Imported Class II Medical Devices

Imported Class II Medical Devices, Total:324 items.

The international standard classification for "Imported Class II Medical Devices" includes: Medical equipment in general , Medical equipment .

The Chinese standard classification for "Imported Class II Medical Devices" includes: Medical sanitary products , General and microsurgical devices , Medical apparatus and devices in general , Public medical equipment .

Professional Standard - Commodity Inspection

SN/T 0323.1-2007 Rules for the inspection of medical equipment for import and export - Part 1 : Infusion and transfusion sets for single use
SN/T 3061-2011 Rules of the Inspection of Packaging for Import Terminally Sterilized Medical Devices
SN/T 0323.2-2007 Rules for the inspection of medical equipment for import and export - Part 2 : Sterile hypodermic syringes for single use
SN/T 1430.1-2004 Rules for the inspection of medical electrical equipment for improt - Ultrasonic medical diagnostic and therapy equipment
SN/T 3062.2-2011 Packing Materials for Terminally Sterilized Medical Devices for Import. Part 2: Paper Bags. Requirements and Test Methods

Shanghai Provincial Standard of the People's Republic of China

DB31/T 1378-2022 Service Specifications for Class II Medical Device Registration

未注明发布机构

DIN EN 15986 E:2009-08 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
DIN 13173 E:2016-07 Medical instruments - Dressing forceps
DIN 58254 E:2017-06 Medical instruments - Scissors for incisions
DIN 96056 E:2015-09 Medical instruments - Bone raspatory
DIN 58852 E:2020-06 Medical instruments - Probes
DIN 96057 E:2022-08 Medical instruments - Raspatory type Sedillot
DIN 96056 E:2022-08 Medical instruments - Bone raspatory
YY 91049-1999 Expanded classification method for three-level categories of medical device standard documents
DIN 96056:2023-03 Medical instruments - Bone raspatory
DIN 58846 E:2017-06 Medical instruments - Raspatories
DIN EN ISO 14971 E:2018-08 Application of medical device risk management in medical devices (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
ANSI/AAMI/ISO 15225:2016 Medical devices—Quality management—Medical device nomenclature data structure
DIN 13119 E:2008-09 Medical instruments bowel scissors
DIN 58852 E:2014-02 Medical instruments - Probes
DIN 58288 E:2017-03 Medical instruments retractor type Langenbeck
DIN 96056:2016-03 Medical instruments - Bone raspatory
DIN 96057 E:2015-09 Medical instruments - Raspatory type Sedillot
ANSI/AAMI/ISO 14971:2019 Medical devices— Application of risk management to medical devices
DIN 13145 E:2008-09 Medical instruments - Mallet of plastic material
DIN 58295 E:2017-03 Medical instruments - Retractor type Volkmann
DIN 13176 E:2016-07 Medical instruments - Organ grasping forceps
DIN 58287 E:2017-03 Medical instruments - Retractor type Körte
DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
DIN 58247 E:2016-07 Medical instruments retractor Roux's
DIN 96057:2016-03 Medical instruments - Raspatory type Sedillot
DIN EN ISO 14971:2022 Medical devices – applying risk management to medical devices
DIN 13173 E:2022-08 Medical instruments - Dressing forceps

国家质量监督检验检疫总局

SN/T 4445.1-2016 Technical requirements for the inspection of medical apparatus for import-Part 1: Medical electrical equipment
SN/T 4445.2-2016 Technical requirements for the inspection of medical apparatus for import-Part 2: Patient monitor

Professional Standard - Agriculture

SN/T 4445.4-2023 Technical requirements for the inspection of medical equipment for importPart 4:Infusion pump
SN/T 4445.3-2018 Technical requirements for the inspection of imported medical devices Part3 : Anaesthetic equipment

Professional Standard - Medicine

YY/T 0316-2008 Medical devices - Application of risk management to medical devices
YY/T 0316-2016 Medical devices-Application of risk management to medical devices
YY/T 0468-2015 Medical devices―Quality management―Medical device nomenclature data structure
YY/T 91049-1999 Third class category expansion variety method for medical devices standard literature
YY 91055-1999 Paint coating for medical devices. Classification and speciation
YY/T 0316-2003 Medical devices -- Application of risk management to medical devices

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

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

国家食品药品监督管理局

YY/T 1474-2016 Medical devices－Application of risk management to medical devices

Guangdong Provincial Standard of the People's Republic of China

DB4420/T 45-2024 Specifications for registration management of Class I medical device products
DB4403/T 277-2022 Medical device unique identification data interface specification

国家药监局

YY/T 0802-2020 Processing of medical devices—Information to be provided by the medical device manufacturer

Group Standards of the People's Republic of China

T/ZGXX 0003-2019 Medical device cleaning agent

GSO

GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
BH GSO 2628:2022 Medical devices and supplies classification criteria
GSO 2628:2021 Medical devices and supplies classification criteria
BH GSO ISO 14971:2017 Medical devices -- Application of risk management to medical devices
OS GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
OS GSO IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
BH GSO ISO 15225:2017 Medical devices -- Quality management -- Medical device nomenclature data structure
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 15225:2016 Medical devices -- Quality management -- Medical device nomenclature data structure
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

German Institute for Standardization

DIN 58795:1988 Medical instruments; mouth gags
DIN 58263:1973 Medical instruments; mouth gag Heister's
DIN 58262:1973 Medical instruments; mouth gag Jennings
DIN 58254:2017-11 Medical instruments - Scissors for incisions
DIN 58254:2006 Medical instruments - Scissors for incisions
DIN 58254:2017 Medical instruments - Scissors for incisions
DIN 58262:2010 Medical instruments - Mouth gag type Jennings
DIN 58263:2010 Medical instruments - Mouth gag type Heister
DIN 96020:2009 Medical instruments - Rip shears type Sauerbruch
DIN 58288:1983 Medical instruments; retractor type Langenbeck
DIN 58287:2010 Medical instruments - Retractor type Körte
DIN 58295:2010 Medical instruments - Retractor type Volkmann
DIN 58846:2017-11 Medical instruments - Raspatories
DIN 58795:2010-02 Medical instruments - Mouth gags - Dimensions for slide bars and tongue depressors
DIN EN 15986:2011-05 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version EN 15986:2011, with CD-ROM
DIN 13199:2010 Medical instruments - Ethmoid rongeur forceps type Weil-Blakesley and Watson-Williams
DIN 58794:1982 Medical instruments; ear forceps
DIN 58795:2010 Medical instruments - Mouth gags - Dimensions for slide bars and tongue depressors
DIN 96056:2009 Medical instruments - Bone raspatory
DIN 58794:2010 Medical instruments - Ear forceps
DIN 58852:2008 Medical instruments - Probes
DIN 13119:1980 Medical instruments; bowel scissors
DIN 58852:2014 Medical instruments - Probes
DIN 13119:2010 Medical instruments - Bowel scissors
DIN 13117:1980 Medical instruments; bone shears
DIN 58852:2021 Medical instruments - Probes
DIN 13117:2013 Medical instruments.Bone shears
DIN 58857:2019-12 Medical instruments - Directors
DIN 58852:1976 Medical instruments; probes
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 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 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 EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
DIN EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
DIN 13173:2005 Medical instruments - Dressing forceps
DIN 58292:2010 Medical instruments - Tracheal hook
DIN 58292:1972 Medical instruments; tracheal hook
DIN 58230:1974 Medical instruments; amputation knives
DIN 58862:1988 Medical instruments; bone curettes
DIN 96057:2023-03 Medical instruments - Raspatory type Sedillot
DIN 58319:2019-12 Medical instruments - Elevators Williger
DIN 13104:2010 Medical instruments - Cartilage knife
DIN 58857:1976 Medical instruments; directors
DIN 13173:2023-03 Medical instruments - Dressing forceps
DIN 13111:2006 Medical instruments - Bandage scissors
DIN 13103:1973 Medical instruments; dissecting scalpels
DIN 58318:2019-12 Medical instruments - Elevators Langenbeck's
DIN 13111:2018 Medical instruments - Bandage scissors
DIN 58846:2017 Medical instruments - Raspatories
DIN 58858:2021-02 Medical instruments - Director type König
DIN 58230:2010 Medical instruments - Amputation knives
DIN 13458:2009 Medical instruments - Ligature needle
DIN 13145:1979 Medical instruments; mallet of plastic material
DIN 58862:2010 Medical instruments - Bone curettes
DIN 13145:2010 Medical instruments - Mallet of plastic material
DIN 58846:1988 Medical instruments; raspatories
DIN 13458:1988 Medical instruments; ligature needle
DIN 13173:2016 Medical instruments - Dressing forceps
DIN 58846:2010 Medical instruments - Raspatories
DIN EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version EN 15986:2011, with CD-ROM
DIN 58259:1976 Medical instruments; needle holder type Masson

Canadian Standards Association (CSA)

CSA ISO 14971-07-CAN/CSA:2007 Medical Devices - Application of Risk Management to Medical Devices second edition
CAN/CSA-ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices (Second Edition)
CSA ISO 13485-03-CAN/CSA:2003 Medical devices - Quality management systems - Requirements for regulatory purposes Second Edition
CAN/CSA-ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes (Second Edition)

PL-PKN

PN Z54093-1986 Medical instruments Notches cuts
PN Z54061-1986 Medical instruments Ears Dimensions

US-FCR

FCR 21 CFR PART 860-2015 MEDICAL DEVICE CLASSIFICATION PROCEDURES
FCR 21 CFR PART 860-2013 MEDICAL DEVICE CLASSIFICATION PROCEDURES
FCR 21 CFR PART 810-2014 MEDICAL DEVICE RECALL AUTHORITY
FCR 21 CFR PART 810-2013 MEDICAL DEVICE RECALL AUTHORITY
FCR 21 CFR PART 810-2015 MEDICAL DEVICE RECALL AUTHORITY

Association Francaise de Normalisation

NF EN 1642:2013 Oral medicine - Medical devices for oral medicine - Dental implants
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 S99-211:2013 Medical devices - Application of risk management to medical devices
NF EN 15986:2011 Symbole à utiliser pour l'étiquetage des dispositifs médicaux - Exigences relatives à l'étiquetage des dispositifs médicaux contenant des phtalates
NF EN ISO 14971:2019 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 Medical devices - Application of risk management to medical devices
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.

RO-ASRO

STAS 10719/1-1984 MEDICAL INSTRUMENTS Clasification and terminology

SCC

DIN 58254 E:2017 Draft Document - Medical instruments - Scissors for incisions
DIN 58263 E:2008 Draft Document - Medical instruments - Mouth gag type Heister
09/30205582 DC BS EN 15986. Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates
CAN/CSA-ISO 14971-2007(R2017) Medical Devices - Application of Risk Management to Medical Devices (Adopted ISO 14971:2007, second edition, 2007-03-01)
DANSK DS/EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
NS-EN 15986:2011 Symbol for use in the labelling of medical devices — Requirements for labelling of medical devices containing phthalates
CEI UNI EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
AENOR UNE-EN 15986:2011 Symbol for use in the labeling of medical devices - Requirements for labeling of medical devices containing phthalates
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
CAN/CSA-ISO 14971:2007(C2012) Medical devices - Application of risk management to medical devices
CEI UNI EN ISO 14971:2020 Medical devices - Application of risk management to medical devices
AAMI/ISO 14971:2019 Medical devices - Application of risk management to medical devices
CAN/CSA-ISO 14971:2007(R2012) Medical Devices - Application of Risk Management to Medical Devices
DANSK DS/EN ISO 14971:2012 Medical devices – Application of risk management to medical devices
DANSK DS/ISO 14971:2020 Medical devices – Application of risk management to medical devices
CAN/CSA-ISO 14971:2001(R2006) Medical Devices - Application of Risk Management to Medical Devices
ISO 14971:2019 Plus Redline Medical devices - Application of risk management to medical devices
CAN/CSA-ISO 14971:2001(C2006) Medical devices - Application of risk management to medical devices
BS EN ISO 14971:2019 Medical devices. Application of risk management to medical devices
DANSK DS/EN ISO 15225:2016 Medical devices – Quality management – Medical device nomenclature data structure
AAMI/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
CEI UNI EN/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
CEI EN 62366:2008 Medical devices - Application of usability engineering to medical devices
AENOR UNE-EN 62366:2009 Medical devices - Application of usability engineering to medical devices
DANSK DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
AAMI/ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
DANSK DS/EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
CEI EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
AENOR UNE-EN 62366/A1:2009 Medical devices - Application of usability engineering to medical devices
DIN 58858 E:2020 Draft Document - Medical instruments - Director type KÃ¶nig
MIL MIL-C-42068-1989 CHEST, MEDICAL INSTRUMENT AND SUPPLY SET
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
DIN 58857:2019 Medical instruments - Directors
BS PD ISO/TR 80002-2:2017 Medical device software-Validation of software for medical device quality systems
DIN 96056:2016 Medical instruments - Bone raspatory
SN-CR 14060:2000 Medical device traceability
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
NS-EN 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements
UNE-EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
DIN EN 15986 E:2009 Draft Document - Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version prEN 15986:2009
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
DANSK DS/ISO 17664-1:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices
NS-EN ISO 14971:2019 Medical devices — Application of risk management to medical devices (ISO 14971:2019)
NS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
NS-EN 556:1994 Sterilization of medical devices — Requirements for medical devices to be labelled "Sterile"
AENOR UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
DANSK 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
CAN/CSA Z314.5-1988 Industrial Sterilization of Medical Devices by the Ethylene Oxide Process
UNE-EN ISO 14971:2001 Medical devices - Application of risk management to medical devices. (ISO 14971:2000)
DANSK DS/EN ISO 17664-2:2024 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical medical devices (ISO 17664-2:2021)
CSA Z314.4-M1979-1979 Industrial Sterilization of Medical Devices by the Steam Process
NS-EN ISO 17664-2:2023 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021)
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
NS-EN 556-1:2001 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1: Requirements for terminally sterilized medical devices
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
NS-EN 556-2:2003 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 2: Requirements for aseptically processed medical devices
AENOR 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
DANSK DS/EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
DIN EN 556-2 E:2014 Draft Document - Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2: Requirements for aseptically processed medical devices; German version prEN 556-2:2014
NS-EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
NS-EN 556-2:2015 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 2: Requirements for aseptically processed medical devices
DANSK DS/EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
DIN 58274:2016 Medical instruments - Iris forceps
CAN/CSA-ISO 17664-1-2023 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
BS PD IEC/TR 80002-1:2009 Medical device software-Guidance on the application of ISO 14971 to medical device software
DIN 96057:2016 Medical instruments - Raspatory type Sedillot
DIN 13184:2016 Medical instruments - Bone holding forceps Farabeuf's
DIN 58318:2019 Medical instruments - Elevators Langenbeck's
NS-EN ISO 15225:2016 Medical devices — Quality management — Medical device nomenclature data structure (ISO 15225:2016)
NS-EN ISO 15225:2010 Medical devices — Quality management — Medical device nomenclature data structure (ISO 15225:2010)
DIN 58319:2019 Medical instruments - Elevators Williger
DIN EN 556-1 E:2023 Draft Document - 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
ISO 14971:2000/AMD1:2003 Amendment 1 - Medical devices - Application of risk management to medical devices
CAN/CSA-ISO 14971-2021 Medical devices – Application of risk management to medical devices (ISO 14971:2019, IDT)
UNE-EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 2: Requirements for aseptically processed 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.
DIN 13460 E:2016 Draft Document - Medical instruments - Needle holder type Heaney
DIN 58295:2017 Medical instruments - Retractor type Volkmann

EU/EC - European Union/Commission Legislative Documents

MEDDEV 2.15-2008 GUIDELINES ON MEDICAL DEVICES Committees/Working Groups contributing to the implementation of the Medical Device Directives (REV 3)
MEDDEV 2.14/1-2012 GUIDELINES ON MEDICAL DEVICES IVD Medical Device Borderline and Classification issues A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES (REV 2)

ZA-SANS

SANS 1593:1994 Disinfectants based on glutaraldehyde for use on medical instruments
SANS 14971:2008 Medical devices - Application of risk management to medical devices

IX-EU/EC

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

RU-GOST R

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 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 10993-13-2016 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric 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

Japanese Industrial Standards Committee (JISC)

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

Korean Agency for Technology and Standards (KATS)

KS P ISO 14971:2021 Medical devices — Application of risk management to medical devices
KS P ISO 14971:2018 Medical devices — Application of risk management to medical devices
KS P ISO 15225-2023 Medical devices — Quality management — Medical device nomenclature data structure
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

British Standards Institution (BSI)

BS EN 62366-1:2015+A1:2020 Medical devices. Application of usability engineering to medical devices
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 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 EN 62366-1:2015 Medical devices. Application of usability engineering to medical devices
BS EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
BS PD IEC/TR 62366-2:2016 Medical devices. Guidance on the application of usability engineering to medical devices
BS EN ISO 14971:2019+A11:2021 Medical devices - Application of risk management to medical devices
BS EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
BS EN 556-1:2024 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for terminally sterilized medical devices
BS EN 556-2:2015 Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'. Requirements for aseptically processed medical devices
BS EN ISO 15225:2016 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 556-1:2001(2006) Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1 : Requirements for terminally sterilized medical devices

CEN - European Committee for Standardization

EN ISO 14971:2009 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 ISO 14971:2007 Medical devices - Application of risk management to medical devices
EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

International Organization for Standardization (ISO)

ISO 14971:2019 Medical devices — Application of risk management to medical devices
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 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

KR-KS

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

European Committee for Standardization (CEN)

EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices
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)

AENOR

UNE-EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
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

Lithuanian Standards Office

LST EN 15986-2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
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

Danish Standards Foundation

DS/EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
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 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed 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

TH-TISI

TIS 14971-2013 Medical devices.application of risk management to medical devices

International Electrotechnical Commission (IEC)

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 TR 62366-2:2016 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
IEC 62366:2007/AMD1:2014 Medical devices - Application of usability engineering to medical devices

ES-UNE

UNE-EN ISO 14971:2020/A11:2022 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN 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 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 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）

AS ISO 14971:2020 Medical devices — Application of risk management to medical devices

American National Standards Institute （ANSI)

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 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

CENELEC - European Committee for Electrotechnical Standardization

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

DIN

DIN EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
DIN 96056:2023 Medical instruments - Bone raspatory
DIN 13173:2023 Medical instruments - Dressing forceps
DIN 13176:2023 Medical instruments - Organ grasping forceps

AT-ON

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)