epin suzhou ltd

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

TL-700 EPIN SUZHOU LTD. of 20

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


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)]


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


(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


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


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


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))


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


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


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


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


(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


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


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


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


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


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


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


USP: United States Pharmacopeia

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