C12 抗生素类药 标准查询与下载

DIN EN 14561:2006 化学消毒剂和防腐剂.评估医学领域用器械灭菌作用的定量病媒试验.试验方法和要求(第2阶段，第2步)

This EN specifies a test method (phase 2/step 2) and requirements for the minimum bactericidal activity of chemical disinfectants products that form a homogeneous, physically stable preparation in hard water and that are used for instrument disinfection in the medical area whether this instruments are defined as medical devices or not. This includes products used for the disinfection of surgical instruments, anaesthetic equipment, endoscopes etc. which are disinfected by immersion into the product.#,,#

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2) English version of DIN EN 14561:2006-08

BS EN 14561:2006 化学消毒剂和防腐剂.评估医学领域用器械灭菌作用的定量病媒试验.试验方法和要求(第2阶段，第1步)

This European Standard specifies a test method and the minimum requirements for bactericidal 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 instruments by immersion – even if they are not covered by the EEC/93/42 Directive on Medical Devices. 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 kindergardens 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 (see Annex E).

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)

BS EN 14562:2006 化学消毒剂和防腐剂.评估医学领域用器械灭真菌或酵母菌作用的定量病媒试验.试验方法和要求(第2阶段，第1步)

This European Standard specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant products for instruments 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 instruments by immersion – even if they are not covered by the EEC/93/42 Directive on Medical Devices. 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 kindergardens 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 (see Annex E).

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)

BS EN 12353:2006 化学消毒剂和防腐剂.杀菌剂、杀孢子剂和杀真菌剂活性测定用试验有机体的保存

This European Standard specifies methods for keeping test organisms used and defined in European Standards for the determination of bactericidal, mycobactericidal, sporicidal and fungicidal activity of chemical disinfectants and antiseptics drawn up by CEN/TC 216. These methods for keeping test organisms can only be carried out in connection with at least one of those standards where a reference to this standard is established. NOTE 1 Annex A (informative) contains a non-exhaustive list of test organisms for which this standard can be applied. NOTE 2 European Standards (EN and prEN) where this European Standard is referenced are listed in the Bibliography.

Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal, sporicidal and fungicidal activity

JIS Z 2801 AMD 1:2006 抗菌产品.抗菌活性和功效的试验.修改件1

Antimicrobial products -- Test for antimicrobial activity and efficacy (Amendment 1)

NF T72-204:2006 化学消毒剂和防腐剂.评估兽医领域中用化学消毒剂和防腐剂灭真菌或酵母菌活性的定量悬浮试验.试验方法和要求(第2阶段,第1步)

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticical activity of chemical desinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1).

DIN EN 14675:2006 化学消毒剂和防腐剂.评估兽医用化学消毒剂和防腐剂的杀病毒剂活性的定量悬浮试验.试验方法和要求(第2阶段,第1步)

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 - with water. This European Standard applies to products that are used in the veterinary area i.e. in the breeding, husbandry, production, transport and disposal of all animals except when in the food chain following death and entry to the processing industry.

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1); English version of DIN E

DIN EN 1275:2006 化学消毒剂和防腐剂.化学消毒剂和防腐剂基本灭真菌或酵母菌作用评价的定量悬浮液试验.试验方法和要求(第1阶段)

This European Standard specifies a test method and the minimum requirements for basic fungicidal or basic yeasticidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted 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 water. This European Standard applies to active substances (antifungal biocides) and to formulations under development that are planned to be used in food, industrial, domestic and institutional, medical and veterinary areas. It applies also to the evaluation of fungicidal or yeasticidal activity of chemical antiseptics and disinfectants when appropriate standards are not available. NOTE 1 This European Standard does not evaluate the activity of a product for an intended use. NOTE 2 This method corresponds to a phase 1 test (Annex F).

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic fungicidal or basic yeasticidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1); English version of DIN EN 1275:2

DIN EN 1040:2006 化学消毒剂和防腐剂.化学消毒剂和防腐剂基本杀菌作用评价的定量悬浮液试验.试验方法和要求(第1阶段)

The document specifies a test method and requirements for minimum bactericidal activity of chemical disinfectant and antiseptic products that form a homogenous physically stable preparation in water. The document is applicable to products for use in agricultural (but not crop protection), domestic service, food hygiene and other industrial fields, institutional, medical and veterinary applications.

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1); English version of DIN EN 1040:2006-03

NF T72-503:2005 化学消毒剂和防腐剂.外科手消毒.试验方法和要求(第2阶段/第2步)

Chemical disinfectants and antiseptics - Surgical hand disinfection - Test method and requirement (phase 2/step 2).

BS EN 14476:2005 化学消毒剂和防腐剂.人类医学中使用的化学消毒剂和防腐剂的病毒定量悬浮试验.试验方法和要求(第2阶段,第1步)

This document specifies a test method and the minimum requirements for virucidal activity of chemical disinfectants or antiseptic products for instruments, surfaces or hands that form a homogeneous physically stable preparation when diluted with hard water - or in the case of ready-to-use products - with water. This document is applicable to a broad spectrum of viruses (Annex B) and 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. It is impossible to determine the virucidal activity of the undiluted product as some dilution is always produced by adding the inoculum and interfering substance. However, a disinfectant or antiseptic which is used in undiluted form is tested in 80% concentration and shall pass this test prior to further assessment. 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 F).

Chemical disinfectants and antiseptics - Virucidal quantitative suspension test for chemical disinfectants and antiseptics used in human medicine - Test method and requirements (phase 2, step 1)

BS EN 14347:2005 化学消毒剂和防腐剂.基本杀孢子活性.试验方法和要求(阶段1、步骤1)

This document specifies a test method (phase 1) and the minimum requirements for sporicidal activity of chemical disinfectant or antiseptic products that form a homogeneous, physically stable preparation when diluted 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. This document applies to products that are used in agricultural (but not crop protection), domestic service, food hygiene and other industrial fields, institutional, medical and veterinary applications. NOTE 1 This method cannot be applied for testing sporicidal activity of a product against spores of Clostridium sp. NOTE 2 This document does not evaluate the activity of a product for an intended use. More specific test methods described in European Standards (see Introduction) are used for further assessement of the efficacy of chemical disinfectants and antiseptics for a defined purpose. NOTE 3 This method corresponds to a phase 1 test (Annex E).

Chemical disinfectants and antiseptics - Basic sporicidal activity - Test method and requirements (phase 1, step 1)

DIN EN 14348:2005 化学消毒剂和抗菌剂.包括仪器消毒剂在内的医用化学消毒剂的杀霉菌活性的评价的定量悬浮试验.试验方法和要求(阶段2,步骤1)

The standard specifies test methods and requirements for the mycobacterial activity of chemical disinfectants and antiseptics that are used in human medicine. The project is also applicable to disinfectants for instruments.

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); Germa

BS EN 14348:2005 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)

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).

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)

ASTM E1589-05 评定急救抗菌药品的标准试验方法

The procedures in this test method should be used for in vivo evaluation the antimicrobial activity of drug products applied topically to the skin that are intended to help prevent infection in minor cuts, scrapes and burns. 5.1.1 This test method is applicable for testing liquids, ointments, powders, films, or dressing containing or impregnated with an antimicrobial for their effect to reduce an enhanced skin microflora or their effects to suppress the growth of the skin flora, or both.1.1 The tests described in this test method are designed to evaluate antimicrobial agents in formulations intended for use as first aid antiseptic products for their ability to reduce or suppress the growth, or both, of the skin microflora.1.2 A knowledge of microbiological techniques is required for these procedures.1.3 The values stated in SI units are to be regarded as the 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.1.4 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects. (See CFR Parts 50 and 56.)

Standard Test Method for Evaluation of First Aid Antiseptic Drug Products

BS EN 14349:2004 化学消毒剂和防腐剂.兽医领域无机械运动无孔表面用化学消毒剂和防腐剂的细菌活性评价用定量表面试验.试验方法和要求(第2阶段/第2步)

This document specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant and antiseptic products that form a homogeneous physically stable preparation in hard water or -in the case of ready-to-use - with water. This document is applicable to products for use in the veterinary field i.e. in the breeding, husbandry, production, transport and disposal of all animals except when in the food chain following death and entry to the processing industry. NOTE 1 Mycobacteria are the subject of a separate standard. NOTE 2 This method corresponds to a Phase 2 Step 2 test (Annex E).

Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of bacterial activity of chemical disinfectants and antiseptics used in the veterinary field on non-porous surfaces without mechanical action - Test method and requireme

BS EN 14204:2004 化学消毒剂和防腐剂.兽医领域中使用的化学消毒剂和防腐剂灭分支杆菌活性评定的定量悬浮试验.试验方法和要求(第2阶段/第1步)

This European Standard specifies a test method and the minimum requirements for mycobactericidal 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, 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 veterinary area - i.e. in the breeding, husbandry, production, transport and disposal of all animals except when in the food chain following death and entry to the processing industry. 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 (Annex F).

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants and antiseptics used in the veterinary field - Test method and requirements (phase 2, step 1)

SN/T 1411-2004 国境口岸常用卫生处理药物中毒急救规程

Emergency rescue codes for druggery poisoning in sanitary treatment at frontier ports

ASTM E1482-04 杀病毒剂功效评价中杀病毒剂中和作用的标准试验方法

This test method is to be used for the removal of virucidal agents from agent-virus mixtures, or from agent-neutralizer-virus mixtures, after the contact period and before the inoculation of these mixtures into host systems for assay of infectivity. The purpose of the test method is to reduce the concentration of agents and neutralizers in order to permit the evaluation of viral infectivity at dilutions that would otherwise be toxic to the host. The test method is applicable to the testing of liquid and pressurized disinfectant products. This test method is compatible with organic soil loads, hard water, disinfectants containing organic solvents, and chemical neutralizers.1.1 This test method covers the use, in conjunction with evaluations of the virucidal efficacy, of disinfectant solutions or pressurized disinfectant spray products intended for use on inanimate nonporous environmental surfaces or for other special applications. The test method may be employed with all viruses and host systems.1.2 This test method should be performed only by persons trained in microbiology and virology.1.3 This test method utilizes gel filtration technology. The effectiveness of the test method is dependent on the ratio of gel bed volume to sample size and uniformity in the preparation of columns and centrifugation conditions. The effectiveness of this test method is maximized by investigator practice and experience with gel filtration techniques.1.4 This test method will reduce, but not necessarily eliminate, disinfectant toxicity while preserving the titer of input virus.1.5 The values stated in SI units are to be regarded as the standard.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 Test Method for Neutralization of Virucidal Agents in Virucidal Efficacy Evaluations

BS EN 13727:2003 化学消毒剂和防腐剂.医疗器械用化学消毒剂杀菌活性评价的定量悬浮试验.试验方法和要求(第2阶段/第1步)

This European Standard specifies a test method and the minimum requirements for bactericidal 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 European Standard applies to products that are used in the medical area for disinfecting instruments by immersion - even if they are not covered by the EEC/93/42 Directive on Medical Devices. 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 (see annex E).

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (Phase 2/Step 1)