Compliance & Standards
10 standards mapped · 10 active boundary conditions
Mapped standards
| Standard | Body | Category | Coverage | Requirements | Status |
|---|---|---|---|---|---|
| IEC 60601-1 | IEC | Safety | 96% | 118 | Aligned |
| IEC 60601-1-2 | IEC | EMC | 92% | 41 | Aligned |
| IEC 62304 | IEC | Software | 91% | 82 | Aligned |
| IEC 81001-5-1 | IEC | Cyber | 78% | 26 | Gap |
| ISO 14971 | ISO | Risk | 94% | 63 | Aligned |
| ISO 13485 | ISO | Quality | 89% | 48 | Partial |
| IEC 62366-1 | IEC | Usability | 85% | 22 | Partial |
| ISO 80601-2-12 | ISO | Safety | 93% | 71 | Aligned |
| FDA 21 CFR 820 | FDA | Quality | 88% | 44 | Partial |
| MDR 2017/745 | EU | Regulatory | 82% | 39 | Partial |
Coverage by category
Current vs target readiness
Derived boundary conditions
Versioned · Compliance Lead approval required before applying to live requirements
| ID | Parameter | Threshold | Drives | Linked reqs | Source |
|---|---|---|---|---|---|
| BC-01 | Tidal volume accuracy | ±4% | CTS | 12 | ISO 80601-2-12 §201.12.4.101 |
| BC-02 | Peak pressure clamp | ≤ 60 cmH2O | CTS | 8 | ISO 80601-2-12 §201.12.4.108 |
| BC-03 | FiO2 delivery accuracy | ±3% abs | CTS | 6 | ISO 80601-2-12 §201.12.4.103 |
| BC-04 | Alarm audibility (bed) | ≥ 65 dBA @ 1m | CTQ | 5 | IEC 60601-1-8 |
| BC-05 | Battery runtime (transport) | ≥ 45 min | CTQ | 4 | Benchmark (Hamilton C6) |
| BC-06 | Apnea backup ventilation start | ≤ 4.0 s | CTS | 3 | ISO 80601-2-12 §201.12.1.103 |
| BC-07 | PEEP stability window | ±1 cmH2O | CTQ | 7 | Benchmark (Dräger Evita) |
| BC-08 | SW cybersecurity update SLA | ≤ 30 days | CTS | 6 | IEC 81001-5-1 §5.2 |
| BC-09 | Trigger response latency | ≤ 100 ms | CTS | 5 | ISO 80601-2-12 §201.12.4.107 |
| BC-10 | Humidifier reach temp | ≥ 37°C in 15 min | CTQ | 4 | ISO 8185 |
Competitor benchmarking
Parameter-by-parameter vs named competitors and regulatory floor
| Parameter | Aeris V500 | Hamilton C6 | Dräger Evita | Reg. floor | Verdict |
|---|---|---|---|---|---|
| Tidal volume accuracy | ±4% | ±5% | ±4% | ±10% | Leads |
| Apnea backup start | ≤4.0s | ≤4.5s | ≤5.0s | ≤5.0s | Leads |
| Battery runtime | 45 min | 60 min | 45 min | 30 min | On par |
| Trigger latency | ≤100 ms | ≤90 ms | ≤120 ms | ≤200 ms | Behind |