欧盟医疗器械指令（MDD）93/42/EEC更新协调标准

欧盟医疗器械指令（MDD）93/42/EEC更新协调标准

212年8月3日，医疗器械指令（MDD）93/42/EEC更新了协调标准，涉及救护车内使用的病人处理设备、配合医疗气体使用的低压软管组件、保健产品的灭菌、化学消毒剂和防腐粉品、医疗器械质量管理体系、医疗器械风险管理、心血管植入物、非侵入性血压测量仪、医疗电气设备的特殊要求以及放射治疗设备等。新增的协调标准如下：

欧洲标准组织	协调性标准	发布于时间	被替代的标准	被替代标准的终止适用日期
CEN	EN 185-3:212 (new) Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher	212-8-3	EN 185:1999	31/12/212
	EN 185-4:212 (new) Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair	212-8-3	EN 185:1999	31/12/212
	EN 185-5:212 (new) Patient handling equipment used in road ambulances - Part 5: Stretcher support	212-8-3	EN 185:1999	31/12/212
	EN ISO 5359:28/A1:211 (new)	212-8-3		3//212
	EN ISO 11137-2:212 (new) Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:212)	212-8-3	EN ISO 11137-2:27	3/9/212
	EN ISO 13485:212 (new) Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:23)	212-8-3	EN ISO 13485:23	212-8-3
	EN ISO 13485:212/AC:212 (new)	212-8-3
	EN 13727:212 (new) Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1)	212-8-3	EN 13727:23	3/11/212
	EN ISO 14971:212 (new) Medical devices - Application of risk management to medical devices (ISO 14971:27, Corrected version 27-1-1)	212-8-3	EN ISO 14971:29	212-8-3
	EN ISO 25539-1:29/AC:211 (new)	212-8-3
	EN ISO 25539-2:29/AC:211 (new)	212-8-3
	EN ISO 81-1:212 (new) Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81-1:27)	212-8-3	EN 1-2:1995+A1:29 EN 1-1:1995+A2:29	31/5/215
Cenelec	EN 1-2-33:22/A2:28/AC:28(new)	212-8-3
	EN 1-2-52:21/AC:211 (new)	212-8-3
	EN 1217:212 (new) Radiotherapy equipment - Coordinates, movements and scales IEC 1217:211	212-8-3	EN 1217:199 and its amendments	11/1/215

详情参见：http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medical-devices/index_en.htm