YY 0033-2000 菌医疗器具生产管理规范
本标准规定了菌医疗器具及其零部件生产与质量管理的基本要求。 菌医疗器具初包装材料的生产也应符合本标准的规定
Good manufacture practice for sterile medical devices
YY/T 0033-2000 菌医疗器具生产管理规范
Good manufacture practice for sterile medical devices
YY/T 0033-1990 菌医疗器具生产管理规范
Sterile medical device production management specifications
BS EN ISO 9626:1991 医疗器具制造用的不锈钢针管
Specifies dimensions, surface and mechanical properties of normal-and-thin-walled tubing of sizes 3.4 mm to 0.3 mm, and of extra-thin-walled tubing
Stainless steel needle tubing for the manufacture of medical devices
T/CAMDI 004-2020 输液、输血、注射医疗器具用丙烯腈-丁二烯-苯乙烯共聚物（ABS）专用料
本文件规定了输液、输血、注射医疗器具用丙烯腈-丁二烯-苯乙烯共聚物专用料（以下简称ABS专用料）的要求
Acrylonitrile-butadiene-styrene copolymer (ABS) special material for infusion, blood transfusion and injection medical equipment
ISO 594-2:1991 注射器、针头和其它医疗器具用锥度(Luer)为6%的锥形配件.第2部分:锁紧配件
Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment; part 2: lock fittings
GOST R 8.705-2010 国家测量统一性保证体系.高能激光医疗器具的嵌入式及外部光度计.验证方法
State system for ensuring the uniformity of measurements. Embedded and external photometers for high-energy laser medical apparatus. Verification procedure
EN ISO 13408-7:2015 保健品的菌加工.第7部分:医疗器具及其组合产品的可供选择的处理(ISO 13408-7:2012)
Dieser Teil von ISO 13408 legt Anforderungen an alternative Ansätze zur Verfahrenssimulation für die Qualifizierung der aseptischer Herstellung von
Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)
DIN 96121:2011 医疗器械.具有硬质合金刀片的Crile-Wood型持针器
Medical instruments - Needle holder type Crile-Wood with carbide inserts
MSZ 4055/2-1982 医疗手工器具刀具， 刀片和枪的监测
0 使用液体化学灭菌剂对包括动物源材料在内的一次性使用医疗器具进行灭菌的确认和常规控制
This International Standard specifies requirements for the development, validation, process control and monitoring of the sterilization, by the use
EN ISO 14160:1998 医疗器械灭菌.使用液体化学灭菌剂对包括动物源材料在内的一次性使用医疗器具进行灭菌的确认和常规控制 ISO 14160-1998
Sterilization of Single-Use Medical Devices Incorporating Materials of Animal Origin - Validation and Routine Control of Sterilization by Liquid Chemical Sterilants ISO 14160: 1998
NF S90-325:1989 外科医疗设备.蒸汽消毒器具
Medical surgical equipment. Steam disinfecting equipment.
DB50/T 1427-2023 医疗卫生机构康复辅助器具配置规范
本文件适用于医疗卫生机构康复辅助器具的配置管理
Specifications for configuration of rehabilitation aids in medical and health institutions
DB1303/T 350-2023 医疗机构强制检定计量器具管理规范
Regulations on the Management of Compulsory Verification of Measuring Instruments in Medical Institutions
YY 0033-2000 菌医疗器具生产管理规范
本标准规定了菌医疗器具及其零部件生产与质量管理的基本要求。 菌医疗器具初包装材料的生产也应符合本标准的规定
Good manufacture practice for sterile medical devices
YY/T 0033-2000 菌医疗器具生产管理规范
Good manufacture practice for sterile medical devices
YY/T 0033-1990 菌医疗器具生产管理规范
Sterile medical device production management specifications
BS EN ISO 9626:1991 医疗器具制造用的不锈钢针管
Specifies dimensions, surface and mechanical properties of normal-and-thin-walled tubing of sizes 3.4 mm to 0.3 mm, and of extra-thin-walled tubing
Stainless steel needle tubing for the manufacture of medical devices
T/CAMDI 004-2020 输液、输血、注射医疗器具用丙烯腈-丁二烯-苯乙烯共聚物（ABS）专用料
本文件规定了输液、输血、注射医疗器具用丙烯腈-丁二烯-苯乙烯共聚物专用料（以下简称ABS专用料）的要求
Acrylonitrile-butadiene-styrene copolymer (ABS) special material for infusion, blood transfusion and injection medical equipment
ISO 594-2:1991 注射器、针头和其它医疗器具用锥度(Luer)为6%的锥形配件.第2部分:锁紧配件
Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment; part 2: lock fittings
GOST R 8.705-2010 国家测量统一性保证体系.高能激光医疗器具的嵌入式及外部光度计.验证方法
State system for ensuring the uniformity of measurements. Embedded and external photometers for high-energy laser medical apparatus. Verification procedure
EN ISO 13408-7:2015 保健品的菌加工.第7部分:医疗器具及其组合产品的可供选择的处理(ISO 13408-7:2012)
Dieser Teil von ISO 13408 legt Anforderungen an alternative Ansätze zur Verfahrenssimulation für die Qualifizierung der aseptischer Herstellung von
Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)
DIN 96121:2011 医疗器械.具有硬质合金刀片的Crile-Wood型持针器
Medical instruments - Needle holder type Crile-Wood with carbide inserts
MSZ 4055/2-1982 医疗手工器具刀具， 刀片和枪的监测
0 使用液体化学灭菌剂对包括动物源材料在内的一次性使用医疗器具进行灭菌的确认和常规控制
This International Standard specifies requirements for the development, validation, process control and monitoring of the sterilization, by the use
EN ISO 14160:1998 医疗器械灭菌.使用液体化学灭菌剂对包括动物源材料在内的一次性使用医疗器具进行灭菌的确认和常规控制 ISO 14160-1998
Sterilization of Single-Use Medical Devices Incorporating Materials of Animal Origin - Validation and Routine Control of Sterilization by Liquid Chemical Sterilants ISO 14160: 1998
NF S90-325:1989 外科医疗设备.蒸汽消毒器具
Medical surgical equipment. Steam disinfecting equipment.
DB50/T 1427-2023 医疗卫生机构康复辅助器具配置规范
本文件适用于医疗卫生机构康复辅助器具的配置管理
Specifications for configuration of rehabilitation aids in medical and health institutions
DB1303/T 350-2023 医疗机构强制检定计量器具管理规范
Regulations on the Management of Compulsory Verification of Measuring Instruments in Medical Institutions
编辑：北检院编辑部
