In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materialsBS EN ISO 18153: 2003 specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement of the catalytic concentration of enzymes. The calibrators and control materials are those provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices. The following subjects are outside the scope of this standard: a)

Annex D Sample backing material

0 mm and larger having a thickness of 3

It defines a standard set of system configurations under which the structural design is carried out

Annex B (informative) Support centres

Have adopted a consistent holistic approach to information security

2 Neck pivot (P) points

Textile machinery designers

and seed drills with integrated and inseparable powered soil-working tools used in agriculture

BS ISO 15686-8 gives guidance on RSL issues and a means of determining the ESL through application of the factor method

industrial

Level 3: BS EN ISO 21535 - Specific requirements for types of non-active surgical implant

It also specifies controls for heating