ivd medical device related

ivd medical device related, Total:333 items.

The international standard classification for "ivd medical device related" includes: Medical equipment in general , Medical equipment .

The Chinese standard classification for "ivd medical device related" includes: Medical apparatus and devices in general , General and microsurgical devices , Public medical equipment .

Professional Standard - Medicine

YY/T 0316-2003 Medical devices -- Application of risk management to medical devices
YY/T 0316-2008 Medical devices - Application of risk management to medical devices
YY/T 0468-2015 Medical devices―Quality management―Medical device nomenclature data structure
YY/T 0316-2016 Medical devices-Application of risk management to medical devices
YY/T 1815-2022 Biological evaluation of medical devices-Application for the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents

未注明发布机构

DIN 96056 E:2022-08 Medical instruments - Bone raspatory
DIN 96057 E:2022-08 Medical instruments - Raspatory type Sedillot
DIN 13173 E:2016-07 Medical instruments - Dressing forceps
DIN 96056:2023-03 Medical instruments - Bone raspatory
DIN 96056 E:2015-09 Medical instruments - Bone raspatory
DIN 13145 E:2008-09 Medical instruments - Mallet of plastic material
ANSI/AAMI/ISO 15225:2016 Medical devices—Quality management—Medical device nomenclature data structure
DIN 13173 E:2022-08 Medical instruments - Dressing forceps
DIN EN ISO 17664-1 E:2021-02 Handling of Healthcare Products Information provided by medical device manufacturers for medical devices Part 1: Critical and semi-critical medical devices (draft)
DIN EN ISO 14971 E:2018-08 Application of medical device risk management in medical devices (draft)
DIN 58852 E:2020-06 Medical instruments - Probes
DIN 58852 E:2014-02 Medical instruments - Probes
DIN 96057 E:2015-09 Medical instruments - Raspatory type Sedillot
DIN 96057:2016-03 Medical instruments - Raspatory type Sedillot
ASTM RR-F02-1005 1989 F1251-Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
DIN 13119 E:2008-09 Medical instruments bowel scissors
DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
ANSI/AAMI/ISO 16142-1:2016 Medical devices—Recognized essential principles of safety and performance of medical devices—Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
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
DIN EN ISO 14971:2022 Medical devices – applying risk management to medical devices
ANSI/AAMI/ISO 14971:2019 Medical devices— Application of risk management to medical devices
DIN 96056:2016-03 Medical instruments - Bone raspatory
DIN 58846 E:2017-06 Medical instruments - Raspatories

Group Standards of the People's Republic of China

T/ZGXX 0003-2019 Medical device cleaning agent
T/ZMDS 50004-2023 Medical device - validation for cleanroom and related controlled environments monitoring system

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

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

国家食品药品监督管理局

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

国家药监局

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

Association Francaise de Normalisation

NF S98-136:2009 Sterilisation of medical devices - Risk management related to the preparation of sterile medical devices within health establishments.
NF S99-172:2017 Use and maintenance of medical devices - Risk management système for risks associated with the use of medical devices
NF S99-170:2013 Maintenance of medical devices - Quality management system for the maintenance and management of risks associated with the operation of 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 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 S99-211:2013 Medical devices - Application of risk management to medical devices
NF EN ISO 10993-2:2022 Biological evaluation of medical devices - Part 2: Animal protection requirements
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
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
NF S90-445:1985 MEDICO-SURGICAL EQUIPMENT. IMPLANTS FOR SURGERY. ORTHOPAEDIC JOINT PROSTHESES. BASIC REQUIREMENTS.
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 S99-172:2003 Use of medical devices - Risk management relative to the use of medical devices in health care 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 S91-224:2009 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry.
NF S91-224*NF EN ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

IX-EU/EC

MEDDEV 2.15/1-1998 Committees/Working Parties Relevant for Medical Devices

SCC

AAMI TIR42:2010 Evaluation of particulates associated with vascular medical devices
AAMI TIR42:2021 Evaluation of particulate associated with vascular medical devices
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
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
DANSK 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)
NS-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)
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
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
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 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)
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)
DANSK DS/ISO/TS 21726:2019 Biological evaluation of medical devices – Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
BS PD ISO/TS 21726:2019 Biological evaluation of medical devices. Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
DANSK DS/ISO 16142-2:2017 Medical devices – Recognized essential principles of safety and performance of medical devices – Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
AAMI/ISO 16142-2:2017 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
DIN EN ISO 17664-2 E:2023 Draft Document - 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); German and English version prEN ISO 176...
DANSK DS/ISO 16142-1:2016 Medical devices – Recognized essential principles of safety and performance of medical devices – Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standard...
AAMI/ISO 16142-1:2016 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
DANSK DS/EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic medical devices
DIN EN ISO 17664-1 E:2021 Draft Document - 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 17664-1:2020); German and English v...
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
BS EN ISO 14971:2019 Medical devices. Application of risk management to medical devices
CAN/CSA-ISO 14971:2001(C2006) Medical devices - Application of risk management to medical devices
DANSK DS/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
ADA 41-2020 Evaluation of Biocompatibility of Medical Devices Used in Dentistry
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
BS 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
SN-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
ADA 41-2015 Evaluation of Biocompatibility of Medical Devices Used in Dentistry
CEI UNI EN/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
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 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
AENOR UNE-EN 62366/A1:2009 Medical devices - Application of usability engineering to medical devices
CEI EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
DANSK DS/EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
MIL MIL-C-42068-1989 CHEST, MEDICAL INSTRUMENT AND SUPPLY SET
DIN 96056:2016 Medical instruments - Bone raspatory
DIN 58857:2019 Medical instruments - Directors
BS PD ISO/TR 80002-2:2017 Medical device software-Validation of software for medical device quality systems
SN-CR 14060:2000 Medical device traceability
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
DANSK DS/ISO/TS 23128:2020 Medical devices – Transfusion set and blood bag compatibility test method
BS PD ISO/TS 23128:2019 Medical devices. Transfusion set and blood bag compatibility test method
CAN/CSA-ISO 10993.9-98:1998 Biological evaluation of medical devices - Part 9: Degradation of materials related to biological testing
NS-EN ISO 14971:2019 Medical devices — Application of risk management to medical devices (ISO 14971:2019)
NS-EN 556:1994 Sterilization of medical devices — Requirements for medical devices to be labelled "Sterile"
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
NS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
AENOR UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
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
UNE-EN ISO 14971:2001 Medical devices - Application of risk management to medical devices. (ISO 14971:2000)
UNE-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
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
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
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
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
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
BS PD IEC/TR 80002-1:2009 Medical device software-Guidance on the application of ISO 14971 to medical device software
DIN 58274:2016 Medical instruments - Iris forceps
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)
DIN 58319:2019 Medical instruments - Elevators Williger
NS-EN ISO 15225:2010 Medical devices — Quality management — Medical device nomenclature data structure (ISO 15225:2010)
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

EU/EC - European Union/Commission Legislative Documents

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)
MEDDEV 2.1/3-1998 GUIDELINES RELATING TO THE DEMARCATION BETWEEN - DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES - DIRECTIVE 93/42/EEC ON MEDICAL DEVICES AND -DIRECTIVE 65/65/EEC RELATING TO MEDICINAL PRODUCTS AND RELATED DIRECTIVES (Rev 5.1)
NO 207/2012-2012 COMMISSION REGULATION on electronic instructions for use of medical devices (Text with EEA relevance)

American National Standards Institute （ANSI)

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/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 16142-2:2017 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
ANSI/AAMI/IEC 62366/A1:2014 Medical devices - Application of usability engineering to medical devices - Amendment 1

KR-KS

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 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 16142-1-2019 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medic
KS P ISO 16142-2-2020 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical d
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

ES-UNE

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)
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 7405:2019 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)

European Committee for Standardization (CEN)

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)
DD ENV 13735-2000 Health Informatics - Interoperability of Patient Connected Medical Devices
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)
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
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
EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'
EN ISO 14971:2019/A11:2021 Medical devices - Application of risk management to medical devices (ISO 14971:2019)

Korean Agency for Technology and Standards (KATS)

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 ISO TS 21726-2023 Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
KS P ISO 16142-2:2020 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical d
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 16142-1:2019 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medic
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 7405:2010 Dentistry-Evaluation of biocompatibility of medical devices used in dentistry
KS P ISO 7405:2014 Dentistry — Evaluation of biocompatibility of medical devices used in dentistry

International Organization for Standardization (ISO)

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 16142-1:2016 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
ISO 14971:2019 Medical devices — Application of risk management to medical devices
ISO 16142-2:2017 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical d
ISO/TS 21726:2019 Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
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/TS 23128:2019 Medical devices — Transfusion set and blood bag compatibility test method
ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
ISO/CD 7405:2023 Dentistry — Evaluation of biocompatibility of medical devices used in dentistry

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)

DIN

DIN 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); German version EN ISO 17664-2:2023
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

CH-SNV

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)

Danish Standards Foundation

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 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 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 ISO 7405:2009 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
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

GSO

GSO ISO 17664-2:2023 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
BH GSO ISO 17664-2:2023 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
GSO ISO/TS 21726:2021 Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
BH GSO ISO/TS 21726:2022 Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
GSO ISO 16142-2:2021 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
BH GSO ISO 16142-2:2022 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
BH GSO ISO 16142-1:2022 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standard...
GSO ISO 16142-1:2021 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
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
BH GSO ISO 15225:2017 Medical devices -- Quality management -- Medical device nomenclature data structure
OS GSO IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
GSO ISO 15225:2016 Medical devices -- Quality management -- Medical device nomenclature data structure
GSO ISO 23128:2022 Medical devices — Transfusion set and blood bag compatibility test method
BH GSO ISO 23128:2023 Medical devices — Transfusion set and blood bag compatibility test method
OS GSO ISO 7405:2016 Dentistry -- Evaluation of biocompatibility of medical devices used in dentistry
BH GSO ISO 7405:2017 Dentistry -- Evaluation of biocompatibility of medical devices used in dentistry
GSO ISO 7405:2016 Dentistry -- Evaluation of biocompatibility of medical devices used in dentistry

German Institute for Standardization

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 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); German and English version prEN ISO 17664-2:2023
DIN EN ISO 17664-2:2024-04 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); German version EN ISO 17664-2:2023
DIN 58846:2017-11 Medical instruments - Raspatories
DIN 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); German version EN ISO 17664-1:2021
DIN 58794:1982 Medical instruments; ear forceps
DIN 58852:2008 Medical instruments - Probes
DIN 96056:2009 Medical instruments - Bone raspatory
DIN 58794:2010 Medical instruments - Ear forceps
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 556-1:2002-03 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 556-1:2023-02 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 556-2:2015-11 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 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 ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
DIN EN ISO 17664-2:2023-09 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); German and English version prEN ISO 17664-2:2023 / Note:...
DIN 58263:1973 Medical instruments; mouth gag Heister's
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 13111:2006 Medical instruments - Bandage scissors
DIN 13173:2023-03 Medical instruments - Dressing forceps
DIN 13103:1973 Medical instruments; dissecting scalpels
DIN EN ISO 7405:2019-03 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12); German version EN ISO 7405:2018
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 58292:2010 Medical instruments - Tracheal hook
DIN 13173:2005 Medical instruments - Dressing forceps
DIN 58292:1972 Medical instruments; tracheal hook
DIN 58230:1974 Medical instruments; amputation knives
DIN 58862:1988 Medical instruments; bone curettes
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 58846:2010 Medical instruments - Raspatories
DIN 13173:2016 Medical instruments - Dressing forceps
DIN 13458:1988 Medical instruments; ligature needle

British Standards Institution (BSI)

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 ISO 17664-1:2021 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Critical and semi-critical medical devices
PD ISO/TS 21726:2019 Biological evaluation of medical devices. Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
DD ENV 13735-2001 Health Informatics - Interoperability of Patient Connected Medical Devices
BS EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of s...
BS EN 62366-1:2015+A1:2020 Medical devices. Application of usability engineering to medical devices
BS EN 62366-1:2015 Medical devices. Application of usability engineering to medical devices
BS EN ISO 14971:2012 Medical devices. Application of risk management 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 14971:2001 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 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
BS EN ISO 7405:2018 Dentistry. Evaluation of biocompatibility of medical devices used in dentistry

American Society for Testing and Materials (ASTM)

ASTM F561-97(2003) Practice for Retrieval and Analysis of Implanted Medical Devices, and Associated Tissues
ASTM F1251-89(2003) Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices

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 ISO 10993-4-2011 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
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 EN 556-1-2011 Sterilization of medical devices. Requirements for medical devices to be designated «sterile». Part 1. Requirements for terminally sterilized 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
JIS T 6001:2021 Evaluation of biocompatibility of medical devices used in dentistry

CEN - European Committee for Standardization

EN ISO 14971:2007 Medical devices - Application of risk management to medical devices
EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
EN ISO 14971:2000 Medical Devices - Application of Risk Management to Medical Devices (Incorporates Amendment A1: 2003)
EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
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
EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

ZA-SANS

SANS 14971:2008 Medical devices - Application of risk management to medical devices
SANS 17664:2007 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable 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

Standard Association of Australia （SAA）

AS ISO 14971:2020 Medical devices — Application of risk management to medical devices
AS 5369:2023 Reprocessing of reusable medical devices and other devices in health and non-health related facilities
AS/NZS 3816:1998 Management of clinical and related wastes

CENELEC - European Committee for Electrotechnical Standardization

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

GOSTR

GOST ISO 10993-4-2020 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
GOST R ISO 7405-2011 Dentistry. Evaluation of biocompatibility of medical devices used in dentistry

AENOR

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 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

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)

US-FCR

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

PL-PKN

PN Z54061-1986 Medical instruments Ears Dimensions

Others: ivd medical device,ivd medical device,medical equipment electrical equipment ivd