PD ISO/TS 17518:2015
Current
The latest, up-to-date edition.
Medical laboratories. Reagents for staining biological material. Guidance for users
Hardcopy , PDF
English
31-05-2015
Important note : All end users must be registered with an Account prior to user licenses being assigned.
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
Gives requirements and guidance for selecting and assessing the quality of reagents to be used for in vitro diagnostic staining in biology.
| Committee |
CH/212
|
| DocumentType |
Standard
|
| Pages |
26
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
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.
| Standards | Relationship |
| ISO/TS 17518:2015 | Identical |
| 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 |
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