标准号: |
ISO 15378-2017 |
英文名称: |
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) |
中标分类: |
0>>0 |
发布日期: |
2017-0901 |
发布单位: |
IX-ISO |
标准状态: |
请与本站工作人员进行确认 |
ICS分类: |
0>>0 |
起草单位/标准公告: |
ISO/TC 76 Transfusions-, Infusions- und Injektionsger?te zur medizinischen und pharmazeutischen Verwendung;ISO/TC 76 Transfusion, infusion and injection equipment for medical and pharmaceutical use;ISO/TC 76 Appareils de transfusion, de perfusion et d'injection à usage médical et pharmaceutique |
正文语言: |
英语 |
页数: |
79P.;A4 |
附注: |
History:ISO 15378-2017-09;ISO/DIS 15378-2016-10;ISO 15378-2015-10;ISO/FDIS 15378-2015-07;ISO/DIS 15378-2014-02;ISO 15378-2011-11;ISO/FDIS 15378-2011-06;ISO 15378-2006-03;ISO/FDIS 15378-2005-10;ISO/DIS 15378-2004-04 |
被代替标准: |
ISO 15378-2015;ISO/DIS 15378-2016 |
引用标准: |
ASTM E 2500-2013;IEC 60300-1-2014;IEC 60601-1-2005;IEC 60812-2006;IEC 61025-2006;IEC 61160-2005;IEC 61882-2016;ISO/IEC GUIDE 2-2004;ISO GUIDE 73-2009;ISO/IEC GUIDE 73-2002;ISO/IEC GUIDE 99-2007;ISO 9000-2015;ISO 9001-2015;ISO 9004-2009;ISO 10001-2007;ISO 10002-2014;ISO 10003-2007;ISO 10004-2012;ISO 10005-2005;ISO 10006-2003;ISO 10007-2017;ISO 10008-2013;ISO 10012-2003;ISO/TR 10013-2001;ISO 10014-2006;ISO 10015-1999;ISO/TR 10017-2003;ISO 10018-2012;ISO 10019-2005;ISO 11135-2014;ISO 11137-1-2006;ISO 11137-2-2013;ISO/TS 11139-2006;ISO 13485-2016;ISO 14001-2015;ISO 14644-1-2015;ISO 14644-2-2015;ISO 14644-3-2005;ISO 14644-4-2001;ISO 14644-5-2004;ISO 14644-7-2004;ISO 14644-8-2013;ISO 14698-1-2003;ISO 14698-2-2003;ISO 14937-2009;ISO 14971-2007;ISO 19011-2011;ISO 31000-2009;ISO 31010-2009;ISO 37500-2014;ISO/IEC 90003-2014 |
内容提要(EN): |
Accident prevention;Definitions;Drugs;Expendable packings;Industrial process measurement;Lock-up;Management systems;Manufacturing;Medical products;Medicaments;Non-reclosable;Packages;Packaging;PDCA;Pharmaceutic packages;Pharmacy;Plan-Do-Check-Act;Production;Production techniques;Purchasing;Qualification tests;Quality;Quality assurance;Quality management;Quality requirements;Risk management;Safety;Safety requirements;Specification (approval);Surveillance (approval);Testing;Testing conditions;Training;Validation;Verification;Medicine;Medical devices |
归属: |
国际 |