Product families
These links search words in indexed titles within the product group. A search match is a candidate for scope review.
Product scope and configuration
Specimens, intended purpose and analytical and clinical performance for diagnostic devices and systems. Define the features below in the product description. They establish the questions to take to the official scope and to the technical evidence.
Keep the description tied to the supplied configuration, including accessories, settings and installation conditions. Record any differences between the product offered and the object examined.
Standard reference discovery
174 bibliographic discovery matches in this group. Matches use official titles, reference families and available ICS classification.
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials
Biotechnology - Guidance for quality control of diagnostic kits used in agriculture, plant and animal pest and disease control and environmental contamination
In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
Evidence priorities
- Intended purpose
Define the object and the question, then identify the controlled record that answers it. Keep the basis, supporting evidence and limits with the resulting conclusion.
- Assay configuration
Define the object and the question, then identify the controlled record that answers it. Keep the basis, supporting evidence and limits with the resulting conclusion.
- Performance study design
Retain the method, assessed configuration, conditions, results and decision together. A report title alone does not establish the scope or limits of the conclusion.
- Calibration and traceability
Connect the assessed design with the released production specification. Keep change decisions, supplier controls and traceability records available for subsequent review.
- Sample handling
Show the differences between supplied variants and assessed specimens. Explain the coverage argument for each difference and identify questions that require further evidence.
A complete file connects the product definition, requirements, assessment evidence and production changes. Read the standard's full requirements when designing the assessment; the index provides the official entry point.
Award evidence schedule for this product group →
The free IESQ Award requires the applicable baseline to be satisfied and a supported margin in a relevant core characteristic. A standard-reference match alone does not establish eligibility.
Legislation research routes
- Medical devices (Directive 93/42/EEC)
- Medical devices (Regulation 2017/745)
- Active implantable medical devices (Directive 90/385/EEC)
- In vitro diagnostic medical devices (Directive 98/79/EC)
- In vitro diagnostic medical devices (Regulation 2017/746)
The frameworks associated with indexed references are discovery routes. The product's characteristics and intended use determine which legislation requires examination.