Taratura, armonizzazione e standardizzazione nelle nuove ISO 17511 e ISO 21151 - SIPMeL

RESOLUTIONS APPROVED AT THE 23rd EA GENERAL ASSEMBLY
LUXEMBOURG
27 & 28 MAY 2009
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EA Resolution 2009 (23) 04
The General Assembly agrees to the transfer of the EA membership jointly from SINCERT and SINAL to the legal entity named ACCREDIA. The date of transfer is to be determined by ACCREDIA and notified to EA in advance.

EA Resolution 2009 (23) 05
The General Assembly agrees to the transfer of the EA membership from SIT (INRIM) to the legal entity named COPA.
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EA Resolution 2009 (23) 25
Following the Laboratory Committee’s recommendation, the General Assembly endorses the Terms of Reference of the EA Health Care WG for Laboratory Medicine (as set out in Document EA/LC(06)07rev5).

EA Resolution 2009 (23) 26
The General Assembly resolves that an accreditation body, when accrediting laboratories for Point of Care Testing (POCT) activities, shall use ISO 22870 in combination with either ISO 15189 or ISO/IEC 17025 as the accreditation criteria.
The accreditation of POCT against ISO 22870 in combination with ISO 15189 or ISO/IEC 17025 is covered under the EA-MLA for testing.

EA Resolution 2009 (23) 27
The General Assembly resolves that an accreditation body, when accrediting a medical reference laboratory, shall use ISO/IEC 17025 together with ISO 15195 as the accreditation criteria.
The accreditation of medical reference laboratories against ISO 15195 in combination with ISO/IEC 17025 is covered under the EA MLA for calibration.
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The World Conference on Doping in Sport held in Lausanne on 2-4 February 1999 produced the Lausanne Declaration on Doping in Sport. This document provided for the creation of an independent international anti-doping agency to be fully operational for the Games of the XXVII Olympiad in Sydney in 2000. Pursuant to the terms of the Lausanne Declaration, the World Anti-Doping Agency was established on 10 November 1999 in Lausanne to promote and coordinate the fight against doping in sport internationally. WADA was set up as a foundation under the initiative of the IOC with the support and participation of intergovernmental organizations, governments, public authorities, and other public and private bodies fighting against doping in sport. The agency consists of equal representatives from the Olympic Movement and public authorities.

http://www.wada-ama.org/en/dynamic.ch2?pageCategory.id=372
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International Standard for Laboratories (version 5.0) (Effective January 1, 2008)
Minimum Required Performance Limits for Detection of Prohibited Substances
Identification Criteria for Qualitative Assays Incorporating Chromatography and Mass Spectrometry
Laboratory Internal Chain of Custody
Laboratory Documentation Packages
Reporting and Evaluation Guidance for Testosterone, Epitestosterone, T/E Ratio and other Endogenous Steroids
Reporting Norandrosterone Findings
Harmonization of the Method for the Identification of Epoetin Alfa and Beta (rEPO) and Darbepoetin Alfa (NESP) by IEF-Double Blotting and Chemiluminescent Detection

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Struttura e meccanismo delle decisioni:
KwakISOTC215decisionstructure.pdf

I documenti in lavorazione:
estrattoKwakReport2007isoTC215standards.pdf
Yun Sik Kwak, MD, PhD
Dept Med Info., Kyungpook Nat’l Univ Sch MedDaegu, Korea

Esempi:
• ISO/TR 22221:2006 Health informatics -Good principles and practices for a clinical data warehouse
• ISO/TR 16056-1:2004 Health informatics -Interoperability of telehealth systems and networks -Part 1: Introduction and definitions
• ISO 17115:2007 Health informatics -Vocabulary for terminological systems
• ISO/TS21091:2005 Health informatics -Directory services for security, communications and identification of professionals and patients
• ISO/TS 22600-1:2006 Health informatics -Privilege management and access control -Part 1: Overview and policy management
• ISO 21549-7:2007 Health informatics -Patient healthcard data -Part 7: Medication data
• ISO/TS 25238:2007 Health informatics -Classification of safety risks from health software
• ISO/TR 27809:2007 Health informatics -Measures for ensuring patient safety of health software

Notizie su ISO TC 215: http://en.wikipedia.org/wiki/ISO_TC_215

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ASTM E387-04

Standard Test Method for Estimating Stray Radiant Power Ratio of Dispersive Spectrophotometers by the Opaque Filter Method

1.1 Stray radiant power (SRP) can be a significant source of error in spectrophotometric measurements, and the danger that such error exists is enhanced because its presence often is not suspected (). This test method affords an estimate of the relative radiant power, that is, the Stray Radiant Power Ratio (SRPR), at wavelengths remote from those of the nominal bandpass transmitted through the monochromator of an absorption spectrophotometer. Test-filter materials are described that discriminate between the desired wavelengths and those that contribute most to SRP for conventional commercial spectrophotometers used in the ultraviolet, the visible, the near infrared, and the mid-infrared ranges. These procedures apply to instruments of conventional design, with usual sources, detectors, including array detectors, and optical arrangements. The vacuum ultraviolet and the far infrared present special problems that are not discussed herein.

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