Medical Device Safety Evaluation and Testing



Chemical Characterization of Materials

ISO 10993-1 and GB/T16886.1 provide a framework for biological evaluation. With the development of scientific knowledge, Biological evaluation system also needs to gradually change from traditional biocompatibility tests to modern concepts based on risk assessment in China. During the risk assessment process, the assessment of chemical/physical properties and in vitro model tests are prioritized.

Chemical Characterization for Medical Device Materials

※ Qualitative of medical device manufacturing materials

※ Characterization of manufactured materials through qualitative and quantitative characterization of material chemical composition

※ Medical device characterization for chemicals introduced during manufacturing (e.g. processing aids, process contaminants, sterilization residues)

※Estimates of the potential for release of chemicals from medical devices or materials of which they are manufactured under conditions of clinical use

※Determination of chemical substances released by medical devices under their conditions of clinical use

Leachables Safety Assessment

Leachables are chemical substances released from medical devices during the continuous contact and function of medical device products with the human body, or when interacting with other media in use (such as blood, medicinal liquids, etc.). While medical devices are functioning, leachables also pose safety hazards to the human body in the short or long term. Therefore, its safety research is not only the content that enterprises need to pay attention to in the stage of product design and development, but also the focus of technical review of related products.

Medical Device Leachables Safety Evaluation

※ Material selection/process optimization evaluation

※ Toxicological Risk Assessment

※ Equivalence Assessment

※ New material screening

Biocompatibility Testing

Good biocompatibility is a prerequisite for the safe and effective clinical application of medical devices. Biological evaluation of medical devices to determine the risk level of potential toxicity and adverse biological reactions caused by device materials in contact with the human body is the basis for the overall benefit-risk assessment of medical devices. Biocompatibility test is an important part of biological evaluation, which provides a solid guarantee for biological evaluation.

Biocompatibility Test

※In vitro cytotoxicity test

※Genotoxicity test

※Sensitization test

※Blood compatibility test

※Stimulation test

※Implantation test

※Systemic toxicity test

※Pyrogen

Microbial Testing

Stricting control of microorganisms is an important quality control requirement in the R&D and production stages of medical device products (especially passive products). Most medical device products that come into contact with the human body require microbial limit testing.

Microbiological Testing

※ Microbial Limit

※ Initial contaminating bacteria testing

※ Sterility check

※ Bacterial endotoxin testing

Cleaning, Disinfection, Sterilization Validation

Reusable medical devices should be designed for user-friendly and efficient cleaning and necessary disinfection or sterilization. Manufacturers of medical devices should adequately specify information on cleaning, disinfection, or sterilization. At the same time, the manufacturer should keep the verification records of the relevant reprocessing information in the system documents according to the requirements of the Good Manufacturing Practice for Medical Devices, to prove that the reprocessing information has been verified and is easy for users to understand and operable.

Cleaning, Disinfection, Sterilization Verification

※ISO17664 - Cleaning Validation / Cleaning Validation

※ISO17665-1 - Moist Heat Sterilization Verification

※ISO17664/17665 - Disinfection Verification

※AAMI TIR12 - Design, Testing, and Labeling of Reusable Medical Device Reprocessing: A Guide for Device Manufacturers

※Hydrogen peroxide low temperature plasma sterilization validation

※Enterprise standard cleaning, disinfection or sterilization verification

 Medical Device Restricted Substance Testing

Article 67 Paragraph 1 of the EU REACH Regulation stipulates: "Substances, mixtures or articles containing restricted substances in Annex XVII shall not be placed on the market if they do not meet the restriction requirements." Restricted substance testing is an essential testing item in major industries.

Restricted Substance Testing

※RoHS Directive "Directive on Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment"

※EU REACH regulation SVHC (Substances of Very High Concern)

※EU REACH Regulation Annex XVII Restricted Substances RSL

※Polycyclic Aromatic Hydrocarbons (PAHs)

※Phthalates

※SCCPs

※ Halogen (F、Cl、Br、I)

※Asbestos

※VOCs

Medical Device Clean Room Environment and Process Water Testing

The construction, acceptance and operation of the clean production workshop shall comply with the requirements of the Quality Management Specification for Medical Device Production and the relevant standards for the construction and acceptance of the relevant clean room. At the same time, the testing of process water in the medical device production process, such as purified water and water for injection, shall comply with the requirements of the Chinese Pharmacopoeia.

Medical device clean room environmental testing

Test items

Applicable objects

Test standards

Air speed/air volume/ventilation times/pressure difference

Temperature/humidity

Number of suspended particles

Noise

Illumination

Settling bacteria / planktonic bacteria / surface microorganisms

Medical device production workshop (clean room), biological safety cabinet, clean workbench

"Code for Construction and Acceptance of Clean Room" GB50591-2019; " Test method for airborne microbe in clean room(zone) of the pharmaceutical industry" GB/T 16292-2010; " Test method for airborne microbe in clean room(zone) of the pharmaceutical industry" GB/T 16293-2010; "Test method for sedimentation bacteria in clean room (zone) of pharmaceutical industry", quality specification for medical device production, etc.

Medical Device Process Water Testing

Test items

Applicable objects

Test standards

PH value, nitrate, nitrite, ammonia, conductivity (25°C), total organic carbon, easily oxidized, non-volatile matter, heavy metal, bacterial endotoxin, microbial limit

Process water such as purified water and water for injection

"Chinese Pharmacopoeia" 2020 Edition

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