Overseas medical industry

Overseas medical industry, Total:285 items.

The international standard classification for "Overseas medical industry" includes: Implants for surgery, prosthetics and orthotics , Services for companies , Medical equipment in general , Laboratory medicine , Wastes in general .

The Chinese standard classification for "Overseas medical industry" includes: Standardization and Quality Management , Extracorporeal circulation, artificial organ and prosthesis device , Standardization and quality management , Medical laboratory equipment , Discharge standard for mobile pollution sources , Pollutants discharge in general .

Professional Standard - Medicine

YY/T 1000.1-2005 Development of medical devices industrial standards—rt1:Stage division, code and procedure
YY/T 1000.2-2005 Development of medical devices industrial standards - Part2: Guidance for work
YY/T 91051-1999 System table for standard of medical devices
YY/T 0606.8-2008 Tissue engineered medical products - Part 8: Alginate

Group Standards of the People's Republic of China

T/CACM 1236-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Pressure Ulcers
T/DZJN 157-2023 Standards for evaluating the capabilities of medical equipment installation, maintenance and operation enterprises
T/CACM 1312-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Cholelithiasis
T/CACM 1207-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Gynecomastia
T/JNWX 17-2024 Medical organization property service standard
T/JCCIA 005-2022 Enterprise Data Migration Specificat
T/CACM 1185-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Flesh goiter
T/SAME 002-2023 Norm for measurement integrity demonstration construction of medical institution in Shanghai
T/CACM 1205-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM impotence disease
T/ZAMEI 0002-2024 Medical device industry credit compliance construction guide
T/CACM 1242-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM GuZhong disease
T/CAMDI 001-2024 China Medical Device Industry Association Medical Polymer Products Professional Branch Standard System Table
T/GXIE 005-2024 Network Security Technology Specification for the Construction of Disaster Recovery System for Information Systems in the Medical Industry
T/CACM 1153-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Sinus
T/CACM 1304-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Intestinal abscess
T/CACM 1150-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Headed Carbuncle
T/CACM 1235-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Chilblain
T/CACM 1315-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Alzheimer ’s disease
T/NAHIEM 111-2024 Technical specifications for transfer windows in biological and medical industries
T/CAMDI 001-2016 Standard System Table of Medical Polymer Products Branch of China Medical Device Industry Association
T/CEMA 008-2024 Guidelines for external treatment of Hainan Poecilobdella manillensis
T/JCCIA 004-2022 Specification for debugging network equipment in data centers in the medical industry
T/CMAM W3-2022 Diagnosis and Treatment Guidelines for Common Diseases in Uyghur Medicine
T/SAMD 0002-2023 Probes for in-vitro diagnostic medical devices
T/SZZX 014-2023 Probes for in-vitro diagnostic medical devices
T/CACM 1206-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Stone gonorrhea
T/CACM 1199-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM fibroadenoma of breast
T/CACM 1247-2019 Guidelines for clinical diagnosis and treatment of surgery in Chinese medicine—Intestinal obstruction
T/CACM 1277-2019 Clinical guidelines for diagnosis and treatment of surgery in TCM Burn
T/SHPPA 001-2019 General Requirements for Evaluation of Brand Index in Shanghai Pharmaceutical Industry

人力资源和社会保障部

LD/T 0.1-2017 Industry standards for social insurance medical service projects

未注明发布机构

DIN EN ISO 18113-4:2010 In vitro diagnostic medical devices — information provided by the manufacturer
DIN 96033:2016-03 Medical instruments - Haemostatic forceps type Wertheim-Cullen
CSA Z387-2019 Safe use of electrosurgical medical devices and systems in health care
DIN EN ISO 18113-5:2010 In vitro diagnostic medical devices — information provided by the manufacturer
DIN 96033 E:2015-09 Medical instruments - Haemostatic forceps type Wertheim-Cullen
DIN 13171 E:2017-06 Medical instruments - Tissue forceps type Adson-Brown
DIN EN ISO 18113-2:2010 In vitro diagnostic medical devices — information provided by the manufacturer
DIN EN ISO 18113-1:2010 In vitro diagnostic medical devices Information provided by the manufacturer
DIN 13468 E:2022-08 Medical instruments - Sponge holding forceps type Förster
DIN EN ISO 18113-3:2010 In vitro diagnostic medical devices — information provided by the manufacturer
DIN 13468 E:2016-07 Medical instruments - Sponge holding forceps type Förster
NF S90-463 Medical surgical equipment. Surgical medical instruments. Scissors. Dimensions and tests.

Professional Standard - Business

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

Hebei Provincial Standard of the People's Republic of China

DB1304/T 437-2023 Safety management specifications for quick-opening pressure vessels in the medical industry

Jiangsu Provincial Standard of the People's Republic of China

DB3210/T 1156-2023 Guide to the safe use of ethylene oxide in the medical device manufacturing industry

Jiangxi Provincial Standard of the People's Republic of China

DB36/T 1248-2020 Guidelines for Construction and Evaluation of Energy Management System in Medical and Health Industry

Professional Standard - Commodity Inspection

SN/T 4159.1-2015 Medical standards and protocols for International Association for Medical Assistance to Travellers (IAMAT) clinics in China

国家药监局

YY/T 1808-2021 In vitro skin irritation test for medical devices
YY/T 1654-2019 Tissue engineering medical device products—Alginate

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

GB/T 29791.2-2013 In vitro diagnostic medical devices―Information supplied by the manufacturer (labelling)―Part 2:In vitro diagnostic reagents for professional use
GB 19218-2003 Technical standard for medical waste incinerator
GB 19217-2003 Technical standard for medical waste transport vehicle
GB/T 29791.3-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer(labelling)—Part 3:In vitro diagnostic instruments for professional use

Guangdong Provincial Standard of the People's Republic of China

DB44/T 2350-2022 Clinical medical transportation operation management specification

中国民用航空局

MH/T 1065-2018 General aviation medical care flight service specification

Beijing Provincial Standard of the People's Republic of China

DB11/T 470-2007 Operation and Management Code for Medical Waste Incineration Plant
DB11/T 1645-2019 Coding specification for key control points of medical behavior

Jilin Provincial Standard of the People's Republic of China

DB22/T 2366-2015 Management specification for multi-site practice of physicians in medical associations

NZ-SNZ

NZS 8171:2005 Allied Health Services Sector Standard
SNZ HB 8171.1-2005 Allied Health Services Sector Standard - Physiotherapy Services Audit Workbook
NZS 8151:2004 Accident and Medical Clinic Standard
SNZ HB 8171.2-2005 Allied Health Services Sector Standards - Chiropractic Services Audit Workbook

GSO

GSO ISO 9626:2013 Stainless steel needle tubing for the manufacture of medical devices
GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
OS GSO ISO 18113-2:2016 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use
OS GSO ISO 18113-3:2016 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 3: In vitro diagnostic instruments for professional use
GSO ISO 18113-3:2016 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 3: In vitro diagnostic instruments for professional use
BH GSO ISO 18113-3:2017 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 3: In vitro diagnostic instruments for professional use
BH GSO ISO 18113-2:2017 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use
GSO ISO 18113-2:2016 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use
BH GSO EN 13532:2022 General requirements for in vitro diagnostic medical devices for self-testing
GSO EN 13532:2021 General requirements for in vitro diagnostic medical devices for self-testing

European Committee for Standardization (CEN)

EN ISO/TR 12296:2013 Ergonomics - Manual handling of people in the healthcare sector
EN ISO 23640:2011 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents [Superseded: CEN EN 13640]
EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
EN ISO 18113-4:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
CEN EN 13532-2002 General Requirements for in Vitro Diagnostic Medical Devices for Self-Testing
EN ISO 18113-2:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

SCC

MIL MIL-DTL-3628/192B-2019 Badge, Qualification, Aviation, Flight Surgeon, U.S. Navy
MIL MIL-DTL-3628/192A-2014 Badge, Qualification, Aviation, Flight Surgeon, U.S. Navy
DIN 13468 E:2016 Draft Document - Medical instruments - Sponge holding forceps type FÃ¶rster
CSA Z314.4-M1979-1979 Industrial Sterilization of Medical Devices by the Steam Process
CSA Z314.5-1979 Industrial Sterilization of Medical Devices by the Ethylene Oxide Process
CAN/CSA Z314.4-1987 Industrial Sterilization of Medical Devices by the Steam Process
CAN/CSA Z314.5-1988 Industrial Sterilization of Medical Devices by the Ethylene Oxide Process
CAN/CSA-Z314.5-1988 Industrial Sterilization of Medical Devices by the Ethylene Oxide Process
CAN/CSA-Z314.4-1987 Industrial Sterilization of Medical Devices by the Steam Process
MIL MIL-DTL-3628/192-1996 BADGE, QUALIFICATION, AVIATION, FLIGHT SURGEON, NAVY (SUPERSEDING MIL-B-10955/36C)
CSA Z387-2013(R2018) Safe use of electrosurgical medical devices and systems in health care
VDI 5707 BLATT 1-2023 Repeat tests on active medical devices in medical use — test principles
VDI 5707 BLATT 1-2023 Repeat tests on active medical devices in medical use — test principles
BS EN ISO 18113-2:2009 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling)-In vitro diagnostic reagents for professional use
AENOR UNE-EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices.
AENOR UNE-EN 13612/AC:1970 Performance evaluation of in vitro diagnostic medical devices.
BS EN ISO 18113-3:2009 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling)-In vitro diagnostic instruments for professional use
MIL MIL-B-10955/36B-1990 BADGE, QUALIFICATION, AVIATION; FLIGHT SURGEON, NAVY (S/S BY MIL-DTL-3628/192)
DIN 96151 E:2011 Draft Document - Medical instruments - Bone curettes type Hemingway
DANSK DS/EN 13612/AC:2003 Performance evaluation of in vitro diagnostic medical devices
BS PD ISO/PAS 23617:2024 Healthcare organization management. Pandemic response (respiratory). Guidance on medical support for socially vulnerable groups
SN-CR 13644:2000 Machine readable cards — Healthcare applications — Logical organisation of data on healthcare professional cards
DANSK DS/EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
DANSK DS/ISO 24227:2023 Validation protocol for walking speed as extracted from various sensor systems that measure human body motion for the healthcare sector
NS-EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
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
DANSK DS/CEN/CR 13644:2001 Machine readable cards - Healthcare applications - Logical organisation of data on healthcare professional cards
NS 3374:2018 Healthcare services — Unisex cover cardigan for healthcare personnel
DANSK DS/EN ISO 18113-3:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use
CIDA 01-1993 Value of Overseas Business Activity
BS PD CR 13644:2001 Machine readable cards. Healthcare applications. Logical organization of data on healthcare professional cards
NS 6092:1980 Marine industry - External wooden doors
DANSK DS/EN ISO 18113-2:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
CSA Z317.10-2009(R2014) Handling of waste materials in health care facilities and veterinary health care facilities
CISPR 23:1987 Determination of limits for industrial, scientific and medical equipment
AENOR UNE-EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing.
CEI CEN/TR 17223:2019 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
DANSK DS/ISO 20916:2019 In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice

RU-GOST R

GOST R 54737-2011 Medical-social expertise. Documentation service of medical-social expertise
GOST R 55635-2013 Medical-social expertise. Requirements to the personnel establishments of medical-social expertise
GOST R 54737-2018 Medical-social expertise. Documentation service of medical-social expertise
GOST R EN 556-1-2009 Sterilization of medical devices. Requirements for medical devices to be designated "sterile". Part 1. Requirements for terminally sterilized medical devices
GOST ISO 10993-5-2011 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
GOST R ISO 23640-2015 In vitro medical devices. Evaluation of stability of in vitro diagnostic reagents
GOST R ISO 10993.5-1999 Medical devices. Biological evaluation of medical devices. Part 5. Tests for cytotoxicity: in vitro methods
GOST R 51352-2013 In vitro diagnostic medical devices. Test methods
GOST R ISO 18113-2-2015 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 2. In vitro diagnostic reagents for professional use
GOST R 57502-2017 Medical equipment. Industrial production regulation
GOST R ISO 18113-3-2015 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 3. In vitro diagnostic instruments for professional use
GOST R 53931-2017 Medical-social expertise. Basic types of services of medical-social expertise

GOSTR

GOST R 55635-2020 Medical-social expertise. Requirements to the personnel establishments of medical-social expertise
GOST R 58262-2018 Medical-social expertise. Quality control of services of medical-social expertise
GOST R 58262-2020 Medical-social expertise. Quality control of services of medical-social expertise
GOST R EN 13612-2010 Performance evaluation of in vitro diagnostic medical devices
GOST R EN 13532-2010 General requirements for in vitro diagnostic medical devices for self-testing

GB-REG

REG 29 CFR PART 1420-2011 FEDERAL MEDIATION AND CONCILIATION SERVICE鈥擜SSISTANCE IN THE HEALTH CARE INDUSTRY
REG 47 CFR PART 18-2011 INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT

GOST

GOST ISO 10993-5-2023 Medical devices. Biological evaluation of medical devices. Part 5. Cytotoxicity studies by in vitro methods
GOST R 59902-2021 Medical-social expertise. Standards for the placement of federal institutions of medical and social expertise
GOST R ISO 10993-5-2009 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity

VDI - Verein Deutscher Ingenieure

VDI 5201 BLATT 1-2015 Adaptability - Description and measurement of the adaptability of manufacturing companies - Medical device industry
VDI 5201 BLATT 1-2017 Adaptability - Description and measurement of the adaptability of manufacturing companies - Medical device industry

BE-NBN

NBN C 74-336-1990 Characteristics of hospital hobs equipped with covers for medical diagnostics

American Society for Testing and Materials (ASTM)

ASTM D8452-22 Standard Guide for Requirements for Medical-related Professionals within the Cannabis and Hemp Industries
ASTM F882-84(2002) Standard Performance and Safety Specification for Cryosurgical Medical Instruments
ASTM F2407/F2407M-22 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities

German Institute for Standardization

DIN V ENV 12612:1997 Medical informatics - Messages for the exchange of healthcare administrative information; English version ENV 12612:1997
DIN 13468:2023-03 Medical instruments - Sponge holding forceps type Förster
DIN 13468:2016 Medical instruments - Sponge holding forceps type Förster
DIN 13468:2005 Medical instruments - Sponge holding forceps type Foerster
DIN 58263:2010 Medical instruments - Mouth gag type Heister
DIN 96012:2009 Medical instruments - Surgical scissors type Olivecrona
DIN 13171:2017 Medical instruments - Tissue forceps type Adson-Brown
DIN 13171:2006 Medical instruments - Tissue forceps type Adson-Brown
DIN EN 13612:2002-08 Performance evaluation of in vitro diagnostic medical devices; German version EN 13612:2002, German and English texts
DIN EN ISO 18113-2:2021-09 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO/DIS 18113-2:2021); German and English version prEN ISO 18113-2:2021 / Note: Date of issue 2021-0...
DIN EN ISO 18113-4:2021-09 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/DIS 18113-4:2021); German and English version prEN ISO 18113-4:2021 / Note: Date of issue 2021-08-06...
DIN 96033:2009 Medical instruments - Haemostatic forceps type Wertheim-Cullen
DIN EN ISO 18113-1:2013-01 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009); German version EN ISO 18113-1:2011 / Note: DIN EN ISO 18113-1 (2010-05) remains valid a...
DIN EN ISO 18113-4:2013-01 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009); German version EN ISO 18113-4:2011 / Note: DIN EN ISO 18113-4 (2010-05) remains valid...
DIN EN ISO 18113-3:2021-09 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/DIS 18113-3:2021); German and English version prEN ISO 18113-3:2021 / Note: Date of issue 202...
DIN 96105:2010 Medical instruments - Surgical scissors, curved on flat, type T?nnis
DIN EN ISO 18113-5:2013-01 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009); German version EN ISO 18113-5:2011 / Note: DIN EN ISO 18113-5 (2010-05) remains va...
DIN EN ISO 18113-5:2021-09 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/DIS 18113-5:2021); German and English version prEN ISO 18113-5:2021 / Note: Date of issue 2021-08...
DIN EN ISO 18113-3:2013-01 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009); German version EN ISO 18113-3:2011 / Note: DIN EN ISO 18113-3 (2010-05) remain...
DIN EN ISO 18113-1:2021-09 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO/DIS 18113-1:2021); German and English version prEN ISO 18113-1:2021 / Note: Date of issue 2021-08-06*I...
DIN EN ISO 18113-2:2013-01 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009); German version EN ISO 18113-2:2011 / Note: DIN EN ISO 18113-2 (2010-05) remains v...
DIN EN 60601-1-11 Berichtigung 1:2011 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 6060
DIN 58253-1:2006 Medical instruments - Part 1: Surgical scissors, curved on flat without carbide inserts
DIN 58252-1:2006 Medical instruments - Part 1: Surgical scissors, straight without carbide inserts

DIN

DIN 13468:2023 Medical instruments - Sponge holding forceps type Förster
DIN 13123:2023 Medical instruments - Vulsellum forceps 2×2 teeth, straight

National Fire Protection Association (NFPA)

NFPA 1581H PART 4 CH 4-1995 Emergency Medical Operations Protection

US-FCR

FCR COE ER 690-1-301-1984 OVERSEA EMPLOYMENT
FCR 47 CFR PART 18-2014 INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT
FCR 47 CFR PART 18-2012 INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT
FCR 47 CFR PART 18-2013 INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT
FCR FED H-08-3 801-6-1987 ALARMS-NONFLAMMABLE MEDICAL GAS AND MEDICAL-SURGICAL VACUUM SYSTEMS

Association Francaise de Normalisation

NF S90-300:1981 MEDICAL AND SURGICAL EQUIPMENT. OXYGENATORS.
NF S90-316:1987 Medico-surgical equipment. Operating tables.
NF S90-701:1988 MEDICO-SURGICAL EQUIPMENT. BIOCOMPATIBILITY OF MATERIALS AND MEDICAL DEVICES. METHODS FOR EXTRACTION.
NF S90-550:1986 Medico-surgical equipment. External breast prostheses.
NF S90-202:1990 Medico-surgical equipment . Infusion sets.
NF S90-463:1982 Medical and surgical equipment. Surgical instruments. Scissors. Dimensions and tests.
NF S90-201:1990 Medico-surgical equipment. Transfusion sets.
NF S90-031:1985 Medico-surgical equipment. Intra-uterine devices.
NF S92-025*NF EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
NF S90-325:1989 Medical surgical equipment. Steam disinfecting equipment.
NF EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
NF S92-032*NF EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
NF S92-032:2014 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
NF S92-010-3*NF EN ISO 18113-3:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3 : in vitro diagnostic instruments for professional use
NF S92-024*NF EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
NF S92-010-2:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2 : in vitro diagnostic reagents for professional use.
NF S92-010-3:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3 : in vitro diagnostic instruments for professional use.
NF S92-010-2*NF EN ISO 18113-2:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2 : in vitro diagnostic reagents for professional use
NF S90-408:1981 Medical and surgical equipment. Implants for surgery. Ceramic materials based on alumina.
NF EN ISO 18113-2:2012 In vitro diagnostic medical devices - Information provided by the manufacturer (labelling) - Part 2: in vitro diagnostic reagents for professional use
NF EN ISO 18113-3:2012 In vitro diagnostic medical devices - Information provided by the manufacturer (labelling) - Part 3: in vitro diagnostic instruments for professional use
NF C74-005:1989 Guidelines for administrative,medical and nursing staff concerned with the safe use of medical electrical equipment
NF S90-033:1986 Medico-surgical equipment. Reusable rubber contraceptive diaphragms.
NF S90-460:1982 Medical and surgical equipment. Surgical instruments. Haemostatic forceps. Dimensions and tests.
NF EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
NF S90-304:1989 MEDICO-SURGICAL EQUIPMENT. HAEMODIALYSIS EQUIPMENT. OPERATING DATA.
NF S90-445:1985 MEDICO-SURGICAL EQUIPMENT. IMPLANTS FOR SURGERY. ORTHOPAEDIC JOINT PROSTHESES. BASIC REQUIREMENTS.
FD S99-212*FD CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485:2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

CN-DB 3

DB3707/T 6-2019 Weifang City’s grassroots party building work standards in the medical and health industry

CZ-CSN

CSN 85 5925-1984 Medieal instrumenta. Surgical needles
CSN 85 5925-1974 Medical instrumente Surgical needles

AT-ON

OVE/ONORM E 8007/A1-2001 Electrical installations in hospitals and locations for medical use outside hospitals (Amendment)

British Standards Institution (BSI)

BS ISO 5741:2023 Healthcare organization management. Pandemic response. Temporary medical facility
BS EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
BS EN ISO 18113-3:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for professional use
BS EN 13612:2002(2003) Performance evaluation of in vitro diagnostic medical devices
BS EN ISO 18113-2:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for professional use
BS EN ISO 18113-3:2024 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - In vitro diagnostic instruments for professional use
BS EN ISO 18113-2:2024 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - In vitro diagnostic reagents for professional use
BS EN ISO 23640:2011 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
BS EN ISO 23640:2013 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
BS ISO 16142-2:2017 Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
PD CR 13644:2001 Machine readable cards. Healthcare applications. Logical organization of data on healthcare professional cards
BS ISO 16571:2014 Systems for evacuation of plume generated by medical devices
BS EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing

Standard Association of Australia （SAA）

AS/NZS 1680.2.5:1997 Interior lighting - Hospital and medical tasks

ES-UNE

UNE-EN 13612/AC:2003 Performance evaluation of in vitro diagnostic medical devices.
UNE-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

AENOR

UNE-EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices.
UNE 20901:1995 GUIDELINES FOR ADMINISTRATIVE, MEDICAL AND NURSING STAFF CONCERNED WITH THE SAFE USE OF MEDICAL ELECTRICAL EQUIPMENT.
UNE-ENV 12612:1998 MEDICAL INFORMATICS. MESSAGES FOR THE EXCHANGE OF HEALTHCARE ADMINISTRATIVE INFORMATION.
UNE-EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing.

Institute of Electrical and Electronics Engineers (IEEE)

IEEE P1073.1.3.6/D6.0:1999 Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - ECG
IEEE P1073.1.3.11/D3.0:1999 Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Capnometer
IEEE P1073.1.3.7/D4.0:1999 Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Blood Pressure
IEEE P1073.1.3.8/D4.0:1999 Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Temperature
IEEE P1073.1.3.10/D3.0:1999 Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Cardiac Output
IEEE P1073.1.3.5/D04:2000 Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Defibrillator Device
IEEE Std P1073.1.3.8/D4.0 IEEE Draft Standard for Medical Device Communications -- Medical Device Data Language (MDDL) Virtual Medical Device, Specialized -- Temperature
IEEE P1073.1.3.9/D3.0:1999 Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Airway Flow
P1073.1.3.4/D3.0 IEEE Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Medical Device Specializations - Pulse Oximeter
IEEE P1073.1.3.4/D3.0 IEEE Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Medical Device Specializations - Pulse Oximeter
IEEE Std P1073.1.3.10/D3.0-1999 IEEE Draft Standard for Medical Device Communications -- Medical Device Data Language (MDDL) Virtual Medical Device, Specialized -- Cardiac Output
NFPA (Fire) 1710 Standard for the Organization and Deployment of Fire Suppression Operations, Emergency Medical Operations, and Special Operations to the Public by Career Fire Departments, 2020 Edition
IEEE P1073.1.3.4/D3.0:1999 (Draft)Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Pulse Oximeter

IAEA - International Atomic Energy Agency

WS-G-2.2-2004 Decommissioning of Medical@ Industrial and Research Facilities

International Organization for Standardization (ISO)

ISO 23640:2011 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
ISO 18113-2:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
ISO 18113-3:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use
ISO 18113-2:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
ISO 18113-3:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
ISO 16571:2014 Systems for evacuation of plume generated by medical devices
ISO/DIS 15193:2024 In vitro diagnostic medical devices — Requirements for reference measurement procedures
ISO/DPAS 23617:2023 Healthcare organization management — Pandemic response (respiratory) — Guidance on medical support for socially vulnerable groups

CO-ICONTEC

ICONTEC 1.565-1980 Paraffin wax used in pharmaceutical industry, cosmetic industry

IEC - International Electrotechnical Commission

IEC TR 60930:1988 Directives de securite pour l?utilisation des appareils electromedicaux@ a l?intention du personnel administratif@ medical et infirmier (Edition 1.0)

NATO - North Atlantic Treaty Organization

AMEPP-9-2008 HEALTH CARE WASTE MANAGEMENT PROCEDURES ABOARD NATO NAVY VESSELS (ED 1)

Korean Agency for Technology and Standards (KATS)

KS P ISO 18113-3-2020 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
KS P ISO 23640:2013 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
KS P ISO 18113-3-2015(2020) In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
KS P ISO 18113-2-2023 In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 2: In vitro diagnostic reagents for professional use
KS P ISO 18113-2:2018 In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 2: In vitro diagnostic reagents for professional use
KS C CISPR 23-2004 Electromagnetic compatibility(EMC)-Determination of limits for industrial, scientific and medical equipment
KS P ISO 23640:2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents

North Atlantic Treaty Organization Standards Agency

STANAG 2087-2008 MEDICAL EMPLOYMENT OF AIR TRANSPORT IN THE FORWARD AREA

PL-PKN

PN Z54063-1988 Medical instruments Scalpel -handles for detachable blades

Federal Aviation Administration (FAA)

FAA 14 CFR PART 121-2011 OPERATING REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL OPERATIONS

Danish Standards Foundation

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
DS/CEN/CR 13644:2001 Machine readable cards - Healthcare applications - Logical organisation of data on healthcare professional cards
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

CEN - European Committee for Standardization

EN ISO 18113-4:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
EN ISO 18113-2:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
PD CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

KR-KS

KS P ISO 18113-2-2018 In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 2: In vitro diagnostic reagents for professional use

International Electrotechnical Commission (IEC)

IEC 60601-1-11:2010/COR1:2011 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 62366:2007/AMD1:2014 Medical devices - Application of usability engineering to medical devices

US-CFR-file

CFR 15-4.26-2014 Commerce and foreign trade. Part4:Disclosure of government information. SubpartB:Privacy act. Section4.26:Special procedures: Medical records.

American National Standards Institute （ANSI)

ANSI/AAMI ST25-1987 Guideline for Industrial Moist Heat Sterilization of Medical Products

IX-CISPR

CISPR 23-1987 Determination of limits for industrial, scientific and medical equipment

U.S. Military Regulations and Norms

ARMY MIL-DTL-3628/109 VALID NOTICE 3-2013 Badge, Occupational, Medical Service Officer, Air Force
ARMY MIL-HDBK-154 B-1982 INSPECTION OF FRESH FRUIT AND VEGETABLE FARMS AND PACKING SHEDS IN OVERSEA AREAS

ZA-SANS

SANS 1409:2008 Outlet sockets and probes for medical (gas and vacuum) services used in hospitals
SANS 1409:2004 Outlet sockets and probes for medical (gas and vacuum) services used in hospitals

Others: Overseas medical industry,The latest overseas medical treatment,Advanced Overseas Medical