Skip to content
Please enter a keyword to search

  • PD ISO/TS 17518:2015

    Current The latest, up-to-date edition.

    Medical laboratories. Reagents for staining biological material. Guidance for users

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  31-05-2015

    Publisher:  British Standards Institution

    Add To Cart

    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Acquiring reagents for in vitro diagnostic
      staining in biology
    5 Information associated with the in vitro diagnostic
      reagent
    6 Validation and verification of biological stains
    Annex A (informative) - Checklist for establishing or
            verifying specifications for biological stains
            and dyes
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives requirements and guidance for selecting and assessing the quality of reagents to be used for in vitro diagnostic staining in biology.

    Scope - (Show below) - (Hide below)

    This Technical Specification 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.

    General Product Information - (Show below) - (Hide below)

    Committee CH/212
    Document Type Standard
    Publisher British Standards Institution
    Status Current

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO/IEC 17065:2012 Conformity assessment — Requirements for bodies certifying products, processes and services
    ISO/TR 24971:2013 Medical devices Guidance on the application of ISO 14971
    ISO 80000-9:2009 Quantities and units Part 9: Physical chemistry and molecular physics
    ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
    ISO 15189:2012 Medical laboratories — Requirements for quality and competence
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    ISO/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
    ISO 19001:2013 In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
    ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    ISO 80000-1:2009 Quantities and units — Part 1: General
    CLSI I/LA28 A2 : 2ED 2011 QUALITY ASSURANCE FOR DESIGN CONTROL AND IMPLEMENTATION OF IMMUNOHISTOCHEMISTRY ASSAYS
    ISO 18113-2:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective