Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
适用范围:ISO 11737-2:2009 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be use...
发布日期:2009-11-01 实施日期:2009-11-01
Packaging materials f'or terminally sterilized medical devices- Part 8:Re-usable sterilization containers for steam sterilizers- Requirements and test methods
适用范围:本部分提供了重复性使用蒸汽火菌容器的要求和试验方法。 本部分所规定的容器顶期用作医疗器械在符合EN 285<sup>2)</sup>的蒸汽灭菌器中灭菌器中灭菌时的包装系统,然后用于器械的运输和贮存。
发布日期:2009-06-16 实施日期:2010-12-01
Ophthalmic implants - Ophthalmic viscosurgical devices
实施日期:2013-09-01
Fettarme Lebensmittel. Bestimmung von Dithiocarbamat-und Thiuramdisulfid-Rueckstaenden. UV-Spektralphotometrisches Xanthogenat-Verfahren Non-Fatty Foods-Determination of Dithiocarbamate and Thiuram Dis...
适用范围:This European Standard specifies a UV spectrometric method for the determination of low-level residues of dithiocarbamate and thiuram disulfide fungicides as xanthogenates. Dithiocarbamate and thiuram ...
实施日期:2000-08-15
Gasket ring on pressure steam sterilizer
适用范围:本标准规定了压力蒸汽灭菌设备用密封垫圈的分类、要求、试验方法、检验规则、标志与使用说明书和包装、运输、贮存。 本标准适用于设计压力不大于0.4 MPa,设计温度在115℃~150℃范围内的压力蒸汽灭菌设备用密封垫圈(以下称“密封...
发布日期:2013-10-21 实施日期:2014-10-01
实施日期:2010-02-28
Standard Test Method for Quantitative Sporicidal Three-Step Method (TSM) to Determine Sporicidal Efficacy of Liquids,Liquid Sprays,and Vapor or Gases on Contaminated Carrier Surfaces
适用范围:<p id="s00018">The quantitative micromethod described herein was designed to fulfill the following specifications:</p> <p id="s00019">4.1.1 To be quantitative (the number of viable spores loaded into c...
实施日期:2005-06-15
Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
适用范围:ISO 80601-2-61:2011 applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as ME equipment. This includes any part necessary...
发布日期:2011-04-01 实施日期:2011-04-01
Test method of HEPA filters for microbiological use
适用范围:この規格は,HEPAフィルタ(高性能エアフィルタ)除菌性能を,試験用粒子を用いてフィルタの漏れ率によって試験する方法について規定する。
Cosmetics microbiology general instructions for microbiological examination
适用范围:This International Standard gives general instructions for carrying out microbiological examinations of cosmetic products, in order to ensure their quality and safety, in accordance with an appropriate...
实施日期:2005-10-15
发布日期:2012-06-30 实施日期:2012-06-30
Vertical mode steam sterilizers
适用范围:本标准规定了立式压力蒸汽灭菌器的术语和定义、分类与标记、要求、试验方法、检验规则和标志、使用说明书、包装、运输、贮存。本标准适用于额定工作压力为0.25MPa以下的立式压力蒸汽灭菌器(以下简称灭菌器)。
实施日期:2006-12-01
实施日期:2009-01-01
Spring full lift safety valves on pressure steam sterilizer
适用范围:本标准规定了压力蒸汽灭菌设备用弹簧全启式安全阀的术语和定义、分类与标记、要求、试验方法、检验规则、标志与使用说明书和包装、运输、贮存及供货。
发布日期:2013-10-21 实施日期:2014-10-01
Rules of the inspection of packaging for import terminally sterilized medical devices
适用范围:本标准规定了直接接触医疗器械灭菌用进口包装容器、包装材料检验模式的选择、取样、试验方法、检验规则、判定原则及不合格处置。
发布日期:2011-09-09 实施日期:2012-04-01
Sterilization of health care products. Chemical indicators. Guidance for selection, use and interpretation of results
适用范围:1.1 This International Standard provides guidance for the selection, use and interpretation of resultsof chemical indicators used in process definition, validation and routine monitoring and overall co...
实施日期:2009-01-31
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