calibrator
This form is printed by the
tracked documents, each as a document defines it. The index’s key is
calibrator (the definitions derivation’s fold:
case set aside, spaces collapsed; each form is matched exactly as printed).
1 observed text defines it.
Counts below are over each row’s current text, the
81 of 126 current
texts the derivation read; a title is read for every one of the 132 tracked rows.
Defined
1 definition in 1 current text, as the definitions derivation’s rules read them, quoted where the term and its text together sit under the quote cap.
- EU IVDR
EUtext first observedchapter-i/section-1/article-2(55)calibrator: a measurement reference material used in the calibration of a device;
In normative sentences
1 sentence in 1 current text
printing one of the forms in the heading and one of the sentence derivation’s listed verbs (shall, should, must, is expected, may). A sentence is a row of printed words; nothing here calls it a requirement. A defining occurrence that lies inside such a sentence is counted here and under Defined; only In body leaves out both.
Each sentence is given by the clause the sentence derivation places it under and the verbs it prints, grouped by clause, each clause followed by its count of sentences; its words are not quoted here, and are served by their offsets at /api/v1/modal-sentences.json.
- EU IVDR
EU1 sentence; text first observedchapter-i/section-1/article-2: 1 sentence (shall, may)
In titles
0 tracked rows whose titles print one of the forms in the heading, read from the title this record holds, by the same exact rule.
No tracked row’s title prints it.
In body
2 occurrences in 1 current text outside every sentence above and outside the term’s own definitions, each counted under the clause anchor the clause-anchor derivation placed last before it; each clause is followed by its count.
- EU IVDR
EU2 occurrences; text first observedannex-ii/6.1.2.4: 1 ·chapter-i/section-1/article-2: 1
Co-occurrence
83 other terms of the index share at least one clause of a current text with this one: a clause a definition sits in, the clause of a sentence above, or the clause a body occurrence is counted under. Terms in order of their key; each with the count of clauses shared and the clauses, by row.
- accessory for an in vitro diagnostic medical device 1 clause:
eu-ivdrchapter-i/section-1/article-2 - adverse event 1 clause:
eu-ivdrchapter-i/section-1/article-2 - analytical performance 1 clause:
eu-ivdrchapter-i/section-1/article-2 - authorised representative 1 clause:
eu-ivdrchapter-i/section-1/article-2 - benefit-risk determination 1 clause:
eu-ivdrchapter-i/section-1/article-2 - CE marking 1 clause:
eu-ivdrchapter-i/section-1/article-2 - CE marking of conformity 1 clause:
eu-ivdrchapter-i/section-1/article-2 - clinical benefit 1 clause:
eu-ivdrchapter-i/section-1/article-2 - clinical data 1 clause:
eu-ivdrchapter-i/section-1/article-2 - clinical evidence 1 clause:
eu-ivdrchapter-i/section-1/article-2 - clinical performance 1 clause:
eu-ivdrchapter-i/section-1/article-2 - companion diagnostic 1 clause:
eu-ivdrchapter-i/section-1/article-2 - conformity assessment 1 clause:
eu-ivdrchapter-i/section-1/article-2 - conformity assessment body 1 clause:
eu-ivdrchapter-i/section-1/article-2 - control material 2 clauses:
eu-ivdrannex-ii/6.1.2.4·chapter-i/section-1/article-2 - corrective action 1 clause:
eu-ivdrchapter-i/section-1/article-2 - device deficiency 1 clause:
eu-ivdrchapter-i/section-1/article-2 - device for near-patient testing 1 clause:
eu-ivdrchapter-i/section-1/article-2 - device for performance study 1 clause:
eu-ivdrchapter-i/section-1/article-2 - device for self-testing 1 clause:
eu-ivdrchapter-i/section-1/article-2 - diagnostic sensitivity 1 clause:
eu-ivdrchapter-i/section-1/article-2 - diagnostic specificity 1 clause:
eu-ivdrchapter-i/section-1/article-2 - distributor 1 clause:
eu-ivdrchapter-i/section-1/article-2 - economic operator 1 clause:
eu-ivdrchapter-i/section-1/article-2 - ethics committee 1 clause:
eu-ivdrchapter-i/section-1/article-2 - European standard 1 clause:
eu-ivdrchapter-i/section-1/article-2 - falsified device 1 clause:
eu-ivdrchapter-i/section-1/article-2 - field safety corrective action 1 clause:
eu-ivdrchapter-i/section-1/article-2 - field safety notice 1 clause:
eu-ivdrchapter-i/section-1/article-2 - fully refurbishing 1 clause:
eu-ivdrchapter-i/section-1/article-2 - generic device group 1 clause:
eu-ivdrchapter-i/section-1/article-2 - harmonised standard 1 clause:
eu-ivdrchapter-i/section-1/article-2 - health institution 1 clause:
eu-ivdrchapter-i/section-1/article-2 - importer 1 clause:
eu-ivdrchapter-i/section-1/article-2 - in vitro diagnostic medical device 1 clause:
eu-ivdrchapter-i/section-1/article-2 - incident 1 clause:
eu-ivdrchapter-i/section-1/article-2 - informed consent 1 clause:
eu-ivdrchapter-i/section-1/article-2 - instructions for use 1 clause:
eu-ivdrchapter-i/section-1/article-2 - intended purpose 1 clause:
eu-ivdrchapter-i/section-1/article-2 - interventional clinical performance study 1 clause:
eu-ivdrchapter-i/section-1/article-2 - investigator 1 clause:
eu-ivdrchapter-i/section-1/article-2 - kit 1 clause:
eu-ivdrchapter-i/section-1/article-2 - label 1 clause:
eu-ivdrchapter-i/section-1/article-2 - lay person 1 clause:
eu-ivdrchapter-i/section-1/article-2 - lifetime 1 clause:
eu-ivdrchapter-i/section-1/article-2 - likelihood ratio 1 clause:
eu-ivdrchapter-i/section-1/article-2 - making available on the market 1 clause:
eu-ivdrchapter-i/section-1/article-2 - manufacturer 1 clause:
eu-ivdrchapter-i/section-1/article-2 - market surveillance 1 clause:
eu-ivdrchapter-i/section-1/article-2 - medical device 1 clause:
eu-ivdrchapter-i/section-1/article-2 - negative predictive value 1 clause:
eu-ivdrchapter-i/section-1/article-2 - notified body 1 clause:
eu-ivdrchapter-i/section-1/article-2 - operator 1 clause:
eu-ivdrchapter-i/section-1/article-2 - performance 1 clause:
eu-ivdrchapter-i/section-1/article-2 - performance evaluation 1 clause:
eu-ivdrchapter-i/section-1/article-2 - performance of a device 1 clause:
eu-ivdrchapter-i/section-1/article-2 - performance study 1 clause:
eu-ivdrchapter-i/section-1/article-2 - performance study plan 1 clause:
eu-ivdrchapter-i/section-1/article-2 - placing on the market 1 clause:
eu-ivdrchapter-i/section-1/article-2 - positive predictive value 1 clause:
eu-ivdrchapter-i/section-1/article-2 - post-market surveillance 1 clause:
eu-ivdrchapter-i/section-1/article-2 - predictive value 1 clause:
eu-ivdrchapter-i/section-1/article-2 - putting into service 1 clause:
eu-ivdrchapter-i/section-1/article-2 - recall 1 clause:
eu-ivdrchapter-i/section-1/article-2 - representative 1 clause:
eu-ivdrchapter-i/section-1/article-2 - Risk / risk 1 clause:
eu-ivdrchapter-i/section-1/article-2 - scientific validity of an analyte 1 clause:
eu-ivdrchapter-i/section-1/article-2 - serious adverse event 1 clause:
eu-ivdrchapter-i/section-1/article-2 - serious incident 1 clause:
eu-ivdrchapter-i/section-1/article-2 - serious public health threat 1 clause:
eu-ivdrchapter-i/section-1/article-2 - single-use device 1 clause:
eu-ivdrchapter-i/section-1/article-2 - software 1 clause:
eu-ivdrchapter-i/section-1/article-2 - specimen receptacle 1 clause:
eu-ivdrchapter-i/section-1/article-2 - sponsor 1 clause:
eu-ivdrchapter-i/section-1/article-2 - standard 1 clause:
eu-ivdrchapter-i/section-1/article-2 - subject 1 clause:
eu-ivdrchapter-i/section-1/article-2 - System / system 1 clause:
eu-ivdrchapter-i/section-1/article-2 - UDI 1 clause:
eu-ivdrchapter-i/section-1/article-2 - Union harmonisation legislation 1 clause:
eu-ivdrchapter-i/section-1/article-2 - Unique Device Identifier 1 clause:
eu-ivdrchapter-i/section-1/article-2 - user 1 clause:
eu-ivdrchapter-i/section-1/article-2 - withdrawal 1 clause:
eu-ivdrchapter-i/section-1/article-2 - written 1 clause:
eu-ivdrchapter-i/section-1/article-2
History
Every text of each row holding the term in any text the store holds under the current version, in the order the texts were first observed. A row’s current text is marked.
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
903e40aaebe6 (current) | 1 | 1 | 2 |
Feed
/atom/term/calibrator.atom carries one entry for each text of a row whose counts above differ from the row’s previous text, and one for the first text of a row holding the term, dated by the text’s first observation. A new version of the derivation is a change of method and is never an entry.
How this page is derived
From the terms-index derivation’s current version, first derived on
, read from
state/terms-index.jsonl. Threshold: a key enters the index when at least 1 observed text of a tracked row defines it, under the definitions derivation's current version. Its version, its rules and
term set, and the versions of the clause-anchor, definitions and sentence derivations it joins, are on
the derivation methods page, which lists every version of each with
the day it was first derived: a change there is a change of method, never a change in a text.
Not read: a term printed in a form no definition under its key carries: a plural or other ending, another letter case, another spacing or a line break between its words, a hyphenated or abbreviated form, a translation; a term a document defines in a form head 3's rules do not read (its own not_reached names them), which enters no key; an occurrence in a text head 1 refused, which is not read; a title is read for its row and is not dated by a text. A position states where an occurrence lies in a text and nothing about what the text says of the term.
| Entry | text_retained | licence_class | quote_allowed | snapshot_available |
|---|---|---|---|---|
| EU IVDR | true | open | true | true |
| EU MDR | true | open | true | true |
| EU AI Act | true | open | true | true |
| EU Cyber Resilience Act | true | open | true | true |
| EU Machinery Regulation | true | open | true | true |
| EU Cybersecurity Act | true | open | true | true |
| EU NIS2 Directive | true | open | true | true |
| ICH Q9(R1) | true | open | true | true |
| ICH Q13 | true | open | true | true |
| EU GMP Chapter 4 | true | open | true | true |
One row for each entry whose own characters this page prints: a text defining a form printed here, or a definition quoted. A row named or linked without its characters printed, or whose title only or sentence clauses only are given, has no row.
Each value is read by the same function the API reads, and each field is defined in the published schema. None of the four is a grant.
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