I.S. EN ISO 14155:2026
Current
Current
The latest, up-to-date edition.
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2026)
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
23-04-2026
Publisher
€124.00
Excluding VAT
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
| DocumentType |
Standard
|
| Pages |
85
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 14155:2026 | Equivalent |
| ISO 14155:2026 | Equivalent |
| BS EN ISO 14155:2026 | Equivalent |
| DIN EN ISO 14155:2026-08 | Equivalent |
Frequently Asked Questions
I.S. EN ISO 14155 is National Standards Authority of Ireland (NSAI)'s standard for clinical investigations of medical devices, while I.S. EN ISO 10555-1 covers intravascular catheters (Ireland). I.S. EN ISO 14155 sets good clinical practice requirements for designing, conducting, recording and reporting medical device clinical investigations. I.S. EN ISO 10555-1 specifies general requirements and test methods for sterile, single-use intravascular catheters.
No — I.S. EN ISO 14155 is an Irish standard published by National Standards Authority of Ireland (NSAI), with its listed region as Ireland.
I.S. EN ISO 14155 sets good clinical practice requirements for designing, conducting, recording and reporting medical device clinical investigations. In practice it is applied by sponsors, investigators and regulators conducting pre- and post-market medical device studies.
I.S. EN ISO 14155 sets good clinical practice requirements for designing, conducting, recording and reporting medical device clinical investigations. It is an Irish standard published by National Standards Authority of Ireland (NSAI).
I.S. EN ISO 14155 is used by sponsors, investigators and regulators conducting pre- and post-market medical device studies. It is an Irish standard published by National Standards Authority of Ireland (NSAI).
Summarise
€124.00
Excluding VAT
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