Which markets recognize, harmonize or adopt each standard, and which edition they accept. Last verified 2026-10-04.
Standards
113
16 topics
Market listings
129
recognition rows
Testing requirements
98
in the pathway pages
Markets
3
with standards listed
A regulator can publish a list of standards it accepts as a way to show that a device or medicine meets the rules. In the United States this is called recognition. In the European Union the equivalent is a harmonized standard, which gives a presumption of conformity. Some markets adopt an international standard as a national standard, with a national code. This page shows each of these statuses by market.
International standards are revised from time to time. Each market decides when a new edition is accepted and may allow a transition period, so two markets can accept different editions of the same standard.
biocompatibility, bench and performance testing, electrical safety, electromagnetic compatibility, software, cybersecurity, usability and human factors, sterilization, packaging and shelf life, risk management, clinical investigation, diagnostic performance (ivd), quality system, local testing, labeling, other.
No. ISO, IEC, ASTM and pharmacopoeia texts are sold by the issuing bodies. This page gives the code, title, edition and a short scope note in our own words, and what each market says about the standard.
| Standard | US | EU | CN |
|---|---|---|---|
| EN 455-3Medical gloves for single use - Part 3: Requirements and testing for biological evaluationCEN · Regional standard · Medical devices | - | Harmonized | - |
| GB/T 16886.1-20222022Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management processChina national standard · National standard · Medical devices | - | - | - |
| GB/T 16886.4-20222022Biological evaluation of medical devices - Part 4: Selection of tests for interactions with bloodChina national standard · National standard · Medical devices | - | - | - |
| GB/T 16886.5-20172017Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicityChina national standard · National standard · Medical devices | - | - | - |
| GB/T 16886.7-20152015Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residualsChina national standard · National standard · Medical devices | - | - | - |
| GB/T 16886.10-20172017Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitizationChina national standard · National standard · Medical devices | - | - | - |
| GB/T 16886.11-20212021Biological evaluation of medical devices - Part 11: Tests for systemic toxicityChina national standard · National standard · Medical devices | - | - | - |
| GB/T 16886.12-20172017Biological evaluation of medical devices - Part 12: Sample preparation and reference materialsChina national standard · National standard · Medical devices | - | - | - |
| GB/T 16886.18-20222022Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management processChina national standard · National standard · Medical devices | - | - | - |
| ISO 10993-1Sixth edition 2025-11 (the fifth edition is 2018)Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management processISO · International standard · Medical devices | Recognized | Harmonized | GB/T 16886.1 |
| ISO 10993-4Third edition 2017-04 with Amendment 1 (2025)Biological evaluation of medical devices - Part 4: Selection of tests for interactions with bloodISO · International standard · Medical devices | Recognized | Harmonized | GB/T 16886.4 |
| ISO 10993-5Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicityISO · International standard · Medical devices | Recognized | Harmonized | GB/T 16886.5 |
| ISO 10993-9Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation productsISO · International standard · Medical devices | - | Harmonized | - |
| ISO 10993-10Fourth edition 2021-11Biological evaluation of medical devices - Part 10: Tests for skin sensitizationISO · International standard · Medical devices | Recognized | Harmonized | GB/T 16886.10 |
| ISO 10993-11Third edition 2017-09Biological evaluation of medical devices - Part 11: Tests for systemic toxicityISO · International standard · Medical devices | Recognized | - | GB/T 16886.11 |
| ISO 10993-12Fifth edition 2021-01 including Amendment 1 (2025)Biological evaluation of medical devices - Part 12: Sample preparation and reference materialsISO · International standard · Medical devices | Recognized | Harmonized | GB/T 16886.12 |
| ISO 10993-15Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloysISO · International standard · Medical devices | - | Harmonized | - |
| ISO 10993-17Second edition 2023-09Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituentsISO · International standard · Medical devices | Recognized | Harmonized | - |
| ISO 10993-18Second edition 2020-01 with Amendment 1 (2022)Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management processISO · International standard · Medical devices | Recognized | Harmonized | GB/T 16886.18 |
| ISO 10993-23First edition 2021-01Biological evaluation of medical devices - Part 23: Tests for irritationISO · International standard · Medical devices | Recognized | Harmonized | - |
| ISO 18562-1Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management processISO · International standard · Medical devices | - | Harmonized | - |
| ISO 18562-2Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matterISO · International standard · Medical devices | - | Harmonized | - |
| ISO 18562-3Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic substancesISO · International standard · Medical devices | - | Harmonized | - |
| ISO 18562-4Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensateISO · International standard · Medical devices | - | Harmonized | - |
| Standard | US | EU | CN |
|---|---|---|---|
| EN 455-1Medical gloves for single use - Part 1: Requirements and testing for freedom of holesCEN · Regional standard · Medical devices | - | Harmonized | - |
| EN 455-2Medical gloves for single use - Part 2: Requirements and testing for physical propertiesCEN · Regional standard · Medical devices | - | Harmonized | - |
| EN 1865-2Patient handling equipment used in ambulances - Part 2: Power assisted stretcherCEN · Regional standard · Medical devices | - | Harmonized | - |
| EN 1865-6Patient handling equipment used in ambulances - Part 6: Powered chairsCEN · Regional standard · Medical devices | - | Harmonized | - |
| EN 13795-1Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gownsCEN · Regional standard · Medical devices | - | Harmonized | - |
| EN 13795-2Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suitsCEN · Regional standard · Medical devices | - | Harmonized | - |
| EN 14683Medical face masks - Requirements and test methodsCEN · Regional standard · Medical devices | - | Harmonized | - |
| IEC 60118-0Electroacoustics - Hearing aids - Part 0: Measurement of the performance characteristics of hearing aidsIEC · International standard · Medical devices | - | Harmonized | - |
| ISO 1135-4Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feedISO · International standard · Medical devices | - | Harmonized | - |
| ISO 1135-5Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatusISO · International standard · Medical devices | - | Harmonized | - |
| ISO 7197Neurosurgical implants - Sterile, single-use hydrocephalus shuntsISO · International standard · Medical devices | - | Harmonized | - |
| ISO 12870Ophthalmic optics - Spectacle frames - Requirements and test methodsISO · International standard · Medical devices | - | Harmonized | - |
| ISO 14607Non-active surgical implants - Mammary implants - Specific requirementsISO · International standard · Medical devices | - | Harmonized | - |
| ISO 14630Non-active surgical implants - General requirementsISO · International standard · Medical devices | - | Harmonized | - |
| ISO 14889Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lensesISO · International standard · Medical devices | - | Harmonized | - |
| ISO 21535Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implantsISO · International standard · Medical devices | - | Harmonized | - |
| ISO 21536Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implantsISO · International standard · Medical devices | - | Harmonized | - |
| ISO 22675Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methodsISO · International standard · Medical devices | - | Harmonized | - |
| ISO 23908Sharps injury protection - Requirements and test methods for sharps protection mechanismsISO · International standard · Medical devices | - | Harmonized | - |
| ISO 80369-2Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applicationsISO · International standard · Medical devices | - | Harmonized | - |
| Standard | US | EU | CN |
|---|---|---|---|
| GB 9706.1-20202020Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceChina national standard · National standard · Medical devices | - | - | - |
| IEC 60601-1Edition 3.2 2020-08 (consolidated version)Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceIEC · International standard · Medical devices | Recognized | Harmonized | GB 9706.1 |
| IEC 60601-2-83Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipmentIEC · International standard · Medical devices | - | Harmonized | - |
| Standard | US | EU | CN |
|---|---|---|---|
| IEC 60601-1-2Edition 4.1 2020-09 (consolidated version)Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and testsIEC · International standard · Medical devices | Recognized | - | YY 9706.102 |
| IEC 61326-2-6Edition 4Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipmentIEC · International standard · Diagnostics (IVD) | Recognized | - | - |
| YY 9706.102-20212021Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and testsChina industry standard (YY) · National standard · Medical devices | - | - | Referenced |
| Standard | US | EU | CN |
|---|---|---|---|
| GB/T 25000.51-20162016Software engineering - Software product Quality Requirements and Evaluation (SQuaRE) - Quality requirements and testing instructions for commercial off-the-shelf (COTS) software productsChina national standard · National standard · Medical devices | - | - | - |
| IEC 62304Edition 1.1 2015-06 (consolidated version)Medical device software - Software life cycle processesIEC · International standard · Medical devices | Recognized | Referenced | YY/T 0664 |
| IEC 82304-1Health software - Part 1: General requirements for product safetyIEC · International standard · Medical devices | - | Referenced | - |
| YY/T 0664-20202020Medical device software - Software life cycle processesChina industry standard (YY) · National standard · Medical devices | - | - | - |
| Standard | US | EU | CN |
|---|---|---|---|
| IEC 80001-5-1Application of risk management for IT networks incorporating medical devices - Part 5-1: Security - Activities in the product life cycleIEC · International standard · Medical devices | - | Referenced | - |
| IEC 81001-5-1Edition 1.0 2021-12Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycleIEC · International standard · Medical devices | Recognized | - | - |
| ISO/IEC 27001Information security management systems - RequirementsISO · International standard · Medical devices | - | Referenced | - |
| YY/T 1843-20222022Medical electrical equipment - Basic requirements for cybersecurityChina industry standard (YY) · National standard · Medical devices | - | - | - |
| Standard | US | EU | CN |
|---|---|---|---|
| IEC 62366-1Edition 1.1 2020-06 (consolidated version)Medical devices - Part 1: Application of usability engineering to medical devicesIEC · International standard · Medical devices | Recognized | - | YY/T 1474 |
| YY/T 1474-20162016Medical devices - Application of usability engineering to medical devicesChina industry standard (YY) · National standard · Medical devices | - | - | - |
| Standard | US | EU | CN |
|---|---|---|---|
| EN 285Sterilization - Steam sterilizers - Large sterilizersCEN · Regional standard · Medical devices | - | Harmonized | - |
| EN 556-1Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devicesCEN · Regional standard · Medical devices | - | Harmonized | - |
| EN 556-2Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devicesCEN · Regional standard · Medical devices | - | Harmonized | - |
| EN 13060Sterilizers for medical purposes - Small steam sterilizers - Requirements and testingCEN · Regional standard · Medical devices | - | Harmonized | - |
| EN 14180Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testingCEN · Regional standard · Medical devices | - | Harmonized | - |
| EN 14222Stainless steel steam boilersCEN · Regional standard · Medical devices | - | Harmonized | - |
| GB 18279-20232023Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devicesChina national standard · National standard · Medical devices | - | - | - |
| ISO 10993-7Second edition 2008-10-15 with Corrigendum 1 (2009) and Amendment 1 (2020)Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residualsISO · International standard · Medical devices | Recognized | - | GB/T 16886.7 |
| ISO 11135Second edition 2014-07-15 including Amendment 1 (2018)Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devicesISO · International standard · Medical devices | Recognized | Harmonized | GB 18279 |
| ISO 11137-1Second edition 2025-04Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devicesISO · International standard · Medical devices | Recognized | Harmonized | - |
| ISO 11137-2Third edition 2013-06 including Amendment 1 (2022)Sterilization of health care products - Radiation - Part 2: Establishing the sterilization doseISO · International standard · Medical devices | Recognized | Harmonized | - |
| ISO 11737-1Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on productsISO · International standard · Medical devices | - | Harmonized | - |
| ISO 11737-2Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization processISO · International standard · Medical devices | - | Harmonized | - |
| ISO 13408-1Aseptic processing of health care products - Part 1: General requirementsISO · International standard · Medical devices | - | Harmonized | - |
| ISO 13408-6Aseptic processing of health care products - Part 6: Isolator systemsISO · International standard · Medical devices | - | Harmonized | - |
| ISO 14160Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivativesISO · International standard · Medical devices | - | Harmonized | - |
| ISO 15883-1Washer-disinfectors - Part 1: General requirements, terms and definitions and testsISO · International standard · Medical devices | - | Harmonized | - |
| ISO 15883-2Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devicesISO · International standard · Medical devices | - | Harmonized | - |
| ISO 15883-3Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containersISO · International standard · Medical devices | - | Harmonized | - |
| ISO 15883-7Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipmentISO · International standard · Medical devices | - | Harmonized | - |
| ISO 17664-1Processing 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 devicesISO · International standard · Medical devices | - | Harmonized | - |
| ISO 17664-2Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devicesISO · International standard · Medical devices | - | Harmonized | - |
| ISO 17665First edition 2024-03Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devicesISO · International standard · Medical devices | Recognized | Harmonized | - |
| ISO 25424Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devicesISO · International standard · Medical devices | - | Harmonized | - |
| Standard | US | EU | CN |
|---|---|---|---|
| ASTM F1980F1980-21Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical DevicesASTM · International standard · Medical devices | Recognized | - | - |
| GB/T 19633.1-20242024Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systemsChina national standard · National standard · Medical devices | - | - | - |
| ISO 11607-1Second edition 2019-02 including Amendment 1 (2023)Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systemsISO · International standard · Medical devices | Recognized | Harmonized | GB/T 19633.1 |
| ISO 11607-2Second edition 2019-02 including Amendment 1 (2023)Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processesISO · International standard · Medical devices | Recognized | Harmonized | - |
| Standard | US | EU | CN |
|---|---|---|---|
| GB/T 42062-20222022Medical devices - Application of risk management to medical devicesChina national standard · National standard · Medical devices | - | - | - |
| ISO 14971Third edition 2019-12Medical devices - Application of risk management to medical devicesISO · International standard · Medical devices | Recognized | Harmonized | GB/T 42062 |
| YY/T 0316-20162016Medical devices - Application of risk management to medical devicesChina industry standard (YY) · National standard · Medical devices | - | - | - |
| Standard | US | EU | CN |
|---|---|---|---|
| ISO 14155Third edition 2020-07Clinical investigation of medical devices for human subjects - Good clinical practiceISO · International standard · Medical devices | Recognized | Harmonized | - |
| Standard | US | EU | CN |
|---|---|---|---|
| CLSI EP062nd EditionEvaluation of the Linearity of Quantitative Measurement ProceduresCLSI · International standard · Diagnostics (IVD) | Recognized | - | - |
| CLSI EP073rd EditionInterference Testing in Clinical ChemistryCLSI · International standard · Diagnostics (IVD) | Recognized | - | - |
| CLSI EP09c3rd EditionMeasurement Procedure Comparison and Bias Estimation Using Patient SamplesCLSI · International standard · Diagnostics (IVD) | Recognized | - | - |
| CLSI EP123rd EditionEvaluation of Qualitative, Binary Output Examination PerformanceCLSI · International standard · Diagnostics (IVD) | Recognized | - | - |
| CLSI EP193rd EditionA Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement ProceduresCLSI · International standard · Diagnostics (IVD) | Recognized | - | - |
| CLSI EP212nd EditionEvaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement ProceduresCLSI · International standard · Diagnostics (IVD) | Recognized | - | - |
| CLSI EP252nd EditionEvaluation of Stability of In Vitro Medical Laboratory Test ReagentsCLSI · International standard · Diagnostics (IVD) | Recognized | - | - |
| CLSI EP351st EditionAssessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement ProceduresCLSI · International standard · Diagnostics (IVD) | Recognized | - | - |
| ISO 17511In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samplesISO · International standard · Diagnostics (IVD) | - | Harmonized | - |
| ISO 20916In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practiceISO · International standard · Diagnostics (IVD) | - | Harmonized | - |
| Standard | US | EU | CN |
|---|---|---|---|
| GB/T 42061-20222022Medical devices - Quality management systems - Requirements for regulatory purposesChina national standard · National standard · Medical devices | - | - | - |
| ISO 13485Third edition 2016Medical devices - Quality management systems - Requirements for regulatory purposesISO · International standard · Devices and medicines | Referenced | Harmonized | GB/T 42061 |
| YY/T 0287-20172017Medical devices - Quality management systems - Requirements for regulatory purposesChina industry standard (YY) · National standard · Medical devices | - | - | - |
| Standard | US | EU | CN |
|---|---|---|---|
| ISO/IEC 170252017General requirements for the competence of testing and calibration laboratoriesISO/IEC · International standard · Devices and medicines | Referenced | - | - |
| Standard | US | EU | CN |
|---|---|---|---|
| ISO 15223-1Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirementsISO · International standard · Medical devices | - | Harmonized | - |
| ISO 18113-1In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirementsISO · International standard · Diagnostics (IVD) | - | Harmonized | - |
| ISO 18113-2In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional useISO · International standard · Diagnostics (IVD) | - | Harmonized | - |
| ISO 18113-3In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional useISO · International standard · Diagnostics (IVD) | - | Harmonized | - |
| ISO 18113-4In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testingISO · International standard · Diagnostics (IVD) | - | Harmonized | - |
| ISO 18113-5In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testingISO · International standard · Diagnostics (IVD) | - | Harmonized | - |
| Standard | US | EU | CN |
|---|---|---|---|
| ISO/IEC 17050-1Conformity assessment - Supplier declaration of conformity - Part 1: General requirementsISO/IEC · International standard · Devices and medicines | Referenced | - | - |
Testing requirements by market are on the pathway pages, for example the United States and European Union pages. Compare two markets on the Regulatory page.
Not legal or regulatory advice. Check the current official rules before you act. Standards texts are not reproduced. Parts of the approvals data are official open data reused under open licences. Data sources.