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歐盟醫(yī)療器械指令(MDD)93/42/EEC更新協(xié)調(diào)標(biāo)準(zhǔn)
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歐盟醫(yī)療器械指令(MDD)93/42/EEC更新協(xié)調(diào)標(biāo)準(zhǔn)
2012年8月30日,醫(yī)療器械指令(MDD)93/42/EEC更新了協(xié)調(diào)標(biāo)準(zhǔn),涉及救護(hù)車內(nèi)使用的病人處理設(shè)備、配合醫(yī)療氣體使用的低壓軟管組件、保健產(chǎn)品的滅菌、化學(xué)消毒劑和防腐粉品、醫(yī)療器械質(zhì)量管理體系、醫(yī)療器械風(fēng)險管理、心血管植入物、非侵入性血壓測量儀、醫(yī)療電氣設(shè)備的特殊要求以及放射治療設(shè)備等。新增的協(xié)調(diào)標(biāo)準(zhǔn)如下:
詳情參見:http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medical-devices/index_en.htm
歐洲標(biāo)準(zhǔn)組織 | 協(xié)調(diào)性標(biāo)準(zhǔn) | 發(fā)布于時間 | 被替代的標(biāo)準(zhǔn) | 被替代標(biāo)準(zhǔn)的終止適用日期 |
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 |
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