11.100.01 标准查询与下载
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Application of medical laboratory risk management in medical laboratories
- ICS
- 11.100.01
- CCS
- C30
- 发布
- 2023-11-27
- 实施
- 2024-06-01
This document provides practical guidance for the estimation and expression of the measurement uncertainty (MU) of quantitative measurand values produced by medical laboratories. Quantitative measurand values produced near the medical decision threshold by point-of-care testing systems are also included in this scope. This document also applies to the estimation of MU for results produced by qualitative (nominal) methods which include a measurement step. It is not recommended that estimates of MU be routinely reported with patient test results, but should be available on request. NOTE See Annex B for an example of application of the MU.
Medical laboratories — Practical guidance for the estimation of measurement uncertainty
- ICS
- 11.100.01
- CCS
- 发布
- 2024-04-25
- 实施
ISO/TS 17518:2015 provides requirements and guidance for selecting and assessing the quality of reagents to be used for in vitro diagnostic staining in biology. This Technical Specification applies to the professional use of reagents for staining in biology by medical laboratories, and in particular, to those who are responsible for the requisition and evaluation of these reagents in medical laboratory disciplines such as clinical cytology, haematology, histopathology, microbiology, and molecular biology.
Medical laboratories — Reagents for staining biological material — Guidance for users
- ICS
- 11.100.01
- CCS
- 发布
- 2024-04-25
- 实施
This document specifies the minimum requirements for equipment and critical aspects of the test methods for best practice in laboratories performing basic examination of human semen collected by ejaculation. This document is applicable to the entire process of basic manual semen examination and also to sample preparation for Computer-Aided Sperm Analysis (CASA). This document does not apply to the post-vasectomy assessments. NOTE Given the medico-legal ramifications surrounding the evaluation of post-vasectomy ejaculates, the methodology in this document is in all likelihood inadequate to establish an ejaculate as being completely “clear” (i.e. no spermatozoa in the ejaculate).
Basic semen examination — Specification and test methods
- ICS
- 11.100.01
- CCS
- 发布
- 2023-05-03
- 实施
This document provides requirements and recommendations for the design, development, verification, validation and implementation of analytical tests for detecting the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using nucleic acid amplification. It addresses pre-examination, examination and post-examination process steps for human specimens. This document is applicable to medical laboratories. It is also intended to be used by in vitro diagnostic developers and manufacturers, as well as by institutions and organizations supporting SARS-CoV-2 research and diagnostics. This document does not apply to environmental samples.
In vitro diagnostic test systems - Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods (ISO/TS 5798:2022)
- ICS
- 11.100.01
- CCS
- 发布
- 2022-11-30
- 实施
- 2023-02-28
1.1 This guide outlines the parameters to consider when designing in vitro tests to assess the potential impact of a delivery device on a cellular product being dispensed. This guide does not provide specific protocols, but rather suggests what should be considered the minimum characterization necessary to assess device cytocompatibility. Topics discussed include selecting an appropriate cell line(s), cell physiology parameters to measure, and relevant test procedure variables. Only cells suspended in liquid and infused through a device are considered. Cell therapies paired with scaffolds, suspended in hydrogels, or administered via other methods (e.g., tissue grafting) are not included in the scope of this document. This document does not address physical characterization of delivery devices, such as mechanics, composition, or degradation. 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. 1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies
- ICS
- 11.100.01
- CCS
- 发布
- 2022-05-12
- 实施
Laboratory glassware－Disposable serological pipettes
- ICS
- 11.100.01
- CCS
- 发布
- 20211231
- 实施
- 20211231
ISO/TS 20658:2017 specifies requirements and good practice recommendations for the collection, transport, receipt and handling of samples intended for medical laboratory examinations. ISO/TS 20658:2017 is applicable to medical laboratories and other medical services involved in laboratory pre-examination processes that include the examination request, patient preparation and identification, sample collection, transport, receipt and storage. It may also be applicable to some biobanks. ISO/TS 20658:2017 does not apply to blood and blood products intended for transfusion.
Medical laboratories — Requirements for collection, transport, receipt, and handling of samples
- ICS
- 11.100.01
- CCS
- 发布
- 2021-07-01
- 实施
Management and safety requirements for clinical laboratory pre-analytical automation system
- ICS
- 11.100.01
- CCS
- 发布
- 20201230
- 实施
- 20201230
What is ISO 22367 about? ISO 22367 discusses risk management for medical laboratories. ISO 22367 outlines a process for a medical laboratory to identify and manage the risks to patients, laboratory workers, and service providers associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling, and monitoring the risks. The requirements in ISO 22367 apply to all aspects of the examinations and services of a medical laboratory, including the pre-examination and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record, and other technical and management processes described in ISO 15189 . Note 1: ISO 22367 does not specify acceptable levels of risk. Note 2: ISO 22367 does not apply to risks from post-examination clinical decisions made by healthcare providers. Note 3: ISO 22367 does not apply to the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks...
Medical laboratories. Application of risk management to medical laboratories
- ICS
- 11.100.01
- CCS
- 发布
- 2020-05-31
- 实施
- 2020-05-31
This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks. The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record and other technical and management processes described in ISO 15189. This document does not specify acceptable levels of risk. This document does not apply to risks from post-examination clinical decisions made by healthcare providers. This document does not apply to the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.
Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020)
- ICS
- 11.100.01
- CCS
- 发布
- 2020-03-11
- 实施
- 2020-06-30
Medical laboratories－Guidance on laboratory implementation of KS P ISO 15189：2006
- ICS
- 11.100.01
- CCS
- 发布
- 20191223
- 实施
- 20191223
BS ISO 17822-2. In vitro diagnostic test systems. Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens - Part 2. Laboratory quality practice guide
- ICS
- 11.100.01
- CCS
- 发布
- 2019-11-11
- 实施
- 2019-11-11
Tests of the PCR kits used to identify target taxa of microorganisms, plants and genetically modified organisms. Quality requirements, safety, transportation and storage
- ICS
- 11.100.01
- CCS
- C53
- 发布
- 2016
- 实施
- 2017-06-01
Scope is not provided for this standard
Medical laboratories -- Reduction of error through risk management and continual improvement
- ICS
- 11.100.01
- CCS
- 发布
- 2015-12-21
- 实施
Scope is not provided for this standard
Medical laboratories -- Requirements for safety
- ICS
- 11.100.01
- CCS
- 发布
- 2015-12-21
- 实施
Management and safety requirements for clinical laboratory pre-analytical automation system
- ICS
- 11.100.01
- CCS
- C50
- 发布
- 2015-07-31
- 实施
Medical laboratories. Particular requirements for quality and competence
- ICS
- 11.100.01
- CCS
- N60
- 发布
- 2015
- 实施
- 2016-06-01
Medical laboratories. Reduction of errors through risk management and continual improvement
- ICS
- 11.100.01
- CCS
- 发布
- 2015
- 实施
- 2016-06-01
Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15); German version EN ISO 15189:2012
- ICS
- 11.100.01
- CCS
- P34
- 发布
- 2014-11-01
- 实施
