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(xiǎn)管理、心血管植入物、非侵入性血壓測(cè)量?jī)x、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：

歐洲標(biāo)準(zhǔn)組織	協(xié)調(diào)性標(biāo)準(zhǔn)	發(fā)布于時(shí)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

詳情參見(jiàn)：http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medical-devices/index_en.htm