GOST ISO 14160-2011
Стерилизация одноразовых медицинских изделий, содержащих материалы животного происхождения. Валидация и текущий контроль стерилизации с помощью жидких стерилизующих средств
一次性使用动物源的医疗器械灭菌 液体灭菌剂灭菌的验证和常规控制
2011-11-29
UNE-EN ISO 14160-1998
STERILIZATION OF SINGLE-USE MEDICAL DEVICES INCORPORTING MATERIALS OF ANIMAL ORIGIN. VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY LIQUID CHEMICAL STERILANTS. (ISO 14160:1998).
含有动物源性材料的一次性医疗器械的灭菌 液体化学灭菌剂灭菌的验证和常规控制 （ISO 14160:1998）
1998-10-21
AAMI/ISO 14160-2011/(R)2016
Sterilization of health care products - liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - requirements for characterization, development, validation and routine control of a sterilization process for medical devices
医疗保健产品的灭菌.利用动物组织及其衍生物的一次性医疗器械用液体化学灭菌剂.医疗器械灭菌过程的特性、开发、验证和常规控制要求
2011-12-05
BS EN ISO 14160-2021
Sterilization of health care products. Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives. Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
医疗保健产品的消毒 利用动物组织及其衍生物的一次性医疗器械用液体化学杀菌剂 医疗器械灭菌过程的特征描述、开发、验证和常规控制要求
2021-07-05
ISO 14160-2020
Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
一次性医疗器械的灭菌 包含动物产地的材料 - 液体化学杀菌剂的灭菌验证和常规控制
2020-09-21
YY/T 0698.7-2009
最终灭菌医疗器械包装材料 第7部分:环氧乙烷或辐射灭菌屏障系统生产用可密封涂胶纸 要求和试验方法
Packaging materials for terminal sterilized medical devices-Part 7:Adhesive coated paper for the manufacture of sealable packs for medical use for sterilization by ethylene oxide or irradiation-Requirements and test methods
2009-06-16
YY/T 0681.7-2011
无菌医疗器械包装试验方法 第7部分：用胶带评价软包装材料上印墨或涂层附着性
Test methods for sterile medical device package—Part 7:Evaluating inks or coating adhesion to flexible packaging materials using tape
2011-12-31
YY/T 0698.9-2009
最终灭菌医疗器械包装材料 第9部分:可密封组合袋、卷材和盖材生产用无涂胶聚烯烃非织造布材料 要求和试验方法
Packaging materials for terminally sterilized medical devices-Part 9:Uncoated nonwoven materials of polyolefines for use in the manufacture of sealable pouches,reels and lids-Requirements and test methods
2009-06-16
YY/T 0698.1-2011
最终灭菌医疗器械包装材料 第1部分:吸塑包装共挤塑料膜 要求和试验方法
Packaging materials for terminal sterilized medical devices-Part 1:Co-extrusion plastic films used for vacuum forming packaging-Requirements and test methods
2011-12-31
YY/T 0681.17-2019
无菌医疗器械包装试验方法 第17部分：透气包装材料气溶胶过滤法微生物屏障试验
Test methods for sterile medical device package—Part 17:Testing the microbial barrier performance of porous package materials using aerosol filtration method
2019-10-23
YY/T 0698.10-2009
最终灭菌医疗器械包装材料 第10部分：可密封组合袋、卷材和盖材生产用涂胶聚烯烃非织造布材料 要求和试验方法
Packaging materials for terminally sterilized medical devices—Part 10:Adhesive coated nonwoven materials of polyolefines for use in the manufacture of sealable pouches,reels and lids—Requirements and test methods
2009-06-16
YY/T 0698.3-2009
最终灭菌医疗器械包装材料 第3部分：纸袋(YY/T 0698.4所规定)、组合袋和卷材(YY/T 0698.5所规定)生产用纸 要求和试验方法
Packaging materials for terminal sterilized medical devices—Part 3:Paper for use in the manufacture of paper bags(specified in YY/T 0698.4)and in the manufacture of pouches and reels(specified in YY/T 0698.5)—Requirements and test methods
2009-06-16