Programmer Medical Devices

Programmer Medical Devices, Total:111 items.

The international standard classification for "Programmer Medical Devices" includes: Medical equipment , Medical equipment in general .

The Chinese standard classification for "Programmer Medical Devices" includes: Medical apparatus and devices in general .

Professional Standard - Medicine

YY/T 0316-2016 Medical devices-Application of risk management to medical devices
YY/T 1474-2016 Medical devices－Application of risk management to medical devices
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

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

AAMI HE75-2009(R2018) Human Factors Engineering in the Design of Medical Devices

US-FCR

FCR 21 CFR PART 860-2015 MEDICAL DEVICE CLASSIFICATION PROCEDURES
FCR 21 CFR PART 860-2013 MEDICAL DEVICE CLASSIFICATION PROCEDURES

German Institute for Standardization

DIN 58857:1976 Medical instruments; directors
DIN EN 1639:2004 Dentistry - Medical devices for dentistry - Instruments
DIN 96115 E:2010 Draft Document - Medical instruments - Gauges type Lexer
DIN 96135 E:2011 Draft Document - Medical instruments - Gauges type Alexander
DIN 96135 E:2011-04 Draft Document - Medical instruments - Gauges type Alexander
DIN EN 1639 E:2008-09 Draft Document - Dentistry - Medical devices for dentistry - Instruments; German version prEN 1639:2008
DIN 96115 E:2010-05 Draft Document - Medical instruments - Gauges type Lexer
DIN 96112 E:2010-05 Draft Document - Medical instruments - Gauges type Killian-Claus, bayonet-shaped
DIN 58852:2021-02 Medical instruments - Probes
DIN EN 62366 E:2006-09 Draft Document - Medical devices - Application of usability engineering to medical devices (IEC 62A/535/CDV:2006); German version prEN 62366:2006
DIN EN ISO 14971:2022 Medical devices – applying risk management to medical devices

GCC Standardization Organization

GSO IEC/TR 62354:2014 General testing procedures for medical electrical equipment
GSO ISO/TR 19727:2021 Medical devices — Pump tube spallation test — General procedure
GSO ISO 17664:2014 Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of resterilizable medical devices
GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices

Association for Electrical, Electronic & Information Technologies (VDE)

VDE-AR-E 2750-200-2013 Approach to the classification of medical devices and the selection of conformity assessment procedures

British Standards Institution (BSI)

BS EN 1639:1997 Dentistry. Medical devices for dentistry. Instruments
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 PD ISO/TR 19727:2017 Medical devices. Pump tube spallation test. General procedure
BS PD IEC/TR 62366-2:2016 Medical devices. Guidance on the application of usability engineering to medical devices
BS EN 1639:2009 Dentistry - Medical devices for dentistry - Instruments
08/30184602 DC BS EN 1639. Dentistry. Medical devices for dentistry. Instruments
BS EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
BS PD IEC/TR 80002-3:2014 Medical device software. Process reference model of medical device software life cycle processes (IEC 62304)
BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
BS EN 62366:2008+A1:2015 Medical devices. Application of usability engineering to medical devices

Standards Norway

NS-EN 1639:2004 Dentistry — Medical devices for dentistry — Instruments
NS-EN 1639:1996 Dentistry — Medical devices for dentistry — Instruments

Danish Standards Foundation

DS/EN 1639:2009 Dentistry - Medical devices for dentistry - Instruments
DANSK DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
DANSK DS/EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
DANSK DS/EN 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices

Lithuanian Standards Office

LST EN 1639-2010 Dentistry - Medical devices for dentistry - Instruments

Swedish Institute for Standards

SS-EN 1639:2005 Dentistry - Medical devices for dentistry - Instruments
SS-EN 62366-1:2016 Medical devices - Part 1: Application of usability engineering to medical devices

Spanish Association for Standardization (UNE)

UNE-EN 1639:2010 Dentistry - Medical devices for dentistry - Instruments
AENOR UNE-EN 62366/A1:2009 Medical devices - Application of usability engineering to medical devices
AENOR UNE-EN 62366:2009 Medical devices - Application of usability engineering to medical devices

Gosstandart of Russia

GOST R IEC 62366-2013 Medical devices. Application of usability engineering to medical devices
GOST R 50444-1992 Medical instruments, apparatus and equipment. General specifications
GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
GOST ISO 11135-2012 Medical devices. Validation and routine control of ethylene oxide sterilization
GOST R ISO 11135-2000 Medical devices. Validation and routine control of ethylene oxide sterilization

International Organization for Standardization (ISO)

ISO/TR 19727:2017 Medical devices — Pump tube spallation test — General procedure
ISO/DIS 15193:2024 In vitro diagnostic medical devices — Requirements for reference measurement procedures
ISO 14971:2019 Medical devices — Application of risk management to medical devices
ISO 14971:2000 Medical devices - Application of risk management to medical devices

Kingdom of Bahrain Testing and Metrology Directorate

BH GSO ISO/TR 19727:2022 Medical devices — Pump tube spallation test — General procedure

International Electrotechnical Commission (IEC)

IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
IEC 62366:2007/AMD1:2014 Medical devices - Application of usability engineering to medical devices
IEC TR 62366-2:2016 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
IEC/TR 62366-2:2016 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
IEC TR 62366-2-2016 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
IEC 62366-1:2015/COR1:2016 Medical devices - Part 1: Application of usability engineering to medical devices
IEC 62366-1:2015+AMD1:2020 CSV Medical devices - Part 1: Application of usability engineering to medical devices
IEC 62366-1:2020 Medical devices - Part 1: Application of usability engineering to medical devices
IEC 62366:2007/AMD 1:2014 Medical devices — Application of usability engineering to medical devices — Amendment 1

Association Francaise de Normalisation

NF S91-170:1996 Dentistry. Medical devices for denstistry. Instruments.
NF S99-211:2013 Medical devices - Application of risk management to medical devices

European Committee for Standardization (CEN)

CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices
EN 1639:2009 Dentistry - Medical devices for dentistry - Instruments
EN 1639:1996 Dentistry - Medical Devices for Dentistry - Instruments
EN 1639:2004 Dentistry - Medical devices for dentistry - Instruments
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

The Directorate General of Specifications and Metrology (DGSM)

OS GSO IEC 62366:2014 Medical devices - Application of usability engineering to medical devices

Comitato Elettrotecnico Italiano

CEI EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
CEI EN 62366:2008 Medical devices - Application of usability engineering to medical devices
CEI EN 62366-1:2016 Medical devices Part 1: Application of usability engineering to medical devices

CENELEC - European Committee for Electrotechnical Standardization

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

SCC

AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices

American National Standards Institute （ANSI)

ANSI/AAMI/IEC 62366/A1:2014 Medical devices - Application of usability engineering to medical devices - Amendment 1

PL-PKN

PN-EN 62366-1-2015-07/A1-2021-03 E Medical devices -- Part 1: Application of usability engineering to medical devices

Korean Agency for Technology and Standards (KATS)

KS P IEC 62366-1-2021 Medical devices — Part 1: Application of usability engineering to medical devices
KS P IEC 62366-1-2018 Medical devices — Part 1:Application of usability engineering to medical devices
KS P IEC 62366-1:2021 Medical devices — Part 1: Application of usability engineering to medical devices
KS P IEC 62366-1:2018 Medical devices — Part 1:Application of usability engineering to medical devices
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 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 IEC TR 62366-2:2020 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
KS P IEC TR 62366-2-2020 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices

Bureau of Indian Standards

IS/IEC 62366-1-2015 Medical Devices Part 1 Application of Usability Engineering to Medical Devices
IS/IEC/TR 62366-2-2016 Medical devices Part 2 Guidance on the Application of Usability Engineering to Medical Devices
IS/IEC/TR 80002-3-2014 Medical Device Software - Part 3 Process Reference Model of Medical Device Software Life Cycle Processes

Japanese Industrial Standards Committee (JISC)

JIS T 62366-1:2022 Medical devices -- Part 1: Application of usability engineering to medical devices
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

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

Ente Nazionale Italiano di Unificazione

UNI EN ISO 14971:2008 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2002 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2012 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2004 Medical devices - Application of risk management to medical devices

South African Bureau of Standard

SANS 14971:2008 Medical devices - Application of risk management to medical devices

CZ-CSN

CSN 36 4800-1966 Electrical medical insíruments

TH-TISI

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