C04 基础标准与通用方法 标准查询与下载
共找到 572 条与 基础标准与通用方法 相关的标准，共 39 页
Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area - Test method and requirements (phase 2, step 2).
- ICS
- 11.080.20
- CCS
- C04
- 发布
- 2009-02-01
- 实施
- 2009-02-07
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose; Technical Corrigendum 1
- ICS
- 11.080.01
- CCS
- C04
- 发布
- 2009-02
- 实施
Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1; Technical Corrigendum 1
- ICS
- 11.080.20
- CCS
- C04
- 发布
- 2009-02
- 实施
Emergency services - Terms and definitions
- ICS
- 01.040.11;11.160
- CCS
- C04
- 发布
- 2009-02
- 实施
Medical laboratories - Reduction of error through risk management and continual improvement; Technical Corrigendum 1
- ICS
- 11.100.01
- CCS
- C04
- 发布
- 2009-01
- 实施
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1
- ICS
- 11.080.01
- CCS
- C04
- 发布
- 2009-01
- 实施
This test method is designed to evaluate the virus-eliminating activity of hygienic handwash and handrub agents from experimentally-contaminated hands. Such formulations may be further assessed in a clinical trial for their effectiveness in the field. This test method incorporates whole-hand exposure and reflects actual use conditions such as friction during hand decontamination, and also enables alternate product forms such as alcohol- or non-alcohol-based liquids, gels, and foams to be tested according to label directions. It is meant to extend, if required, the results of testing with Test Method E 1838, which gives precise reductions in virus infectivity on a limited area of the hands. It may also serve as an alternative test method when product form is not amenable to testing by Test Method E 1838. This test method is not meant for use with surgical hand scrubs or preoperative skin preparations. Note 28212;Application of viruses on the entire surface of both hands entails a greater risk to the subjects than using fingerpads only. Therefore, greater care is needed to ensure that the hands of the participants are free from any apparent damage. Also, virus preparations must be thoroughly screened for, or documented to be free from, extraneous or adventitious pathogens before use in such tests. 1.1 This test method is designed to evaluate handwash or handrub agents for their ability to reduce viral contamination from hands. Note 18212;A knowledge of virological techniques is required for this test method. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 This standard may involve hazardous materials, operations and equipment. 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. The user should consult a reference for laboratory safety recommendations. (3-5)
Standard Test Method for Evaluation of Hygienic Handwash and Handrub Formulations for Virus-Eliminating Activity Using the Entire Hand
- ICS
- 11.080.20
- CCS
- C04
- 发布
- 2009
- 实施
This guide is intended to provide guidance regarding the use of risk analysis in the development, day-to-day running, and continuous improvement of pharmaceutical processes incorporating Process Analytical Technology (PAT). Since PAT is defined as being “risk-based” (see FDA Guidance for Industry), it is important that a consistent approach to the use of risk methodologies is adopted, to ensure rapid transfer of process understanding within the development and manufacturing teams, and to the regulators where that is appropriate. 4.2 This guidance only covers those aspects of risk assessment related to “risk to product quality.” Other aspects (such as “risk to patient”) should be covered in the conventional manner.1.1 This document provides guidance on the assessment of risks to product quality within and related to PAT processes in the pharmaceutical industry. It addresses those risks to product quality arising from, associated with, identified by, or modified by the implementation of PAT in pharmaceutical development and manufacturing for primary, secondary, and biotech sectors of the industry. It does not replace those assessments of risk currently undertaken by pharmaceutical companies, but is, rather, an additional component focused specifically upon the evaluation and design of PAT processes. See Practice E 2474, Guide E 2500, and ICH Q8. 1.2 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. Note that safety in this context refers to operational and operator safety, not to patient safety.
Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
- ICS
- 11.120.10
- CCS
- C04
- 发布
- 2009
- 实施
Guide for Developing a Disaster Recovery Plan for Medical Transcription Departments and Businesses
- ICS
- 13.200
- CCS
- C04
- 发布
- 2009
- 实施
These are minimum standards applicable to those performing seized-drug analyses. These standards are intended to apply to any laboratory analyst who: examines and analyzes seized drugs or related materials, or directs such examinations to be done, independently has access to unsealed evidence in order to remove samples from evidence for examination and As a consequence of such examinations, signs reports for court or investigative purposes.1.1 This practice describes prerequisite formal education, training, and continuing professional development for those performing seized-drug analysis. It also describes the kinds of professional documents (for example, texts, manuals, or journals) that should be present in laboratories where analysis of seized drugs is conducted.
Standard Practice for Education and Training of Seized-Drug Analysts
- ICS
- 71.040.40 (Chemical analysis)
- CCS
- C04
- 发布
- 2009
- 实施
1.1 This terminology standard includes terms that relate to the examination performed by forensic document examiners. Note 18212;The terms in the Terminology Section refer to typical copybook styles of writing and do not account for exceptional forms.
Standard Terminology Relating to the Examination of Questioned Documents
- ICS
- 01.040.11 ; 11.020
- CCS
- C04
- 发布
- 2009
- 实施
1.1 이 표준은 방사선을 이용한 의료기기 멸균 공정의 작업명세서 작성, 검정 및 일상적
Sterilization of health care products－Radiation－Part 1：Requirements for development, validation and routine control of a sterilization process for medical devices
- ICS
- 11.080.01
- CCS
- C04
- 发布
- 2008-12-30
- 实施
- 2008-12-30
이 표준은 멸균성에 대한 특정 요구사항을 달성하기 위해 필요한 최소선량을 결정하는 방법과2
Sterilization of health care products-Radiation-Part 2:Establishing the sterilization dose
- ICS
- 11.080.01
- CCS
- C04
- 发布
- 2008-12-30
- 实施
- 2008-12-30
이 표준은 KS P ISO 11137 제1부 및 제2부의 선량 계측 관련 요구사항에 대한
Sterilization of health care products－Radiation－Part 3：Guidance on dosimetric aspects
- ICS
- 11.080.01
- CCS
- C04
- 发布
- 2008-12-30
- 实施
- 2008-12-30
Prostheses and orthoses - Factors to be considered when specifying a prosthesis for a person who has had a lower limb amputation
- ICS
- 11.040.40;11.180.10
- CCS
- C04
- 发布
- 2008-12
- 实施
Prostheses and orthoses - Factors to be included when describing physical activity of a person who has had a lower limb amputation(s) or who has a deficiency of a lower limb segment(s) present at birth
- ICS
- 11.040.40;11.180.10
- CCS
- C04
- 发布
- 2008-12
- 实施
Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007); German version EN ISO 11140-3:2007, Corrigendum to DIN EN ISO 11140-3:2007-07; Ge
- ICS
- 11.080.20
- CCS
- C04
- 发布
- 2008-12
- 实施
Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment (IEC 61223-2-6:2006); German version EN 61223-2-6:2007
- ICS
- 11.040.50
- CCS
- C04
- 发布
- 2008-12
- 实施
1.1 This International Standard provides guidance for the selection, use and interpretation of results of chemical indicators used in process definition, validation and routine monitoring and overall control of sterilization processes. This International Standard applies to indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor one or more of the variables required of a sterilization process. These chemical indicators are not dependent for their action on the presence or absence of a living organism. 1.2 This International Standard does not consider indicators for use in those processes that rely on physical removal of microorganisms, e.g. filtration. 1.3 This International Standard is not intended to apply to indicators for use in combination processes, for example, washer disinfectors or CIP (cleaning in place) and SIP (sterilization in place).
Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008); English version of DIN EN ISO 15882:2008-12
- ICS
- 11.080.01
- CCS
- C04
- 发布
- 2008-12
- 实施
1.1 This International Standard provides guidance for the selection, use and interpretation of results of chemical indicators used in process definition, validation and routine monitoring and overall control of sterilization processes. This International Standard applies to indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor one or more of the variables required of a sterilization process. These chemical indicators are not dependent for their action on the presence or absence of a living organism. 1.2 This International Standard does not consider indicators for use in those processes that rely on physical removal of microorganisms, e.g. filtration. 1.3 This International Standard is not intended to apply to indicators for use in combination processes, for example, washer disinfectors or CIP (cleaning in place) and SIP (sterilization in place).
Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results
- ICS
- CCS
- C04
- 发布
- 2008-11-20
- 实施
