UNE-EN ISO 21649:2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)
Hardcopy , PDF
04-10-2023
Spanish, Castilian, English
27-01-2010
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 Requirements
5.1 General requirements
5.2 Noise requirements
5.3 Dose specification requirements
5.4 Uncertainty of measurements and conformance with
specifications
5.5 Performance profile requirements
5.6 Test requirements
6 Test methods
6.1 General
6.2 Test procedures
6.3 Test conditions
6.4 Test evaluations
7 Test report
8 Information supplied by the manufacturer
8.1 General
8.2 Marking
8.3 Instructions for use
Annex A (informative) Two-sided tolerance limit factors (k)
Annex B (informative) Examples of accuracy limit calculations
and random settings
Annex C (informative) Correspondence between ISO/IEC
standards and EN standards
Annex ZA (informative) Relationship between this
International Standard and the Essential
Requirements of EU Directive 93/42/EEC
Bibliography
Applies to safety and performance and testing requirements for single-use and multiple-use needle-free injection systems intended for human use in clinics and other medical settings and for personal use by patients.
| Committee |
CTN 111
|
| DocumentType |
Standard
|
| Pages |
40
|
| PublisherName |
Asociacion Espanola de Normalizacion
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NF EN ISO 21649 : 2009 | Identical |
| ISO 21649:2006 | Identical |
| NBN EN ISO 21649 : 2009 | Identical |
| NEN EN ISO 21649 : 2009 | Identical |
| NS EN ISO 21649 : 2009 | Identical |
| I.S. EN ISO 21649:2009 | Identical |
| SN EN ISO 21649 : 2010 | Identical |
| BS EN ISO 21649:2009 | Identical |
| EN ISO 21649:2009 | Identical |
| ONORM EN ISO 21649 : 2010 | Identical |
| DIN EN ISO 21649:2010-01 | Identical |
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