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Medical device network batch

Medical device network batch, Total:500 items.

In the international standard classification, Medical device network batch involves: Applications of information technology, Medical equipment, Laboratory medicine, Graphical symbols, Pharmaceutics, Vocabularies, Sterilization and disinfection, Rubber and plastics products, Software development and system documentation, Quality, Medical sciences and health care facilities in general, Dentistry, Information sciences. Publishing, Birth control. Mechanical contraceptives, First aid.

US-FCR, Medical device network batch

FCR 21 CFR PART 814-2015 PREMARKET APPROVAL OF MEDICAL DEVICES
FCR 21 CFR PART 814-2014 PREMARKET APPROVAL OF MEDICAL DEVICES
FCR 21 CFR PART 814-2013 PREMARKET APPROVAL OF MEDICAL DEVICES
FCR 21 CFR PART 810-2015 MEDICAL DEVICE RECALL AUTHORITY
FCR 21 CFR PART 810-2013 MEDICAL DEVICE RECALL AUTHORITY
FCR 21 CFR PART 810-2014 MEDICAL DEVICE RECALL AUTHORITY
FCR 21 CFR PART 821-2015 MEDICAL DEVICE TRACKING REQUIREMENTS
FCR 21 CFR PART 860-2015 MEDICAL DEVICE CLASSIFICATION PROCEDURES
FCR 21 CFR PART 860-2013 MEDICAL DEVICE CLASSIFICATION PROCEDURES

Group Standards of the People's Republic of China, Medical device network batch

T/ZMDS 20003-2019 Medical device security risk control – information of medical device security capabilities
T/CSBME 009-2019 Quality Evaluation Method of Cybersecurity in Medical Devices
T/ZGXX 0003-2019 Medical device cleaning agent
T/SHBX 005-2023 Sterilizable packaging films for medical devices

PL-PKN, Medical device network batch

PN Z54045-1986 Medical instruments Clik? Profile of mesh
PN Z54061-1986 Medical instruments Ears Dimensions
PN-EN 62366-1-2015-07/A1-2021-03 E Medical devices -- Part 1: Application of usability engineering to medical devices
PN Z54093-1986 Medical instruments Notches cuts

RU-GOST R, Medical device network batch

GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
GOST R IEC 62366-2013 Medical devices. Application of usability engineering to medical devices
GOST R ISO 15225-2014 Medical devices. Quality management. Medical device nomenclature data structure
GOST R ISO 15223-2-2013 Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Part 2. Symbol development, selection and validation
GOST EN 556-1-2011 Sterilization of medical devices. Requirements for medical devices to be designated «sterile». Part 1. Requirements for terminally sterilized medical devices
GOST ISO 10993-13-2011 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST ISO 10993-13-2016 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST ISO/TS 10993-20-2011 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices
GOST R 55544-2013 Medical devices software. Part 1. Guidance on the application of ISO 14971 medical devices software
GOST R 56429-2015 Medical devices. Clinical evaluation
GOST ISO 10993-1-2011 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GOST ISO 10993-11-2011 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST R ISO 10993-11-1999 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic to xicity
GOST ISO 10993-18-2011 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
GOST R ISO 10993-10-1999 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and sensitization
GOST ISO 10993-5-2011 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
GOST ISO 10993-7-2016 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
GOST R ISO 17664-2012 Sterilization of medical devices. Information to be provided by the manufacturer for the processing of resterilizable medical devices
GOST R 57449-2017 Medical devices. Guidance on the application of ISO 14971
GOST R 57502-2017 Medical equipment. Industrial production regulation

British Standards Institution (BSI), Medical device network batch

BS EN 62366-1:2015 Medical devices. Application of usability engineering to medical devices
BS EN 62366-1:2015+A1:2020 Medical devices. Application of usability engineering to medical devices
BS EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
BS ISO 15223-2:2010 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Symbol development, selection and validation
BS PD IEC/TR 62366-2:2016 Medical devices. Guidance on the application of usability engineering to medical devices
BS EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
BS EN ISO 14971:2019+A11:2021 Medical devices - Application of risk management to medical devices
BS EN ISO 15225:2016 Medical devices. Quality management. Medical device nomenclature data structure
BS EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
BS ISO 17664-2:2021 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Non-critical medical devices
BS EN 556-2:2015 Tracked Changes. Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'. Requirements for aseptically processed medical devices
23/30457240 DC BS EN 556-2. Sterilization of medical devices. Requirements for medical devices to be designated ''STERILE" - Part 2. requirements for aseptically processed medical devices
23/30457243 DC BS EN 556-1. Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Part 1. Requirements for terminally sterilized medical devices
BIP 2071-2005 Medical devices: ISO 13485 and ISO 9001
19/30378069 DC BS ISO 17664-2. 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
BS EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
DD ISO/TS 10993-20:2006 Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of medical devices

CEN - European Committee for Standardization, Medical device network batch

EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
EN ISO 14971:2007 Medical devices - Application of risk management to medical devices
EN ISO 14971:2000 Medical Devices - Application of Risk Management to Medical Devices (Incorporates Amendment A1: 2003)
EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
EN 1441:1997 Medical Devices - Risk Analysis
EN 556-2:2015 "Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices"

Association Francaise de Normalisation, Medical device network batch

NF S99-211:2013 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 EN ISO 14971/A11:2021 Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux
NF EN ISO 14971:2019 Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux
NF S99-014-2*NF ISO 15223-2:2010 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 2 : symbol development, selection and validation.
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
NF S99-012:2010 Medical devices - Quality management - Medical device nomenclature data structure.
NF S99-401:1994 Dispositifs médicaux - Élastomère de silicone de qualité médicale
NF S98-136:2009 Sterilisation of medical devices - Risk management related to the preparation of sterile medical devices within health establishments.
NF EN 556-1:2002 Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage STERILE - Partie 1 : exigences relatives aux dispositifs médicaux stérilisés au stade terminal
NF S98-107-2*NF EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2 : requirements for aseptically processed medical devices
NF S90-300:1981 MEDICAL AND SURGICAL EQUIPMENT. OXYGENATORS.
NF EN 556-2:2015 Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage "STÉRILE" - Partie 2 : exigences pour les dispositifs médicaux soumis à un traitement aseptique
NF S98-107-2:2004 "Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2 : requirements for aseptically processed medical devices".
NF S98-107-1*NF EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 1 : requirements for terminally sterilized 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
NF S99-015*NF EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates.
NF S90-031:1985 Medico-surgical equipment. Intra-uterine devices.
NF S91-170:1996 Dentistry. Medical devices for denstistry. Instruments.
NF S99-004:2008 Symbols for use in the labelling of medical devices.

European Committee for Standardization (CEN), Medical device network batch

EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices
EN 556:1998 Sterilization of Medical Devices - Requirements for Terminally - Sterilized Medical Devices to Be Labelled "Sterile" Ratified European Text; Includes Amendment 1: 1994
EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'
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)
EN ISO 14971:2019/A11:2021 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
EN 556-2:2003 Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 2: Requirements for aseptically processed medical devices
prEN 556-1991 Sterilization of medical devices; sterility assurance level for medical devices labelled "Sterile"; requirements

ZA-SANS, Medical device network batch

SANS 14971:2008 Medical devices - Application of risk management to medical devices
SANS 15223:2006 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied

Korean Agency for Technology and Standards (KATS), Medical device network batch

KS P ISO 14971:2018 Medical devices — Application of risk management to medical devices
KS P ISO 14971:2021 Medical devices — Application of risk management to medical devices
KS P ISO 15225-2014(2019) Medical devices — Quality management — Medical device nomenclature data structure
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
KS P IEC 62366-1:2018 Medical devices — Part 1:Application of usability engineering to medical devices
KS P IEC 62366-1:2021 Medical devices — Part 1: Application of usability engineering to medical devices
KS P ISO 15223-2007(2012) Medical devices－Symbols to be used with medical device labels, labelling and information to be supplied
KS P ISO TR 80002-2:2021 Medical device software — Part 2: Validation of software for medical device quality systems
KS P IEC TR 62366-2:2020 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
KS X IEC TR 80001-2-1-2015(2020) Application of risk management for IT-networks incorporating medical devices — Part 2-1: Step by step risk management of medical IT-networks — Practical applications and examples

Japanese Industrial Standards Committee (JISC), Medical device network batch

JIS T 14971:2003 Medical devices -- Application of risk management to medical devices
JIS T 14971:2012 Medical devices -- Application of risk management to medical devices
JIS T 62366-1:2022 Medical devices -- Part 1: Application of usability engineering to medical devices
JIS T 0307:2004 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied

KR-KS, Medical device network batch

KS P ISO 14971-2018 Medical devices — Application of risk management to medical devices
KS P ISO 14971-2021 Medical devices — Application of risk management to medical devices
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
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
KS P IEC 62366-1-2018 Medical devices — Part 1:Application of usability engineering to medical devices
KS P IEC 62366-1-2021 Medical devices — Part 1: Application of usability engineering to medical devices
KS P ISO TR 80002-2-2021 Medical device software — Part 2: Validation of software for medical device quality systems
KS P IEC TR 62366-2-2020 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices

TH-TISI, Medical device network batch

TIS 14971-2013 Medical devices.application of risk management to medical devices
TIS 2278-2006 Sterilization of medical devices-information to be provided by the manufacturer for the processing of resterilizable medical devices

Professional Standard - Medicine, Medical device network batch

YY/T 0316-2016 Medical devices.Application of risk management to medical devices
YY/T 0316-2008 Medical devices.Application of risk management to medical devices
YY/T 0316-2003 Medical devices-Application of risk management to medical devices
YY/T 0468-2015 Medical devices.Quality management.Medical device nomenclature data structure
YY 0466-2003 Medical devices-Symbols to be used with medical device labels,labelling and information to be supplied
YY/T 0297-1997 Clinical investigation of medical devices
YY/T 0618-2017 Bacterial endotoxins.Test methodologies,routine monitoring,and alternatives to batch testing
YY/T 1406.1-2016 Medical device software.Part 1:Guidance on the application of ISO 14971 to medical device software
YY/T 1406.1-2016/IEC/TR 80002-1 Medical Device Software Part 1: Guidelines for YY/T 0316 Applied to Medical Device Software
YY/T 0615.1-2007 Requirements for medical devices to be designated“STERILE”.part 1:Requirements for terminally sterilized medical devices
YY/T 0615.2-2007 Requirements for medical devices to be dwsignated“SIERILE”.Part 2:Requirements for aseptically processed medical devices

International Electrotechnical Commission (IEC), Medical device network batch

IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
IEC 62366:2007/AMD1:2014 Medical devices - Application of usability engineering to medical devices
IEC TR 62366-2:2016 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
IEC 62366-1:2015/COR1:2016 Medical devices - Part 1: Application of usability engineering to medical devices
IEC 62366-1:2020 Medical devices - Part 1: Application of usability engineering to medical devices
IEC 62366-1:2015+AMD1:2020 CSV Medical devices - Part 1: Application of usability engineering to medical devices
ISO/TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems
ISO/TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems
ISO TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems
ISO/TR 24971:2020 Medical devices -- Guidance on the application of ISO 14971

International Organization for Standardization (ISO), Medical device network batch

ISO 14971:2000 Medical devices - Application of risk management to medical devices
IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
ISO 15223-2:2010 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
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
IEC TR 62366-2-2016 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
IEC/TR 62366-2:2016 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
IEC 62366:2007/AMD 1:2014 Medical devices — Application of usability engineering to medical devices — Amendment 1
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 15223:2000 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied
ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
IEC TR 80002-1:2009 Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
IEC TR 80002-1:2009 Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
IEC/TR 80002-1:2009 Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
IEC 62366-1:2015/AMD1:2020 Medical devices — Part 1: Application of usability engineering to medical devices — Amendment 1
ISO 14971:2000/Amd 1:2003 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements
IEC 62366-1:2015/AMD 1:2020 Medical devices — Part 1: Application of usability engineering to medical devices — Amendment 1
ISO 14971:2019 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Medical device network batch

GB/T 42062-2022 Medical devices—Application of risk management to medical devices
GB/Z 42217-2022 Medical device —Validation of software for medical device quality system

未注明发布机构, Medical device network batch

DIN EN ISO 14971:2022 Medical devices – applying risk management to medical devices
BS EN 556-1:2001(2006) Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1 : Requirements for terminally sterilized medical devices
DIN EN ISO 10993-18:2009 Biological assessment of medical devices

German Institute for Standardization, Medical device network batch

DIN 58846:2017-11 Medical instruments - Raspatories
DIN 58852:2008 Medical instruments - Probes
DIN 58852:1976 Medical instruments; probes
DIN 58794:1982 Medical instruments; ear forceps
DIN 13119:1980 Medical instruments; bowel scissors
DIN 96056:2009 Medical instruments - Bone raspatory
DIN 13119:2010 Medical instruments - Bowel scissors
DIN 13117:2013 Medical instruments.Bone shears
DIN 58852:2021 Medical instruments - Probes
DIN 58794:2010 Medical instruments - Ear forceps
DIN 13117:1980 Medical instruments; bone shears
DIN 58852:2014 Medical instruments - Probes
DIN 58857:2019-12 Medical instruments - Directors
DIN 58263:1973 Medical instruments; mouth gag Heister's
DIN EN 556-1:2002-03 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001 / Note: To be replaced by DIN EN 556-1 (2023-02).
DIN EN 556-1 Berichtigung 1:2006-12 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001, Corrigenda to DIN EN 556-1:2002-03; German version EN 556-1...
DIN EN 556-2:2023-02 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: requirements for aseptically processed medical devices; German and English version prEN 556-2:2023 / Note: Date of issue 2023-01-06*Intended as r...
DIN EN 556-2:2015-11 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2015 / Note: To be replaced by DIN EN 556-2 (2023-02).
DIN EN 556-1:2023-02 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German and English version prEN 556-1:2023 / Note: Date of issue 2023-01-06*Intended as r...
DIN EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
DIN EN ISO 14971:2022-04 Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019 + A11:2021
DIN 58846:2017 Medical instruments - Raspatories
DIN 58292:1972 Medical instruments; tracheal hook
DIN 58857:1976 Medical instruments; directors
DIN 58846:1988 Medical instruments; raspatories
DIN 58862:1988 Medical instruments; bone curettes
DIN 13458:1988 Medical instruments; ligature needle
DIN 58230:2010 Medical instruments - Amputation knives
DIN 13145:2010 Medical instruments - Mallet of plastic material
DIN 13458:2009 Medical instruments - Ligature needle
DIN 58846:2010 Medical instruments - Raspatories
DIN 13173:2016 Medical instruments - Dressing forceps
DIN 13111:2018 Medical instruments - Bandage scissors
DIN 58862:2010 Medical instruments - Bone curettes
DIN 13145:1979 Medical instruments; mallet of plastic material
DIN 13173:2005 Medical instruments - Dressing forceps
DIN 58858:2021-02 Medical instruments - Director type König
DIN 96057:2023-03 Medical instruments - Raspatory type Sedillot
DIN 13173:2023-03 Medical instruments - Dressing forceps
DIN 58319:2019-12 Medical instruments - Elevators Williger
DIN 58318:2019-12 Medical instruments - Elevators Langenbeck's
DIN 13103:1973 Medical instruments; dissecting scalpels
DIN 58230:1974 Medical instruments; amputation knives
DIN 58292:2010 Medical instruments - Tracheal hook
DIN 13104:2010 Medical instruments - Cartilage knife
DIN 13111:2006 Medical instruments - Bandage scissors
DIN 58285:2008 Medical instruments - Retractor type Volkmann
DIN 58247:2016 Medical instruments - Retractors type Roux
DIN 58290:1972 Medical instruments; retractor Bergmann's
DIN 58265:1974 Medical instruments; needle holder Finochietto's
DIN 58256:1976 Medical instruments; needle holder, type T?nnis
DIN 58259:1976 Medical instruments; needle holder type Masson
DIN 58315:1979 Medical instruments; retractors Cushing's
DIN 58863:1979 Medical instruments; bone curettes type Volkmann
DIN 58240:1983 Medical instruments; retractors type Israel
DIN 58248:1983 Medical instruments; retractor type Jansen
DIN 58249:1983 Medical instruments; retractors type Weitlaner
DIN 58257:1983 Medical instruments; needle holder type Crile
DIN 58285:1983 Medical instruments; retractor type Volkmann
DIN 58286:1983 Medical instruments; retractor type Kocher
DIN 58287:1983 Medical instruments; retractor type K?rte
DIN 58855:1983 Medical instruments; director type Kirschner
DIN 58312:1988 Medical instruments; rib contractor
DIN 58795:1988 Medical instruments; mouth gags
DIN 58247:1973 Medical instruments; retractor Roux's
DIN 58262:1973 Medical instruments; mouth gag Jennings
DIN 58296:1973 Medical instruments; raspatories Semb's
DIN 96053:2009 Medical instruments - Retractor type Ollier
DIN 96053:2021 Medical instruments - Retractor type Ollier
DIN 58312:2010 Medical instruments - Rib contractor
DIN 58285:2021 Medical instruments - Retractor type Volkmann
DIN 58285:2014 Medical instruments - Retractor type Volkmann
DIN 13176:2016 Medical instruments - Organ grasping forceps
DIN 58247:2010 Medical instruments - Retractors type Roux
DIN 13176:2005 Medical instruments - Organ grasping forceps
DIN 58295:2017-08 Medical instruments - Retractor type Volkmann
DIN 13176:2023-03 Medical instruments - Organ grasping forceps
DIN 58247:2023-03 Medical instruments - Retractors type Roux
DIN 58286:2017-08 Medical instruments - Retractor type Kocher
DIN 96053:2021-02 Medical instruments - Retractor type Ollier
DIN 58288:2017-08 Medical instruments - Retractor type Langenbeck
DIN 58285:2021-02 Medical instruments - Retractor type Volkmann
DIN 58249:2023-03 Medical instruments - Retractors type Weitlaner
DIN 58287:2017-08 Medical instruments - Retractor type Körte
DIN 13460:2023-03 Medical instruments - Needle holder type Heaney
DIN 96149:2011 Medical instruments - Bone curettes type Daubenspeck
DIN 58318:2008 Medical instruments - Elevators Langenbeck's
DIN EN ISO 17664-1:2021-11 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); German version EN ISO 17664-1:2021
DIN 58853:2008 Medical instruments - Probes with eye
DIN 58853:2014 Medical instruments - Probes with eye
DIN 58271:2006 Medical instruments - Dressing forceps, bayonet
DIN 58274:2009 Medical instruments - Iris forceps
DIN 58254:2017 Medical instruments - Scissors for incisions
DIN 58853:1976 Medical instruments; probes with eye
DIN 58860:1976 Medical instruments; osteotomes type Lexer
DIN 58243:1982 Medical instruments; intestinal forceps type Kocher
DIN 58239-1:1983 Medical instruments; tissue forceps
DIN 58273:1983 Medical instruments; fixation forceps
DIN 58274:1983 Medical instruments; iris forceps
DIN 58276:1983 Medical instruments; forceps type Adson
DIN 58278:1983 Medical instruments; cilia forceps
DIN 58847:1988 Medical instruments; bone holding forceps
DIN 58317:1973 Medical instruments; elevator Henke's
DIN 58318:1973 Medical instruments; elevators Langenbeck's
DIN 58319:1973 Medical instruments; elevators Williger
DIN 58273:2021 Medical instruments - Fixation forceps
DIN 58243:2009 Medical instruments - Intestinal forceps type Kocher
DIN 58243:2021 Medical instruments - Intestinal forceps type Kocher
DIN 13453:2010 Medical instruments - Tonsil scissors
DIN 96074:2010 Medical instruments - Elevator type Freer
DIN 96022:2009 Medical instruments - Bone forceps type Citelli
DIN 96144:2011 Medical instruments - Raspatories type Williger
DIN 13175:1983 Medical instruments; tongue forceps, type Young
DIN 96160:2011 Medical instruments - Wire guide
DIN 58853:2021 Medical instruments - Probes with eye
DIN 58273:2009 Medical instruments - Fixation forceps
DIN 13175:2013 Medical instruments.Tongue forceps type Young
DIN 96060:2009 Medical instruments - Elevator type Langenbeck
DIN 96144:2017 Medical instruments - Raspatories type Williger
DIN 13184:2005 Medical instruments - Bone holding forceps Farabeuf's
DIN 13185:2005 Medical instruments - Onychia forceps
DIN 96079:2010 Medical instruments - Retractor type Middeldorpf
DIN 58271:2017 Medical instruments - Dressing forceps, bayonet
DIN 58278:2010 Medical instruments - Cilia forceps
DIN 96057:2009 Medical instruments - Raspatory type Sedillot
DIN 13103:2010 Medical instruments - Dissecting scalpels
DIN 58254:2006 Medical instruments - Scissors for incisions
DIN 96067:2009 Medical instruments - Ear hook type Lucae
DIN 58276:2017-08 Medical instruments - Forceps type Adson
DIN 96140:2017-11 Medical instruments - Osteotomes type Stille
DIN 58254:2017-11 Medical instruments - Scissors for incisions
DIN 13128:2023-03 Medical instruments - Intestinal forceps type Allis
DIN 58860:2017-08 Medical instruments - Osteotomes type Lexer
DIN 58861:2017-08 Medical instruments - Osteotomes type Lambotte
DIN 58243:2021-02 Medical instruments - Intestinal forceps type Kocher
DIN 58785:2017-08 Medical instruments - Ear specula type Hartmann
DIN 58273:2021-02 Medical instruments - Fixation forceps
DIN 13184:2023-03 Medical instruments - Bone holding forceps Farabeuf's
DIN 58313:2021-02 Medical instruments - Cotton carrier, straight
DIN 13111:2018-08 Medical instruments - Bandage scissors
DIN 58857:2008 Medical instruments - Directors
DIN 58853:2021-02 Medical instruments - Probes with eye
DIN EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2003
DIN 58266:1974 Medical instruments; needle holder Crile-Wood's
DIN 58286:2010 Medical instruments - Retractor type Kocher
DIN 58259:2010 Medical instruments - Needle holder type Masson
DIN 58315:2010 Medical instruments - Retractors type Cushing
DIN 13183:2005 Medical instruments - Plaster breaker Wolff's
DIN 58248:2010 Medical instruments - Retractor type Jansen
DIN 96028:2009 Medical instruments - Haemostatic forceps type Dieffenbach
DIN 96147:2011 Medical instruments - Intestunal spatulas type Kader
DIN 13194:2005 Medical instruments - Rongeur type Beyer
DIN 13146:2010 Medical instruments - Mallet type Hajek
DIN 58242:2009 Medical instruments - Haemostatic forceps type Dandy
DIN 58313:2009 Medical instruments - Cotton carrier, straight
DIN 58241:1970 Medical instruments; Crile's haemostatic forceps
DIN 58242:1970 Medical instruments; Dandy's haemostatic forceps
DIN 58293:1972 Medical instruments; tracheal hook Bose's
DIN 58250:1976 Medical instruments; scalpels
DIN 58251:1976 Medical instruments; scalpels type Bergmann
DIN 58850:1976 Medical instruments; eye scalpels
DIN 58232:1979 Medical instruments; Kocher's haemostatic forceps
DIN 58245:1979 Medical instruments; towel clamps, Backhaus
DIN 58260:1979 Medical instruments; ligature needle type Deschamps
DIN 58246:1981 Medical instruments; peritoneum forceps, Mikulicz
DIN 58313:1981 Medical instruments; cotton carrier; straight
DIN 13104:1973 Medical instruments; cartilage knife
DIN 13191:2016 Medical instruments - Rongeur type Stille
DIN 58242:2016 Medical instruments - Haemostatic forceps type Dandy
DIN 13193:2016 Medical instruments - Rongeurs type Luer
DIN 13146:1979 Medical instruments; mallet type Hajek
DIN 13452:2006 Medical instruments - Scissors type Kilner
DIN 13192:2016 Medical instruments - Rongeur type Ruskin
DIN 13128:2005 Medical instruments - Intestinal forceps type Allis
DIN 13190:2016 Medical instruments - Bone cutting forceps type Liston
DIN 96035:2009 Medical instruments - Haemostatic forceps type Semb
DIN 13128:2016 Medical instruments - Intestinal forceps type Allis
DIN 96015:2009 Medical instruments - Plaster scissors type Stille
DIN 13191:2005 Medical instruments - Rongeur type Stille
DIN 58296:2008 Medical instruments - Raspatories Semb's
DIN 58317:2010 Medical instruments - Elevator type Henke
DIN 13147:1979 Medical instruments; mallet type Bergmann
DIN 58850:2010 Medical instruments - Eye scalpels
DIN 96101:2010 Medical instruments - Bone raspatory type Jansen
DIN 96073:2009 Medical instruments - Tongue depressor, double-ended
DIN 58241:2009 Medical instruments - Haemostatic forceps type Crile
DIN 58244:2009 Medical instruments - Intestinal forceps type Mayo-Robson
DIN 58244:2021 Medical instruments - Intestinal forceps type Mayo-Robson
DIN 58270:2006 Medical instruments - Dressing forceps, angular
DIN 96031:2009 Medical instruments - Haemostatic forceps type Guyon
DIN 96073:2021 Medical instruments - Tongue depressor, double-ended
DIN 96099:2010 Medical instruments - Hemostatic chissels type Passow
DIN 13452:2017 Medical instruments - Scissors type Kilner
DIN 96016:2009 Medical instruments - Bone cutting forceps type Dahlgreen
DIN 58245:2021 Medical instruments - Towel clamps type Backhaus
DIN 58241:2016 Medical instruments - Haemostatic forceps type Crile
DIN 58246:2009 Medical instruments - Peritoneum forceps type Mikulicz
DIN 58246:2016 Medical instruments - Peritoneum forceps type Mikulicz
DIN 96066:2009 Medical instruments - Strabismus hook type Graefe
DIN 96081:2010 Medical instruments - Retractor type Alm
DIN 13194:2016 Medical instruments - Rongeur type Beyer
DIN 96065:2009 Medical instruments - Iris hook type Graefe
DIN 13147:2010 Medical instruments - Mallet type Bergmann
DIN 58313:2021 Medical instruments - Cotton carrier, straight
DIN 13105:1983 Medical instruments; autopsy knife
DIN 13187:2005 Medical instruments - Bone holding forceps type Semb
DIN 96151:2011 Medical instruments - Bone curettes type Hemingway
DIN 58231:2009 Medical instruments - Haemostatic forceps type Halstead
DIN 58245:2009 Medical instruments - Towel clamps type Backhaus
DIN 58260:2008 Medical instruments - Ligature needle type Deschamps
DIN 13192:2005 Medical instruments - Rongeur type Ruskin
DIN 13174:2005 Medical instruments - Splinter forceps type Stieglitz
DIN 58250:2010 Medical instruments - Scalpels
DIN 13193:2005 Medical instruments - Rongeurs type Luer
DIN 13192:2023-03 Medical instruments - Rongeur type Ruskin
DIN 13191:2023-03 Medical instruments - Rongeur type Stille
DIN 96073:2021-02 Medical instruments - Tongue depressor, double-ended
DIN 58845:2017-08 Medical instruments - Bone levers type Hohmann
DIN 13465:2023-03 Medical instruments - Haemostatic forceps type Adson
DIN 58847:2023-03 Medical instruments - Bone holding forceps type Verbrugge
DIN 58244:2021-02 Medical instruments - Intestinal forceps type Mayo-Robson
DIN 58260:2017-08 Medical instruments - Ligature needle type Deschamps
DIN 58245:2021-02 Medical instruments - Towel clamps type Backhaus
DIN 13194:2023-03 Medical instruments - Rongeur type Beyer
DIN 96100:2023-03 Medical instruments - Raspatory type Farabeuf-Collin
DIN 13469:2023-03 Medical instruments - Dissecting forceps type Adson
DIN 13105:2010 Medical instruments - Autopsy knife
DIN 13190:2005 Medical instruments - Bone cutting forceps type Liston
DIN 58270:2017 Medical instruments - Dressing forceps, angular
DIN 58240:2010 Medical instruments - Retractors type Israel
DIN 58240:2016 Medical instruments - Retractors type Israel
DIN 58294:1972 Medical instruments; lid retractor Desmarres'
DIN 58864:1979 Medical instruments; bone curettes type Simon, type Schr?der and type Halle
DIN 58859:1982 Medical instruments; dissector type T?nnis, double-ended
DIN 13460:1982 Medical instruments; needle holder type Heaney
DIN 58319:2008 Medical instruments - Elevators Williger
DIN 96163:2011 Medical instruments - Retractor type Volkmann, short, blunt
DIN 96076:2010 Medical instruments - Self-retaining retractor type Wullstein
DIN 58262:2010 Medical instruments - Mouth gag type Jennings
DIN 13464:1982 Medical instruments; retractor type Sch?nborn
DIN 58290:2010 Medical instruments - Retractor type Bergmann
DIN 58863:2010 Medical instruments - bone curettes type Volkmann
DIN 96138:2011 Medical instruments - Tympanum perforators type Lucae
DIN 13460:2010 Medical instruments - Needle holder type Heaney
DIN 13460:2016 Medical instruments - Needle holder type Heaney
DIN 13137:2023-03 Medical instruments - Abdominal retractor type Fritsch
DIN 58240:2023-03 Medical instruments - Retractors type Israel
DIN 58294:2017-08 Medical instruments - Lid retractor type Desmarres
DIN 58257:2010 Medical instruments - Needle holder type Crile
DIN 96095:2010 Medical instruments - Lachrymal dilatators type Wilder
DIN 13464:2010 Medical instruments - Retractor type Schönborn
DIN 58263:2010 Medical instruments - Mouth gag type Heister
DIN 96115:2010 Medical instruments - Gauges type Lexer
DIN 58859:2010 Medical instruments - Dissector type Tönnis, double-ended
DIN EN ISO 10993-17:2021-12 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO/DIS 10993-17:2021); German and English version prEN ISO 10993-17:2021 / Note: Date of issue 2021-11-12*Intended as replacement for DIN...
DIN 58855:2008 Medical instruments - Director type Kirschner
DIN 58858:2014 Medical instruments - Director type König
DIN 96042:2006 Medical instruments - Packaging - Technical specification
DIN 13177:2005 Medical instruments - Kidney stone forceps type Randall
DIN 13178:2016 Medical instruments - Gall stone forceps type Desjardins
DIN 58279:2006 Medical instruments - First aid box scissors
DIN 58238-1:2006 Medical instruments - Part 1: Dissection forceps, straight
DIN 58293:2008 Medical instruments - Tracheal hook Bose's
DIN 58234:2009 Medical instruments - Hemostatic forceps type Rochester-Pean
DIN 58276:2010 Medical instruments - Forceps type Adson
DIN 58231:1970 Medical instruments; Halstead's mosquito forceps
DIN 58861:1976 Medical instruments; osteotomes type Lambotte
DIN 58233:1979 Medical instruments; Overholt-Gei?end?rfer's haemostatic forceps
DIN 58858:1979 Medical instruments; director type K?nig
DIN 58234:1983 Medical instruments; haemostatic forceps type Rochester-Pean
DIN 58238-2:1983 Medical instruments; dissection forceps, curved
DIN 58239-2:1983 Medical instruments; tissue forceps, curved
DIN 58288:1983 Medical instruments; retractor type Langenbeck
DIN 58845:1988 Medical instruments; bone levers type Hohmann
DIN 58796:1989 Medical instruments; laryngeal mirrors with handle
DIN 13453:1982 Medical instruments; tonsil scissors
DIN 96064:2009 Medical instruments - Dura hook type Tönnis
DIN 58855:2014 Medical instruments - Director type Kirschner
DIN 58237:2006 Medical instruments - Splinter forceps type Feilchenfeld

Danish Standards Foundation, Medical device network batch

DS/EN ISO 14971:2013 Medical devices - Application of risk management to medical devices
DS/EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
DS/CEN/CR 14060:2001 Medical device traceability
DS/EN 556-1/AC:2006 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 1: Requirements for terminally sterilized medical devices
DS/EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 1: Requirements for terminally sterilized medical devices
DS/EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices
DS/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)
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/EN 556:1995 Sterilization of medical devices - Requirements for medical devices to be labelled "Sterile"
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
DS/EN 1639:2009 Dentistry - Medical devices for dentistry - Instruments
DS/IEC/TR 80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
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 1640:2009 Dentistry - Medical devices for dentistry - Equipment
DS/EN 1641:2009 Dentistry - Medical devices for dentistry - Materials
DS/ISO/TR 24971:2013 Medical devices - Guidance on the application of ISO 14971

ES-UNE, Medical device network batch

UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN ISO 14971:2020/A11:2022 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN 556-1:2002/AC:2007 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
UNE-EN 556-2:2016 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed 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)

Standard Association of Australia （SAA）, Medical device network batch

AS ISO 14971:2020 Medical devices — Application of risk management to medical devices
AS/NZS 4815 Set:2008 Sterilising Medical instruments Set
ISO 10993-17:2023 Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents

国家食品药品监督管理局, Medical device network batch

YY/T 1474-2016 Application of medical device usability engineering to medical devices

American National Standards Institute （ANSI), Medical device network batch

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
ANSI/AAMI/ISO 15223-2:2010 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 2: Symbol development, selection and validation
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/IEC 62366/A1:2014 Medical devices - Application of usability engineering to medical devices - Amendment 1
ANSI/AAMI ST108:2023 Water for the processing of medical devices

Canadian Standards Association (CSA), Medical device network batch

CSA ISO 14971-07-CAN/CSA:2007 Dispositifs Medicaux - Application De La Gestion Des Risques Aux Dispositifs Medicaux deuxieme edition
CAN/CSA-ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices (Second Edition)

CENELEC - European Committee for Electrotechnical Standardization, Medical device network batch

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

Jiangsu Provincial Standard of the People's Republic of China, Medical device network batch

DB32/T 3769-2020 Basic requirements for medical device network information security
DB3212/T 1065-2021 Standards for Quality Evaluation of Medical Devices Used in Medical Institutions
DB32/T 4553-2023 Guidelines for Monitoring Adverse Events of Medical Devices in Medical Institutions

国家药监局, Medical device network batch

YY/T 0802-2020 Disposal of medical devices Information provided by medical device manufacturers

Lithuanian Standards Office , Medical device network batch

LST EN 556-1-2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
LST EN 556-2-2004 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
LST EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010)
LST EN 556-1-2002/AC-2006 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
LST EN 1639-2010 Dentistry - Medical devices for dentistry - Instruments
LST EN 1641-2010 Dentistry - Medical devices for dentistry - Materials
LST EN 1640-2010 Dentistry - Medical devices for dentistry - Equipment

AENOR, Medical device network batch

UNE-EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
UNE-EN 1639:2010 Dentistry - Medical devices for dentistry - Instruments
UNE-EN 1641:2010 Dentistry - Medical devices for dentistry - Materials
UNE-EN 1640:2010 Dentistry - Medical devices for dentistry - Equipment

AT-ON, Medical device network batch

OENORM 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/FDIS 17664-1:2021)

CH-SNV, Medical device network batch

SN 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)

卫生健康委员会, Medical device network batch

WS/T 654-2019 Medical device safety management

VN-TCVN, Medical device network batch

TCVN 6916-2001 Medical devices.Symbols to be used with medical device labels, labelling and information to be supplied

RO-ASRO, Medical device network batch

STAS E 10719/2-1986 Medical instruments RESISTANCE TESTING AT CORROSION AND REPEATED STERILIZATIONS STAINLESS STEEL MEDICAL INSTIUMENTS
STAS 10719/1-1984 MEDICAL INSTRUMENTS Clasification and terminology
STAS 5460-1968

US-AAMI, Medical device network batch

AAMI TIR34-2014 Water for the reprocessing of medical devices

EU/EC - European Union/Commission Legislative Documents, Medical device network batch

MEDDEV 2.15-2008 GUIDELINES ON MEDICAL DEVICES Committees/Working Groups contributing to the implementation of the Medical Device Directives (REV 3)

US-CFR-file, Medical device network batch

CFR 21-814.3-2014 Food and Drugs. Part814:Premarket approval of medical devices. Section814.3:Definitions.
CFR 21-814.84-2013 Food and Drugs. Part814:Premarket approval of medical devices. Section814.84:Reports.

IX-EU/EC, Medical device network batch

MEDDEV 2.4/1 PART 2-2001 Guidelines for the Classification of Medical Devices Rev 8