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(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
有產(chǎn)品辦理檢測(cè)認(rèn)證或想了解更多詳情資訊,請(qǐng)聯(lián)系億博檢測(cè)中心:
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