Assistive & Wearable / Exoskeleton — Demonstration Protocol

Foreword. This Test Protocol is new in the VRS 2026 edition and is the Assistive & Wearable sector’s extension of VRS-GEN-203, the intrinsic demonstration protocol. A wearable robot is the one class of machine whose user is inside it: the joint it drives is the wearer’s joint, the surface it heats is the wearer’s skin, and the fault it suffers is suffered while strapped to a person who may not be able to step away. The sector’s anchor regimes — the personal-care robot standard, the medical rehabilitation-robot particular standard for the regulated class, the battery and medical-electrical families — test those things on rigs, and so does this Protocol: every powered test is on the manufacturer’s instrumented anthropomorphic rig, and the demonstrator wears the device only unpowered or in its declared standby mode, for the doffing and fitting steps. Regulatory fit for the medical class is documentary and is scored from the pack. The Protocol carries only what the intrinsic steps do not already witness. Steps run between Parts E and F of VRS-GEN-203, in the same session, on the same feed, into the same export. Standards carry no step identifiers; every step here names the VRS-ASW-201 subclause that requires it. As a protocol it is versioned vX.Y.Z (VRS-GEN-004 §5.4). Requirements use “shall”.

Introduction

The Assistive & Wearable anchor set is ISO 13482 for personal-care robots (which covers the industrial and consumer exoskeleton classes), IEC 80601-2-78 for medical rehabilitation robots (the regulated class), IEC 62133 for the body-worn battery, and the general medical-electrical and usability standards for a device that is fitted to a person by a fitter. What those regimes share is the rig: joint limits, misalignment, runaway and power loss are tested on an instrumented dummy limb, because the alternative is testing them on a person. This Protocol follows that discipline exactly. The rig is the manufacturer’s, instrumented with the manufacturer’s sensors; the person appears only where the device is unpowered or in standby — to time the emergency release and to be fitted.

The steps concentrate on the moments a wearer cannot control: a stumble, a spasm, a fault at mid-step, a battery that runs out, a joint that locks or runs away. Each is produced on the rig by the manufacturer’s own input and the device’s declared response is witnessed against its torque and time limits. The fitting step matters because most wearable injuries are pressure injuries, and the data step matters because gait and force data are health-adjacent. Support for dependent users and the incident record are documentary and are scored from the pack.

1 Scope

This Protocol specifies the Assistive & Wearable / Exoskeleton demonstration steps by which the criteria of VRS-ASW-201 Clause 6 are demonstrated at the Certified tier, for every application class of VRS-ASW-201 §7.3 (medical exoskeleton · industrial exoskeleton · consumer/wellness wearable robot · prosthetic/orthotic powered device). It applies to every Certified Assistive & Wearable / Exoskeleton assessment, by every Certified route of VRS-GEN-003 §6.9.

It specifies: how this Protocol relates to VRS-GEN-203 (Clause 4); the envelope the manufacturer declares before the session (Clause 5); the steps (Clause 6); and a worked example (Clause 7). Annex A maps every VRS-ASW-201 criterion to its intrinsic steps, its sector steps, or neither.

It does not: repeat any session requirement, step, marking rule or record rule of VRS-GEN-203, all of which apply unchanged; define any criterion, point, ceiling or ladder (VRS-ASW-201); or define the Assistive & Wearable / Exoskeleton information pack (VRS-GEN-013). Every powered test is performed on the manufacturer’s instrumented anthropomorphic rig; the demonstrator wears the device only unpowered or in its declared standby mode, for the doffing and fitting steps. Regulatory fit for the medical class is documentary and is scored from the pack.

2 Normative references

• VRS-GEN-203, Demonstration Protocol — Intrinsic — session requirements (Clause 4), step rules (Clause 5), marks and scores (Clause 7), Session Record (Clause 8), all of which apply to this Protocol.

• VRS-ASW-201, Assistive & Wearable / Exoskeleton — AR Assessment Protocol — the criteria whose Certified rows this Protocol serves; application classes (§7.3).

• VRS-ASW-001, Assistive & Wearable / Exoskeleton Sector Standard — the declared envelope and class fields.

• • VRS-GEN-101, Safety — the intrinsic safety criteria the Assistive & Wearable pool contributes to.
• • VRS-GEN-103, Serviceability & Support — the intrinsic calibration and commissioning step that serves part of VRS-ASW-201 §6.6.
• • VRS-GEN-105, Cyber Posture — the intrinsic authentication and telemetry-disclosure steps that serve part of VRS-ASW-201 §6.7.

• VRS-GEN-003, Governance Charter and Independence — Certified routes and route parity (§6.9).

3 Terms and definitions

Terms defined in VRS-GEN-001 and VRS-GEN-203 apply. In addition:

3.1 test rig — the manufacturer’s anthropomorphic rig — dummy limb, torso or full-body fixture — instrumented with the manufacturer’s torque, force and displacement sensors, on which every powered step is performed.

3.2 standby mode — the declared device state in which no powered assistance is delivered, in which alone the demonstrator may wear the device.

3.3 doffing — release and exit from the device by the wearer using the declared emergency release, timed.

3.4 compliant mode — the declared joint state on fault or power loss in which the limb can be moved by hand within a declared force.

3.5 misalignment — a declared offset between the device’s joint axis and the rig’s, in mm or degrees.

3.6 perturbation input — a declared rig-actuator or push-tool input representing a stumble, a spasm or tremor, or a wearer resisting assistance.

3.7 skin-contact surface — a declared surface of the device in contact with the wearer, with its declared temperature limit.

3.8 interface pressure — the pressure at a declared cuff, strap or socket interface, read by the manufacturer’s pressure-mapping sensor or indicator film.

3.9 fitter — the person who performs the declared fitting protocol; in this Protocol the demonstrator.

4 Relationship to the intrinsic protocol

4.1 This Protocol shall be run only as part of a session under VRS-GEN-203. Every requirement of VRS-GEN-203 Clause 4 applies to every step here without repetition or exception.

4.2 Position in the session. The steps of Clause 6 shall run after VRS-GEN-203 Part E and before VRS-GEN-203 Part F, so that one continuous recording and one export cover both protocols. The endurance sample opened in VRS-GEN-203 Part C continues to run through this Protocol.

4.3 Step identifiers. Steps shall carry identifiers of the form ASW-110.nn; they are Session Record step identifiers under the same rules as VRS-GEN-203 §5.1 and shall never be reused.

4.4 Required by. Every step shall name the VRS-ASW-201 subclause(s) whose Certified row it serves. VRS-ASW-201 carries no reference back to this Protocol.

4.5 Classes and declared subjects. Each step lists the application classes it applies to. A step whose class is not in the assessed envelope shall not be run. A step whose subject the manufacturer has not declared shall be marked not declared and has no effect on any score (VRS-GEN-203 §3.10). Parts 1, 2 and 3 shall be run for every Assistive & Wearable assessment; Part 5 for every class fitted to the wearer by a fitter (VRS-ASW-201 §7.3).

4.6 Bound. The sum of step bounds for one class shall not exceed 120 min. Marks, failure, declined steps, continuation sessions and the Session Record follow VRS-GEN-203 Clauses 5, 7 and 8.

4.7 Criteria witnessed by intrinsic steps. Where a sector criterion’s Certified row is already witnessed by intrinsic steps, Annex A names them and the criterion is scored from those marks together with any sector steps listed. VRS-ASW-201 §6.1 (class anchor and regulatory fit) is documentary and has no step; nothing witnessed under this Protocol is evidence of medical clearance for the regulated class.

4.8 The rig and the person. Every step that powers a joint, applies a perturbation, cuts power under load, simulates runaway or lock, or raises temperature shall be performed on the test rig. The demonstrator shall wear the device only unpowered or in the declared standby mode and only for the doffing (ASW-110.03) and fitting (ASW-110.08) steps; no person shall wear the device under powered assistance during the session (VRS-GEN-203 §4.8). A step so performed shall be marked not achieved and the ground recorded.

4.9 Regulatory standing. For the medical exoskeleton and prosthetic/orthotic classes nothing witnessed under this Protocol shall be presented as evidence of, or a substitute for, medical-device clearance, and no mark shall alter the documentary scoring of VRS-ASW-201 §6.1.

4.10 Admissibility of a mark. A step’s mark shall be inadmissible, and the step shall be marked not achieved, where the dimension, mass, speed, force or condition it depends on was not shown on camera, or where the configuration demonstrated differs from the assessed one. The observer shall record the ground.

5 The declared envelope

5.1 Before the session the manufacturer shall have declared, in the information pack and per assessed application class: the application class; the test rig and its instrumentation; each powered joint’s torque limit (N·m) and range of motion (degrees); the misalignment tolerance (mm or degrees) and the fault-injection means; the compliant-mode force (N); the emergency release and doffing time (s) powered-standby and unpowered; the power-loss safe state and time to releasable (s); the perturbation inputs (displacement mm, frequency Hz, opposing force N) and declared responses with times (s); the skin-contact surfaces and temperature limit (°C) with warm-up period (min); the thermal, runaway and lock test inputs; the low-energy threshold (%); the fitting protocol, size range, interfaces and pressure limit (kPa); and the captured data, destinations, consent step, second factor and deletion control.

5.2 Every apparatus in Clause 6 shall be sized from those declarations and no other source (VRS-GEN-203 §4.7). A parameter not declared makes the steps that depend on it not declared (4.5); a manufacturer that declares a smaller envelope demonstrates a smaller envelope and is scored against it under VRS-ASW-201.

5.3 The declared envelope shall match the one recorded for the rating (VRS-ASW-001, VRS-GEN-009); a step demonstrated at a value other than the declared one shall be inadmissible (4.10).

6 The steps

Columns: ID — Session Record step identifier · Step — outcome to witness · Classes — application classes the step applies to (4.5) · Witness — means (VRS-GEN-203 §3.13) · Apparatus — manufacturer-supplied, at declared value · Bound — minutes · Required by — VRS-ASW-201 subclause(s) served.

6.1 Part 1 — Joint torque, range and misalignment

On the manufacturer’s instrumented rig: every joint to its torque limit and range stops, then misaligned, then faulted to the compliant state.

6.2 Part 2 — Emergency doffing and entrapment

The only steps in which a person wears the device — unpowered or in standby — to time the emergency release; the power-loss case is on the rig under load.

6.3 Part 3 — Wearer-intent mismatch and stumble response

A stumble, a spasm, a wearer who resists: produced on the rig by the manufacturer’s own inputs, three times each, against the torque and time limits.

6.4 Part 4 — Body-worn power and thermal safety

Extends the intrinsic energy-safety step with the body-worn specifics: skin temperature after warm-up, thermal cut-off, runaway and lock protection, and a device that stays doffable when the battery runs down.

6.5 Part 5 — Fit, adjustment and interface pressure

Most wearable injuries are pressure injuries. The fitting protocol is performed and the interface pressure read.

6.6 Part 6 — Wearer data handling

Extends the intrinsic authentication and telemetry steps for health-adjacent data: consent, second factor, deletion.

6.7 Timing budget. All 9 steps sum to 86 min. Per class, with every applicable step declared: medical exoskeleton 86 min · industrial exoskeleton 86 min · consumer/wellness wearable robot 86 min · prosthetic/orthotic powered device 86 min. Every class is within the 120 min bound of 4.6.

7 Worked example (informative)

A manufacturer of a hypothetical industrial lift-assist exoskeleton (class: industrial exoskeleton) declares: a torso-and-hip rig instrumented with load cells; 35 N·m hip torque and a 0–110° hip range; 15 mm axis-offset tolerance; compliant mode movable at under 20 N; a two-buckle emergency release with a 10 s doffing time in standby and 15 s unpowered; power-loss free mode within 1 s; perturbations of a 50 mm sudden displacement, a 4 Hz oscillation and a 150 N opposing force with a yield within 200 ms; 41 °C skin-contact limit after a 20 min warm-up; a runaway test input with protected state within 300 ms; low-energy standby at 10 %; a fitting protocol over three sizes with a 30 kPa strap-pressure limit read by indicator film; and an app capturing lift counts and hip angles, stored on the device with optional cloud sync, second factor by authenticator, and per-session deletion.

After VRS-GEN-203 Part E the sector steps run from 12:40 at the rig. ASW-110.01: each hip driven to 33 N·m on the load cell against 35; a 40 N·m command clipped; range stops at 0° and 110° with the limit state on the feed (achieved). ASW-110.02: 15 mm offset fixture, torque stays under limit with a misalignment warning; hip-sensor disconnect, joints free, rig limb moved at 14 N (achieved). ASW-110.03: demonstrator in standby releases both buckles and steps out in 7 s; unpowered, 11 s (achieved). ASW-110.04: rig mid-lift under 20 kg, power cut, joints free in under 1 s, limb moved by hand at 12 N (achieved). ASW-110.05: displacement, oscillation and opposing force each three times; yield within 200 ms on the feed every time, torque never above 35 N·m (achieved). ASW-110.06: after 20 min, contact thermometer reads 36–38 °C on the hip pads against 41; thermal-test input, assistance reduced with the alert (achieved). ASW-110.07: runaway input, protected state in 240 ms; lock input, release to compliant; from 12 %, standby at 10 % and buckles still release (achieved). ASW-110.08: fitting on the second demonstrator in standby, three adjustment points, alignment check; indicator film at the shoulder and hip straps shows under 30 kPa; fitting logged in the app (achieved). ASW-110.09: app shows lift counts and hip angles on device, cloud sync off, consent screen, authenticator required, session deleted and gone (achieved). Sector time 86 min; VRS-GEN-203 Part F follows.

The reviewer scores VRS-ASW-201 §6.2 from ASW-110.01 and ASW-110.02 with GEN-203.16; §6.3 from ASW-110.03, ASW-110.04 and ASW-110.07 with GEN-203.07; §6.4 from ASW-110.02, ASW-110.04 and ASW-110.05 with GEN-203.11; §6.5 from ASW-110.06 and ASW-110.07 with GEN-203.07; §6.6 from ASW-110.08 with GEN-203.31; §6.7 from ASW-110.09 with GEN-203.32 and GEN-203.37; §6.1, §6.8 and §6.9 from the pack. No number in this example is a requirement; every apparatus value came from the manufacturer’s own declaration.

Annex A (normative) — Criterion coverage

Every criterion of VRS-ASW-201 Clause 6 appears once with the intrinsic steps (VRS-GEN-203) and the sector steps (this Protocol) that witness it, or the statement that it has none.

Bibliography

• ISO 13482:2014, Robots and robotic devices — Safety requirements for personal care robots.
• IEC 80601-2-78:2019, Medical electrical equipment — Part 2-78: Particular requirements for the basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation.
• ISO/TR 23482-1:2020, Robotics — Application of ISO 13482 — Part 1: Safety-related test methods.
• ASTM F3443-20, Standard Practice for Load Handling When Using an Exoskeleton.
• ASTM F3444-20, Standard Test Method for Evaluating Exoskeleton Fit and Comfort.
• IEC 60601-1:2005+AMD1:2012+AMD2:2020, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance.
• IEC 62133-2:2017, Secondary cells and batteries containing alkaline or other non-acid electrolytes — Safety requirements for portable sealed secondary lithium cells.
• ISO 13732-1:2006, Ergonomics of the thermal environment — Methods for the assessment of human responses to contact with surfaces — Part 1: Hot surfaces.
• ISO 22523:2006, External limb prostheses and external orthoses — Requirements and test methods.
• IEC 62366-1:2015+AMD1:2020, Medical devices — Part 1: Application of usability engineering to medical devices.

Change history