- Standard No.
- YY/T 0616.1-2016
- Language
- Chinese, Available in English version
- Release Date
- 2016
- Published By
- Professional Standard - Medicine
- Latest
-
YY/T 0616.1-2016
- Replace
-
YY/T 0616-2007
- Scope
- This part of YY/T 0616 specifies the requirements for biological safety evaluation of disposable medical gloves, and provides requirements for labeling and disclosure of information on the test methods used. This section applies to the biological safety evaluation of disposable medical gloves.
YY/T 0616.1-2016 Referenced Document
- GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*， 2022-04-15 Update
- GB/T 16886.10 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization*， 2017-12-29 Update
- GB/T 16886.11 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity*， 2021-11-26 Update
- GB/T 16886.12 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials*， 2023-11-27 Update
- GB/T 16886.13 Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices*， 2017-12-29 Update
- GB/T 16886.14 Biological evaluation of medical devices--Part 14: Identification and quantification of degradation products from ceramics
- GB/T 16886.15 Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys*， 2022-12-30 Update
- GB/T 16886.16 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables*， 2021-11-26 Update
- GB/T 16886.17 Biological evaluation of medical devices.Part 17:Establishment of allowable limits for leachable substances
- GB/T 16886.18 Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process*， 2022-12-30 Update
- GB/T 16886.19 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials*， 2022-12-30 Update
- GB/T 16886.2 Biological evaluation of medical devices.Part 2: Animal welfare requirements
- GB/T 16886.20 Biological evaluation of medical devices.Part 20:Principles and methods for immunotoxicology testing of medical devices
- GB/T 16886.3 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity*， 2019-06-04 Update
- GB/T 16886.4 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood*， 2022-04-15 Update
- GB/T 16886.5 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Tests*， 2018-07-01 Update
- GB/T 16886.6 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation*， 2022-04-15 Update
- GB/T 16886.7 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals
- GB/T 16886.9 Biological Evaluation of Medical Devices Part 9: Qualitative and Quantitative Framework for Potential Degradation Products*， 2022-12-30 Update
- GB/T 21869 Medical gloves.Determination of removable surface powder
- ISO 7000 Graphical symbols for use on equipment — Index and synopsis*， 2019-07-12 Update
- YY/T 0316 Medical devices.Application of risk management to medical devices
- YY/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements*， 2023-09-05 Update
YY/T 0616.1-2016 history
- 2016 YY/T 0616.1-2016 Medical gloves for single use.Part 1:Requirements and testing for biological evaluation
- 2007 YY/T 0616-2007 Medical gloves for single use.Requirements and testing for biological evaluation
YY/T 0616.1-2016 Medical gloves for single use.Part 1:Requirements and testing for biological evaluation has been changed from YY/T 0616-2007 Medical gloves for single use.Requirements and testing for biological evaluation.