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医疗器械指令更新协调标准

发布日期: 2017-05-18 来源:tbtguide 字号: [ ]

    2012-8-30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

协调标准

发布时间

被替代标准

CEN

EN 1865-3:2012 (new)

Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher

2012-8-30

EN 1865:1999

N 1865-4:2012 (new)

Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair

2012-8-30

EN 1865:1999

EN 1865-5:2012 (new)

Patient handling equipment used in road ambulances - Part 5: Stretcher support

2012-8-30

EN 1865:1999

EN ISO 5359:2008/A1:2011 (new)

2012-8-30

 

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

EN ISO 13485:2012 (new)

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

2012-8-30

EN ISO 13485

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

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

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

Cenelec

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

 

 

 

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