YY/T 0681.4-2021
无菌医疗器械包装试验方法 第4部分：染色液穿透法测定透气包装的密封泄漏
Test methods for sterile medical device package—Part 4:Detecting seal leaks in porous packages by dye penetration
2021-03-09
YY/T 0681.11-2014
无菌医疗器械包装试验方法 第11部分：目力检测医用包装密封完整性
Test methods for sterile medical device package—Part 11:Determining integrity of seals for medical packaging by visual inspection
2014-06-17
YY/T 0681.18-2020
无菌医疗器械包装试验方法 第18部分：用真空衰减法无损检验包装泄漏
Test methods for sterile medical device package—Part 18:Nondestructive detection of leaks in packages by vacuum decay method
2020-03-31
YY/T 0681.2-2010
无菌医疗器械包装试验方法 第2部分：软性屏障材料的密封强度
Test methods for sterile medical device package—Part 2:Seal strength of flexible battier materials
2010-12-27
UNE-EN 868-4-2009
Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
最终灭菌医疗器械的包装第4部分:纸袋要求和试验方法
2009-12-02
YY/T 0698.4-2009
最终灭菌医疗器械包装材料 第4部分：纸袋 要求和试验方法
Packaging materials for terminal sterilized medical devices—Part 4:Paper bags—Requirements and test methods
2009-06-16
UNE-EN 868-2-2009
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
最终灭菌医疗器械的包装第2部分:灭菌包装要求和试验方法
2009-12-02
YY/T 0681.16-2019
无菌医疗器械包装试验方法 第16部分：包装系统气候应变能力试验
Test methods for sterile medical device package—Part 16:Test for climatic stressing of packaging system
2019-05-31
YY/T 0698.2-2022
最终灭菌医疗器械包装材料 第2部分：灭菌包裹材料 要求和试验方法
Packaging materials for terminal sterilized medical devices—Part 2:Sterilization wrap—Requirements and test methods
2022-10-17
YY/T 0681.1-2018
无菌医疗器械包装试验方法 第1部分:加速老化试验指南
Test methods for sterile medical device package—Part 1:Test guide for accelerated aging
2018-12-20
YY/T 0681.9-2011
无菌医疗器械包装试验方法 第9部分：约束板内部气压法软包装密封胀破试验
Test methods for sterile medical device package—Part 9:Burst testing of flexible package seals using internal air pressurization weight restraining plates
2011-12-31
YY/T 0681.5-2010
无菌医疗器械包装试验方法 第5部分:内压法检测粗大泄漏(气泡法)
Test methods for sterile medical device package-Part 5:Deteting gross leaks in medical packaging by internal pressurization(bubble test)
2010-12-27
YY/T 0681.10-2011
无菌医疗器械包装试验方法 第10部分:透气包装材料微生物屏障分等试验
Test methods for sterile medical device package-Part 10:Test for microbial barrier ranking of porous package material
2011-12-31
YY/T 0681.3-2010
无菌医疗器械包装试验方法 第3部分:无约束包装抗内压破坏
Test methods for sterile medical device package. Part 3:Internal pressurization failure resistance of unrestrained packages
2010-12-27
YY/T 0698.8-2009
最终灭菌医疗器械包装材料 第8部分：蒸汽灭菌器用重复性使用灭菌容器 要求和试验方法
Packaging materials for terminally sterilized medical devices—Part 8:Re-usable sterilization containers for steam sterilizers—Requirements and test methods
2009-06-16
UNE-EN 868-6-2009
Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
最终灭菌医疗器械的包装第6部分:低温灭菌用纸要求和试验方法
2009-12-02
YY/T 0681.8-2011
无菌医疗器械包装试验方法 第8部分：涂胶层重量的测定
Test methods for sterile medical device package—Part 8:Coating/adhesive weight determination
2011-12-31
YY/T 0681.15-2019
无菌医疗器械包装试验方法 第15部分：运输容器和系统的性能试验
Test methods for sterile medical device package—Part 15:Performance testing of shipping containers and systems
2019-10-23
UNE-EN 868-1-1997
PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED. PART 1: GENERAL REQUIREMENTS AND TEST METHODS.
待灭菌医疗器械的包装材料和系统 第1部分:一般要求和试验方法
1997-11-28
YY/T 0681.12-2022
无菌医疗器械包装试验方法 第12部分：软性屏障材料抗揉搓性
Test methods for sterile medical device package—Part 12:Flex durability of flexible barrier materials
2022-05-18