About CEN
The European Committee for Standardization is one of three European Standardization Organizations (together with CENELEC and ETSI) that have been officially recognized by the European Union and by the European Free Trade Association (EFTA) as being responsible for developing and defining voluntary standards at European level.
- |
Project
| Reference | EN ISO 15194:2009 |
|---|---|
| Title | In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009) |
| Work Item Number | 00140062 |
| Abstract/Scope | ISO 15194:2009 specifies requirements for certified reference materials and the content of their supporting documentation, in order for them to be considered of higher metrological order in accordance with ISO 17511. It is applicable to certified reference materials classifiable as primary measurement standards, secondary measurement standards and international conventional calibrators that function either as calibrators or trueness control materials. ISO 15194:2009 also provides requirements on how to collect data for value determination and how to present the assigned value and its measurement uncertainty. ISO 15194:2009 applies to certified reference materials with assigned values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities. ISO 15194:2009 does not apply to reference materials that are parts of an in vitro diagnostic measuring system, although it is possible that many elements are helpful. |
| Status |
Published
|
| Reference Document |
ISO 15194:2009 (EQV)
|
| date of Availability (DAV) | 2009-05-01 |
| ICS | 11.100.10 - In vitro diagnostic test systems |
| A-Deviation(s) | |
| Special National Condition(s) |
Legal
| Directive(s) | 98/79/EC |
|---|---|
| Mandate(s) | M/252 |
| Citation in OJEU | C 183 (2010-07-07) for Directive 98/79/EC |
Implementation Dates
| date of Ratification (DOR) (1) | 2009-04-16 |
|---|---|
| date of Availability (DAV) (2) | 2009-05-01 |
| date of Announcement (DOA) (3) | 2009-08-31 |
| date of Publication (DOP) (4) | 2009-11-30 |
| date of Withdrawal (DOW) (5) | 2012-04-30 |
Relations
| Supersedes | |
|---|---|
| Superseded by | prEN ISO 15194 |
| Normative reference (6) |
ISO 13485
ISO 17511:2003
ISO 18153
ISO 31-0 ISO 31-0/Amd 1 ISO 31-0/Amd 2 ISO 31-10 ISO 31-10/Amd 1 ISO 31-11 ISO 31-9 ISO 31-9/Amd 1 ISO 5725-2 ISO Guide 31 ISO Guide 34 ISO Guide 35 ISO/IEC Guide 98-3:2008
ISO/IEC Guide 99:2007
|
| Sales Points |
|
(1) Date of ratification (dor) date when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved
(2) Date of availability (dav) date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat
(3) Date of announcement (doa) latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level
(4) Date of publication (dop) latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement
(5) Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn
(6) This list of normative references is purely indicative. The only official list of normative reference is the list of the published standard.
In the case of undated standard, a link to the last dated version is provided.
In the case of series, a link to each standard identified in the series is provided.
We also invite you to check (via the website) whether corrigenda and/or amendments shall be read in conjunction with the main standard.