Standards search

Manufacturers’considerations for in vitro diagnostic medical devices in a public health crisis

30.60 Close of voting/ comment period

Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood — Part 1: Isolated RNA

30.99 CD approved for registration as DIS

Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood — Part 2: Isolated DNA

30.99 CD approved for registration as DIS

Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood — Part 3: Preparations for analytical CTC staining

30.99 CD approved for registration as DIS

In vitro diagnostic medical devices — Requirements for reference measurement procedures

40.60 Close of voting

In vitro diagnostic medical devices — Requirements for certified reference materials and the content of supporting documentation

40.60 Close of voting

In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 3: Interpretation and reports

40.99 Full report circulated: DIS approved for registration as FDIS

Medical laboratories — Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests

40.60 Close of voting

Guidance on the validation and verification of quantitative and qualitative methods

00.00 Proposal for new project received

Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for saliva – Isolated DNA

00.00 Proposal for new project received

Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 3: Disc diffusion reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases

00.00 Proposal for new project received

Guidance for emerging technologies intended for medical laboratory use

00.00 Proposal for new project received

Guidance on personnel training and competence

00.00 Proposal for new project received

Clinical laboratory testing — Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing

90.20 Standard under periodical review

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

90.93 Standard confirmed

Medical laboratories — Practical guidance for the estimation of measurement uncertainty

90.93 Standard confirmed

Requirements and recommendations for supervisors and operators of point-of-care testing (POCT) equipment

60.00 Standard under publication

Guidance for supervisors and operators of point-of-care testing (POCT) devices

90.92 Standard to be revised