NF S95-164-2009

Medical supply units.

ISO 11737-2-2009

医疗器械的灭菌 微生物学方法 第2部分:定义、确认和保持灭菌过程的无菌试验

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

YY/T 0698.8-2009

最终灭菌医疗器械包装材料 第8部分：蒸汽灭菌器用重复性使用灭菌容器 要求和试验方法

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 285^2）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

EN ISO 15798-2013

眼科植入物 黏弹性眼科植入装置

Ophthalmic implants - Ophthalmic viscosurgical devices

实施日期：2013-09-01

BS EN 12396-3-2000

清淡食品.二硫化基甲酸盐和二硫化四烷基秋兰姆残留物的测定.紫外分光光度黄酸盐法

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

YY/T 0158-2013

压力蒸汽灭菌设备用密封垫圈

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

BS EN ISO 11607-1-2009

Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems

实施日期：2010-02-28

ASTM E2414-2005

定量杀孢子三步法测定液体、液体喷洒和蒸气或气体对受污染载体表面的杀孢子功效的试验方法

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

ISO 80601-2-61-2011

医用电气设备 第2-61部分:脉搏血氧仪的基本安全和基本性能特殊要求

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

JIS K3801-2000

除菌用HEPA过滤器性能试验方法

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。

ISO 21148-2005

化妆品 微生物学 微生物检查通则

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

NF S98-101-1-2007

Sterilization of health care products - Ethylene oxide - Part 1 : requirements for development, validation and routine control of a sterilization process for medical devices.

BS EN 12182-2012

Assistive products for persons with disability. General requirements and test methods

发布日期：2012-06-30  实施日期：2012-06-30

YY 0154-1994

压力蒸汽灭菌设备用弹簧式安全阀

实施日期：1994-07-01

YY 1007-2005

立式压力蒸汽灭菌器

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

ANSI/AAMI/ISO 14161-2009

Sterilization of health care products. Biological indicators. Guidance for the selection,use and interpretation of results [superseded:Aami st34]

实施日期：2009-01-01

YY 0154-2013

压力蒸汽灭菌设备用弹簧全启式安全阀

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

NF S99-507-1996

Biological evaluation of medical devices. Part 7 : ethylene oxide sterilization residuals.

SN/T 3061-2011

进口医疗器械灭菌包装检验操作规程

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

BS EN ISO 15882-2008

卫生护理产品灭菌 化学指示剂 结果选择,使用和解释的指南

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