Medical device noise standard requirements

Medical device noise standard requirements, Total:308 items.

The international standard classification for "Medical device noise standard requirements" includes: Sterilization and disinfection in general , Graphical symbols for use on specific equipment , Medical equipment in general , Laboratory medicine , Sterilization and disinfection .

The Chinese standard classification for "Medical device noise standard requirements" includes: Public medical equipment , Medical apparatus and devices in general , General requirements on medical devices , , Acoustic Measurement , Sanitation in general .

Professional Standard - Medicine

YY/T 0466.1-2009 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
YY/T 0048-1991 Basic requirements for working drawings of medical device products
YY/T 0287-2017 Medical devices-Quality management systems- Requirements for regulatory purposes
YY/T 91051-1999 System table for standard of medical devices
YY/T 0615.1-2007 Requirements for medical devices to be designated STERILE - Part 1: Requirements for terminally sterilized medical devices
YY/T 0287-2003 Medical devices - Quality management systems - Requirements for regulatory purposes
YY 0466-2003 Medical devices -- Symbols to be used with medical device labels labelling and information to be supplied
YY/T 0615.2-2007 Requirements for medical devices to be designated“STERILE” - Part 2: Requirements for aseptically processed medical devices
YY/T 0466.1-2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
YY/T 1473-2016 Guide to the development and inclusion of safety aspects in Standards for medical devices
YY/T 0467-2003 Medical devices - Guide to the selection of standards in support of recognized essential principles of safety and performance of medical devices
YY 91056-1999 Evaluating requirements for corrosion test of electroplated metallic coatings of medical instruments
YY/T 1454-2016 General requirements for in vitro diagnostic medical devices for self-testing
YY/T 1441-2016 General requirements of performance evaluation of in vitro diagnostic medical devices
YY/T 0467-2016 Medical devices-Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices

国家药监局

YY/T 1630-2018 Fundamental requirements for unique device identifier

未注明发布机构

CAN/CSA-ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
ANSI/AAMI SW96-2023 Standard for medical device security - Security risk management for device manufacturers
DIN EN 15986 E:2009-08 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
ANSI/AAMI/ISO 13485:2016(2019) Medical devices—Quality management systems— Requirements for regulatory purposes
DIN EN ISO 15223-1 E:2015-08 Medical devices Symbols used for labeling, marking and providing information on medical devices Part 1: General requirements (draft)
DIN EN 556-2 E:2014-02 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
DIN EN ISO 13485 E:2014-04 Medical device quality management system regulatory requirements (draft)
DIN EN ISO 15223-1 E:2009-06 Medical devices Symbols used for labeling, marking and providing information on medical devices Part 1: General requirements (draft)
DIN EN ISO 13485 E:2015-05 Medical device quality management system regulatory requirements (draft)

Group Standards of the People's Republic of China

T/SXS 128-2023 Medical device safety management requirements specification
T/CAMDI 029-2024 Additive Manufacturing-General requirements for Medical-Engineering Interaction of Personalized Medical Devices
T/SXS 129-2023 Medical device enterprise management credit evaluation standards
T/CAMDI 026-2019 Group standard for special requirements for customized medical device quality system

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

GB/T 4129-1995 Acoustics--Determination of sound power levels of noise sources--Requirements for the performance and calibration of reference sound source
GB 27949-2011 General Requirements for Disinfectants for Medical Devices
GB/T 42061-2022 Medical devices—Quality management systems—Requirements for regulatory purposes
GB/T 27949-2011 Hygienic requirements for medical items disinfection

国家市场监督管理总局、中国国家标准化管理委员会

GB 27949-2020 General requirements of disinfectant of medical instruments

Jiangsu Provincial Standard of the People's Republic of China

DB32/T 3769-2020 Basic requirements for medical device network information security

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

Shanxi Provincial Standard of the People's Republic of China

DB14/T 2253-2020 Basic requirements for entrusted storage and distribution services of medical devices

国家食品药品监督管理局

YY/T 1613-2018 Requirements for process characterization and control in radiation sterilization of medical devices

Tianjin Provincial Standard of the People's Republic of China

DB12/T 1016-2020 General requirements for design and implementation of medical device traceability system

European Committee for Standardization (CEN)

EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'
EN 556-2:2003 Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 2: Requirements for aseptically processed medical devices
prEN 556-1991 Sterilization of medical devices; sterility assurance level for medical devices labelled "Sterile"; requirements
EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (Remains Current)
EN ISO 15223-1:2021 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
EN 556:1998 Sterilization of Medical Devices - Requirements for Terminally - Sterilized Medical Devices to Be Labelled "Sterile" Ratified European Text; Includes Amendment 1: 1994
prEN 46002-1991 Particular requirements for the application of EN 29002 for medical devices
prEN 46001-1992 Quality systems; medical devices; particular requirements for the application of EN 29001
EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (Incorporating corrigendum July 2012)
EN ISO 13485:2000 Quality Systems - Medical Devices - Particular Requirements for the Application of EN ISO 9001 Revision of EN 46001:1996; Identical to ISO 13485:1996
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 ISO 13488:2000 Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002 Revision of EN 46002: 1996; Identical to ISO 13488: 1996; Superseded by EN ISO 13485:2003
EN 46001:1993 Quality Systems - Medical Devices - Particular Requirements for the Application of EN 29001

Association Francaise de Normalisation

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 EN 556-2:2015 Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage "STÉRILE" - Partie 2 : exigences pour les dispositifs médicaux soumis à un traitement aseptique
NF S98-107-1*NF EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 1 : requirements for terminally sterilized 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 S98-107-2:2004 "Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2 : requirements for aseptically processed medical devices".
NF S98-107-2*NF EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2 : requirements for aseptically processed medical devices
NF EN 15986:2011 Symbole à utiliser pour l'étiquetage des dispositifs médicaux - Exigences relatives à l'étiquetage des dispositifs médicaux contenant des phtalates
NF S99-014-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1 : general requirements.
NF S99-101:2012 Medical devices - Quality management systems - Requirements for regulatory purposes
NF EN ISO 13485:2016 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 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
NF S99-101/A11*NF EN ISO 13485/A11:2021 Medical devices - Quality management systems - Requirements for regulatory purposes
NF S90-445:1985 MEDICO-SURGICAL EQUIPMENT. IMPLANTS FOR SURGERY. ORTHOPAEDIC JOINT PROSTHESES. BASIC REQUIREMENTS.
NF EN ISO 13485/A11:2021 Medical devices - Quality management systems - Requirements for regulatory purposes
XP S98-224*XP ISO/TS 22421:2021 Sterilization of health care products - Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
XP ISO/TS 22421:2021 Sterilization of healthcare products - Common requirements for sterilizers used for terminal sterilization of medical devices in healthcare settings
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 EN 50637:2017 Electromedical devices - Special basic safety and essential performance requirements of medical beds for children
NF S99-004:2008 Symbols for use in the labelling of medical devices.
NF S99-014-2*NF ISO 15223-2:2010 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 2 : symbol development, selection and validation.

SCC

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 556:1994 Sterilization of medical devices — Requirements for medical devices to be labelled "Sterile"
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
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
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
AENOR UNE-EN 556-2:2016 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
DANSK DS/EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
DIN EN 556-2 E:2014 Draft Document - Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2: Requirements for aseptically processed medical devices; German version prEN 556-2:2014
NS-EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
NS-EN 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements
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
UNE-EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
UNE-EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 2: Requirements for aseptically processed medical devices
09/30205582 DC BS EN 15986. Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates
DANSK DS/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 15986:2011 Symbol for use in the labelling of medical devices — Requirements for labelling of medical devices containing phthalates
NS-EN 556:1994+A1:1998 Sterilization of medical devices — Requirements for terminally-sterilized medical devices to be labelled "Sterile" (including amendment A1:1998)
NEMA/MITA UMD P1-2020 Remanufacturing of Ultrasound Medical Devices
BS EN 556:1995 Sterilization of medical devices. Requirements for terminally-sterilized devices to be labelled 'Sterile'
AAMI/ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements
AAMI/ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements
AENOR UNE-EN 556-1:2002 Sterilization of medical products. Requirements for medical devices to be designated "STERILE". Part 1: Requirements for sterilized medical devices in their terminal state.
DANSK DS/ISO 15223-1:2007 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
DIN EN 15986 E:2009 Draft Document - Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version prEN 15986:2009
AAMI/ISO 15223-1:2022 Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements
AENOR UNE-ENV 50076:1993 COMPLEMENTARY REQUIREMENTS (TO THE EN 29001 STANDARD) FOR ACTIVE MEDICAL DEVICES. (OFFICIAL VERSION ENV 50076:1990).
NS-EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)
09/30176675 DC BS EN ISO 15223-1. Medical devices. Symbols to be used with medical device labels , labelling and information to be supplied. Part 1. General requirements
VDI/VDE 2426 BLATT 2-2000 Catalogs in the maintenance and management of medical technology — Standardized equipment catalog
DANSK DS/EN ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes
DANSK DS/EN ISO 13485/AC:2018 Medical devices – Quality management systems – Requirements for regulatory purposes
CAN/CSA-ISO 13485:2003(R2013) Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
AENOR UNE-EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing.
BS EN ISO 15223-1:2016 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied-General requirements
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
HIMSS/NEMA HN 1-2008 Manufacturer Disclosure Statement for Medical Device Security
HIMSS/NEMA HN 1-2013 Manufacturer Disclosure Statement for Medical Device Security
CSA Z314.0-13:2014 Reprocessing of medical devices — General requirements Proprietary copy
BS EN ISO 10993-2:1998 Biological evaluation of medical devices-Animal welfare requirements
DANSK DS/EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
NS-EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
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
DANSK DS/ISO/TR 16142:2006 Medical devices – Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
BS EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects-General requirements
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
AAMI/ISO TIR16142:2005 Medical devices- Guidance on the selection of standards in support of recognized essential principles of safety and performance of 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
UNE-EN 61157:1996 REQUIREMENTS FOR THE DECLARATION OF THE ACOUSTIC OUTPUT OF MEDICAL DIAGNOSTIC ULTRASONIC EQUIPMENT.
NS-EN ISO 15223-1:2016 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)
DANSK DS/EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)
DANSK DS/ISO/TS 22421:2021 Sterilization of health care products – Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
AAMI SW96:2023 Standard for medical device security—Security risk management for device manufacturers
NS-EN 15424:2007 Sterilization of medical devices — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
NS 8150:1984 Woodworking machines - Measurement of noise - Coordinating standard
UNE-EN 15424:2007 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
DANSK DS/EN ISO 25424:2011 Sterilization of medical devices – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices
NS-EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
AAMI ST98:2022 Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices
AS ISO 13485:2002 Quality systems - Medical devices - Particular requirements for the application of ISO 9001
CAN/CSA-ISO 13488-1998(R2001) Quality systems - Medical devices - Particular requirements for the application of ISO 9002
AAMI/ISO 13485:1996 Quality systems - Medical devices - Particular requirements for the application of ISO 9001
AENOR UNE-EN ISO 13485/AC:2016 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
NS-EN 46001:1993 Quality systems — Medical devices — Particular requirements for the application of EN 29001
NS-EN ISO 13485:2012 Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003)

Danish Standards Foundation

DS/EN 556:1995 Sterilization of medical devices - Requirements for medical devices to be labelled "Sterile"
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
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 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
Standardpakke Medicinsk udstyr 1-2009 Standards package - Medical devices - Basic standards
DS/EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
DS/ISO/TS 22421:2021 Sterilization of health care products – Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
DS/EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes
DS/ISO/TR 16142:2006 Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
DS/EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
DS/EN 46002:1993 Quality systems. Medical devices. Particular requirements for the application of EN 29002
DS/EN 46001:1993 Quality systems. Medical devices. Particular requirements for the application of EN 29001

RU-GOST R

GOST EN 556-1-2011 Sterilization of medical devices. Requirements for medical devices to be designated «sterile». Part 1. Requirements for terminally sterilized medical devices
GOST R ISO 15223-1-2014 Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Part 1. General requirements
GOST R 57501-2017 Maintenance of medical devices. 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 R ISO 20857-2016 Sterilization of medical devices. Dry heat. Requirements for development, validation and routine control of a sterilization process for medical devices
GOST R 57504-2017 Medical devices. Syringe pumps. Technical requirements for governmental purchases
GOST 23941-2002 Noise of machines. Methods for determination of noise characteristics. General requirements
GOST 23941-1979 Noise. Methods of determinations of noise characteristics. General requirements
GOST ISO 13485-2017 Medical devices. Quality management systems. Requirements for regulatory purposes
GOST R 57506-2017 Medical devices. Implantable defibrillators and other active implantable medical devices intended to treat tachyarrhythmia. Technical requirements for governmental purchases

British Standards Institution (BSI)

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
23/30457240 DC BS EN 556-2. Sterilization of medical devices. Requirements for medical devices to be designated ''STERILE" - Part 2. requirements for aseptically processed medical devices
BS EN 556-1:2001(2006) Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1 : Requirements for terminally sterilized medical devices
BS EN ISO 15223-1:2012 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
BS EN ISO 15223-1:2017 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
23/30457243 DC BS EN 556-1. Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Part 1. Requirements for terminally sterilized medical devices
BS EN 556-2:2004 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices
PD ISO/TS 22421:2021 Sterilization of health care products. Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
BS EN ISO 13488:2001 Quality systems - Medical devices - Particular requirements for the application
BS EN ISO 10993-2:2022 Biological evaluation of medical devices - Animal welfare requirements
BS EN ISO 10993-2:2006 Biological evaluation of medical devices - Animal welfare requirements
BS ISO 15223-2:2010 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Symbol development, selection and validation
PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices. General requirements

CEN - European Committee for Standardization

EN 556-2:2015 "Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices"
EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
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 15424:2007 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development@ validation and routine control of a sterilization process for medical devices

German Institute for Standardization

DIN EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2003
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 556-1:2002-03 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 556-1 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 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
DIN EN 556-2:2015 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
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 EN 13532:2002-08 General requirements for in vitro diagnostic medical devices for self-testing; German version EN 13532:2002, German and English texts
DIN EN ISO 15223-1/A1:2019 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016); German and English version EN ISO 15223-1:2016/prA1:2019
DIN EN ISO 15223-1:2020 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO/DIS 15223-1:2020); German and English version prEN ISO 15223-1:2020
DIN EN ISO 13485/A1:2019 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German and English version EN ISO 13485:2016/prA1:2019
DIN EN ISO 13485:2021-12 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 + AC:2018 + A11:2021

ES-UNE

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 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 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)

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
UNE-EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
UNE-EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing.

US-FCR

FCR 21 CFR PART 821-2015 MEDICAL DEVICE TRACKING REQUIREMENTS
FCR 21 CFR PART 814-2015 PREMARKET APPROVAL OF MEDICAL DEVICES
FCR 21 CFR PART 814-2014 PREMARKET APPROVAL OF MEDICAL DEVICES
FCR 21 CFR PART 814-2013 PREMARKET APPROVAL OF MEDICAL DEVICES
FCR 21 CFR PART 808-2013 EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS
FCR 21 CFR PART 808-2014 EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS
FCR 21 CFR PART 808-2015 EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS

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 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
LST EN 15986-2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
LST EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)

DIN

DIN EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

KR-KS

KS P ISO 15223-1-2019 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
KS P ISO 13485-2018 Medical devices — Quality management systems — Requirements for regulatory purposes
KS P ISO 15223-2-2019 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
KS P ISO 13488-2002 Quality systems－Medical devices－Particular requirements for the application of ISO 9002

Korean Agency for Technology and Standards (KATS)

KS P ISO 15223-1:2019 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
KS P ISO 13485:2007 Medical devices－Quality management systems－Requirements for regulatory purposes
KS P ISO 13485-2023 Medical devices — Quality management systems — Requirements for regulatory purposes
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 TR 16142:2007 Medical devices－Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
KS P ISO TR 16142-2007(2012) Medical devices－Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
KS P ISO TR 16142-2019 Medical devices－Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
KS P ISO 15223-2019 Medical devices－Symbols to be used with medical device labels, labelling and information to be supplied
KS P ISO 15223-2:2019 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
KS P ISO 13488:2002 Quality systems－Medical devices－Particular requirements for the application of ISO 9002

VDI - Verein Deutscher Ingenieure

VDI/VDE 2426 Blatt 2-1995 Standardized catalogue of medical devices

GSO

BH GSO 2680:2022 Halal medical device – General requirements
GSO 2680:2021 Halal medical device – General requirements
BH GSO 2628:2022 Medical devices and supplies classification criteria
GSO 2628:2021 Medical devices and supplies classification criteria
OS GSO ISO 15223-1:2020 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
GSO ISO 15223-1:2020 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
BH GSO ISO 13485:2017 Medical devices -- Quality management systems -- Requirements for regulatory purposes
GSO ISO/TS 22421:2023 Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
GSO ISO 13485:2016 Medical devices -- Quality management systems -- Requirements for regulatory purposes
BH GSO ISO/TS 22421:2023 Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
BH GSO EN 13532:2022 General requirements for in vitro diagnostic medical devices for self-testing
GSO EN 13532:2021 General requirements for in vitro diagnostic medical devices for self-testing
OS GSO ISO 13485:2016 Medical devices -- Quality management systems -- Requirements for regulatory purposes
BH GSO ISO 25424:2017 Sterilization of medical devices -- Low temperature steam and formaldehyde -- Requirements for development, validation and routine control of a sterilization process for medical devices
OS GSO ISO 25424:2016 Sterilization of medical devices -- Low temperature steam and formaldehyde -- Requirements for development, validation and routine control of a sterilization process for medical devices
GSO ISO 25424:2016 Sterilization of medical devices -- Low temperature steam and formaldehyde -- Requirements for development, validation and routine control of a sterilization process for medical devices

International Organization for Standardization (ISO)

ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
ISO 15223-1:2021 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
ISO 15223-1:2007 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
ISO 15223-1:2007/Amd 1:2008 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements; Amendment 1
ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 14971:2000/Amd 1:2003 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements
ISO 15223:2000 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied
ISO/TR 16142:1999 Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
ISO/TR 16142:2006 Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
ISO/DIS 15194:2024 In vitro diagnostic medical devices — Requirements for certified reference materials and the content of supporting documentation
ISO 15223:2000/Amd 2:2004 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied; Amendment 2
ISO 13485:1996 Quality systems - Medical devices - Particular requirements for the application of ISO 9001
ISO/DIS 15193:2024 In vitro diagnostic medical devices — Requirements for reference measurement procedures
ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 13488:1996 Quality systems - Medical devices - Particular requirements for the application of ISO 9002

GOSTR

GOST R ISO 15223-1-2020 Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Part 1. General requirements
GOST R ISO 10993-2-2009 Standardization in the Russian Federation. Medical devices. Biological evaluation of medical devices. Part 2. Animal welfare requirements
GOST R EN 13532-2010 General requirements for in vitro diagnostic medical devices for self-testing
GOST R 52990.1-2008 Noise of machines. Textile machinery. Noise test code. Part 1. Common requirements
GOST 31425.1-2010 Noise of machines. Noise test code for textile machinery. Part 1. Common requirements

VN-TCVN

TCVN 6916-1-2008 Medical devices.Symbols to be used with medical device labels, labelling and information to be supplied.Part 1: General requirements
TCVN 6916-2001 Medical devices.Symbols to be used with medical device labels, labelling and information to be supplied

PL-PKN

PN Z54058-1990 Medical instruments Needle holders Re?uirements and tests
PN Z54032-1989 Medical instruments Haemostatic forceps Re?uirements and tests
PN Z58022-1973 Medical instruments ynaecological curettes echnical requirements and tests
PN Z54094-1972 Medical and surgical instruments Forceps Technical requirements and tes?s

ZA-SANS

SANS 15223:2006 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied

US-AAMI

ANSI/AAMI/ISO 15223-1:2012 Medical devices.Symbols to be used with medical device labels, labeling, and information to be supplied.Part 1: General requirements

Japanese Industrial Standards Committee (JISC)

JIS Q 13485:2005 Medical devices -- Quality management systems -- Requirements for regulatory purposes
JIS T 0307:2004 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied

TH-TISI

TIS 13485-2004 Medical devices.quality management systems.requirements for regulatory purposes

CZ-CSN

CSN 01 1615-1987 Noise. Principal provisions for standardi-zing the noise characteristics of machines
CSN 36 4721-1983 X-ray primary collimators of medical apparatus Basic sizes Technical requirements
CSN ISO 6926:1993 Acoustics. Determination of sound power levels of noise sources. Requirements for the performance and calibration of reference sound sources

International Electrotechnical Commission (IEC)

IEC 61157:1992 Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment
ISO/TR 24971:2013 Medical devices -- Guidance on the application of ISO 14971

Underwriters Laboratories (UL)

UL 2800 BULLETIN-2014 UL Standard for Safety Medical Device Interoperability
UL 2800 BULLETIN-2017 UL Standard for Safety Medical Device Interoperability
UL 2800 BULLETIN-2016 UL Standard for Safety Medical Device Interoperability
UL 2800-1-2022 UL Standard for Safety Medical Device Interoperability
UL 2800 BULLETIN-2013 UL Standard for Safety Medical Device Interoperability
UL 2800 BULLETIN-2015 UL Standard for Safety Medical Device Interoperability
UL 2800-1-2019 UL Standard for Safety Medical Device Interoperability (First Edition)

IEEE - The Institute of Electrical and Electronics Engineers@ Inc.

IEEE 1073-1996 Standard for Medical Device Communications Overview and Framework

National Electrical Manufacturers Association（NEMA)

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

GOST

GOST R 50444-2020 Medical instruments, apparatus and equipment. General technical requirements

American National Standards Institute （ANSI)

ANSI/AAMI SW96:2023 Standard for medical device security - Security risk management for device manufacturers

RO-ASRO

STAS 12916-1991 Human use medical instruments. Retractors. General technical requirements for quality

Standard Association of Australia （SAA）

AS ISO 14155.1:2004 Clinical investigations of medical devices for human subjects - General requirements
AS ISO 13485:2017 Medical devices — Quality management systems — Requirements for regulatory processes

American Society for Testing and Materials (ASTM)

ASTM F619-20 Standard Practice for Extraction of Materials Used in Medical Devices
ASTM F619-02 Standard Practice for Extraction of Medical Plastics
ASTM F619-79(1997)e1 Standard Practice for Extraction of Medical Plastics

Canadian Standards Association (CSA)

CSA ISO 13485-03-CAN/CSA:2003 Medical devices - Quality management systems - Requirements for regulatory purposes Second Edition

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