This is to attest that
EPIN SUZHOU LTD. NO. 558 FENHU AVENUE, LILI TOWN, WUJIANG DISTRICT
SUZHOU, 215211, PEOPLE’S REPUBLIC OF CHINA
Testing Laboratory TL-700
has met the requirements of AC89, IAS Accreditation Criteria for Testing Laboratories as well as the FDA ASCA Pilot specifications and has demonstrated compliance with ISO/IEC Standard 17025:2017, General requirements for the
competence of testing and calibration laboratories. This organization is accredited to provide the services specified in the scope of accreditation.
Effective Date February 14, 2021
President
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EPIN SUZHOU LTD. www.epintek.com
Contact Name Forest Yu Contact Phone +86-85184614538 Accredited to ISO/IEC 17025:2017 FDA ASCA Pilot Program
Effective Date February 14, 2021
FDA ASCA Pilot Program Scope
Biocompatibility Testing of Medical Devices ASTM F720 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig
Maximization Test Test Method: Guinea Pig Maximization Sensitization SOP: EPIN-SOP-AM-045
ASTM F756 Standard Practice for Assessment of Hemolytic Properties of Materials Test Method: Direct and Indirect Hemolysis SOP: EPIN-SOP-BT-002
ISO 10993-4 Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood Test Method:
a) Complement Activation SOP: EPIN-SOP-BT-003
b) Direct and Indirect Hemolysis, in conjunction with ASTM F756-17 SOP: EPIN-SOP-BT-002
ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity Test Method: MEM Elution Cytotoxicity (Qualitative evaluation per Table 1 in subclause 8.5.1 of ISO 10993-5:2009). SOP: EPIN-SOP-CT-006
ISO 10993-10 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization Test Methods:
a) Guinea Pig Maximization Sensitization, in conjunction with ASTM F720-17 SOP: EPIN-SOP-AM-001
b) Dermal Irritation SOP: EPIN-SOP-AM-003
c) Intracutaneous Reactivity Irritation SOP: EPIN-SOP-AM-004
d) Closed Patch Sensitization SOP: EPIN-SOP-AM-002
ISO 10993-11 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity Test Methods:
a) Acute Systemic Toxicity SOP: EPIN-SOP-AM-010
b) Material-Mediated Pyrogenicity, in conjunction with USP <151> SOP: EPIN-SOP-AM-012
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ISO 10993-12 Biological evaluation of medical devices – Part 12: Sample preparation and reference materials (Exception: Clause 10.3.10, Annex D) Test Method: Sample preparation for all test types SOP: EPIN-SOP-SM-002
USP <151> Pyrogen Test (USP Rabbit Test) (Exceptions:
- Last sentence of first paragraph "A validated, equivalent in vitro pyrogen or bacterial endotoxin test may be used in place of the in vivo rabbit pyrogen test, where appropriate."
- Section "Radioactive Pharmaceuticals.") Test Method: Material-Mediated Pyrogenicity SOP: EPIN-SOP-AM-012
Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems and Laboratory Medical Equipment ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text)
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
ANSI/AAMI HA60601-1-11:2015
Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD)
IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-2-2 Edition 6.0 2017-03
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
IEC 60601-2-10 Edition 2.1 2016-04
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
IEC 60601-2-16 Edition 5.0 2018-4
Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemonfiltration equipment
IEC 60601-2-18 Edition 3.0 2009-08
Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
IEC 60601-2-19 Edition 2.1 2016-04
CONSOLIDATED VERSION Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
IEC 60601-2-20 Edition 2.1 2016-04
CONSOLIDATED VERSION Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators [Including: Amendment 1 (2016)]
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IEC 60601-2-21 Edition 2.1 2016-04
CONSOLIDATED VERSION Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers [Including: Amendment 1 (2016)]
IEC 60601-2-22 Edition 3.1 2012-10
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60601-2-50 Edition 3.0 2020-09
Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
IEC 60601-2-52 Edition 1.0 2009-12
Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds [Including: Technical Corrigendum 1 (2010)]
IEC 60601-2-57 Edition 1.0 2011-01
Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
IEC 61010-1 Edition 3.1 2017-01
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
IEC 80601-2-60 Edition 2.0 2019-06
Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
Regular Scope Electrical
AAMI ST81 Sterilization of medical device – information to be provided by the manufacturer for the processing of resterilizable medical device
AAMI ST98 Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices.
AAMI TIR12 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
AAMI TIR30 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
AAMI TIR42 Evaluation of particulates associated with vascular medical devices
ANSI/AAMI 60601-2-25 Medical electrical equipment - part 2-25: particular requirements for the basic safety and essential performance of electrocardiographs (exclusions: section 201.8.5.5.1 (defibrillation protection), section .201.17.202 (electromagnetic compatibility of ME equipment and ME systems))
ANSI/AAMI 60601-2-27 Medical electrical equipment - part 2-27: particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (exclusions: section 201.8.5.5 (defibrillation-proof applied parts), section 201.11.6.5 (IP testing), section 201.17.202 (electromagnetic compatibility of ME equipment and ME systems))
ANSI/AAMI ES60601-1 Medical electrical equipment - part 1: general requirements for basic safety and essential performance (exclusions: section 8.5.5 (defibrillation applied parts), section 8.8.4.2 (ageing rubber in oxygen), section 8.9.1.7 (CTI test), section 9.5.2 (cathode ray tubes), section 9.6.3 (hand-transmitted vibration), section 9.7.5 (pressure vessels), section 10.3 (microwave radiation), section 11.2.2
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(ME equipment and ME systems used in conjunction with oxygen rich environment), section 11.6.5 (IP test), section 15.4.2 (PTC’s), section 15.4.3.4 (performance tests of primary and secondary battery), section annex a.10.4 (LEDs), section annex G (protection against hazards of ignition of flammable anesthetic mixtures))
ANSI/AAMI HA60601-1-11 Medical electrical equipment - part 1-11: collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (exclusions: section 8.3.1/8.3.2 (IP test), section 10.1.2/10.1.3 (shock test; broad-band random vibration test; free fall test), section 12.1 (class B according to CISPR 11:2009), section 12.5 (ESD testing)
ASTM D882 Standard Test Method for Tensile Properties of Thin Plastic Sheeting
ASTM D3078 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
ASTM E1766 Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices
ASTM E1837 Determine Efficacy of Disinfection Processes for Reusable Medical Devices (Simulated Use Test)
ASTM E2314 Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)
ASTM F88/88M Standard Test Method for Seal Strength of Flexible Barrier Materials
ASTM F719 Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation
ASTM F749 Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
ASTM F756 Standard Practice for Assessment of Hemolytic Properties of Materials
ASTM F813 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
ASTM F895 Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
ASTM F1140/F1140M Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
ASTM F1886/F1886M Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
ASTM F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM F2147 Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
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ASTM F2382 Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT)
ASTM F2888 Standard Practice for Platelet Leukocyte Count—An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials
ASTM F3127 Validating Cleaning Processes Used During the Manufacture of Medical Devices
ASTM F3208 Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
ASTM F3293 Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
BP Appendix XIV C Test for Bacterial Endotoxins (LAL Test)
BP Appendix XIV D Test for Pyrogens
CEN ISO/TS 15883-5 Washer disinfectors —Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy
CP Part IV<0903> Insoluble Particles Test
CP Part IV <1101> Sterility Test
CP Part IV <1105> Microbiological Methods-Part 1:Determination of a Population of Microbial Enumeration Tests
CP Part IV <1106> Microbiological Examination of Nonsterile Products: Control Bacteria Inspection Method
CP Part IV <1107> Microbial Limits of Non-sterile Drugs
CP Part IV <1141> Abnormal Toxicity Test
CP Part IV <1142> Pyrogen Test
CP Part IV <1143> Bacterial Endotoxins Test
CP Part IV <1147> Allergic Test
DIN EN 13697 Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the evaluation of bactericidal and/ or fungicial activity of chemical disinfectants used in food, industrial, domestic and institutional - Test method and requirements without mechanical action (phase2, step 1)
DIN 58953-6 Sterilization - Sterile Supply - Part 6: Microbial Barrier Testing of Packaging Materials for Medical Devices Which Are to Be Sterilized
EN 285 Sterilization — Steam sterilizers — Large sterilizers
EN 455-3 Endotoxin test
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EN 868-5 Packaging for terminally sterilized medical devices— Part 5: Sealable pouches and reels of porous materials and plastic film construction – Requirements and test methods
EN 1422 Sterilizers for medical purposes — Ethylene oxide sterilizers— Requirements and test methods
EN 12184 Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods
EN 13060 Small steam sterilizers
EN 13544-1 Respiratory therapy equipment - Part 1: Nebulizing systems and their components
EN 13624 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase2, step 1)
EN 13697 Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the evaluation of bactericidal and/ or fungicial activity of chemical disinfectants used in food, industrial, domestic and institutional - Test method and requirements without mechanical action (phase2, step 1)
EN 13727 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase2, step 1)
EN 14683 Medical face masks – Requirements and test methods
EN 14885 Chemical disinfectants and antiseptics – Application of European standards for chemical disinfectants and antiseptics
EN 50563 External a.c – d.c. and a.c. power supplies – determination of no-load power and average efficiency of active modes
EN 80601-2-13 Medical electrical equipment – part 2-13: particular requirements for basic safety and essential performance of an anesthetic workstation (exclusions: section 201.4.10.101 (pneumatic power input), section 201.11.8.102 (sound measurement according requirements of IEC 60601-1-8:2006 clauses 6.3.3.1 and 6.3.3.2), section 201.12.4.103 (respiratory gas monitoring equipment), section201.12.4.104.1 (exhaled volume monitoring equipment accuracy), section 202 (electromagnetic compatibility), section 203 (radiation protection in diagnostic x-ray equipment), section annex BB (test for flammability of anesthetic agent)
EN ISO 7405 Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
EN ISO 7491 Dental material-Determination of colour stability
EN ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
EN ISO 10993-2 Biological evaluation of medical devices – Part 2: Animal welfare requirements
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EN ISO 10993-3/10993-12 Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
EN ISO 10993-4/10993-12 Biological evaluation of medical devices – part 4: selection of tests for interactions with blood
EN ISO 10993-5/10993-12 Biological evaluation of medical devices – part 5: tests for in vitro cytotoxicity
EN ISO 10993-6/10993-12 Biological evaluation of medical devices – part 6: tests for local effects after implantation
EN ISO 10993-10/10993-12
Biological evaluation of medical devices – part 10: tests for irritation and skin sensitization
EN ISO 10993-11/10993-12
Biological evaluation of medical devices – part 11: tests for systemic toxicity
EN ISO 11607-1 Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems
EN ISO 11737-1 Sterilization of health care products —Microbiological methods — Part 1: Determination of a population of microorganisms on products
EN ISO 11737-2 Sterilization of health care products—Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
EN ISO 15883-1 Washer-disinfectors — Part 1: General requirements, terms and definitions and tests
EN ISO 15883-2 Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
EN ISO 17664 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices
EN ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
EN ISO 25424 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
EN/ISO 80601-2-61 Medical electrical equipment – part 2-61: particular requirements for basic safety and essential performance of pulse oximeter equipment (exclusions: section 201.10 (protection against unwanted and excessive radiation hazards – test per IEC 62471:2006 and IEC 60825-2:2004+A1:2006), section 201.11.6.5 (ingress of water or particulate matter into ME equipment and ME systems), section 201.15.3.5.101 (additional requirements for rough handling), section 201.17 (electromagnetic compatibility of ME equipment and ME systems) section 202 (electromagnetic compatibility- requirements and tests))
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FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
GB 4793.1 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1: General requirements
GB 4793.9 Safety requirements for electrical equipment for measurement, control, and laboratory use –Part 9: Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes
GB 9706.1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GB 9706.4 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
GB 9706.19 Medical electrical equipment- Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
GB 18278.1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
GB 19335 Blood flow products for single use-General specification
GB 50073 Code for design of clean room
GB 50591 Code for construction and acceptance of cleanroom
GB/T 14233.2 Test methods for infusion, transfusion, injection equipment for medical use—Part 2: Biological test methods
GB/T 15171 Test methods for leaks in sealed flexible packages
GB/T 16292 Test method for airborne particles in clean room(zone) of the pharmaceutical industry
GB/T 16293 Test method for airborne microbe in clean room(zone) of the pharmaceutical industry
GB/T 16294 Test method for settling microbe in clean room(zone) of the pharmaceutical industry
GB/T 16886.1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
GB/T 16886.2 Biological evaluation of medical devices – Part 2: Animal welfare requirements
GB/T 16886.3/16886.12 Biological evaluation of medical devices – part 3: tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.4/16886.12 Biological evaluation of medical devices – part 4: selection of tests for interactions with blood
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GB/T 16886.5/16886.12 Biological evaluation of medical devices – part 5: tests for in vitro cytotoxicity
GB/T 16886.6/16886.12 Biological evaluation of medical devices – part 6: tests for local effects after implantation
GB/T 16886.10/16886.12 Biological evaluation of medical devices – part 10: tests for irritation and skin sensitization
GB/T 16886.11/16886.12 Biological evaluation of medical devices – part 11: tests for systemic toxicity
GB/T 19633.1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
GB/T 19633.2 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
GB/T 19973.1 Sterilization of medical devices —Microbiological methods — Part 1: Determination of a population of microorganisms on products
GB/T 19973.2 Sterilization of medical devices —Microbiological methods – Part 2: Tests of sterility performed in the validation of a sterilization process
IEC/EN 60204-1 Safety of machinery —electrical equipment of machines —part 1: general requirements (exclusions: section 18.2.2 (test methods in TN-systems - test 2 – fault loop impedance test)
IEC/EN 60601-1 Medical electrical equipment - part 1: general requirements for basic safety and essential performance (exclusions: section 8.5.5 (defibrillation applied parts), section 8.8.4.2 (ageing rubber in oxygen), section 8.9.1.7 (CTI Test), section 9.5.2 (cathode ray tubes), section 9.6.3 (hand-transmitted vibration), section 9.7.5 (pressure vessels), section 10.3 (microwave radiation), section 11.2.2 (ME equipment and ME systems used in conjunction with oxygen rich environment), section 11.6.5 (IP test), section 15.4.2 (PTC’s), section 15.4.3.4 (performance tests of primary and secondary battery), section annex A.10.4 (LEDs), section annex G (protection against hazards of ignition of flammable anesthetic mixtures))
IEC/EN 60601-1(EQV) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC/EN 60601-1-3 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC/EN 60601-1-6 Medical electrical equipment - part 1-6: collateral standard: usability
IEC/EN 60601-1-8 Medical electrical equipment - part 1-8: collateral standard: general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC/EN 60601-1-9 Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance- Collateral Standard: Requirements for environmentally conscious design
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IEC/EN 60601-1-11 Medical electrical equipment - part 1-11: collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (exclusions: section 8.3.1/8.3.2 (IP test), section 10.1.2/10.1.3 (shock test; broad-band random vibration test; free fall test), section 12.1 (class B according to CISPR 11:2009), section 12.5 (ESD testing))
IEC/EN 60601-2-2 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
IEC/EN 60601-2-2(EQV) Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
IEC/EN 60601-2-3 Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment
IEC/EN 60601-2-10 Medical electrical equipment - part 2-10: particular requirements for the basic safety and essential performance of nerve and muscle stimulators (exclusions: section 201.17 (electromagnetic compatibility of ME equipment and ME systems), section 202 (electromagnetic compatibility – requirements and tests))
IEC/EN 60601-2-16 Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemodiafiltration equipment
IEC/EN 60601-2-18 MEDICAL electrical equipment – part 2-18: particular requirements for the basic safety and essential performance of endoscopic equipment (exclusions: section 201.11.6.5 (ingress of water or particulate matter into ME equipment and ME systems), section 201.17 (electromagnetic compatibility of ME equipment and ME systems), section 202 (electromagnetic compatibility – requirements and tests)
IEC/EN 60601-2-18(EQV) Medical electrical equipment- Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
IEC/EN 60601-2-19 Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
IEC/EN 60601-2-20 Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
IEC/EN 60601-2-21 Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
IEC/EN 60601-2-22 Medical electrical equipment - part 2-22: particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC/EN 60601-2-24 Medical electrical equipment - part 2-24: particular requirements for the basic safety and essential performance of infusion pumps and controllers (exclusions: section 201.11.6.3/201.11.6.5 (IP testing), section 201.12.1 (accuracy of controls and instruments), section 201.12.4.4.104 (protection against
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unintended BOLUS volumes and by occlusion), section 201.17.202 (electromagnetic compatibility of ME equipment and ME systems))
IEC 60601-2-25 Medical electrical equipment - part 2-25: particular requirements for the basic safety and essential performance of electrocardiographs (exclusions: section 201.8.5.5.1 (defibrillation protection), section .201.17.202 (electromagnetic compatibility of ME equipment and ME systems))
IEC/EN 60601-2-27 Medical electrical equipment - part 2-27: particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (exclusions: section 201.8.5.5 (defibrillation-proof applied parts), section 201.11.6.5 (IP testing), section 201.17.202 (electromagnetic compatibility of me equipment and me systems))
IEC/EN 80601-2-30 Medical electrical equipment - part 2-30: particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers (exclusions: section 201.11.6.5 (ingress of water or particulate matter into ME equipment and ME systems), section 201.15.2.5.102 (shock and vibration for other than transport), section 201.15.2.5.102 (shock and vibration for transport), section 201.17 (electromagnetic compatibility of ME equipment and ME systems),section 202 (electromagnetic compatibility- requirements and tests))
IEC/EN 60601-2-37 Medical electrical equipment —Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
IEC/EN 60601-2-41 Medical electrical equipment - part 2-41: particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis (exclusions: section 201.17 (electromagnetic compatibility of ME equipment and ME systems))
IEC/EN 60601-2-41(EQV) Medical electrical equipment - Part 2-41: Particular requirements for the safety of surgical luminaries and luminaries for diagnosis
IEC/EN 60601-2-43 Medical electrical equipment – Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
IEC/EN 60601-2-44 Medical electrical equipment – Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
IEC/EN 60601-2-46 Medical electrical equipment - part 2-46: particular requirements for the basic safety and essential performance of operating tables (exclusions: section 201.11.6.5 (ingress of water or particulate matter into ME equipment and ME systems), section 201.17 (electromagnetic compatibility of ME equipment and ME systems) section 202 ((electromagnetic compatibility- requirements and tests))
IEC/EN 60601-2-50 Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
IEC/EN 60601-2-52 Medical electrical equipment –part 2-52: particular requirements for basic safety and essential performance of medical beds (exclusions: section 201.11.6.5
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(ingress of water or particulate matter into ME equipment and ME systems), section 201.17 (electromagnetic compatibility of ME equipment and ME systems) section 202 ((electromagnetic compatibility- requirements and tests))
IEC/EN 60601-2-54 Medical electrical equipment – Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
IEC/EN 60601-2-57 Medical electrical equipment – Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use (exclusions: tests per IEC 62471)
IEC/EN 60601-2-63 Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
IEC/EN 60601-2-65 Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
IEC/EN 60601-2-66 Medical electrical equipment – part 2-66: particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems (exclusions: section 201.11.6.5 (IP testing according), section 201.17 (electromagnetic compatibility of ME equipment and ME systems))
IEC/EN 60825-1 Safety of laser products - part 1: equipment classification and requirements
IEC/EN 60950-1 Information technology equipment – safety – part 1: general requirements (exclusions: section 2.3.5 (test for operating voltages generated externally), section 2.10.4 (test for tracking index), section 2.10.5.4 (partial discharge testing), section 2.10.9 & 2.10.10 & 2.10.11 and 2.10.8.2 (thermal cycling and thermal ageing), section 2.10.8.4 (abrasion resistance test), section 3.2.5.1 (power supply cord test), section 4.2.8 (cathode ray tube), section 4.3.12 (flammable liquids), section 4.3.13.2 (ionizing radiation), section 4.3.13.3 (effect UV radiation on materials), section 4.3.13.4 (human exposure to UV radiation), section 4.3.13.5.1/ 4.3.13.5.2 (LEDs), section 4.6.2 (distillate fuel oil as described in annex A.3.2), section 4.7.3 (material flammability test), section 4.7.3.6 (materials used in high-voltage components), section 6.2.2.1/7.4.3 (impulse test), section 7.4.2 (voltage surge test), section annex Q (component flammability), section annex AA (mandrel test), section annex CC (evaluation of IC current limiters))
IEC/EN 61010-1 Safety requirements for electrical equipment for measurement, control, and laboratory use – part 1: general requirements (exclusions: section 6.7.1.3 (CTI test), section 9.3.1/14.7 (flammability test), section 10.5.3 (vicat test), section 11.6 (IP testing), section 11.7 (fluid pressure & leakage), section 12.3 (UV radiation), section 12.4 (microwave radiation), section 12.5.2 (ultrasonic pressure), section 13.2.3 (high vacuum devices))
IEC/EN 61010-1(EQV) Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1: General requirements
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IEC/EN 61010-2-010 Safety requirements for electrical equipment for measurement, control and laboratory use – part 2-010: particular requirements for laboratory equipment for the heating of materials
IEC/EN 61010-2-040 Safety requirements for electrical equipment for measurement, control and laboratory use – part 2-040: particular requirements for sterilizers and washer-disinfectors used to treat medical materials
IEC/EN 61010-2-081 Safety requirements for electrical equipment for measurement, control and laboratory use – part 2-081: particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes
IEC/EN 61010-2-081(EQV)
Safety requirements for electrical equipment for measurement, control, and laboratory use –Part 9: Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes
IEC/EN 61010-2-091 Safety requirements for electrical equipment for measurement, control and laboratory use- Part 2-091: Particular requirements for cabinet X-ray systems
IEC/EN 61010-2-101 Safety requirements for electrical equipment for measurement, control, and laboratory use – part 2-101: particular requirements for in vitro diagnostic (IVD)
IEC/EN 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices
IEC/EN 62368-1 Audio/video, information and communication technology equipment – part 1: safety requirements (exclusions: section 5.4.1.11 (vicat test), section 5.4.2, 5.4.3, 5.4.4 (impulse test generator circuit 1 and circuit 3 of table D.1), section 5.4.5.1 (antenna terminal insulation), section 5.4.7 (thermal cycling test), section .8.5.5.2.2 (high pressure lamps), section 8.6.3.1(glass slide test), section 8.12 (telescoping or rod antennas), section 10 (radiations), section annex E (test conditions for equipment contain audit amplifiers), section annex G.9 (power supply cord tests), section annex G.13 (IC current limiters), section annex G.14 (test for resistor serving as safeguard), section annex G.18.6. (abrasion resistance test), section annex G.21 (liquid filled components), section annex M.6.1.2 (test to simulate internal faults nail piercing test), section annex M.8 (spark test), section annex S (tests for resistance to heat and fire), section annex U (mechanical strength of CRTs and protection against the effects of implosion))
IEC/EN 80601-2-60 Medical electrical equipment – part 2-60: particular requirements for the basic safety and essential performance of dental equipment (exclusions: section 201.8.10.4.101 (HF surgical equipment that is incorporated in the dental equipment), section 201.10.4 (LEDs), section 201.17 (electromagnetic compatibility of ME equipment and ME systems))
ISO 1924-2 Paper and board -- Determination of tensile properties -- Part 2: Constant rate of elongation method (20 mm/min)
ISO 7176-1 Wheelchairs -- Part 1: Determination of static stability
ISO 7176-2 Wheelchairs -- Part 2: Determination of dynamic stability of electrically powered wheelchairs
ISO 7176-3 Wheelchairs -- Part 3: Determination of effectiveness of brakes
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ISO 7176-4 Wheelchairs -- Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
ISO 7176-6 Wheelchairs -- Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
ISO 7176-8 Wheelchairs -- Part 8: Requirements and test methods for static, impact and fatigue strengths
ISO 7176-10 Wheelchairs -- Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
ISO 7176-13 Wheelchairs -- Part 13: Determination of coefficient of friction of test surfaces
ISO 7176-14 Wheelchairs -- Part 14: Power and control systems for electrically powered wheelchairs and scooters -- Requirements and test methods
ISO 7176-15 Wheelchairs -- Part 15: Requirements for information disclosure, documentation and labeling
ISO 7176-19 Wheelchairs -- Part 19: Wheeled mobility devices for use as seats in motor vehicles
ISO 7176-22 Wheelchairs -- Part 22: Set-up procedures
ISO 7405 Dentistry — Evaluation of biocompatibility of medical devices
ISO 7491 Dental material-Determination of colour stability
ISO 7494-1 Dentistry -- Dental units -- Part 1: General requirements and test methods
ISO 7494-2 Dentistry -- Dental units -- Part 2: Air, water, suction and wastewater systems
ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
ISO 10993-2 Biological evaluation of medical devices – Part 2: Animal welfare requirements
ISO 10993-3/10993-12 Biological evaluation of medical devices – part 3: tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-4/10993-12 Biological evaluation of medical devices – part 4: selection of tests for interactions with blood
ISO 10993-5/10993-12 Biological evaluation of medical devices – part 5: tests for in vitro cytotoxicity
ISO 10993-6/10993-12 Biological evaluation of medical devices – part 6: tests for local effects after implantation
ISO 10993-10/10993-12 Biological evaluation of medical devices – part 10: tests for irritation and skin sensitization
ISO 10993-11/10993-12 Biological evaluation of medical devices – part 11: tests for systemic toxicity
ISO 11607-1 Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier
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ISO 11737-1 Sterilization of medical devices —microbiological methods — part 1: determination of a population of microorganisms on products
ISO 11737-2 Sterilization of medical devices – microbiological methods – part 2: tests of sterility-performed in the definition, validation and maintenance of a sterilization process
ISO 14644-1 Cleanrooms and associated controlled environments -- Part 1: Classification of air cleanliness by particle concentration
ISO 14644-2 Cleanrooms and associated controlled environments -- Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
ISO 15883-1 Washer-disinfectors — Part 1: General requirements, terms and definitions and tests
ISO 15883-2 Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
ISO 17664 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices
ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 25424 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 80601-2-13 Medical electrical equipment – part 2-13: particular requirements for basic safety and essential performance of an anesthetic workstation (exclusions: section 201.4.10.101 (pneumatic power input), section 201.12.4.103 (respiratory gas monitoring equipment), section 201.12.4.104.1 (exhaled volume monitoring equipment accuracy), section 202 (electromagnetic compatibility), section 203 (radiation protection in diagnostic x-ray equipment), section annex BB (test for flammability of anesthetic agent))
ISO /TR 10993-33 Biological evaluation of medical devices – part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3
ISO/TS 15883-5 Washer disinfectors —Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy
OECD 452 Chronic Toxicity Studies
OECD 471 AMES test
OECD 473 In vitro Mannalian chronicmosame Aberration Test
OECD 474 Mammalian Erythocyte Micronucleus Test
OECD 476 In Vitro Mammalian Cell Gene Mutation Test
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OECD 490 In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene
Ph. Eur. Method 2.6.1 Test for Sterility
Ph. Eur. Method 2.6.8 Test for Pyrogens
Ph. Eur. Method 2.6.14 Test for Bacterial Endotoxins (LAL Test)
T/CAMDI 009 Sterile Medical Device Package - Part 1: Test methods for particulate matter
UL 61010-1 Safety requirements for electrical equipment for measurement, control, and laboratory use – part 1: general requirements (exclusions: section DVD.4 (conduit enclosure entry tests))
USP <51> Antimicrobal effectiveness testing
USP <61> Microbal enumeration
USP <71> Sterility test
USP <85> Endotoxin test
USP <87> Biological Reactivity Tests, in vitro
USP <88> Biological Reactivity Tests, in vivo
USP<151> Pyrogen Test
USP <788> Particulate Matter in Injections. Method 1: Light obscuration particle count test.
USP <1113> Microbial Characterization, Identification, and Strain Typing
USP <1184> Biological Reactivity Tests, In Vivo
WS 310.1 Central sterile supply department (CSSD)-Part 1: Management standard
WS 310.2 Central sterile supply department (CSSD)-Part 2: Standard for oprating procedure of cleaning, disinfection and sterilization
WS 310.3 Central sterile supply department (CSSD)-Part 3: Surveillance standard for cleaning, disinfection and sterilization
WS/T 367 Regulation of disinfection technique in healthcare settings
YBB 00012003 Test for Cytotoxicity
YBB 00272004 Test for Insoluble Particulate Matter of Packing Materials
YY 0033 Good manufacture practice for sterile medical devices
YY 0627 Medical electrical equipment - Part 2-41: Particular requirements for the safety of surgical luminaries and luminaries for diagnosis
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YY 0648 Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
YY 0719.4 Ophthalmic optics–Contact lens care products–Part 4: Antimicrobial preservative efficacy testing and determining discard date
YY 0719.7 Ophthalmic optics–Contact lens care products–Part 7: Biological evaluation test methods
YY/T 0127.1 Biological evaluation of medical devices used in dentistry– Part 2: Tests method–hemolytic
YY/T 0127.4 Biological evaluation of medical devices used in dentistry– Part 2: Tests method–Bone implant test
YY/T 0127.8 Biological evaluation of dental material – Part 2: Biological evaluation test method of dental materials–Subcutaneous implant test
YY/T 0127.9 Biological evaluation of medical devices used in dentistry– Part 2: Tests method–Cytotoxicity tests: Agar diffusion test and filter diffusion test
YY/T 0127.10 Biological evaluation of medical devices used in dentistry– Part 2: tests method–Salmonella typhimurium reverse mutation assay (Ames mutagenicity test)
YY/T 0127.12 Dentistry— Biological evaluation of medical devices used in dentistry– Part 2: tests method–Micronucleus test
YY/T 0127.13 Biological evaluation of medical devices used in dentistry– Part 13: Oral mucous irritation test
YY/T 0127.14 Biological evaluation of medical devices used in dentistry– Part 2: Tests method–Acute oral toxicity test
YY/T 0127.15 Biological evaluation of medical devices used in dentistry– Part 15: Subactute and aubchronic systemic toxicity test: oral route
YY/T 0127.16 Biological evaluation of medical devices used in dentistry– Part 2: Test method–In vitro mammalian chromosome aberration test
YY/T 0127.17 Biological evaluation of medical devices used in dentistry– Part 17: Mouse lymphoma cells (TK) gene mutation test
YY/T 0268 Dentistry—Biological evaluation of medical devices used in dentistry—Part 1:Evaluation and test
YY/T 0616.1 Medical gloves for single use- Part1: Requirements and testing for biological evaluation
YY/T 0681.1 Test methods for sterile medical device package—Part 1: Test guide for accelerated aging
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YY/T 0681.2 Test methods for sterile medical device package—Part 2: Seal strength of flexible battier materials
YY/T 0681.3 Test methods for sterile medical device package—Part 3: Internal pressurization failure resistance of unrestrained packages
YY/T 0681.4 Test methods for sterile medical device package—Part 4: Detecting sealleaks in porous packages by dye penetration
YY/T 0681.11 Test methods for sterile medical device package—Part 11: Determining integrity of seals for medical packaging by visual inspection
YY/T 0681.14 Test methods for sterile medical device package—Part 14: Testing the microbial barrier for porous packaging materials under moist conditions and with passage of air
YY/T 0698.5 Packaging material for terninal sterilized medical devices—Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction—Requirements and test methods
YY/T 0802 Sterilization of medical devices-Information to be provided by the manufacturer for the processing of resterilizable medical devices
YY/T 0870.1 Tests for genotoxicity of medical devices —Part 1: Bacterial reverse mutation test
YY/T 0870.2 Tests for genotoxicity of medical devices—Part 2: In vitro mammalian chromosome aberration test
YY/T 0870.3 Tests for genotoxicity of medical devices—Part 3: In vitro mammalian cell gene mutation test using mouse lymphoma cells
YY/T 0870.4 Tests for genotoxicity of medical devices—Part 4: Mammalian bone marrow erythocyte micronucleus test
YY/T 0878.3 Test for complement activation of medical devices —Parts 3:Assay for the product of complement activation(C3a and SC5b-9)
YY/T 1295 Biological evaluation of medical devices – Nanomaterial: Endotoxins test
YY/T 1495 Microbiological test method for demonstrating cleaning and disinfection efficacy
YY/T 1500 Pyogen test medical devices —Monocyte-activation test—Human whole blood ElISA Method
YY/T 1556 Test methods for particle contamination of infusion, transfusion and injection equipment for medical use
YY/T 1623 Test method of effectiveness of sterilization processes for reusable medical devices
AAMI: Association for the Advancement of Medical Instrumentation
IEC: International Electrotechnical Commission
UL: Underwriters Laboratories
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USP: United States Pharmacopeia