PN EN ISO 11608-5 : 2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS (ISO 11608-5:2012)
07-09-2023
09-05-2013
Describes requirements and test methods for the automated functions of needle-based injection systems with automated functions (NIS-AUTO), for the administration of medicinal products in humans, including but not limited to: a) drug product preparation (e.g. reconstitution); b) needle preparation; c) air removal; d) priming; e) dose setting; f) actuation; g) needle insertion; h) injection of the medicinal product; i) disabling the NIS-AUTO; j) needle retraction; k) needle shielding; l) needle hiding; m) sharps injury protection; & n) needle removal.
| Committee |
TC 247
|
| DocumentType |
Standard
|
| PublisherName |
Polish Committee for Standardization
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| EN ISO 11608-5:2012 | Identical |
| ISO 11608-5:2012 | Identical |
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