EN 285-2015 灭菌.蒸汽消毒器.大型杀菌器.pdf

标准号：EN 285-2015
中文名称：灭菌.蒸汽消毒器.大型杀菌器
英文名称：Sterilization - Steam sterilizers - Large sterilizers
发布日期：2015-12
代替标准：FprEN 285-2015;EN 285+A2-2009
采用标准：DIN EN 285-2016,IDT;BS EN 285-2016,IDT;NF S98-011-2016,IDT;SN EN 285-2016,IDT;OENORM EN 285-2016,IDTN-EN 285-2016,IDT;SS-EN 285-2016,IDT;UNE-EN 285-2016,IDT;DS/EN 285-2016,IDT;UNI EN 285:2016-2016,IDT;STN EN 285-2016,IDT;CSN EN 285-2016,IDT;DS/EN 285-2016,IDT;NEN-EN 285:2016 en-2016,IDT;SFS-EN 285:en-2016,IDT
标准简介：This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i. e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizers for medical devices. However, specific loads (e. g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads. This European Standard applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l. Large steam sterilizers can also be used during the commercial production of medical devices. This European Standard does not specify requirements for large steam sterilizers intended to use, contain or be exposed to flammable substances or substances which could cause combustion. This European Standard does not specify requirements for equipment intended to process biological waste or human tissues. This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer. NOTE 1 Attention is drawn to the standards for quality management systems e. g. EN ISO 13485. NOTE 2 Environmental aspects are addressed in Annex A.
文件格式：PDF
文件大小：1.73MB
文件页数：106


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