标准号:BS EN 14348-2005
中文标准名称:化学消毒剂和防腐抗菌剂.评定包括仪器消毒剂在内的医用化学消毒剂灭分支杆菌活性用定量悬浮试验.试验方法和要求(阶段2,步骤1)
英文标准名称:Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1)
标准类型:C12
发布日期:2005/2/9 12:00:00
实施日期:2005/2/9 12:00:00
中国标准分类号:C12
国际标准分类号:11.080.20
适用范围:This document specifies a test method and the minimum requirements for mycobactericidal (or tuberculocidal) activity of chemical disinfectant products that form a homogeneous, physically stable preparation when diluted with hard water - or in the case of ready-to-use products - with water. Products can only be tested at a concentration of 80 % or less as some dilution is always produced by adding the test organisms and interfering substance.
This document applies to products that are used in the medical area including those that are covered by the EEC/93/42 Directive on Medical Devices.
This document applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:
in hospitals, in community medical facilities and in dental institutions;
in clinics of schools, of kindergartens and of nursing homes;
and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patients.
NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.
NOTE 2 This method corresponds to a phase 2, step 1 test (see Annex E).