11.080.20 消毒剂和防腐剂 标准查询与下载
共找到 273 条与 消毒剂和防腐剂 相关的标准，共 19 页
1.1 This test method is designed to determine the residual killing activity of skin antiseptics against transient microbial skin flora on the hands .2 It may be used to evaluate products that are used with the aid of water and rinsed off and those that are used without the aid of water and not rinsed off. 1.2 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects (see 21 CFR Parts 50 and 56). 1.3 This test method should be performed by persons with training in microbiology, in facilities designed and equipped for work with potentially infectious agents at biosafety level 2. 1.4 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. For more specific precautionary statements see 8.1.
Standard Test Method for Determining the Residual Kill Activity of Hand Antiseptic Formulations
- ICS
- 11.080.20
- CCS
- 发布
- 2016-11-15
- 实施
Chemical disinfectants and antiseptics. Surgical hand disinfection. Test method and requirements (phase 2, step 2)
- ICS
- 11.080.20
- CCS
- G04
- 发布
- 2016-02-29
- 实施
- 2016-02-29
This European Standard specifies a test method simulating practical conditions for establishing whether a product for surgical handrub and handwash reduces the release of resident and eventually present transient microbial flora on hands when used for the treatment of clean hands of volunteers. This European Standard applies to products for surgical handrub or handwash for use in 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 patient. EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations". NOTE This method corresponds to a phase 2, step 2 test.
Chemical disinfectants and antiseptics - Surgical hand disinfection - Test method and requirements (phase 2@ step 2)
- ICS
- 11.080.20
- CCS
- G77
- 发布
- 2016-02
- 实施
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1); German version EN 13727:2012+A2:2015
- ICS
- 11.080.20
- CCS
- C19
- 发布
- 2015-12
- 实施
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity in the medical area - Test method and requirements (Phase 2/Step 1); German version EN 14476:2013+A1:2015
- ICS
- 11.080.20
- CCS
- C19
- 发布
- 2015-12
- 实施
1.1 This guide covers the methods for determining the death rate kinetics expressed as D-values. These values can be derived from the construction of a kill curve (or survivor curve) or by using other procedures for determining the number of survivors after exposure to antimicrobial chemicals or formulations. Options for calculations will be presented as well as the method for calculation of a concentration coefficient. 1.1.1 The test methods are designed to evaluate antimicrobial agents in formulations to define a survivor curve and to subsequently calculate a D-value. The tests are designed to produce data and calculate values that provide basic information of the rate-of-kill of antimicrobial formulations tested against single, selected microorganisms. In addition, calculated D-values from survivor curves from exposure at different dilutions of antimicrobial can be used to show the effect of dilution by calculation of the concentration exponent, η (2). D-value determination assumes the ideal of first-order killing reactions that are reflected in a straight-line reduction in count where a count-versus-time plot is done. The goal here is not to determine the time at which no survivors are found, but to determine a standard value that can be used in processing and exposure determinations or used to estimate dilutions. 1.1.2 As an example of potential use of kill curve data, the published FDA, OTC Tentative Final Monograph for HealthCare Antiseptic Drug Products, Proposed Rule, June 17, 1994 has suggested the testing of topically applied antimicrobial products using survival curve (or kill curve) calculations. The methods described in this guide are applicable to these products, but adjustments such as the use of antifoaming agents when the reaction mixture is stirred may be necessary to counteract the presence of detergents in many formulations. Frequently the sampling for these tests is done after very short intervals of exposure to the formulation, such as 30 and 60 s. This methodology also has been applied to preservative testing of antimicrobial ingredients in more complex cosmetic formulations (5). 1.2 The test methods discussed should be performed only by those trained in microbiological techniques. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
Standard Guide for Determination of a Survival Curve for Antimicrobial Agents Against Selected Microorganisms and Calculation of a D-Value and Concentration Coefficient
- ICS
- 11.080.20
- CCS
- 发布
- 2015-10-01
- 实施
This European Standard specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant and antiseptic 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 (97 % with a modified method for special cases) as some dilution is always produced by adding the test organisms and interfering substance. This European Standard applies to products that are used in the medical area in the fields of hygienic handrub, hygienic handwash, surgical handrub, surgical handwash, instrument disinfection by immersion, and surface disinfection by wiping, spraying, flooding or other means. This European Standard applies to areas and situations where disinfection or antisepsis 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. NOTE 3 This method cannot be used to evaluate the activity of products against Legionella in watersystems against mycobacteria and against bacterial spores. EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1)
- ICS
- 11.080.20
- CCS
- C12
- 发布
- 2015-10
- 实施
This European Standard specifies a test method and the minimum requirements for virucidal activity of chemical disinfectant and antiseptic products that form a homogeneous physically stable preparation when diluted with hard water - or in the case of ready-to-use products, i. e, products that are not diluted when applied, - with water. Products can only be tested at a concentration of 80 % (97 %, with a modified method for special cases) as some dilution is always produced by adding the test organisms and interfering substance. This European Standard applies to products that are used in the medical area in the fields of hygienic handrub, hygienic handwash, instrument disinfection by immersion, surface disinfection by wiping, spraying, flooding or other means and textile disinfection. This European Standard 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. NOTE 3 EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity in the medical area - Test method and requirements (Phase 2/Step 1)
- ICS
- 11.080.20
- CCS
- C12
- 发布
- 2015-09
- 实施
Chemical disinfectants and antiseptics. Chemical-thermal textile disinfection. Test method and requirements (phase 2 step 2)
- ICS
- 11.080.20
- CCS
- C12
- 发布
- 2015-08-31
- 实施
- 2015-08-31
Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of bactericidal and yeasticidal activity on non-porous surfaces with mechanical action employing wipes in the medical area (4- field test) - Test method and requirements
- ICS
- 11.080.20
- CCS
- 发布
- 2015-08-31
- 实施
This European Standard specifies a test method and the minimum requirements for the microbicidal activity of a defined disinfection process for the treatment of contaminated textile. This procedure is carried out by using a washing machine as defined in 5.3.2.18 and refers to the disinfection step without prewash. This procedure is not limited to certain types of textile. The suppliers instructions shall be sufficient to allow the method in the standard to be carried out fully (e. g. dosing disinfectant in whatever washing phase e. g. rinsing, disinfecting at 40 °C). This European Standard applies to areas and situations where disinfection is indicated. Such indications occur in patient care, for example: in hospitals, in community medical facilities and in dental institutions; in schools, kindergartens and nursing homes; institutions where patients are accommodated, which could suffer from transmissible diseases; other applications where hygienic treatment of textile is necessary (e. g. food processing, hotels, workwear e. g. from the pharmaceutical industry, laboratories, foodstuffs area or similar institutions). The method described is intended to determine the activity of a product or product combination under the conditions in which they are used. This is a phase 2, step 2 laboratory test that simulates the conditions of application of the product. NOTE This method corresponds to a phase 2, step 2 test (see EN 14885).
Chemical disinfectants and antiseptics - Chemical-thermal textile disinfection - Test method and requirements (phase 2, step 2)
- ICS
- 11.080.20
- CCS
- C12
- 发布
- 2015-08-01
- 实施
Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of bactericidal and yeasticidal activity on non-porous surfaces with mechanical action employing wipes in the medical area (4-field test) - Test method and requirements (
- ICS
- 11.080.20
- CCS
- 发布
- 2015-06
- 实施
Chemical disinfectants and antiseptics. Quantitative test method for the evaluation of bactericidal and yeasticidal activity on non-porous surfaces with mechanical action employing wipes in the medical area (4- field test). Test method and requirements (p
- ICS
- 11.080.20
- CCS
- C12
- 发布
- 2015-04-30
- 实施
- 2015-04-30
This European Standard specifies a test method and the minimum requirements for bactericidal and yeasticidal 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. This European Standard applies to products that are used in the medical area for disinfecting non-porous surfaces including surfaces of medical devices by wiping - regardless if they are covered by the 93/42/EEC Directive on Medical Devices or not. This European Standard includes `ready-to-use wipes` which are impregnated with a microbicidal solution. This European Standard 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 This method corresponds to a phase 2, step 2. test. EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of bactericidal and yeasticidal activity on non-porous surfaces with mechanical action employing wipes in the medical area (4- field test) - Test method and requirements
- ICS
- 11.080.20
- CCS
- Y44
- 发布
- 2015-04
- 实施
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014); German version EN ISO 11140-1:2014
- ICS
- 11.080.20
- CCS
- C05
- 发布
- 2015-03
- 实施
La méthode décrite est destinée à déterminer l'activité désinfectante des procédés utilisés dans les secteurs 1) de la santé humaine, 2) vétérinaire, 3) agro-alimentaire, industriel et collectivité par des procédés physiques et/ou chimiques.
Methods of airborne disinfection of surfaces - Determination of bactericidal, fongicidal, yeasticidal, mycobactericidal, tuberculicidal sporicidal and virucidal activity, including bacteriophages
- ICS
- 11.080.20
- CCS
- 发布
- 2014-11-08
- 实施
- 2014-11-08
Compound Sodium Hypochlorite Disinfectant
- ICS
- 11.080.20
- CCS
- C12
- 发布
- 2014-10-14
- 实施
- 2014-12-01
Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014); German version EN ISO 11135:2014
- ICS
- 11.080.20
- CCS
- C47
- 发布
- 2014-10-01
- 实施
BS EN 16777. Chemical disinfectants and antiseptics. Quantitative non-porous surface test without mechanical action for the evaluation of virucidal activity of chemical disinfectants used in the medical area. Test method and requirements (phase…
- ICS
- 11.080.20
- CCS
- 发布
- 2014-07-28
- 实施
- 2014-07-28
