medical Device Communication - Domain Information Model

American National Standards Institute （ANSI)

ANSI/ASTM E1744:2005 Practice for View of Emergency Medical Care in the Electronic Health Record
ANSI/AAMI/ISO 17664-2:2022 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

KR-KS

KS P ISO 17664-2-2022 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