ISO/TS 17518:2015
Current
The latest, up-to-date edition.
Medical laboratories — Reagents for staining biological material — Guidance for users
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
English, French
16-04-2015
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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.
| DocumentType |
Technical Specification
|
| Pages |
15
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Standards | Relationship |
| XP ISO/TS 17518 : 2015 XP | Identical |
| NEN NPR ISO/TS 17518 : 2015 | Identical |
| PD 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 |
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, flexible and cost effective.