Class II medical device use management

Class II medical device use management, Total:203 items.

The international standard classification for "Class II medical device use management" includes: Medical equipment in general , Medical Sciences and health care facilities in general , Medical equipment .

The Chinese standard classification for "Class II medical device use management" includes: Medical apparatus and devices in general , General and microsurgical devices , Medical science , Public medical equipment .

Professional Standard - Medicine

YY/T 0468-2015 Medical devices―Quality management―Medical device nomenclature data structure
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 0316-2016 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/T 42062-2022 Medical devices—Application of risk management to medical devices

未注明发布机构

ANSI/AAMI/ISO 13485:2016(2019) Medical devices—Quality management systems— Requirements for regulatory purposes
CAN/CSA-ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
ANSI/AAMI/ISO 15225:2016 Medical devices—Quality management—Medical device nomenclature data structure
DIN EN ISO 14971 E:2018-08 Application of medical device risk management in medical devices (draft)
DIN EN 15986 E:2009-08 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
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 58293 E:2014-02 Medical instruments - Tracheal hook Bose's

卫生健康委员会

WS/T 654-2019 Safety management for 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

Group Standards of the People's Republic of China

T/CHAS 10-4-7-2021 Quality and safety management of Chinese hospital—— Part 4-7: Medical management —— medical devices management
T/SXS 128-2023 Medical device safety management requirements specification
T/CAMDI 008-2016 General rules for the implementation of medical device manufacturing quality management regulations for sterile medical device manufacturing equipment

Shanghai Provincial Standard of the People's Republic of China

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

Jiangsu Provincial Standard of the People's Republic of China

DB3212/T 1065-2021 Standards for Quality Evaluation of Medical Devices Used in Medical Institutions

国家药监局

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

国家食品药品监督管理局

YY/T 1474-2016 Medical devices－Application of risk management to 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)
CAN/CSA-ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes (Second Edition)
CSA ISO 13485-03-CAN/CSA:2003 Medical devices - Quality management systems - Requirements for regulatory purposes Second Edition
CSA ISO 14971:2021 Medical devices - Application of risk management to medical devices (Adopted ISO 14971:2019, third edition, 2019-12)

RU-GOST R

GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
GOST R ISO 15225-2014 Medical devices. Quality management. Medical device nomenclature data structure
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 IEC 62366-2013 Medical devices. Application of usability engineering to medical devices

SCC

CSA Z314.22-16:2016 Management of borrowed reusable medical devices
CAN/CSA-Z314.22-2010 Management of borrowed and reusable 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
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
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
CAN/CSA-ISO 14971-2007(R2017) Medical Devices - Application of Risk Management to Medical Devices (Adopted ISO 14971:2007, second edition, 2007-03-01)
NS-EN ISO 14971:2019 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)
UNE-EN ISO 14971:2001 Medical devices - Application of risk management to medical devices. (ISO 14971:2000)
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)
CAN/CSA-ISO 14971-2021 Medical devices – Application of risk management to medical devices (ISO 14971:2019, IDT)
ISO 14971:2000/AMD1:2003 Amendment 1 - 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
AAMI/ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
05/30140005 DC BS EN ISO 14971 ED 2. Medical devices. Application of risk management to medical devices
DIN EN ISO 14971 E:2018 Draft Document - Medical devices - Application of risk management to medical devices (ISO/DIS 14971:2018); German and English version prEN ISO 14971:2018
DANSK DS/EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
CAN/CSA-Z314.22-2004(C2009) Management of borrowed, shared and rented medical devices
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
NS-EN ISO 15225:2010 Medical devices — Quality management — Medical device nomenclature data structure (ISO 15225:2010)
NS-EN ISO 15225:2016 Medical devices — Quality management — Medical device nomenclature data structure (ISO 15225:2016)
AS/NZS 3551:1996 Technical management programs for medical devices
AAMI TIR12:2010 Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
CAN/CSA-Z314.22-2004(R2009) Management of loaned, shared, and leased medical devices
UNE-EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure (ISO/FDIS 15225:2009)
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
NS-EN ISO 14971:2012 Medical devices — Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
NS-EN ISO 14971:2009 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
UNE-EN ISO 14971:2009 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
CAN/CSA-ISO 13485-2003(R2013) Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes (Adopted ISO 13485:2003 second edition, 2003-07-15)
DANSK DS/EN ISO 13485/AC:2018 Medical devices – Quality management systems – Requirements for regulatory purposes
DANSK DS/EN ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes
CAN/CSA-ISO 13485:2003(C2013) Medical devices - Quality management systems - Requirements for regulatory purposes
CEI UNI EN/ISO 13485:2017 Medical devices - Quality management systems - Requirements for regulatory purposes
CAN/CSA-ISO 13485:2003(R2013) Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
DIN EN ISO 14971/A1 E:2009 Draft Document - Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); English version FprEN ISO 14971:2009, Amendment 1
CAN/CSA-ISO 14971-2001 Medical Devices - Application of Risk Management to Medical Devices (Adopted ISO 14971:2000, first edition, 2000-12-15)
VDI/VDE 2426 BLATT 2-2000 Catalogs in the maintenance and management of medical technology — Standardized equipment catalog
NS-EN 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements
UNE-EN 980:2008 Symbols for use in the labelling of medical devices
DIN EN ISO 15225 E:2015 Draft Document - Medical devices - Quality management - Medical device nomenclature data structure (ISO/DIS 15225:2015); German and English version prEN ISO 15225:2015
NS-EN 980:2008 Symbols for use in the labelling of medical devices
CAN/CSA-Z314.8-2000(R2007) Decontamination of Reusable Medical Devices
CAN/CSA Z314.8-2008(R2013) Decontamination of Reusable Medical Devices
CAN/CSA-Z314.8-2000(C2007) Decontamination of reusable medical devices
DANSK DS/EN 980:2008 Symbols for use in the labelling of medical devices
CSA Z314.23-16:2016 Chemical sterilization of reusable medical devices in healthcare settings
UNE-EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
CAN/CSA-Z314.8-2008(R2013) Decontamination of Reusable Medical Devices
CAN/CSA Z314.8-2000(R2005) Decontamination of Reusable Medical Devices
CAN/CSA-Z314.8-2008(C2013) Decontamination of reusable medical devices
CSA Z314.8-14:2014 Decontamination of reusable 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
ISO 14971:2000/Amd 1:2003 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements
ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes

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 Q 13485:2005 Medical devices -- Quality management systems -- Requirements for regulatory purposes

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 13485:2018 Medical devices — Quality management systems — Requirements for regulatory purposes
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 13485-2023 Medical devices — Quality management systems — Requirements for regulatory purposes
KS P ISO 13485:2007 Medical devices－Quality management systems－Requirements for regulatory purposes

Association Francaise de Normalisation

NF S99-211:2013 Medical devices - Application of risk management to medical devices
NF S99-172:2017 Use and maintenance of medical devices - Risk management système for risks associated with the use of medical devices
NF S99-211/A11*NF EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices
NF EN ISO 14971:2019 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 S99-012:2010 Medical devices - Quality management - Medical device nomenclature data structure.
XP S99-223:2020 Medical Device - Benefit risk management
NF S98-136:2009 Sterilisation of medical devices - Risk management related to the preparation of sterile medical devices within health establishments.
NF S99-172:2003 Use of medical devices - Risk management relative to the use of medical devices in health care establishments.
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 S99-015*NF EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates.
NF S99-101/A11*NF EN ISO 13485/A11:2021 Medical devices - Quality management systems - Requirements for regulatory purposes
NF S99-101*NF EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
NF EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
NF EN ISO 13485/A11:2021 Medical devices - Quality management systems - Requirements for regulatory purposes
NF S99-101:2012 Medical devices - Quality management systems - Requirements for regulatory purposes

KR-KS

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 13485-2018 Medical devices — Quality management systems — Requirements for regulatory purposes

ZA-SANS

SANS 14971:2008 Medical devices - Application of risk management to medical devices
SANS 13485:2004 Medical devices - Quality management systems - Requirements for regulatory purposes
SANS 1593:1994 Disinfectants based on glutaraldehyde for use on medical instruments

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 ISO 14971:2019/A11:2021 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

British Standards Institution (BSI)

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 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 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
BS EN ISO 15225:2016 Medical devices. Quality management. Medical device nomenclature data structure
18/30370883 DC BS EN ISO 14971. Medical devices. Application of risk management to medical devices
BS PD CEN ISO/TR 14969:2005(2006) Medical devices — Quality management systems — Guidance on
BIP 0115-2014 Implementing an ISO 13485 Quality Management System for Medical Devices
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

TH-TISI

TIS 14971-2013 Medical devices.application of risk management to medical devices
TIS 13485-2004 Medical devices.quality management systems.requirements for regulatory purposes

GSO

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
GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
GSO ISO 15225:2016 Medical devices -- Quality management -- Medical device nomenclature data structure
BH GSO ISO 15225:2017 Medical devices -- Quality management -- Medical device nomenclature data structure
BH GSO ISO 13485:2017 Medical devices -- Quality management systems -- Requirements for regulatory purposes
OS GSO ISO 13485:2016 Medical devices -- Quality management systems -- Requirements for regulatory purposes
GSO ISO 13485:2016 Medical devices -- Quality management systems -- Requirements for regulatory purposes
BH GSO 2628:2022 Medical devices and supplies classification criteria
GSO 2628:2021 Medical devices and supplies classification criteria

Standard Association of Australia （SAA）

AS ISO 14971:2020 Medical devices — Application of risk management 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 ISO 13485:2018/A11:2022 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
UNE-EN ISO 13485:2018 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016). (Consolidated version)

Danish Standards Foundation

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 ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes

German Institute for Standardization

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 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 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 58293:2014 Medical instruments - Tracheal hook Bose's
DIN 58293:2008 Medical instruments - Tracheal hook Bose's
DIN 58292:2010 Medical instruments - Tracheal hook
DIN 58292:1972 Medical instruments; tracheal hook
DIN 13181-1:1973 Medical instruments; McKenzie's instruments for brain clips, clips applying

GOST

GOST ISO 14971-2021 Medical devices. Application of risk management to medical devices

International Electrotechnical Commission (IEC)

IEC 62366:2007/AMD1:2014 Medical devices - Application of usability engineering to medical devices
IEC 60930:1988 Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical electrical equipment
IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
IEC TR 60930:2008 Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems

American National Standards Institute （ANSI)

ANSI/AAMI/IEC 62366/A1:2014 Medical devices - Application of usability engineering to medical devices - Amendment 1
AAMI TIR32:2004 Medical device software risk management
AAMI TIR32:2004(R2016) Medical device software risk management
AAMI TIR12:2004 Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
AAMI TIR34:2014 Water for the reprocessing of medical devices
AAMI TIR34:2014(R2017) Water for the reprocessing of medical devices
AAMI TIR34:2007 Water for the reprocessing of medical devices
ANSI/AAMI TIR57:2016(R2023) Principles for medical device security - Risk management

Lithuanian Standards Office

LST EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010)
LST EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)