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2. Other English version GB Standards are not ready translated, only after get your order, then we translate them, time usually need 3-5 days . |
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GB/T 16886.9-2022 Biological evaluation of medical devices - Part 9: Qualitative and quantitative framework for potential degradation products - 英文版 |
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GB/Z 16886.22-2022 Biological Evaluation of Medical Devices Part 22: Guidelines for Nanomaterials - 英文版 |
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GB/Z 42217-2022 Medical devices for the validation of medical device quality system software - 英文版 |
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GB/T 19702-2021 In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Requirements for content and presentation of reference measurement procedures - 英文版 |
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GB/T 16886.16-2021 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables - 英文版 |
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GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity - 英文版 |
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GB 9706.245-2020 Medical electrical equipment—Part 2-45: Particular requirements for the basic safety and essential performance of mammographie X-ray equipment and mammographie stereotactic devices - 英文版 |
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GB/T 19703-2020 In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Requirements for certified reference materials and the content of supporting documentation - 英文版 |
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GB/T 16886.3-2019 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity - 英文版 |
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GB/T 19974-2018 Sterilization of health care products—General requirement for characterization of a sterilization agent and the development,validation and routine control of a sterilization process for medical devices - 英文版 |
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GB/T 19973.2-2018 Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition，validation and maintenance of a sterilization process - 英文版 |
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GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization - 英文版 |
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GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity - 英文版 |
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GB/T 16886.9-2017 Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation products - 英文版 |
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GB 18280.1-2015 Sterilization of health care products—Radiation—Part 1：Requirements for development，validation and routine control of a sterilization process for medical devices - 英文版 |
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GB 16174.2-2015 Implants for surgery—Active implantable medical devices—Part 2: Cardiac pacemakers - 英文版 |
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GB 16174.1-2015 Implants for surgery—Active implantable medical devices—Part 1: General requirements for safety, marking and for information to be provided by the manufacturer - 英文版 |
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GB/T 16886.6-2015 Biological evaluation of medical devices—Part 6: Tests for local effects after implantation - 英文版 |
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GB/T 18457-2015 Stainless steel needle tubing for the manufacture of medical devices - 英文版 |
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GB/T 16886.20-2015 Biological evaluation of medical devices—Part 20: Principles and methods for immunotoxicology testing of medical devices - 英文版 |
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GB 18279.1-2015 Sterilization of health care products—Ethylene oxide—Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices - 英文版 |
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GB 18278.1-2015 Sterilization of health care products—Moist heat—Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices - 英文版 |
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GB/T 19633.2-2015 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes - 英文版 |
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GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems - 英文版 |
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GB/T 16886.16-2013 Biological evaluation of medical devices―Part 16: Toxicokinetic study design for degradation products and leachables - 英文版 |
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GB/T 29791.5-2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for selftesting - 英文版 |
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GB/T 29791.4-2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for selftesting - 英文版 |
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GB/T 29791.3-2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use - 英文版 |
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GB/T 29791.2-2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use - 英文版 |
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GB/T 29791.1-2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements - 英文版 |
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