欧盟医疗器械指令（MDD）93/42/EEC更新协调标准2012年8月30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 1865-3:2012 (new)
Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher
2012-8-30
EN 1865:1999
31/12/2012

EN 1865-4:2012 (new)
Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair
2012-8-30
EN 1865:1999
31/12/2012

EN 1865-5:2012 (new)
Patient handling equipment used in road ambulances - Part 5: Stretcher support
2012-8-30
EN 1865:1999
31/12/2012

EN ISO 5359:2008/A1:2011 (new)
2012-8-30
 
30/06/2012

EN ISO 11137-2:2012 (new)
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012)
2012-8-30
EN ISO
11137-2:2007
30/09/2012

EN ISO 13485:2012 (new)
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
2012-8-30
EN ISO
13485:2003
2012-8-30

EN ISO 13485:2012/AC:2012 (new)
2012-8-30
 
 

EN 13727:2012 (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)
2012-8-30
EN 13727:2003
30/11/2012

EN ISO 14971:2012 (new)
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
2012-8-30
EN ISO
14971:2009
2012-8-30

EN ISO 25539-1:2009/AC:2011 (new)
2012-8-30
 
 

EN ISO 25539-2:2009/AC:2011 (new)
2012-8-30
 
 

EN ISO 81060-1:2012 (new)
Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)
2012-8-30
EN 1060-2:1995+A1:2009
EN 1060-1:1995+A2:2009
31/05/2015

Cenelec
EN 60601-2-33:2002/A2:2008/AC:2008(new)
2012-8-30
 
 

EN 60601-2-52:2010/AC:2011 (new)
2012-8-30
 
 

EN 61217:2012 (new)
Radiotherapy equipment - Coordinates, movements and scales
IEC 61217:2011
2012-8-30
EN 61217:1996
and its amendments
11/01/2015

详情参见：http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medical-devices/index_en.htm
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2012.9.24