9342eec協(xié)調(diào)標(biāo)準(zhǔn)

1、93/42/EEC 協(xié)調(diào)標(biāo)準(zhǔn)標(biāo)準(zhǔn)代號(hào) 標(biāo)準(zhǔn)英文名稱 標(biāo)準(zhǔn)中文名稱被替代的標(biāo)準(zhǔn) 對(duì)應(yīng)的國(guó)內(nèi)標(biāo)準(zhǔn)EN 285:2006 Sterilization - Steam sterilizers - Large sterilizers消毒 蒸氣消毒 大型消毒設(shè)備EN 285:1996EN 375:2001Information supplied by the manufacturer with in vitro diagnostic

2、 reagents for professional use由生產(chǎn)商提供的專業(yè)用活體外診斷試劑的信息EN 376:2002Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing生產(chǎn)者在實(shí)驗(yàn)室中用自檢測(cè)診斷試劑提供信息EN 455-1:2000Medical gloves for singl

3、e use - Part 1: Requirements and testing for freedom from holes醫(yī)療專用手套.防洞要求和試驗(yàn)EN 455-1:1993EN 455-2:2000Medical gloves for single use - Part 2: Requirements and testing for physical properties (including Technical Corrige

4、ndum 1:1996)醫(yī)療專用手套.物理性能要求和試驗(yàn)EN 455-2:1995EN 455-3:2006Medical gloves for single use - Part 3: Requirements and testing for biological evaluation醫(yī)療專用手套.生物評(píng)價(jià)的要求和試驗(yàn)EN 455-3:1999EN 556-1:2001Sterilization of medical devices

5、- Requirements for medical devices to be designated “STERILE“ - Part 1: Requirements for terminally sterilized medical devicesEN 556-1:2001/AC:2006醫(yī)療設(shè)備的滅菌.擬被認(rèn)定為無(wú)菌的醫(yī)療設(shè)備的要求.對(duì)最終滅菌設(shè)備的要求EN 556:1994 + A1:1998EN 556-2:2003

6、Sterilization of medical devices - Requirements for medical devices to be designated “STERILE“ - Part 2: Requirements for aseptically processed medical devices醫(yī)療器械的消毒 標(biāo)明為“消過毒”的醫(yī)療器械的要求 第 2部分：消毒處理的醫(yī)療器械的要求EN 591:2001 I

7、nstructions for use for in vitro diagnostic instruments for 專用試管診斷儀的使用devices 信息EN 1060-1:1995Non-invasive sphygmomanometers - Part 1: General requirementsEN 1060-1:1995/A1:2002非侵入式血壓計(jì).第 1 部分:一般要求.修改件 A1Note 3EN 1060-2

8、:1995Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers非侵入式血壓表.第 2 部分:機(jī)械血壓表的補(bǔ)充要求EN 1060-3:1997Non-invasive sphygmomanometers - Part 3: Supplementary requirements for elec

9、tro-mechanical blood pressure measuring systemsEN 1060-3:1997/A1:2005非侵入式血壓表.第 3 部分:電機(jī)血壓表的補(bǔ)充要求Note 3EN 1060-4:2004Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of a

10、utomated non-invasive sphygmomanometers非介入式血壓計(jì).第 4 部分:自動(dòng)非介入式血壓計(jì)整體系統(tǒng)精確度測(cè)定的試驗(yàn)過程EN 1089-3:2004Transportable gas cylinders - Gas cylinder identification (excluding LPG) - Part 3: Colour coding可移動(dòng)式氣瓶.氣瓶標(biāo)識(shí)(不包括LPG).第 3 部分:色碼EN

11、 1089-3:1997EN 1280-1:1997Agent specific filling systems for anaesthetic vaporizers - Part 1: Rectangular keyed filling systemsEN 1280-1:1997/A1:2000麻醉氣化裝置制劑特殊添充系統(tǒng).拒形鍵控填充系統(tǒng)Note 3EN 1281-2:1995Anaesthetic and respirator

12、y equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:1987 modified)麻醉和呼吸設(shè)備圓錐形接頭第 2 部分：螺紋承重連接頭EN 1282-2:2005Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, mod