YY/T 1446-2016
Medical endoscopes.Endotherapy device.Palmate retractor (English Version)

Standard No.

YY/T 1446-2016

Language

Chinese, Available in English version

Release Date

2016

Published By

Professional Standard - Medicine

Latest

YY/T 1446-2016

Scope

This standard specifies the scope, terms and definitions, requirements, and test methods of palm-type instruments. This standard applies to palm instruments used in endoscopic surgery.

YY/T 1446-2016 Referenced Document

• GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use.Part 1:Chemical analysis methods
• GB/T 14233.2 Test methods for infusion,transfusion,injection equipment for medical use.Part 2:Biological test methods
• 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 1962.1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment.Part 1:General requirement
• GB/T 1962.2 Conical fittings with a 6%(Luer)taper for syringes,needles and certain other medical equipment Part 2: Lock fittings
• YY/T 0149-2006 Medical instruments of stainless steel - Test methods of corrosion resistance

YY/T 1446-2016 history

• 2016 YY/T 1446-2016 Medical endoscopes.Endotherapy device.Palmate retractor