BS EN ISO 22413-2013

药物制剂的转换装置 试验方法和要求

Transfer sets for pharmaceutical preparations. Requirements and test methods

发布日期：2013-04-30  实施日期：2013-04-30

NF S98-107-2-2004

"Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2 : requirements for aseptically processed medical devices".

EN ISO 22413-2011

Transfer sets for pharmaceutical preparations. Requirements and test methods

实施日期：2011-06-01

EN 556-2-2003

医疗器械的消毒 标有“STERILE”医疗器械的要求 第2部分:无菌处理医用品的要求

Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 2:Requirements for aseptically processed medical devices

实施日期：2003-12-01

ISO 13408-5-2006

医疗保健产品的无菌处理 第5部分:在适当的位置灭菌

Aseptic processing of health care products. Part 5:Sterilization in place first edition [superseded:Aami 13408-5]

适用范围： This part of ISO 13408 specifies the general requirements for sterillization in place (SIP) applied to product contact surfaces of the equipment used in the manufacture of sterile health care product...

实施日期：2006-11-15

EN ISO 22413-2013

药液转移器 要求和试验方法

Transfer sets for pharmaceutical preparations. Requirements and test methods

实施日期：2013-02-01

ISO 11737-1 CORR 1-2007

Sterilization of medical devices microbiological methods. Part 1:Determination of a population of microorganisms on products technical corrigendum 1 [superseded:Iso 11737-3]

实施日期：2007-05-15

ISO 25539-1-2003

心血管植入物 血管内器械 第1部分:血管内假体

Cardiovascular implants -- Endovascular devices -- Part 1: Endovascular prostheses

适用范围：ISO 25539-1:2003 specifies requirements for endovascular prostheses, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, mate...

发布日期：2003-03-01  实施日期：2003-03-01

ANSI/AAMI/ISO 13408-5-2006

Aseptic processing of health care products. Part 5:Sterilization in place

实施日期：2006-01-01

ISO 17218-2014

Sterile acupuncture needles for single use

发布日期：2014-02-03  实施日期：2014-02-03

ANSI/AAMI/ISO 13408-2-2003

Aseptic processing of health care products. Part 2:Filtration

实施日期：2003-01-01

ISO 13408-1-2008

医疗保健产品的无菌处理 第1部分:一般要求

Aseptic processing of health care products. Part 1:General requirements second edition

适用范围：1.1 This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes,programmes and procedures for development, validation and routine control of the manufacturing proc...

实施日期：2008-06-15

DIN EN ISO 22413-2013

药物制剂用转移装置 要求和试验方法

Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2010); German version EN ISO 22413:2013

DIN EN 556-2-2004

医疗器械的消毒 标有“STERILE”医疗器械的要求 第2部分:无菌处理医用品的要求

Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 2: Requirements for aseptically processed medical devices

NF S93-071/A1-1999

Sterile urethral catheters for single use.

NF S93-201-2013

Transfer sets for pharmaceutical preparations - Requirements and test methods

ISO 22413-2010

药物制剂用转移装置 要求和试验方法

Transfer sets for pharmaceutical preparations -- Requirements and test methods

适用范围：ISO 22413:2010 applies to sterilized single use transfer sets that are used for pharmaceutical preparations.

发布日期：2010-06-01  实施日期：2010-06-01

ISO 25539-1 AMD 1-2005

心血管植入物 血管内装置 第1部分:血管内修复术 修改件1:试验方法

Cardiovascular implants. Endovascular devices. Part 1:Endovascular prostheses. Amendment 1:Test methods

适用范围：This is Amendment 1 to ISO 25539-1-2003 (Cardiovascular implants — Endovascular devices —Parti:Endovascular prosthesesAMENDMENT 1: Test methods)

实施日期：2005-07-15

ISO 13408-6-2005

医疗保健产品的无菌处理 第6部分:隔离系统

Aseptic processing of health care products. Part 6:Isolator systems first edition

适用范围：This part of ISO 13408 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolat...

实施日期：2005-06-15

ASTM F1980-2007

消毒医疗装置包装加速老化试验指南

Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

适用范围：<p>1.1 This guide provides information for developing accelerated aging protocols to rapidly determine the effects, if any, due to the passage of time on the sterile integrity of the sterile barrier sy...

实施日期：2007-04-01