11.100.01 标准查询与下载
共找到 72 条与 相关的标准，共 5 页
Medical laboratories - Reduction of error through risk management and continual improvement
- ICS
- 11.100.01
- CCS
- N60
- 发布
- 2010-01-01
- 实施
이 기술 보고서는 KS P ISO 15189의 품질 및 적격성에 대한 특정기술 및 운영과
Medical laboratories－Guidance on laboratory implementation of KS P ISO 15189：2006
- ICS
- 11.100.01
- CCS
- C44
- 发布
- 2009-12-29
- 实施
- 2009-12-29
이 기술표준은 검사실 의료주기의 검사측면, 특히 검사 전 및 검사 후 측면과 관련하여 위험
Medical laboratories-Reduction of error through risk management and continual improvement
- ICS
- 11.100.01
- CCS
- C75
- 发布
- 2009-12-29
- 实施
- 2009-12-29
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
Validation is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled. There are numerous documents that address the topic of validation but there are few validation protocols for methods specific to seized drug analysis. This standard makes recommendations for the validation of both qualitative and quantitative methods used for the analysis of seized drugs. 1.1 This practice addresses the validation of qualitative and quantitative seized-drug analytical methods. It discusses the validation of analytical methods in terms of their part in analytical schemes and in terms of performance characteristics including brief mention of measurement uncertainty and quality control parameters. 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.
Standard Practice for Validation of Seized-Drug Analytical Methods
- ICS
- 11.100.01
- CCS
- A92
- 发布
- 2009
- 实施
Medical laboratories - Reduction of error through risk management and continual improvement
- ICS
- 11.100.01
- CCS
- C75
- 发布
- 2008-06-30
- 实施
- 2008-06-30
Medical laboratories - Reduction of error through risk management and continual improvement
- ICS
- 11.100.01
- CCS
- P33
- 发布
- 2008-06-30
- 实施
- 2008-06-30
ISO/TS 22367:2008 characterizes the application of ISO 15189 as a system for reducing laboratory error and improving patient safety by applying the principles of risk management, with reference to examination aspects, especially to pre- and post-examination aspects, of the cycle of laboratory medical care. ISO/TS 22367:2008 proposes a methodology for finding and characterizing medical laboratory error that would be avoided with the application of ISO 15189.
Medical laboratories - Reduction of error through risk management and continual improvement
- ICS
- 11.100.01
- CCS
- C75
- 发布
- 2008-05
- 实施
1.1 This International Standard specifies requirements for quality and competence particular to medical laboratories. 1.2 This International Standard is for use by medical laboratories in developing their quality management systems and assessing their own competence, and for use by accreditation bodies in confirming or recognising the competence of medical laboratories.
Medical laboratories - Particular requirements for quality and competence (ISO 15189:2007); English version of DIN EN ISO 15189:2007-08
- ICS
- 11.100.01
- CCS
- C04
- 发布
- 2007-08
- 实施
이 규격은 배출에 조절되는 일회용 유리제 혈청 피펫의 일반적인 실험실 목적의 요구 사항
Laboratory glassware－Disposable serological pipettes
- ICS
- 11.100.01
- CCS
- N64
- 发布
- 2006-12-20
- 实施
- 2006-12-20
Medical laboratories. Particular requirements for quality and competence
- ICS
- 11.100.01
- CCS
- 发布
- 2006
- 实施
- 2008-01-01
Laboratory medicine. Requirements for reference measurement laboratories
- ICS
- 11.100.01
- CCS
- 发布
- 2006
- 实施
- 2008-01-01
This Technical Report provides guidance to medical laboratories describing how a medical laboratory can implement a quality system to meet the specific technical and management requirements for quality and competence in ISO 15189:2003. Bodies engaged in the recognition of the competence of medical laboratories may also be able to use this Technical Report as a basis to assist laboratories in establishing a quality system to meet national requirements, while at the same time conforming to appropriate International Standards. This guidance applies both to newly established and existing laboratories and encompasses both the management and technical requirements of ISO 15189:2003.
Medical laboratories - Guidance on laboratory implementation of ISO 15189:2003
- ICS
- 11.100.01
- CCS
- C44
- 发布
- 2005-02
- 实施
Laboratory medicine - Requirements for reference measurement laboratories.
- ICS
- 11.100.01
- CCS
- C37
- 发布
- 2004-09-01
- 实施
- 2004-09-20
This International Standard gives the specific requirements for reference measurement laboratories in laboratory medicine. Examinations of properties with results reported on a nominal or ordinal scale are not included. This International Standard is not applicable to routine medical laboratories.
Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003); German version EN ISO 15195:2003
- ICS
- 11.100.01
- CCS
- C05
- 发布
- 2004-01
- 实施
When evaluating the results of quantitative and qualitative tests in laboratory medicine cut-off-values are needed unless reference values are not available. This standard is applicable to the determination of these cut-off-values.
Laboratory medicine - Decision-marking criteria
- ICS
- 11.100.01
- CCS
- C04
- 发布
- 2003-12
- 实施
This International Standard specifies requirements for safe practices in the medical laboratory.
Medical laboratories - Requirements for safety
- ICS
- 11.100.01
- CCS
- C04
- 发布
- 2003-11-12
- 实施
- 2003-11-12
ISO 15195:2003 gives the specific requirements for reference measurement laboratories in laboratory medicine. Examinations of properties with results reported on a nominal or ordinal scale are not included. ISO 15195:2003 is not applicable to routine medical laboratories. The general requirements for the competence of calibration laboratories are laid down in ISO/IEC 17025 for testing and calibration laboratories. ISO 15195:2003 refers to the specific aspects of calibration laboratories in the field of laboratory medicine where such "calibration laboratories" are usually denoted as "reference measurement laboratories". ISO 15195:2003 may form a basis for the accreditation of a reference measurement laboratory that applies for official recognition of the performance of a reference measurement procedure. Reference measurement laboratories are usually accredited by national metrology institutes or national accrediting bodies.
Laboratory medicine - Requirements for reference measurement laboratories
- ICS
- 11.100.01
- CCS
- C04
- 发布
- 2003-10-31
- 实施
- 2003-10-31
This International Standard specifies requirements for safe practices in the medical laboratory.
Medical laboratories - Requirements for safety
- ICS
- 11.100.01
- CCS
- C64
- 发布
- 2003-10
- 实施
This International Standard gives the specific requirements for reference measurement laboratories in laboratory medicine. Examinations of properties with results reported on a nominal or ordinal scale are not included. This International Standard is not applicable to routine medical laboratories. NOTE 1 It is the laboratory's responsibility to comply with the relevant legal health and safety requirements. NOTE 2 Requirements for routine medical laboratories are specified in ISO 15189.
Laboratory medicine - Requirements for reference measurement laboratories
- ICS
- 11.100.01
- CCS
- C44
- 发布
- 2003-10
- 实施
