加拿大卫生部发布医疗器械认可标准清单

2019-03-21 11:55 阅读数：4390 标签：

加拿大卫生部重新评估了医疗器械相关的适用标准，并且进行适当的增加、更新和删减，于2月25日发布了一份医疗器械认可标准的清单。

增加的标准如下

1.1 ISO 5840-1:2015 Cardiovascular implants - Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements

1.2 ISO 5840-2:2015 Cardiovascular implants - Cardiac valve prostheses - Part 2: Cardiovascular implants - Surgically implanted heart valve substitutes

1.3 ISO 14708-6:2010 Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)

1.4 ISO 14708-7:2013 Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear implant systems

1.5 ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems

1.6 ASTM F1140-13 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages

1.7 ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)

1.8 ASTM F88-15 Standard Test Method for Seal Strength of Flexible Barrier Materials

1.9 ASTM F1829-17 Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear

1.10 ASTM F1875-98 (R2014) Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface

1.11 ASTM F2582-14 Standard Test Method for Impingement of Acetabular Prostheses

1.12 ASTM F2665-09 (R2014) Standard Specification for Total Ankle Replacement Prosthesis

1.13 ISO 14160:2011 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

1.14 IEC 80601-2-58:2016- Ed.2.1 Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery

更新的标准如下

2.1 ISO 7198:2016 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches

2.2 ISO 14708-1:2014 Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer.

2.3 ISO 14708-3:2017 Active implantable medical devices -- Part 3: Implantable neurostimulators

2.4 IEC 62304:2015 Medical device software - Software life cycle processes

2.5 ISO 22442-1:2015 Ed.2 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management

2.6 ISO 22442-2:2015 Ed.2 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling

2.7 ISO 11979-2:2014 Ophthalmic implants -- Intraocular lenses -- Part 2: Optical properties and test methods

2.8 IEC 60601-1-3:2013 Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment

2.9 IEC 60601-2-37:2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

2.10 IEC 60601-2-44:2016 Medical electrical equipment - Part 2-44:Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography

2.11 IEC 60601-2-54:2015 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

2.12 ISO 11135:2014 Sterilization of health care products – Ethylene oxide – Requirements for development, validation and routine control of a sterilization process for medical devices

2.13 ISO 11137-2:2013 Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose

以下标准从原清单中删除

3.1 ISO 5840:2005 Cardiovascular implants - Cardiac valve prostheses

3.2 CAN/CSA C22.2 NO 60601-1-2-08:2008 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests

3.3 CAN/CSA C22.2 NO 60601-1-08:2008 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

3.4 CAN/CSA Z900.1-12 :2012 Cells tissues, and organs for transplantation: General requirements

3.5 CAN/CSA-ISO 14971-07:2007 Medical devices – Application of risk management to medical devices

3.6 IEC 61010-1:2001-Ed.2.0 Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements

IEC 61010-1/Cor.1:2002

IEC 61010-1/Cor.2:2003

3.7 IEC 61010-2-101:2002-Ed.1.0 Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

3.8 CAN/CSA Z11135-1-09:2009 Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices