YY/T 0616-2007
Medical gloves for single use.Requirements and testing for biological evaluation (English Version)
- Standard No.
- YY/T 0616-2007
- Language
- Chinese, Available in English version
- Release Date
- 2007
- Published By
- Professional Standard - Medicine
- Status
- 2017-01
- Replace By
- YY/T 0616.1-2016
- Latest
- YY/T 0616.1-2016
- Scope
- This standard specifies the requirements for biological safety evaluation of disposable medical gloves, and provides information on labeling and glove packaging requirements as well as test methods used. This standard also includes a review of immunological test methods for the determination of soluble proteins and allergens.
YY/T 0616-2007 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 16886.12 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials*， 2023-11-27 Update
- GB/T 16886.5 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Tests*， 2018-07-01 Update
- GB/T 16886.7 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals*， 2015-12-10 Update
- YY/T 0316 Medical devices.Application of risk management to medical devices*， 2016-01-26 Update
YY/T 0616-2007 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
