Three states of medical product environment

Three states of medical product environment, Total:153 items.

The international standard classification for "Three states of medical product environment" includes: Environment and environmental protection in general , Environmental protection , Other standards related to wastes , Other standards related to sterilization and disinfection , Sterilization and disinfection in general , Environmental testing , Test conditions and procedures in general , Medical Sciences and health care facilities in general , Implants for surgery, prosthetics and orthotics .

The Chinese standard classification for "Three states of medical product environment" includes: Specifications for pollution control , Urban domestic pollution source control standards , Public medical equipment , Basic standards and general methods , Environmental Condition and General Test Method , Marking, packaing, transport and storage , Medical science , Orthopedic devices .

Group Standards of the People's Republic of China

T/CQSES 01-2017 Mornitoring data storage standard of water eco-environment in the Three Gorges Reservoir
T/EERT 001-2018 Environmental protection product evaluation methods and procedures
T/SAMD 0005-2023 Technical Guidelines for Domestic Class I Medical Device Filing
T/WHAEPI 008-2023 Third-party ecological environment technology (environmental steward) service specifications
T/HAEPI 01-2021 Service specification for third-party ecological environment butler
T/AHEMA 18-2022 Special Hospital for Ecology and Environment—Specialized Hospital for Atmospheric Environment Service Specification
T/GDES 6-2016 Environmental Product Declaration Labeling
T/APEP 1020-2021 Eco-environmental product bidding procurement service specification
T/SAME 010-2024 Specifications for evaluation of medical equipment products brand—Ventilator
T/SDSES 001-2021 Eco-environmental quality evaluation and control requirements for agricultural producing area

Professional Standard - Environmental Protection

HJ/T 307-2006 The Technical Requirement for Environmental Labeling Products-Ecotypic Textile
HJ/T 351-2007 Technical Requirement for Environmental Labeling Products Eco - Housing
HJ 2539-2014 Technical requirement for environmental labeling products - Printing - Recess printing

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

GB/T 14093.1-2009 Environmental technical requirements of machinery products for the warm-damp environments
GB/T 14093.6-1997 Environmental technical requirements of machinery products for ocean environment
GB/T 14093.7-2009 Environmental technical requirements of machinery products for mine environments
GB/T 14093.5-2009 Environmental technical requirements of machinery products for dry heat environments
GB/T 14093.2-2009 Environmental technical requirements of machinery products for cold environments
GB/T 14093.6-2009 Environmental technical requirements of machinery products for ocean environments
GB/T 19971-2015 Sterilization of health care products―Vocabulary
GB 18279-2023 Sterilization of health-care products—Ethylene oxide—Requirements for the development,validation and routine control of a sterilization process for medical devices
GB/T 14093.3-1993 Environmental technical requirements of machinery products for plateau environment
GB/T 14093.1-1993 Environmental technical requirements of machinery products for the warm-damp environments
GB/T 14093.5-1997 Environmental technical requirements of machinery products for dry heat environment
GB/T 18773-2008 Environmental sanitation standard for incineration of medical treatment wastes
GB/T 14093.3-2009 Environmental technical requirements of machinery products for plateau environments
GB/T 15621-1995 Environmental technical requirements of machinery products for mine environment
GB/T 18773-2002 Environmental sanitation standard for incineration of medical treatment wastes
GB/T 14093.2-1993 Environment technical requirements of machinery products for cold environment
GB/T 19971-2005 Sterilization of health care products-Vocabulary

Professional Standard - Urban Construction

CJ/T 3036-1995 Environmental sanitation standard for incineration of medical treatment wastes
CJ 3036-1995 Environmental hygiene standards for medical waste incineration

Xinjiang Provincial Standard of the People's Republic of China

DB65/T 2927-2009 Pollution.free agriculture products The habitat environment of Pleurotus ferulas Lanzi
DB65/T 3723-2015 Ecological and healthy orchard production environment

未注明发布机构

CGA M-24-2024 STANDARD FOR MITIGATING OXYGEN HAZARDS IN THE HEALTH CARE ENVIRONMENT
ANSI/AAMI/ISO 13408-7:2012(2018) Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products
DIN EN ISO 11135 E:2011-09 Requirements for the development, validation and routine control of ethylene oxide medical device sterilization processes for sterilization of healthcare products (draft)
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

Professional Standard - Medicine

YY/T 0083-1992 Product nameplate for medical instruments and equipment
YY 0083-1992 Product nameplate for medical equipment

Professional Standard - Hygiene

WS/T 512-2016 Regulation for cleaning and disinfection management of environmental surface in healthcare

国家食品药品监督管理局

YY/T 1445-2016 Tissue engineering medical device products--Terminology
YY/T 0567.7-2016 Aseptic processing of health care products. Part 7: Alternative processes for medical devices and combination products

Beijing Provincial Standard of the People's Republic of China

DB11/T 1927-2021 Technical Guidelines for Environmental Impact Assessment of Construction Projects for Medical Institutions

Guangdong Provincial Standard of the People's Republic of China

DB44/T 1624-2015 Environmental declaration for LED lighting products Type III environmental declaration

国家药监局

YY/T 1699-2020 Tissue engineering medical device products—Chitosan

SCC

VDI 4075 BLATT 5-2014 Production-integrated environmental protection (PIUS) — Healthcare
VDI 4075 BLATT 5-2014 Production-integrated environmental protection (PIUS) — Healthcare
MIL MIL-C-37964-1985 CONTAINER, ENVIRONMENTAL PROTECTION MEDICAL SUPPLIES
AENOR UNE-EN 556-1:2002 Sterilization of medical products. Requirements for medical devices to be designated "STERILE". Part 1: Requirements for sterilized medical devices in their terminal state.
CEI 62-252:2017 Guide to managing medical IT software and networks in the healthcare context Part 2: Medical IT networks
CAN/HSO 11013:2022 Cannabis Use for Medical Purposes: Inpatient Care Settings
BS PD ISO/TR 25555:2024 Ageing societies. Accessibility and usability considerations for home healthcare products, related services and environments
DANSK DS/ISO 16428:2015 Implants for surgery - Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
AAMI/ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices
AAMI/ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.
CAN/CGSB-2.161-M91-1991 Assessment of Efficacy of Antimicrobial Agents for Use on Environmental Surfaces and Medical Devices
AAMI ST90:2017 Processing of health care products - Quality management systems for processing in health care facilities
CAN/CGSB-2.161-1997 Assessment of Efficacy of Antimicrobial Agents for Use on Environmental Surfaces and Medical Devices
BS PD ISO/TS 21560:2020 General requirements of tissue-engineered medical products
CSA Z314.10.1-15:2015 Selection and use of gowns and operating drapes for healthcare settings
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
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
AAMI ST35:2003 Safe Handling and Biological Decontamination of Reusable Medical Devices in Health Care Facilities and in Nonclinical Settings
CAN/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
DANSK DS/EN ISO 12894:2001 Ergonomics of the thermal environment - Medical supervision of individuals exposed to extreme hot or cold environments
DANSK DS/EN 62570:2015 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment

U.S. Military Regulations and Norms

ARMY UFGS-12 35 70-2009 MEDICAL AND DENTAL CASEWORK

British Standards Institution (BSI)

DD ENV 12610-1998 Medical informatics. Medical product identification
DD ENV 12610:1998 Medical informatics. Medical product identification
BS DD ENV 12610:1998 Medical informatics - Medical product identification
BS ISO 16428:2005 Implants for surgery - Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
BS EN ISO 11135:2014 Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
PD ISO/TS 21560:2020 General requirements of tissue-engineered medical products
BS EN ISO 14045:2012(2015) Environmental management — Eco - efficiency assessment of product systems — Principles, requirements and guidelines

US-FCR

FCR AF I48-119-1994 MEDICAL SERVICE ENVIRONMENTAL QUALITY PROGRAMS

Compressed Gas Association (U.S.)

CGA SB-31-2013 Hazards of oxygen in the health care envioronment

RU-GOST R

GOST R 15.013-1994 System of product development and launching into manufacture. Medical products
GOST R 14.12-2006 Ecological management. Integrating evironmental aspects into product design and development
GOST R ISO 16428-2014 Implants for surgery. Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
GOST R 57298-2016 Radiopharmaceutical medicinal products. General requirements for organization of production of radiopharmaceuticals in medical organizations
GOST R 50325-2011 Medical products. Radiation sterilization. Dosimetric techniques
GOST R 15.013-2016 System of products development and launching into manufacture. Medical devices

Defense Logistics Agency

DLA MIL-C-37964-1985 CONTAINER, ENVIRONMENTAL PROTECTION MEDICAL SUPPLIES

IN-BIS

IS 10150-1981 Guidelines for Sterilization of Medical Products

GOST

GOST R 56429-2021 Medical devices. Clinical еvaluation
GOST ISO 14971-2021 Medical devices. Application of risk management to medical devices
GOST R IEC 62366-1-2023 Medical devices. Part 1. Application of usabilityengineering to medical devices
GOST R ISO 10993-7-2009 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
GOST R ISO 10993-14-2009 Medical devices. Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics
GOST R ISO 10993-12-2009 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and control materials
GOST R ISO 10993-13-2009 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST R ISO 10993-4-2009 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
GOST IEC 62304-2022 Medical devices. Software. Life cycle processes
GOST R 60.2.2.2-2023 Robots and robotic devices. Medical electrical equipment. Part 4-1. Guidance on medical electrical equipment and medical electrical systems employing a degree of autonomy
GOST R 59767-2021 Medical devices. Risk management. Risk assessment in the desing and development of medical devices
GOST ISO 10993-23-2023 Medical devices. Biological evaluation of medical devices. Part 23. Irritant studies

HU-MSZT

MNOSZ 14678-1955 Stands for medical products (suspended)

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

North Atlantic Treaty Organization Standards Agency

STANAG 2478-2006 MEDICAL SUPPORT PLANNING FOR NUCLEAR, BIOLOGICAL AND CHEMICAL ENVIRONMENTS

Association Francaise de Normalisation

NF EN 1641:2009 Art dentaire - Dispositifs médicaux pour l'art dentaire - Produits
NF EN ISO 11135:2014 Sterilization of healthcare products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices
NF EN ISO 13408-7:2015 Aseptic processing of healthcare products - Part 7: alternative processes for medical devices and combination products
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
FD E01-008:2014 Mechanical products - Environmental data
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 EN ISO 14045:2012 Environmental management - Assessment of eco-efficiency of product systems - Principles, requirements and guidelines

Korean Agency for Technology and Standards (KATS)

KS P ISO 16428-2022 Implants for surgery－Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
KS P ISO 16428-2007(2017) Implants for surgery－Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
KS P ISO 16428:2007 Implants for surgery－Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
KS C IEC 60601-1-12:2020 Medical electrical equipment — Part 1-12: General requirements for basic safety and essential performance — Collateral Standard: Requirements for medical electrical equipment and medical electrical sy
KS I ISO 14045-2021 Environmental management -- Eco-efficiency assessment of product systems -- Principles, requirements and guidelines

International Organization for Standardization (ISO)

ISO/DIS 11135 Sterilization of health care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
IEC TR 62653:2012 Guidelines for the safe use of medical products in dialysis treatment
IEC/TR 62653:2012 Guidelines for the safe use of medical products in dialysis treatment
IEC TR 62653:2012 Guidelines for the safe use of medical products in dialysis treatment
ISO 16428:2005 Implants for surgery - Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
ISO/DTR 25555:2023 Ageing societies — Accessibility and usability considerations for home-based healthcare products, related services and environments
ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO/IEC TR 33023:2024 Information technology
ISO 12894:2001 Ergonomics of the thermal environment - Medical supervision of individuals exposed to extreme hot or cold environments
ISO 17664-2:2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices

NATO - North Atlantic Treaty Organization

STANAG 2549-2011 EMERGENCY MEDICAL CARE IN THE OPERATIONAL ENVIRONMENT - AMEDP-24 (ED 1)
AMEDP-7(D)-2007 CONCEPT OF OPERATIONSOF MEDICAL SUPPORT INCHEMICAL BIOLOGICAL RADIOLOGICAL AND NUCLEAR ENVIRONMENTS

American Society for Testing and Materials (ASTM)

ASTM F2503-20 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
ASTM F2503-23 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
ASTM F2503-23e1 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

KR-KS

KS P ISO 16428-2007(2022) Implants for surgery－Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
KS C IEC 60601-1-12-2020 Medical electrical equipment — Part 1-12: General requirements for basic safety and essential performance — Collateral Standard: Requirements for medical electrical equipment and medical electrical sy
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

GSO

GSO ISO 16428:2016 Implants for surgery -- Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
GSO ASTM F2503:2022 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
BH GSO ISO 16428:2017 Implants for surgery -- Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
OS GSO ISO 16428:2016 Implants for surgery -- Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
BH GSO ASTM F2503:2023 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
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
GSO ISO 13408-7:2015 Aseptic processing of health care products -- Part 7: Alternative processes for medical devices and combination products
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
GSO ISO 12894:2015 Ergonomics of the thermal environment -- Medical supervision of individuals exposed to extreme hot or cold environments
GSO IEC 62570:2017 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
OS GSO IEC 62570:2017 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment

German Institute for Standardization

DIN EN 62570:2016-09 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment (IEC 62570:2014); German version EN 62570:2015
DIN VDE 0753-4:2009 Guideline for the safe use of medical products in dialysis treatment - Text in German and English
DIN EN ISO 12894:2002-08 Ergonomics of the thermal environment - Medical supervision of individuals exposed to extreme hot or cold environments (ISO 12894:2001); German version EN ISO 12894:2001

CZ-CSN

CSN 85 5200-1988 Climatic tests election for medical products

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 ISO 12894:2001 Ergonomics of the thermal environment - Medical supervision of individuals exposed to extreme hot or cold environments

ES-UNE

UNE-EN 62570:2015 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment (Endorsed by AENOR in July of 2015.)

American National Standards Institute （ANSI)

ISO/DIS 11135:2023 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
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

National Fire Protection Association (NFPA)

NFPA FPH SECTION 8-2003 Materials, Products, and Environments

GOSTR

GOST R ISO 12894-2019 Ergonomics of the thermal environment. Medical supervision of individuals exposed to extreme hot or cold environments

Others: