Medical equipment noise

Medical equipment noise, Total:352 items.

The international standard classification for "Medical equipment noise" includes: Tobacco, tobacco products and related equipment , Medical equipment in general , Hospital equipment , Medical equipment .

The Chinese standard classification for "Medical equipment noise" includes: Tobacco curing machinery , Medical apparatus and devices in general , General and microsurgical devices , Medical ultrasound, laser, high-frequency instrument and equipment , Public medical equipment .

Professional Standard - Commodity Inspection

SN/T 1430.1-2004 Rules for the inspection of medical electrical equipment for improt - Ultrasonic medical diagnostic and therapy equipment

Group Standards of the People's Republic of China

T/CAMDI 008-2016 General rules for the implementation of medical device manufacturing quality management regulations for sterile medical device manufacturing equipment
T/ZGXX 0003-2019 Medical device cleaning agent

Professional Standard - Tobacco

YC/T 362-2010 Tobacco machinery—Measurement of the equipments sound pressure level

Professional Standard - Construction Industry

JG/T 5079.1-1996 Construction machinery and equipment—Noise limits
JG/T 5079.2-1996 Construction machinery and equipment—Measurement method for noise

建设部

JG/T 5079.1-1995 Noise limits for construction machinery and equipment
JG/T 5079.2-1995 Construction machinery and equipment noise measurement methods

Professional Standard - Medicine

YY/T 0316-2016 Medical devices-Application of risk management to medical devices
YY/T 0802.1-2024 Disposal of medical devices Information to be provided by the medical device manufacturer Part 1: Medium and high risk medical devices
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 0802.2-2024 Disposal of medical devices - Information to be provided by the medical device manufacturer - Part 2: Low-risk 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
GB 9706.7-1994 Medical electrical equipment－Particular requirements for the safety of ultrasonic therapy equipment
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

国家药监局

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

SCC

NS-EN 1640:2004 Dentistry — Medical devices for dentistry — Equipment
NS-EN 1640:2009 Dentistry — Medical devices for dentistry — Equipment
NS-EN 1640:1996 Dentistry — Medical devices for dentistry — Equipment
NEMA/MITA UMD P1-2020 Remanufacturing of Ultrasound Medical Devices
BS EN 62366:2008+A1:2015 Medical devices. Application of usability engineering to medical devices
DIN EN 1640 E:2008 Draft Document - Dentistry - Medical devices for dentistry - Equipment; German version prEN 1640:2008
08/30184608 DC BS EN 1640. Dentistry. Medical devices for dentistry. Equipment
HIMSS/NEMA HN 1-2008 Manufacturer Disclosure Statement for Medical Device Security
HIMSS/NEMA HN 1-2013 Manufacturer Disclosure Statement for Medical Device Security
AENOR UNE-EN ISO 15225:2016 Medical devices. Quality management. Structure of nomenclature data for medical devices. (ISO 15225:2016).
NS-EN 1265:1999 Noise test code for foundry machines and equipment
BS EN 1265:1999 Noise test code for foundry machines and equipment
NS-ISO 4871:1984 Acoustics — Noise labelling of machinery and equipment (ISO 4871:1989)
BS EN ISO 11688-1:1998 Acoustics. Recommended practice for the design of low-noise machinery and equipment-Planning
DANSK DS/EN ISO 4871:2009 Acoustics - Declaration and verification of noise emission values of machinery and equipment
BS EN ISO 4871:1997 Acoustics. Declaration and verification of noise emission values of machinery and equipment
CAN/CSA-ISO 14971:2007(C2012) Medical devices - Application of risk management to medical devices
AAMI/ISO 14971:2019 Medical devices - Application of risk management to medical devices
CEI UNI EN ISO 14971:2020 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
DANSK DS/EN ISO 14971:2012 Medical devices – Application of risk management to medical devices
CAN/CSA-ISO 14971:2007(R2012) 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 11689/AC:2009 Acoustics - Procedure for the comparison of noise-emission data for machinery and equipment
DANSK DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
DANSK DS/EN ISO 11689:1997 Acoustics - Procedure for the comparison of noise-emission data for machinery and equipment
AENOR UNE-EN 62366:2009 Medical devices - Application of usability engineering to medical devices
CEI EN 62366:2008 Medical devices - Application of usability engineering to medical devices
CAN/CSA-C22.2 No.601.2.5-1992 Electromedical devices - Part two: Special safety rules for ultrasound therapy devices
AAMI/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
CEI UNI EN/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
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
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
MIL MIL-C-42068-1989 CHEST, MEDICAL INSTRUMENT AND SUPPLY SET
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
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
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
DANSK DS/EN ISO 12001:2009 Acoustics - Noise emitted by machinery and equipment - Rules for the drafting and presentation of a noise test code
DANSK DS/EN ISO 11688-2:2002 Acoustics - Recommended practice for the design of low-noise machinery and equipment - Part 2: Introduction to the physics of low-noise design
CEI EN 61157:2009 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
DIN 96056:2016 Medical instruments - Bone raspatory
NS-EN 1265:1999+A1:2008 Safety of machinery — Noise test code for foundry machines and equipment
AENOR UNE-EN 1265+A1:2009 Safety of machinery - Noise test code for foundry machines and equipment
DANSK DS/EN 61157:2008 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
DANSK DS/EN 61157/A1:2008 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
DIN 58857:2019 Medical instruments - Directors
BS EN ISO 12001:1997 Acoustics. Noise emitted by machinery and equipment. Rules for the drafting and presentation of a noise test code
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
BS PD ISO/TR 80002-2:2017 Medical device software-Validation of software for medical device quality systems
NS-EN 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements
CEI EN 61157/A1:2009 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
SN-CR 14060:2000 Medical device traceability
AAMI TIR12:2010 Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
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
ASA S12.61-2020 Declaration and Verification of Noise Emission Values of Machinery, Equipment, and Products
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 14971:2007 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"
NS-EN 1639:2009 Dentistry — Medical devices for dentistry — Instruments
NS-EN ISO 14971:2019 Medical devices — Application of risk management to medical devices (ISO 14971:2019)
NS-EN ISO 4871:1996 Acoustics — Declaration and verification of noise emission values of machinery and equipment (ISO 4871:1996)
DANSK DS/EN 1639:2009 Dentistry - Medical devices for dentistry - Instruments
DIN 13457 E:2008 Draft Document - Medical instruments - Urethral bougies and dilating sounds type Dittel
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
AENOR UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
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)
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
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
AENOR UNE-EN ISO 4871:2010 Acoustics - Declaration and verification of noise emission values of machinery and equipment (ISO 4871:1996)
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 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)
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
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

Spanish Association for Standardization (UNE)

UNE-EN 1640:2010 Dentistry - Medical devices for dentistry - Equipment
UNE-EN 61157:1996 REQUIREMENTS FOR THE DECLARATION OF THE ACOUSTIC OUTPUT OF MEDICAL DIAGNOSTIC ULTRASONIC EQUIPMENT.
UNE-EN ISO 14971:2020/A11:2022 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN 1265:2000 NOISE TEST CODE FOR FOUNDRY MACHINES AND EQUIPMENT
UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN ISO 11689:1997/AC:2009 Acoustics - Procedure for the comparison of noise-emission data for machinery and equipment (ISO 11689:1996/Cor 1:2007)
UNE-EN ISO 4871:1997 ACOUSTICS. DECLARATION AND VERIFICATION OF NOISE EMISSION VALUES OF MACHINERY AND EQUIPMENT. (ISO 4871:1996).
UNE-EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
UNE-EN 61157:2007/A1:2013 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment (Endorsed by AENOR in May of 2013.)
UNE-EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
UNE-EN 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 1639:2004 Dentistry - Medical devices for dentistry - Instruments
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)
UNE-EN ISO 4871:2010 Acoustics - Declaration and verification of noise emission values of machinery and equipment (ISO 4871:1996)
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 1265:2000+A1:2009 Safety of machinery - Noise test code for foundry machines and equipment

DIN

DIN EN 1640:2004 Dentistry - Medical devices for dentistry - Equipment
DIN EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

Danish Standards Foundation

DS/EN 1640:2009 Dentistry - Medical devices for dentistry - Equipment
DS/EN ISO 4871:2009 Acoustics - Declaration and verification of noise emission values of machinery and equipment
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/EN ISO 11688-2:2003 Acoustics - Recommended practice for the design of low-noise machinery and equipment - Part 2: Introduction to the physics of low-noise design
DS/CEN/CR 14060:2001 Medical device traceability
DS/EN 61157:2008 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
DS/EN 61157/A1:2013 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
Standardpakke - Akustik 3-2021 Standards Package – Acoustics 3 – Noise emitted by machinery and equipment
DS/EN 1265+A1:2009 Safety of machinery - Noise test code for foundry machines and equipment

Lithuanian Standards Office

LST EN 1640-2010 Dentistry - Medical devices for dentistry - Equipment
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 1265-2001+A1-2009 Safety of machinery - Noise test code for foundry machines and equipment
LST EN ISO 4871:2010 Acoustics - Declaration and verification of noise emission values of machinery and equipment (ISO 4871:1996)
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

RU-GOST R

GOST R 50444-1992 Medical instruments, apparatus and equipment. General specifications
GOST R 56331-2014 Medical electrical equipment. Medical diagnostic ultrasonic equipment. Technical requirements for governmental purchases
GOST R IEC 62359-2011 Medical equipment. General requirements for methods of determination of mechanical and thermal fields safe indices for medical ultrasonic diagnostic equipment
GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
GOST R IEC 62366-2013 Medical devices. Application of usability engineering to medical devices
GOST R ISO 15225-2014 Medical devices. Quality management. Medical device nomenclature data structure
GOST R ISO 10993-12-1999 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials
GOST ISO 10993-12-2011 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and control materials
GOST R ISO 10993.7-1999 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
GOST R ISO 10993.13-1999 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices / Note: To be replaced by GOST R ISO 10993-13 (2009).
GOST R ISO 10993.5-1999 Medical devices. Biological evaluation of medical devices. Part 5. Tests for cytotoxicity: in vitro methods
GOST ISO 10993-16-2016 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST 31327-2006 Noise of machines. Procedure for the comparison of noise-emission data for machinery and equipment

British Standards Institution (BSI)

BS EN 1640:2009 Dentistry - Medical devices for dentistry - Equipment
BS EN 556-2:2004 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices
18/30370883 DC BS EN ISO 14971. Medical devices. Application of risk management to medical devices
PD IEC/TR 80002-1:2009 Medical device software. Guidance on the application of ISO 14971 to medical device software
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
BS EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
BS EN 62366-1:2015+A1:2020 Medical devices. Application of usability engineering 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/TR 11688-2:2001 Acoustics - Recommended practice for the design of low-noise machinery and equipment - Introduction to the physics of low-noise design
BS PD IEC/TR 62366-2:2016 Medical devices. Guidance on the application of usability engineering to medical devices
BS EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
BS EN ISO 14971:2019+A11:2021 Medical devices - Application of risk management to medical devices
BS EN ISO 11689:1996(2009) Acoustics — Procedure for the comparison of noise - emission data for machinery and equipment
BS EN ISO 12001:2009 Acoustics - Noise emitted by machinery and equipment - Rules for the drafting and presentation of a noise test code
BS EN ISO 12001:2010 Acoustics. Noise emitted by machinery and equipment. Rules for the drafting and presentation of a noise test code
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
18/30359002 DC BS IEC 62366-1 AMD1. Medical devices. Part 1. Application of usability engineering to medical devices
BS EN ISO 14971:2007 Medical devices - Application of risk management to medical devices
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 11689:1996 Acoustics - Procedure for the comparison of noise-emission data for machinery and equipment
BS EN ISO 11689:1997 Acoustics. Procedure for the comparison of noise-emission data for machinery and equipment
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 62366:2008 Medical devices - Application of usability engineering to medical devices

Standard Association of Australia （SAA）

AS 60417.2.6:2004 Graphical symbols for use on equipment - Medical equipment
AS 2684:1984 Medical equipment - Humidifiers, for medical use
AS 3781:1990 Acoustics - Noise labelling of machinery and equipment
AS ISO 14971:2020 Medical devices — Application of risk management to medical devices
AS 2901:1986 Medical devices - Characteristics of audible and visible alarm signals

European Committee for Standardization (CEN)

EN 1640:2009 Dentistry - Medical devices for dentistry - Equipment
EN 1640:1996 Dentistry - Medical Devices for Dentistry - Equipment
EN 1640:2004 Dentistry - Medical devices for dentistry - Equipment
EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices
EN 556:1994 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 12001:1996 Acoustics - Noise Emitted by Machinery and Equipment - Rules for the Drafting and Presentation of a Noise Test Code ISO 12001: 1996

GOST

GOST R ISO/TS 10993-20-2009 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices
GOST R 50444-2020 Medical instruments, apparatus and equipment. General technical requirements

Association Francaise de Normalisation

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 S98-136:2009 Sterilisation of medical devices - Risk management related to the preparation of sterile medical devices within health establishments.
NF S31-400*NF EN ISO 12001:2009 Acoustics - Noise emitted by machinery and equipment - Rules for the drafting and presentation of a noise test code.
NF S90-701:1988 MEDICO-SURGICAL EQUIPMENT. BIOCOMPATIBILITY OF MATERIALS AND MEDICAL DEVICES. METHODS FOR EXTRACTION.
NF S90-222:1986 Medico-surgical equipment. Transfusion equipment. 250 ml glass bottles.
NF S90-221:1986 Medico-surgical equipment. Transfusion equipment. 500 ml glass bottles.
NF S99-211:2013 Medical devices - Application of risk management to medical devices
NF S90-463 Medical surgical equipment. Surgical medical instruments. Scissors. Dimensions and tests.
NF S90-463:1982 Medical and surgical equipment. Surgical instruments. Scissors. Dimensions and tests.
NF EN 1265+A1:2009 Machinery Safety – Acoustic Test Code for Foundry Machinery and Equipment
NF EN 1265/IN1:2009 Machinery Safety – Acoustic Test Code for Foundry Machinery and Equipment
NF EN ISO 4871:2009 Acoustique - Déclaration et vérification des valeurs d'émission sonore des machines et équipements
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 EN ISO 11689:1997 Acoustics - Procedure for comparing sound emission data from machines and equipment
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 S31-520*NF EN ISO 11689:1997 Acoustics - Procedure for the comparison of noise emission data for machinery and equipment
NF S99-012:2010 Medical devices - Quality management - Medical device nomenclature data structure.
NF EN ISO 11688-2:2004 Acoustics - Recommended practice for the design of noise-reduced machinery and equipment - Part 2: introduction to the physics of noise-reduced design
NF C15-211:2006 Low-voltage electrical installations - Installations in medically used rooms
NF S90-460:1982 Medical and surgical equipment. Surgical instruments. Haemostatic forceps. Dimensions and tests.
NF S31-400:1997 Acoustics. Noise emitted by machinery and equipment. Rules for the drafting and presentation of a noise test code.
NF C97-904:1994 Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment.
NF S99-401:1994 Dispositifs médicaux - Élastomère de silicone de qualité médicale
NF EN 1639:2009 Art dentaire - Dispositifs médicaux pour l'art dentaire - Instruments
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 C74-054:2008 Medical devices - Application of usability engineering to medical devices.

Institute of Electrical and Electronics Engineers (IEEE)

IEEE P1073.1.3.5/D04:2000 Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Defibrillator Device

National Electrical Manufacturers Association（NEMA)

NEMA HN 1-2013 Manufacturer Disclosure Statement for Medical Device Security

RO-ASRO

STAS SR ISO 6081:1996 Acoustics - Noise emitted by machinery and equipment. Guidelines for the preparation of test codes of engineering grade requiring noise measurement at the operator's or bystander's position.
STAS 1484-1950 medical instruments. Boxes for storing first aid equipment and materials

GOSTR

GOST R 58976-2020 Medical devices. Software. Part 2. Validation of software for medical device quality systems
GOST R 52990.7-2010 Noise of machines. Textile machinery. Noise test code. Part 7. Dyeing and finishing machinery and equipment
GOST ISO/TR 10993-22-2020 Medical devices. Biological evaluation of medical devices. Part 22. Guidance on nanomaterials
GOST 23450-1979 Man-made noise from industrial, scientific medical and domestic radio-frequency equipment. Standards and measuring methods

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 0601-2-5:2005 Medical electrical equipment -- Particular requirements for the safety of ultrasonic physiotherapy equipment

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 C 1103-1990 Glossary of Terms Used in Medical Electrical Equipment (General Terms)
KS I ISO 4871:2020 Acoustics — Declaration and verification of noise emission values of machinery and equipment
KS B ISO TR 11688-2-2023 Acoustics－Recommended practice for the design of low-noise machinery and equipment－Part 2：Introduction to the physics of low-noise design
KS B ISO 11689-2008(2018) Acoustics－Procedure for the comparison of noise-emission data for machinery and equipment
KS B ISO 11689-2023 Acoustics－Procedure for the comparison of noise-emission data for machinery and equipment
KS P ISO 15225-2023 Medical devices — Quality management — Medical device nomenclature data structure
KS I ISO 12001:2020 Acoustics — Noise emitted by machinery and equipment —Rules for the drafting and presentation of a noise test code
KS C IEC 61157:2014 Requirement for the declaration of the acoustic output of medical diagnostic ultrasonic equipment
KS P ISO 15225-2014(2019) Medical devices — Quality management — Medical device nomenclature data structure
KS C IEC 61157:2004 Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment
KS B ISO TR 11688-1-2023 Acoustics－Recommended practice for the design of low-noise machinery and equipment－Part 1：Planning
KS B ISO TR 11688-1-2008(2018) Acoustics－Recommended practice for the design of low-noise machinery and equipment－Part 1：Planning
KS B ISO TR 11688-2-2008(2018) Acoustics－Recommended practice for the design of low-noise machinery and equipment－Part 2：Introduction to the physics of low-noise design

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 I ISO 4871-2023 Acoustics — Declaration and verification of noise emission values of machinery and equipment
KS I ISO 4871-2020 Acoustics — Declaration and verification of noise emission values of machinery and equipment
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 I ISO 12001-2020 Acoustics — Noise emitted by machinery and equipment —Rules for the drafting and presentation of a noise test code
KS B ISO 11689-2008(2023) Acoustics－Procedure for the comparison of noise-emission data for machinery and equipment
KS B ISO TR 11688-2-2008(2023) Acoustics－Recommended practice for the design of low-noise machinery and equipment－Part 2：Introduction to the physics of low-noise design
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

CEN - European Committee for Standardization

EN ISO 14971:2007 Medical devices - Application of risk management to medical devices
EN ISO 14971:2000 Medical Devices - Application of Risk Management to Medical Devices (Incorporates Amendment A1: 2003)
EN ISO 14971:2009 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 15223-1:2021/CD Amd 1:2024 Medical devices
ISO/CD 20417:2024 Medical devices

South African Bureau of Standard

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

GSO

GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
OS GSO EN 1265:2011 Noise test code for foundry machines and equipment
OS GSO ISO 4871:2010 Acoustics – Declaration and verification of noise emission values of machinery and equipment
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 4871:2010 Acoustics – Declaration and verification of noise emission values of machinery and equipment
BH GSO ISO 15225:2017 Medical devices -- Quality management -- Medical device nomenclature data structure
OS GSO ISO 12001:2011 Acoustics - Noise emitted by machinery and equipment - Rules for the drafting and presentation of a noise test code
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 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 12001:2011 Acoustics - Noise emitted by machinery and equipment - Rules for the drafting and presentation of a noise test code
OS GSO IEC 61157:2014 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
GSO EN 1639:2021 Dentistry — Medical devices for dentistry —Instruments
BH GSO EN 1639:2022 Dentistry — Medical devices for dentistry —Instruments

German Institute for Standardization

DIN EN ISO 4871:2009-11 Acoustics - Declaration and verification of noise emission values of machinery and equipment (ISO 4871:1996); German version EN ISO 4871:2009
DIN EN ISO 14971:2022 Medical devices – applying risk management to medical devices
DIN 58846:2017-11 Medical instruments - Raspatories
DIN EN ISO 11203:1996 Acoustics a Noise emissions from machines and devices
DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
DIN EN ISO 11689 Berichtigung 1:2009-09 Acoustics - Procedure for the comparison of noise emission-data for machinery and equipment (ISO 11689:1996); German version EN ISO 11689:1996, Corrigendum to DIN EN ISO 11689:1997-03; German version EN ISO 11689:1996/AC:2009
DIN EN ISO 11688-2:2001 Acoustics - Recommended practice for the design of low-noise machinery and equipment - Part 2: Introduction to the physics of low-noise design (ISO/TR 11688-2:1998); German version EN ISO 11688-2:2000
DIN EN ISO 11688-2:2001-03 Acoustics - Recommended practice for the design of low-noise machinery and equipment - Part 2: Introduction to the physics of low-noise design (ISO/TR 11688-2:1998); German version EN ISO 11688-2:2000
DIN EN ISO 12001:2010-01 Acoustics - Noise emitted by machinery and equipment - Rules for the drafting and presentation of a noise test code (ISO 12001:1996); German version EN ISO 12001:2009
DIN 58794:1982 Medical instruments; ear forceps
DIN 96056 E:2015-09 Medical instruments - Bone raspatory
DIN 58794:2010 Medical instruments - Ear forceps
DIN 58852 E:2020-06 Medical instruments - Probes
DIN EN 1265:2009-07 Safety of machinery - Noise test code for foundry machines and equipment; German version EN 1265:1999+A1:2008 / Note: DIN EN 1265 (2000-02) remains valid alongside this standard until 2009-12-28.
DIN 58852:2008 Medical instruments - Probes
DIN 13117:1980 Medical instruments; bone shears
DIN 13119:2010 Medical instruments - Bowel scissors
DIN 58852:2014 Medical instruments - Probes
DIN 58852:2021 Medical instruments - Probes
DIN 58852 E:2014-02 Medical instruments - Probes
DIN 96056:2016-03 Medical instruments - Bone raspatory
DIN 58857:2019-12 Medical instruments - Directors
DIN 13117:2013 Medical instruments.Bone shears
DIN 96056:2009 Medical instruments - Bone raspatory
DIN 13119 E:2008-09 Medical instruments bowel scissors
DIN 96056:2023-03 Medical instruments - Bone raspatory
DIN EN ISO 14971 E:2018-08 Application of medical device risk management in medical devices (draft)
DIN 13119:1980 Medical instruments; bowel scissors
DIN 58852:1976 Medical instruments; probes
DIN 96056 E:2022-08 Medical instruments - Bone raspatory
DIN EN 61157:2013-11 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment (IEC 61157:2007 + A1:2013); German version EN 61157:2007 + A1:2013 / Note: DIN EN 61157 (2008-07) and DIN EN 61157 Berichtigung 1 (2009-03) remain valid ...
DIN EN 62366:2008 Medical devices - Application of usability engineering to medical devices (IEC 62366:2007); German version EN 62366:2008
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 1639:2010-02 Dentistry - Medical devices for dentistry - Instruments; German version EN 1639:2009
DIN EN 556-2:2023-02 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: requirements for aseptically processed medical devices; German and English version prEN 556-2:2023 / Note: Date of issue 2023-01-06*Intended as r...
DIN EN 556-1 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 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 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
DIN 58263:1973 Medical instruments; mouth gag Heister's
DIN 96057 E:2022-08 Medical instruments - Raspatory type Sedillot

US-FCR

FCR NAV DM-3.10-1983 NOISE AND VIBRATION CONTROL FOR MECHANICAL EQUIPMENT

BE-NBN

NBN-ISO 4871:1992 Acoustics. Noise labelling of machinery and equipment
NBN-ISO 6081:1992 Acoustics. Noise emitted by machinery and equipment. Guidelines for the preparation of test codes of engineering grade requiring noise measurements at the operator's or bystander's position

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 61157:2007+AMD1:2013 CSV Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
IEC 61157:1992 Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment
IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices

CZ-CSN

CSN 84 7106-1983 Medlcal eguipment. Methods, means and processes of sterllization and desinfection of items for medical use. Terms and definitions.

American National Standards Institute （ANSI)

ANSI/AAMI/ISO 14971:2019 Medical devices— Application of risk management to 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 15225:2016 Medical devices—Quality management—Medical device nomenclature data structure
AAMI TIR12:2004 Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
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 62366:2007 Medical devices - Application of usability engineering to medical devices
ANSI/AAMI/IEC 62366/A1:2014 Medical devices - Application of usability engineering to medical devices - Amendment 1

HU-MSZT

MSZ 11143-1970 Medical equipment and tools. permissible noise level

CENELEC - European Committee for Electrotechnical Standardization

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

VDI - Verein Deutscher Ingenieure

VDI 3720 Blatt 1-2014 Design of low-noise machinery and equipment - construction tasks and methodology

NATO - North Atlantic Treaty Organization

STANAG 2127-1989 Medical Surgical and Dental Instruments Equipment and Supplies (ED 3 AMD 1)

Canadian Standards Association (CSA)

CAN/CSA-ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices (Second Edition)
CSA ISO 14971-07-CAN/CSA:2007 Medical Devices - Application of Risk Management to Medical Devices second edition
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

American Society for Testing and Materials (ASTM)

ASTM E3418-23e1 Standard Practice for Calculating Scientifically Justifiable Limits of Residues for Cleaning of Pharmaceutical and Medical Device Manufacturing Equipment and for Medical Devices

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