Limits of heavy metals in medical devices

Limits of heavy metals in medical devices, Total:266 items.

The international standard classification for "Limits of heavy metals in medical devices" includes: food products in general , Other products of non-ferrous metals , Products of the chemical industry in general , Medical equipment in general , Alcohols. Ethers , Laboratory medicine , Postal services , Food additives , Sterilization and disinfection in general , Other standards related to sterilization and disinfection .

The Chinese standard classification for "Limits of heavy metals in medical devices" includes: Labor safety technology in general , Medical apparatus and devices in general , Basic standards and general methods for dye , Heavy metals and their alloys , Tooth paste, soap and detergent , Postal packaging , Food additive and nutrition enhancer sanitation , General and microsurgical devices , Public medical equipment .

未注明发布机构

DIN 96123 E:2017-06 Medical instruments - Needle holder type Finochietto with carbide inserts
DIN EN ISO 13485:2001 Quality assurance systems for medical devices
DIN 96128 E:2017-06 Medical instruments - Needle holder type Wangensteen with carbide inserts
ANSI/AAMI/ISO 10993-15:2019 Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys
ANSI/AAMI/ISO 15225:2016 Medical devices—Quality management—Medical device nomenclature data structure
DIN 13109 E:2008-09 Medical instruments - Wire cutting scissors without carbide inserts
DIN 58854 E:2022-08 Medical instruments - Myrtle leaf probes
ANSI/AAMI/ISO 14971:2019 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 16886.15-2003 Biological eveluation of medical devices--Part 15:Inentificatoin and quantificatoin of degradation products from metals and alloys
GB/Z 42217-2022 Medical device —Validation of software for medical device quality system
GB/T 16886.18-2022 Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process
GB 20424-2006 The specification for limit on harmful element content of the heavy metal concentrates products
GB 7532-1987 Organic chemical products－Determination of heary metals content－General method－Visual limit test
GB/T 5009.74-2003 Method for limit test of heavy metals in food additives
GB/T 13216.12-1991 Test methods for glycerines--Limit test for heavy metal
GB 20814-2014 Limit and determination of the quantity of heavy-metal elements in dye products
GB 20814-2006 Limit and determination of the quantity of 10 heavy-metal elements in dye products
GB/T 16886.17-2005 Biological evaluation of medical devices - Part 17 : Estabilishment of allowable limits for leachable substances
GB 43352-2023 Limits of heavy metals and other specific substances in express packaging
GB/T 16886.15-2022 Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys

Professional Standard - Agriculture

120药典四部-2015 0800 Limit inspection method 0821 Heavy metal inspection method
101药典四部-2020 0800 Limit inspection method 0821 Heavy metal inspection method
澳门第23/2018号行政法规 Maximum limit of heavy metal pollutants in food
GB/T 8451-1987 Method for limit test of heavy metals in food additives

Professional Standard - Medicine

YY/T 0468-2015 Medical devices―Quality management―Medical device nomenclature data structure
YY/T 0802-2010 Sterilization of medical devices—Information to be provided by the manufacturer for the processing of resterilizable medical devices
YY 91056-1999 Evaluating requirements for corrosion test of electroplated metallic coatings of medical instruments

Group Standards of the People's Republic of China

T/CAMDI 040-2020 Special requirements for the quality management system of metal additive manufacturing medical device production
T/CHAS 10-4-7-2021 Quality and safety management of Chinese hospital—— Part 4-7: Medical management —— medical devices management
T/SAMD 0003-2023 Mechanically actuated micro-plunger pumps for medical devices
T/CAMDI 009.10-2024 Cleanliness of primary package for sterile medical device Part 10：Limits of contamination
T/SZZX 015-2023 Mechanically actuated micro-plunger pumps for medical devices
T/CAMDI 009.10-2020 Cleanliness of primary package for sterile medical device - Part 10：limits of contamination
T/CAMDI 009.10-2023 Cleanliness of primary package for sterile medical device - Part 10：Limits of contamination
T/CAMDI 008-2016 General rules for the implementation of medical device manufacturing quality management regulations for sterile medical device manufacturing equipment

Jiangsu Provincial Standard of the People's Republic of China

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

中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会

GB/T 16886.13-2017 Biological evaluation of medical devices-Part 13:Identification and quantification of degradation products from polymeric medical devices
GB/T 20424-2006 The specification for limit on harmful element content of the heavy metal concentrates products

Professional Standard - Petrochemical Industry

SH/T 0405-1992 Vaseline heavy metal limit test method

Inner Mongolia Provincial Standard of the People's Republic of China

DB15/T 2691-2022 Regulations on safety limits of mycotoxins and heavy metals in silage corn

National Health Commission of the People's Republic of China

GB 5009.74-2014 National Food Safety Standard-Method for limit test of heavy metals in food additives

国家食品药品监督管理局

YY/T 1478-2016 Traceability information of disinfection and sterilization reusable medical devices

ZA-SANS

SANS 5014:1987 Heavy metals in pharmaceutical solutions, limit test
SANS 17664:2007 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices

CZ-CSN

CSN 84 6620-1955 Metal pair medical device box (two wings)
CSN 07 8510 Z1-1995 Colour marking of metal pressure vessels for gases for medical use
CSN 07 8510-1988 Colour marking of metal pressure vessels for gases for medical use

SCC

CSA Z314.23-16:2016 Chemical sterilization of reusable medical devices in healthcare settings
CAN/CSA-ISO 14971:2007(C2012) Medical devices - Application of risk management to medical devices
CEI UNI EN ISO 14971:2020 Medical devices - Application of risk management to medical devices
AAMI/ISO 14971:2019 Medical devices - Application of risk management to medical devices
CAN/CSA-ISO 14971:2007(R2012) Medical Devices - Application of Risk Management to Medical Devices
DANSK DS/EN ISO 14971:2012 Medical devices – Application of risk management to medical devices
DANSK DS/ISO 14971:2020 Medical devices – Application of risk management to medical devices
CAN/CSA-ISO 14971:2001(R2006) Medical Devices - Application of Risk Management to Medical Devices
ISO 14971:2019 Plus Redline Medical devices - Application of risk management to medical devices
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
VDI 5707 BLATT 1-2023 Repeat tests on active medical devices in medical use — test principles
VDI 5707 BLATT 1-2023 Repeat tests on active medical devices in medical use — test principles
CEI EN 62366:2008 Medical devices - Application of usability engineering to medical devices
AENOR UNE-EN 62366:2009 Medical devices - Application of usability engineering to medical devices
DANSK DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
DANSK DS/EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
CEI 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
DANSK DS/EN ISO 15225:2016 Medical devices – Quality management – Medical device nomenclature data structure
AAMI/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
CEI UNI EN/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
AAMI/ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
NS-EN ISO 14971:2019 Medical devices — Application of risk management to medical devices (ISO 14971:2019)
NS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
UNE-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
AENOR UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN ISO 14971:2001 Medical devices - Application of risk management to medical devices. (ISO 14971:2000)
BS PD ISO/TR 80002-2:2017 Medical device software-Validation of software for medical device quality systems
BS PD IEC/TR 80002-1:2009 Medical device software-Guidance on the application of ISO 14971 to medical device software
CAN/CSA-ISO 14971-2021 Medical devices – Application of risk management to medical devices (ISO 14971:2019, IDT)
ISO 14971:2000/AMD1:2003 Amendment 1 - Medical devices - Application of risk management to medical devices
CAN/CSA-Z314.8-2000(R2007) Decontamination of Reusable Medical Devices
CAN/CSA Z314.8-2008(R2013) Decontamination of Reusable Medical Devices
CAN/CSA-Z314.8-2000(C2007) Decontamination of reusable medical devices
DANSK DS/EN 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
CAN/CSA-Z314.8-2008(R2013) Decontamination of Reusable Medical Devices
CAN/CSA-Z314.8-2008(C2013) Decontamination of reusable medical devices
CSA Z314.8-14:2014 Decontamination of reusable medical devices
CAN/CSA Z314.8-2000(R2005) Decontamination of Reusable Medical Devices
CEI EN 62366-1:2016 Medical devices Part 1: Application of usability engineering to medical devices
NS-EN ISO 15225:2016 Medical devices — Quality management — Medical device nomenclature data structure (ISO 15225:2016)
NS-EN ISO 15225:2010 Medical devices — Quality management — Medical device nomenclature data structure (ISO 15225:2010)
05/30140005 DC BS EN ISO 14971 ED 2. Medical devices. Application of risk management to medical devices
DIN EN ISO 14971 E:2018 Draft Document - Medical devices - Application of risk management to medical devices (ISO/DIS 14971:2018); German and English version prEN ISO 14971:2018
CSA Z314.22-16:2016 Management of borrowed reusable medical devices
UNE-EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure (ISO/FDIS 15225:2009)
AAMI TIR12:2010 Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
CSA Z314-2023 Reprocessing of medical devices in Canada in all healthcare settings
BS EN 62366:2008+A1:2015 Medical devices. Application of usability engineering to medical devices
CAN/CSA-Z17664-2006(R2011) Sterilization of Medical Devices - Information to be Provided by the Manufacturer for the Processing of Resterilizable Medical Devices
CAN/CSA-Z314.22-2010 Management of borrowed and reusable medical devices
AAMI/ISO 10993-15:2019 Biological evaluation of medical devices?Part 15: Identification and quantification of degradation products from metals and alloys
AAMI ST35:2003 Safe Handling and Biological Decontamination of Reusable Medical Devices in Health Care Facilities and in Nonclinical Settings
DANSK DS/ISO 10993-15:2023 Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys
DANSK DS/EN ISO 10993-15:2009 Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys
UNE-EN 980:2008 Symbols for use in the labelling of medical devices
NS-EN 980:2008 Symbols for use in the labelling of medical devices
DANSK DS/EN 980:2008 Symbols for use in the labelling of medical devices
NS-EN ISO 14971:2012 Medical devices — Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
NS-EN ISO 14971:2009 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
UNE-EN ISO 14971:2009 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
DIN EN ISO 15225 E:2015 Draft Document - Medical devices - Quality management - Medical device nomenclature data structure (ISO/DIS 15225:2015); German and English version prEN ISO 15225:2015
CAN/CSA-ISO 14971-2007(R2017) Medical Devices - Application of Risk Management to Medical Devices (Adopted ISO 14971:2007, second edition, 2007-03-01)
DANSK DS/EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
BS EN ISO 10993-13:2009 Biological evaluation of medical devices-Identification and quantification of degradation products from polymeric medical devices
DIN EN ISO 14971/A1 E:2009 Draft Document - Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); English version FprEN ISO 14971:2009, Amendment 1
CEI UNI EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling 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
AENOR UNE-EN 15986:2011 Symbol for use in the labeling of medical devices - Requirements for labeling of medical devices containing phthalates
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
UNE-EN ISO 10993-15:2001 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys. (ISO 10993-15:2000)
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
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
NS-EN ISO 10993-15:2023 Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)
DIN EN 980 E:2006 Draft Document - Symbols for use in the labelling of medical devices; German version prEN 980:2006
DIN 96141 E:2011 Draft Document - Medical instruments - Chisels and gauges type Partsch
CAN/CSA-ISO 14971-2001 Medical Devices - Application of Risk Management to Medical Devices (Adopted ISO 14971:2000, first edition, 2000-12-15)
NS-EN ISO 10993-15:2009 Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)
DANSK DS/EN ISO 10993-17:2009 Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances
NS-EN ISO 10993-15:2000 Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)

British Standards Institution (BSI)

BS EN ISO 10993-15:2001 Biological evaluation of medical devices - Identification and quantification of degradation products from metals and alloys
BS EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
BS EN ISO 15225:2016 Medical devices. Quality management. Medical device nomenclature data structure
BS EN 46003:1999 Quality systems for the manufacture of medical devices
BS EN ISO 10993-18:2020+A1:2023 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
18/30370883 DC BS EN ISO 14971. Medical devices. Application of risk management to medical devices
ISO 10993-18:2020/Amd.1:2022 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
PD IEC/TR 80002-1:2009 Medical device software. Guidance on the application of ISO 14971 to medical device software
BS EN ISO 10993-13:2010 Biological evaluation of medical devices. Part 13: Identification and quantification of degradation products from polymeric medical devices
BS PD CEN ISO/TR 14969:2005(2006) Medical devices — Quality management systems — Guidance on
BS EN ISO 10993-15:2009 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)

RU-GOST R

GOST ISO 10993-15-2011 Medical devices. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys
GOST R ISO 10993-15-2001 Medical devices. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys
GOST R ISO 15225-2014 Medical devices. Quality management. Medical device nomenclature data structure
GOST ISO 10993-17-2011 Medical devices. Biological evaluation of medical devices. Part 17. Establishment of allowable limits for leachable substances
GOST 19126-2007 Medical metallic instruments. General specifications
GOST ISO 10993-13-2016 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST ISO 10993-13-2011 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST ISO 10993-14-2011 Medical devices. Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics

GSO

BH GSO ISO 14971:2017 Medical devices -- Application of risk management to medical devices
OS GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
OS GSO IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
BH GSO ISO 15225:2017 Medical devices -- Quality management -- Medical device nomenclature data structure
GSO ISO 15225:2016 Medical devices -- Quality management -- Medical device nomenclature data structure
GSO ISO/TR 80002-2:2021 Medical device software — Part 2: Validation of software for medical device quality systems
BH GSO ISO/TR 80002-2:2022 Medical device software — Part 2: Validation of software for medical device quality systems
GSO ISO 10993-15:2016 Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys
BH GSO ASTM F2459:2023 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
GSO ASTM F2459:2022 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
BH GSO ISO 10993-17:2017 Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances
GSO ISO 10993-17:2016 Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances
OS GSO ISO 10993-17:2016 Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances

Association Francaise de Normalisation

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 S99-012:2010 Medical devices - Quality management - Medical device nomenclature data structure.
NF S99-501-15*NF EN ISO 10993-15:2009 Biological evaluation of medical devices - Part 15 : identification and quantification of degradation products from metals and alloys
NF EN ISO 10993-15:2009 Biological assessment of medical devices - Part 15: identification and quantification of degradation products from metals and alloys
NF EN ISO 10993-17:2009 Évaluation biologique des dispositifs médicaux - Partie 17 : établissement des limites admissibles des substances relargables
NF S90-010:1987 Medico-surgical equipment. Reusable all-glass or metal-and-glass syringes for medical use. Part 1 : dimensions.
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 ISO 10993-13:2010 Biological assessment of medical devices - Part 13: identification and quantification of degradation products of polymer-based medical devices
NF S99-170:2013 Maintenance of medical devices - Quality management system for the maintenance and management of risks associated with the operation of medical devices

ES-UNE

UNE-EN ISO 14971:2020/A11:2022 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)

Canadian Standards Association (CSA)

CSA Z314.23-2012 Sterilization by chemical agent of reusable medical devices in healthcare establishments (first edition)
CSA ISO 14971-07-CAN/CSA:2007 Medical Devices - Application of Risk Management to Medical Devices second edition
CAN/CSA-ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices (Second Edition)
CSA Z314.8-2014 Decontamination of reusable medical devices (Fourth Edition)
CSA Z314.8-08-2008 Decontamination of reusable medical devices Third Edition
CSA ISO 14971:2021 Medical devices - Application of risk management to medical devices (Adopted ISO 14971:2019, third edition, 2019-12)

Standard Association of Australia （SAA）

AS ISO 14971:2020 Medical devices — Application of risk management to medical devices
AS 5330:2019 Drying cabinets for reusable medical devices
AS 5369:2023 Reprocessing of reusable medical devices and other devices in health and non-health related facilities

Danish Standards Foundation

DS/EN ISO 14971:2013 Medical devices - Application of risk management to medical devices
DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
DS/EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
DS/EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
DS/IEC/TR 80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software

European Committee for Standardization (CEN)

CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices
EN ISO 10993-15:2000 Biological Evaluation of Medical Devices - Part 15: Identification and Quantification of Degradation Products from Metals and Alloys ISO 10993-15:2000
EN ISO 10993-13:1998 Biological Evaluation of Medical Devices - Part 13: Identification and Quantification of Degradation Products from Polymeric Medical Devices ISO 10993-13:1998
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 10993-15:2023 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)
EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure

International Organization for Standardization (ISO)

IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
IEC/TR 80002-1:2009 Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
IEC TR 80002-1:2009 Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
IEC TR 80002-1:2009 Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
ISO 10993-15:2019 Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
ISO 10993-18:2020 Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process

CENELEC - European Committee for Electrotechnical Standardization

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

CEN - European Committee for Standardization

EN ISO 10993-15:2009 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
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

Korean Agency for Technology and Standards (KATS)

KS P ISO 15225-2023 Medical devices — Quality management — Medical device nomenclature data structure
KS P ISO 15225-2014(2019) Medical devices — Quality management — Medical device nomenclature data structure
KS C CISPR 23-2004 Electromagnetic compatibility(EMC)-Determination of limits for industrial, scientific and medical equipment
KS P IEC TR 62366-2:2020 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
KS P ISO TR 80002-2:2021 Medical device software — Part 2: Validation of software for medical device quality systems
KS P ISO 10993-15-2006(2016) Biological evaluation of medical devices－Part 15：Identification and quantification ofdegradation products from metals and alloys
KS P ISO 10993-15:2021 Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
KS P ISO 10993-17-2022 Biological evaluation of medical devices — Part 17：Establishment of allowable limits for leachable substances

German Institute for Standardization

DIN EN ISO 14971:2022-04 Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019 + A11:2021
DIN EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
DIN 58866:2010 Medical instruments - Septum knives type Ballenger
DIN 96115:2010 Medical instruments - Gauges type Lexer
DIN 58854:1976 Medical instruments; myrtle leaf probes
DIN 58854:2010 Medical instruments - Myrtle leaf probes
DIN 96123:2017 Medical instruments - Needle holder type Finochietto with carbide inserts
DIN 96128:2017 Medical instruments - Needle holder type Wangensteen with carbide inserts
DIN 96128:2011 Medical instruments - Needle holder type Wangensteen with carbide inserts
DIN 96112:2010 Medical instruments - Gauges type Killian-Claus, bayonet-shaped
DIN 96123:2011 Medical instruments - Needle holder type Finochietto with carbide inserts
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 13109:2010 Medical instruments - Wire cutting scissors without carbide inserts
DIN 13459:2021-01 Medical instruments - Needle holder type Stratte with carbide inserts
DIN 58236-1:1982 Medical instruments; needle holder type Mathieu without carbide inserts
DIN EN ISO 10993-15:2023-07 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019); German version EN ISO 10993-15:2023
DIN EN ISO 10993-15:2023 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)

TH-TISI

TIS 2278-2006 Sterilization of medical devices-information to be provided by the manufacturer for the processing of resterilizable medical devices
TIS 2395.13-2008 Biological evaluation of medical devices.part 13: identification and quantification of degradation products from polymeric medical devices
TIS 2395.15-2008 Biological evaluation of medical devices.part 15: identification and quantification of degradation products from metals and alloys

Japanese Industrial Standards Committee (JISC)

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

PL-PKN

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

Lithuanian Standards Office

LST EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010)
LST EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)
LST EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

GOST

GOST R ISO 10993-15-2009 Medical devices. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys
GOST ISO 14971-2021 Medical devices. Application of risk management to medical devices
GOST ISO 10993-15-2023 Medical devices. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys
GOST R ISO 10993-13-2009 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST R 59767-2021 Medical devices. Risk management. Risk assessment in the desing and development of medical devices

DIN

DIN 58854:2023 Medical instruments - Myrtle leaf probes

American National Standards Institute （ANSI)

AAMI TIR12:2004 Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
BS EN ISO 10993-15:2023 Biological evaluation of medical devices Identification and quantification of degradation products from metals and alloys (British Standard)

AENOR

UNE-EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)
UNE-EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

KR-KS

KS P IEC TR 62366-2-2020 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
KS P ISO TR 80002-2-2021 Medical device software — Part 2: Validation of software for medical device quality systems
KS P ISO 10993-15-2021 Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys

International Electrotechnical Commission (IEC)

ISO/TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems
ISO TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems
ISO/TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems

Indonesia Standards

SNI 7387-2009 Maximum limits for heavy metal contamination in food

VN-TCVN

TCVN 7391-15-2007 Biological evaluation of medical devices.Part 15: Identification and quantification of degradation products from metals and alloys
TCVN 7391-17-2007 Biological evaluation of medical devices.Part 17: Establishment of allowable limits for teachable substances
TCVN 7209-2002 Soil quality.Maximum allowable limits of heavy metals in the soil

VDE - VDE Verlag GmbH@ Berlin@ Germany

VDE 0750-241-1/A1-2019 Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62A/1288/CDV:2018); German and English version EN 62366-1:2015/prA1:2018

American Society for Testing and Materials (ASTM)

ASTM F2401-16 Standard Practice for Security Checkpoint Metal Detector Screening of Persons with Medical Devices
ASTM E3418-23 Standard Practice for Calculating Scientifically Justifiable Limits of Residues for Cleaning of Pharmaceutical and Medical Device Manufacturing Equipment and for Medical Devices
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

BR-ABNT

ABNT NBR 12188-2012 Centralized supply of medical gases, gases for medical devices and vacuum for use in health care services

IT-UNI

UNI EN ISO 10993-18:2021 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process

Others: The limit of heavy metal elements in dye products and,"Limit and Determination of 12 Heavy Metal Elements in Dye Products",Limits of heavy metals in food,Limits and limits of 10 heavy metal elements in dye products,Limits of Heavy Metals in Food Additives