欧盟体外诊断医疗器械指令（IVDD）98/79/EC更新协调标准
2012年8月30日，体外诊断医疗器械指令（IVDD）98/79/EC更新了协调标准，主要关于医疗器械质量管理体系及医疗器械风险管理。新发布了ENISO13485-2012及该标准的修订版，替换了2003版的质量管理体系标准，被替换的标准于2012年8月31日起终止适用。同时，ENISO 14971:2009也与发布之日起不再适用，新的替换标准为EN ISO 14971:2012
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: Heavyduty 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 forregulatory 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 suspensiontest for the evaluation of bactericidal activity in the medicalarea - 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 testmethods 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 | 11/01/20 |
