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Chinese National Standard: GB/T

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Std ID Description (Standard Title) Detail
GB/T 14233.2-2005 Test methods for infusion, transfusion, injection equipment for medical use -- Part 2: Biological test methods GB/T 14233.2-2005
GB/T 18458.3-2005 Part 3 of the switch to infusion: a one-time use dark infusion GB/T 18458.3-2005
GB/T 1962.1-2001 Conical fittings with a 6% (Luer) taper for syringes needles and certain other medical equipment -- Part 1: General requirement GB/T 1962.1-2001
GB/T 1962.2-2001 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment -- Part 2: Lock fittings GB/T 1962.2-2001
GB/T 14233.1-1998 Infusion, transfusion, injection equipment for medical use--Part 1: Chemical analysis methods GB/T 14233.1-1998
GB/T 10160-1995 Test methods of locking force and opening force for medical use forceps GB/T 10160-1995
GB/T 14233.1-1993 Infusion, transfusion, injection equipment for medical use--Part 1: Chemical analysis methods GB/T 14233.1-1993
GB/T 14233.2-1993 Test methods for infusion, transfusion, injection equipment for medical use. Part 2: Biological test methods GB/T 14233.2-1993
GB/T 12256-1990 Test method for stiffness of hypodermic needle tubing GB/T 12256-1990
GB/T 10162-1988 Method of determination for pulling force of clamping of medical forceps GB/T 10162-1988
GB/T 4506-1984 Method for the test of sharpness and strength of needles tips GB/T 4506-1984
GB/T 17827-1999 Guidelines for radiotherapy treatment rooms design GB/T 17827-1999
GB/T 21666-2025 Absorbent incontinence aids for urine and/or faeces - General guidelines on evaluation GB/T 21666-2025
GB/T 45214-2025 Data quality evaluation method of human whole genome sequencing GB/T 45214-2025
GB/T 16886.17-2025 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents GB/T 16886.17-2025
GB/T 44138-2024 Cardiovascular implants - Cardiovascular absorbable implants GB/T 44138-2024
GB/T 16886.10-2024 Biological evaluation of medical devices - Part 10: Tests for skin sensitization GB/T 16886.10-2024
GB/T 42216.4-2024 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 4: In situ detection technique GB/T 42216.4-2024
GB/T 44353.1-2024 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management GB/T 44353.1-2024
GB/T 44353.2-2024 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling GB/T 44353.2-2024
GB/T 44418-2024 Assistive products - Guidelines on cognitive accessibility - Daily time management GB/T 44418-2024
GB/T 42080.3-2024 DNA Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA GB/T 42080.3-2024
GB/T 44467-2024 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA GB/T 44467-2024
GB/T 44585.1-2024 Application of risk management for medical device connecting IT-network - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software GB/T 44585.1-2024
GB/T 44586.1-2024 In vitro diagnostic medical devices - Multiplex molecular testing for nucleic acids - Part 1: Terminology and general requirements for nucleic acid quality evaluation GB/T 44586.1-2024
GB/T 44665-2024 General requirements for upper and lower limb motor function rehabilitation equipment with assessment and training GB/T 44665-2024
GB/T 44671-2024 Basic semen examination - Specification and test methods GB/T 44671-2024
GB/T 44672-2024 In vitro diagnostic medical devices - Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples GB/T 44672-2024
GB/T 44827-2024 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma GB/T 44827-2024
GB/T 14191.3-2023 Prosthetics and orthotics - Vocabulary - Part 3: Terms relating to orthoses GB/T 14191.3-2023
GB/T 42818.1-2023 Cognitive accessibility - Part 1: General guidelines GB/T 42818.1-2023
GB/T 42984.1-2023 Health software - Part 1: General requirements for product safety GB/T 42984.1-2023
GB/T 16886.12-2023 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials GB/T 16886.12-2023
GB/T 16886.23-2023 Biological evaluation of medical devices - Part 23: Tests for irritation GB/T 16886.23-2023
GB/T 43278-2023 Medical laboratories - Application of risk management to medical laboratories GB/T 43278-2023
GB/T 43279.1-2023 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA GB/T 43279.1-2023
GB/T 43279.2-2023 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA GB/T 43279.2-2023
GB/T 43279.3-2023 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma GB/T 43279.3-2023
GB/T 16886.1-2022 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process GB/T 16886.1-2022
GB/T 16886.4-2022 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood GB/T 16886.4-2022
GB/T 16886.6-2022 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation GB/T 16886.6-2022
GB/T 41522-2022 Method of DNA microarray for detection of three canine viruses GB/T 41522-2022
GB/T 21919-2022 Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures GB/T 21919-2022
GB/T 40887.2-2022 Wheelchair containment and occupant retention systems for accessible transport vehicles designed for use by both sitting and standing passengers - Part 2: Systems for forward-facing wheelchair seated passengers GB/T 40887.2-2022
GB/T 41696-2022 Classification and general technical requirements of lower limb rehabilitation training devices GB/T 41696-2022
GB/T 41697-2022 Assistive products for persons with disability - General requirements and test methods GB/T 41697-2022
GB/T 41840-2022 Lower limb orthoses components - Polyurethane elastic ankle GB/T 41840-2022
GB/T 41843-2022 Assessment of rehabilitation set for classification of functioning, disability and health GB/T 41843-2022
GB/T 42060-2022 Medical laboratories - Requirements for collection, transport, receipt, and handling of samples GB/T 42060-2022
GB/T 42061-2022 Medical devices - Quality management systems - Requirements for regulatory purposes GB/T 42061-2022
GB/T 42062-2022 Medical devices - Application of risk management to medical devices GB/T 42062-2022
GB/T 16886.15-2022 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys GB/T 16886.15-2022
GB/T 16886.18-2022 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process GB/T 16886.18-2022
GB/T 16886.19-2022 Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials GB/T 16886.19-2022
GB/T 16886.9-2022 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products GB/T 16886.9-2022
GB/T 42080.1-2022 RNA Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA GB/T 42080.1-2022
GB/T 42080.2-2022 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins GB/T 42080.2-2022
GB/T 42216.1-2022 RNA Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded(FFPE) tissue - Part 1: Isolated RNA GB/T 42216.1-2022
GB/T 42216.2-2022 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded(FFPE) tissue - Part 2: Isolated proteins GB/T 42216.2-2022
GB/T 42216.3-2022 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA GB/T 42216.3-2022
GB/T 42218-2022 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer GB/T 42218-2022
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 GB/T 19702-2021
GB/T 39889-2021 Braille writing board GB/T 39889-2021
GB/T 22576.2-2021 Medical laboratories - Requirements for quality and competence - Part 2: Requirements in the field of clinical hematological examination GB/T 22576.2-2021
GB/T 22576.3-2021 Medical laboratories - Requirements for quality and competence - Part 3: Requirements in the field of urine examination GB/T 22576.3-2021
GB/T 22576.4-2021 Medical laboratories - Requirements for quality and competence - Part 4: Requirements in the field of clinical chemistry examination GB/T 22576.4-2021
GB/T 22576.5-2021 Medical laboratories - Requirements for quality and competence - Part 5: Requirements in the field of clinical immunology examination GB/T 22576.5-2021
GB/T 22576.6-2021 Medical laboratories - Requirements for quality and competence - Part 6: Requirements in the field of clinical microbiological examination GB/T 22576.6-2021
GB/T 22576.7-2021 Medical laboratories - Requirements for quality and competence - Part 7: Requirements in the field of transfusion medicine GB/T 22576.7-2021
GB/T 16886.11-2021 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity GB/T 16886.11-2021
GB/T 16886.16-2021 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables GB/T 16886.16-2021
GB/T 40887.1-2021 Wheelchair containment and occupant retention systems for accessible transport vehicles designed for use by both sitting and standing passengers - Part 1: Systems for rearward-facing wheelchair seated passengers GB/T 40887.1-2021
GB/T 40888-2021 Aids for ostomy and incontinence - Irrigation sets - Requirements and test methods GB/T 40888-2021
GB/T 14191.4-2021 Prosthetics and orthotics - Vocabulary - Part 4: Terms relating to limb amputation GB/T 14191.4-2021
GB/T 39367.1-2020 In vitro diagnostic test systems. Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens - Part 1: General requirements, terms and definitions GB/T 39367.1-2020
GB/T 19703-2020 (In Vitro Diagnostic Medical Devices Measurement of Biological Source Samples Requirements for certified reference materials and supporting document content) GB/T 19703-2020
GB/T 29790-2020 (Instant inspection quality and ability requirements) GB/T 29790-2020
GB/T 16886.3-2019 Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity GB/T 16886.3-2019
GB/T 37908-2019 General analysis regulation of the label-free protein microarray based on imaging ellipsometry GB/T 37908-2019
GB/T 35029-2018 Method based the microarray for mutation detection of hereditary hearing loss GB/T 35029-2018
GB/T 36136-2018 General requirements of DNA array-based M. tuberculosis drug resistance detection GB/T 36136-2018
GB/T 22576.1-2018 Medical laboratories -- Requirements for quality and competence -- Part 1: General requirements GB/T 22576.1-2018
GB/T 33752-2017 Aldehyde slide for microarrays GB/T 33752-2017
GB/T 33805-2017 Technical requirement of laser confocal biochip scanner GB/T 33805-2017
GB/T 33806-2017 Technical requirement of area fluorescent imaging microarray scanner GB/T 33806-2017
GB/T 16886.12-2017 Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials GB/T 16886.12-2017
GB/T 35533-2017 General technical requirement for chromosomal abnormality detection microarray GB/T 35533-2017
GB/T 16886.13-2017 Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices GB/T 16886.13-2017
GB/T 16886.5-2017 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity GB/T 16886.5-2017
GB/T 16886.9-2017 Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products GB/T 16886.9-2017
GB/T 16886.10-2017 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization GB/T 16886.10-2017
GB/T 16886.6-2015 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation GB/T 16886.6-2015
GB/T 16886.20-2015 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices GB/T 16886.20-2015
GB/T 16886.7-2015 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals GB/T 16886.7-2015
GB/T 16886.16-2013 Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables GB/T 16886.16-2013
GB/T 29790-2013 Point-of-care testing (POCT) -- Requirements for quality and competence GB/T 29790-2013
GB/T 29888-2013 General requirements of DNA array-based mycobacteria identification GB/T 29888-2013
GB/T 29889-2013 DNA microarray for disease susceptibility DNA polymorphisms GB/T 29889-2013
GB/T 16886.1-2011 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process GB/T 16886.1-2011
GB/T 16886.11-2011 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity GB/T 16886.11-2011
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