NP-200 system security design review
NimbusPump NP-200 Program · candidate AREV-0004 vs effective baseline DRB-0007
PRJ-2026-0042-DRV-0001Threat review
Standards knowledge base
Controlled framework context bound to release KBR-2026-02 for this review.
Sources by applicability
| Category | Count | Share |
|---|---|---|
| Required | 3 | 43% |
| Contractual | 2 | 29% |
| Informative | 2 | 29% |
Release workflow
- Draft (passed)
- Technical review (passed)
- Quality / regulatory approval (passed)
- Effective (current)
- Superseded (pending)
- KBR-2026-03 curator update for the IEC 81001-5-1 amendment watchDrafttechnical review pending
- KBR-2026-02 bound to this review, its analyses and its reportsEffective
- KBR-2026-01 superseded; DRB-0006 and DRB-0007 stay bound to it as-ofSuperseded
Standards monitor
- Official-source sweep: no new editions for 7 sourcesSweep
- Curator disposition due: IEC 81001-5-1 amendment ballotWatch
- Markets
- United States (FDA premarket) · European Union (MDR)
- Product type
- Connected Class II large-volume infusion system
- Lifecycle stage
- Secure design & implementation (PSLF-03)
- Knowledge release
- KBR-2026-02
- Approved by
- Sam Okafor + Elena Vasquez
- Approved
- 22 Jan 2026
- IEC 81001-5-1:2021 - Health software security lifecycleKBS-0002 · IEC · 2021ContractualEffective
- Jurisdiction
- International
- Entitlement
- Entitled
- IEC 62443-4-1:2018 - Secure product development lifecycleKBS-0005 · IEC · 2018ContractualEffective
- Jurisdiction
- International
- Entitlement
- Metadata only
- AAMI TIR57:2016/(R)2023 - Medical device security risk managementKBS-0004 · AAMI · 2016, reaffirmed 2023InformativeEffective
- Jurisdiction
- United States
- Entitlement
- Entitled
- FIRST CVSS v4.0 - Technical severity noteKBS-0007 · FIRST · v4.0InformativeEffective
- Jurisdiction
- International
- Entitlement
- Entitled
- FDA premarket cybersecurity guidance (2025) + FD&C 524B profileKBS-0001 · US FDA · Final guidance, 27 Jun 2025RequiredEffective
- Jurisdiction
- United States
- Entitlement
- Entitled
- ISO 14971:2019 - Medical device risk managementKBS-0003 · ISO · 2019RequiredEffective
- Jurisdiction
- International
- Entitlement
- Entitled
- MDCG 2019-16 Rev.1 - EU medical device cybersecurity guidanceKBS-0006 · European Commission MDCG · Rev.1RequiredEffective
- Jurisdiction
- European Union
- Entitlement
- Entitled
7 sources