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• 医疗器械指令（MDD）93/42/EEC 部分协调标准（截至2011年9月28日）[注1]：

协调标准编号及其修订件	对应的IEC标准	备注
EN 60601-1:1990 EN 60601-1:1990/A1:1993+ EN 60601-1:1990/A2:1995+	IEC 60601-1:1988
EN 60601-1:2006	IEC 60601-1:2005	替换EN 60601-1:1990及其修订件； 替换EN 60601-1-1:2001、EN 60601-1-4:1996及其修订件。
EN 60601-1-1:2001	IEC 60601-1-1:2000
EN 60601-1-2:2001 EN 60601-1-2:2001/ A1:2006+	IEC 60601-1-2:2001
EN 60601-1-2:2007	IEC 60601-1-2:2007	替换EN 60601-2:2001及其修订件
EN 60601-1-2:2007/AC：2010
EN 60601-1-3:1994	IEC 60601-1-3:1994
EN 60601-1-3:2008	IEC 60601-1-3:2008	替换EN 60601-1-3:1994
EN 60601-1-4:1996 EN 60601-1-4:1996/ A1:1999+	IEC 60601-1-4:1996
EN 60601-1-6:2004	IEC 60601-1-6:2004
EN 60601-1-6:2007	IEC 60601-1-6:2006	替换EN 60601-1-6:2004
EN 60601-1-6:2007/AC:2010
EN 60601-1-8:2004 EN 60601-1-8:2004/ A1:2006+	IEC 60601-1-8:2003
EN 60601-1-8:2007	IEC 60601-1-8:2006	替换EN 60601-1-8:2004
EN 60601-1-10:2008	IEC 60601-1-10:2007

 93/42/EEC 新增加的协调性标准：[注2]

欧洲标准组织	协调性标准	第一次发布于OJ	被替代的标准	被替代标准的过期日期
CEN	EN ISO 13408-1:2011 (new) Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008)	This is the first publication	EN 13824:2004 Note 2.1	31/12/2011
CEN	EN ISO 13408-2:2011 (new) Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)	This is the first publication	EN 13824:2004 Note 2.1	31/12/2011
CEN	EN ISO 13408-3:2011 (new) Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)	This is the first publication	EN 13824:2004 Note 2.1	31/12/2011
CEN	EN ISO 13408-4:2011 (new) Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)	This is the first publication	EN 13824:2004 Note 2.1	31/12/2011
CEN	EN ISO 13408-5:2011 (new) Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)	This is the first publication	EN 13824:2004 Note 2.1	31/12/2011
CEN	EN ISO 13408-6:2011 (new) Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)	This is the first publication	EN 13824:2004 Note 2.1	31/12/2011

具体内容详见：Directive 93/42/EEC相关协调标准

• 有源植入式医疗器械指令（AIMDD）90/385/EEC 部分协调标准（截至2011年9月28日）[注1]

协调标准编号及其修订件	对应的IEC标准	备注
EN 45502-1:1997
EN 60601-1:1990 EN 60601-1:1990/ A1:1993+ EN 60601-1:1990/ A2:1995+	IEC 60601-1:1988
EN 60601-1:2006	IEC 60601-1:2005	替换EN 60601-1-1:1990及其修订件
EN 60601-1:2006/AC:2010
EN 60601-1-6:2010	IEC 60601-1-6:2010
EN 62304:2006/AC:2008

90/385/EEC 新增加的协调性标准：[注3]

欧洲标准组织	协调性标准	第一次发布于OJ	被替代的标准	被替代标准的过期日期
CEN	EN ISO 13408-1:2011 (new) Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008)	This is the first publication	EN 13824:2004 Note 2.1	31/12/2011
CEN	EN ISO 13408-2:2011 (new) Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)	This is the first publication	EN 13824:2004 Note 2.1	31/12/2011
CEN	EN ISO 13408-3:2011 (new) Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)	This is the first publication	EN 13824:2004 Note 2.1	31/12/2011
CEN	EN ISO 13408-4:2011 (new) Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)	This is the first publication	EN 13824:2004 Note 2.1	31/12/2011
CEN	EN ISO 13408-5:2011 (new) Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)	This is the first publication	EN 13824:2004 Note 2.1	31/12/2011
CEN	EN ISO 13408-6:2011 (new) Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)	This is the first publication	EN 13824:2004 Note 2.1	31/12/2011

具体内容详见：Directive 90/385/EEC相关协调标准 

体外诊断医疗器械指令（IVDD）98/79/EC 新增加的协调性标准:[注4]

欧洲标准组织	协调性标准	第一次发布于OJ	被替代的标准	被替代标准的过期日期
CEN	EN ISO 13408-1:2011 (new) Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008)	This is the first publication
CEN	EN ISO 13408-2:2011 (new) Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)	This is the first publication
CEN	EN ISO 13408-3:2011 (new) Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)	This is the first publication
CEN	EN ISO 13408-4:2011 (new) Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)	This is the first publication
CEN	EN ISO 13408-5:2011 (new) Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)	This is the first publication
CEN	EN ISO 13408-6:2011 (new) Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)	This is the first publication

具体内容详见：Directive 98/79/EC相关协调标准