Do not release mass production because an LED therapy device sample turns on, looks finished and matches a catalog photo. Approve an identified sample revision against a controlled specification, reproducible test results, final labeling and packaging, an exact-model document map, and a written production-control plan.
В этом руководстве, “sample approval” means a buyer’s procurement release. It is not FDA approval, Маркировка CE, laboratory certification or any other regulatory authorization.
Перед подписанием, answer three questions:
- What exactly is this unit? Record the model, идентификатор образца, пересмотр, configuration and whether it is a standard sample, modified sample, engineering prototype or production-intent sample.
- What did it prove? Record the requirement, метод испытания, результат, evidence and unresolved deviation for each critical feature.
- What controls the next units? Lock the specification, reference sample, change-notification rules and pilot or production inspection plan.
If any answer is missing, the sample is not ready to release mass production.
What Does Sample Approval Actually Release?
A sample decision should release only the stage and configuration named in the approval record.
Use these as working procurement labels—not universal regulatory stage definitions:
| Тип образца | What it may help evaluate | What it does not automatically release |
|---|---|---|
| Standard production sample | An existing platform’s current appearance, элементы управления, accessories and user workflow | Your private-label artwork, custom configuration or target-market evidence |
| Modified sample | A named change such as color, логотип, пользовательский интерфейс контроллера, wavelength mode or packaging | Other changes that were not represented in the unit |
| Engineering prototype | A design question such as fit, электроника, оптика, controls or mechanical feasibility | Final materials, cosmetic finish, production process or mass-production repeatability |
| Production-intent or pre-production sample | The planned BOM, manufacturing method, произведение искусства, accessories and pack-out at a near-production stage | Future lot consistency, final market authorization or shipment acceptance |
Ask the supplier to state which label applies and what is intentionally non-production. A hand-built prototype may be useful and still be unsuitable as a golden sample. A standard stock unit may be production-ready and still fail to represent your private-label version.
What Are the Immediate Stop Conditions?
Stop the approval before detailed scoring if the sample cannot be traced or has an unresolved critical gap.
Do not release production when:
- the model, sample ID or revision is missing;
- the quotation, specification and physical unit describe different configurations;
- a critical mode, таймер, контроллер, power supply or safety function does not operate as specified;
- the adapter, батарея, затыкать, controller or accessory differs from the planned sellable kit without an approved change;
- optical values cannot be tied to a stated mode, позиция, расстояние, instrument and sample;
- labeling or sales claims exceed the intended-use and evidence scope planned for the market;
- the supplier relies on a test report, certificate or regulatory record that cannot be connected to the exact model and configuration;
- an engineering prototype is being presented as the final production reference;
- a known material, компонент, прошивка, artwork or packaging change has no impact assessment;
- the supplier cannot explain how future production will be compared with the approved reference.
A stop condition does not always mean the project must be abandoned. It means the current version cannot be approved until the gap is resolved and documented.
Build the Approval Record Before Testing
Create one master record so product, качество, согласие, logistics and the supplier are judging the same sample.
Use one row per requirement:
| Поле | Что записывать |
|---|---|
| Requirement ID | Stable number linked to the specification, drawing, artwork or quality plan |
| Requirement | The expected material, dimension, function, выход, этикетка, accessory or pack-out |
| Acceptance criterion | A written pass condition and tolerance where applicable |
| Test or inspection method | Setup, инструмент, режим, расстояние, продолжительность, sample condition and responsible party |
| Observed result | Actual measurement or finding—not only “OK” |
| Доказательство | Фото, video, номер отчета, data file, artwork revision or signed record |
| Статус | Проходить / Conditional / Неудача / Н/Д |
| Deviation and action | What differs, who owns it, required evidence and due date |
| Approval authority | Named buyer and supplier approvers, decision date and released stage |
Do not use “N/A” as a blank. Give the project-specific reason. Do not use “Conditional” for a critical safety, требовать, core-function or document-scope failure.
Gate 1: Can You Identify the Exact Configuration?
Freeze identity before appearance or performance testing. В противном случае, a passing result may belong to a configuration you never order.
Record at least:
- legal manufacturer and supplier SKU;
- buyer SKU and brand name, if already assigned;
- exact model and sample ID;
- аппаратное обеспечение, прошивка, controller and UI revision where relevant;
- LED package count, chip-count convention, array and wavelength/mode map;
- main materials, optical layers and skin-contact parts;
- печатная плата, водитель, батарея, adapter and plug configuration;
- accessories and replacement parts;
- этикетка, ОБЛАКО, artwork and packaging revisions;
- целевой рынок, intended use and planned claim set;
- list of approved custom changes and known open items.
Photographs help, but they do not replace a controlled configuration sheet. Photograph the front, назад, разъемы, этикетки, controller screens, аксессуары, packaging and any areas that are difficult to describe. Give the photo set the same sample ID and revision as the record.
Gate 2: Does the Flexible Pad Match the Mechanical and Material Definition?
For a flexible LED pad, test the permitted positioning behavior—not an improvised folding stunt.
Проверять:
- overall dimensions, thickness and weight against the agreed method;
- silicone or other body material, обработка поверхности, color and odor expectations;
- швы, edge finish, strain relief, connectors and cable exits;
- LED-package retention and any local dispensing or bonding process;
- allowed bending, curving or wrapping positions;
- actions prohibited by the specification or IFU, such as folding, creasing, crushing or heavy pressure;
- holders, ремни, headrest and other positioning accessories;
- cleaning method and whether repeated cleaning affects finish, print, adhesion or connectors;
- storage and pack-out position, especially if a smaller carton would force a tighter bend than the approved design permits.
Do not generalize one construction method across all flexible pads. Например, an epoxy dispensing process may secure LED packages locally without making the entire product an “epoxy-coated device.” Record the actual construction of the selected model.
For skin-contact materials on a medical-device project, confirm at Gate 8 whether the exact materials, contact type and duration are covered by the biological-evaluation evidence; do not treat a visual and odor check as material qualification.
If no minimum bend radius or positioning limit has been defined, mark it as an open requirement. Do not invent one during sample review.
Gate 3: Do the Controls and Complete User Workflow Work?
Test the sellable workflow from unpacking to storage, not isolated button functions.
Run every agreed combination of:
- power on/off and startup state;
- light mode or wavelength combination;
- уровень яркости;
- timer selection and automatic stop;
- настройка пульса, if the exact model is specified to have one;
- controller pairing, range and multi-device behavior where applicable;
- зарядка, battery indication and low-power behavior;
- main-device power connection and adapter behavior;
- memory, restart or power-interruption behavior claimed in the specification;
- error indication and recovery described in the IFU;
- an agreed continuous-run and power-cycle sequence, with the duration, режим, ambient conditions and post-test checks recorded.
Then ask intended operators to set up, позиция, бегать, clean and store the product using only the proposed instructions. Record where they hesitate or make different choices. A function that only works after supplier coaching is not yet a repeatable channel workflow.
Keep the controller and power architecture explicit. A wireless controller’s charging cable is not necessarily the main device’s power path. The sample, diagram, руководство, carton contents and sales demonstration must tell the same story.
Gate 4: Are the Optical Results Tied to the Sample?
Visible light confirms that emitters turn on. It does not verify wavelength, излучение, spatial distribution or photobiological safety.
For each relevant mode, connect the physical sample to:
- measured spectral output or wavelength report;
- irradiance values at defined points or a defined grid;
- measurement distance or contact plane;
- point, average and peak definitions;
- instrument and sensor identification;
- calibration context where available;
- warm-up and operating condition;
- яркость, timer and pulse state;
- идентификатор образца, конфигурация, test date and report number;
- agreed acceptance limits and disposition of outliers.
An irradiance value measured at the emitting surface cannot be compared directly with a value measured at a stand-off distance. A center-point peak cannot be treated as a full-area average. A result from one mode cannot silently cover every mixed-light mode.
А Wakelife guide to IEC 62471, отчеты о длине волны и освещенности explains the measurement and evidence fields in detail. Keep this sample-approval record shorter: link each result to the exact method and flag any mismatch for technical review.
А МЭК 62471 official scope covers photobiological hazard evaluation for non-laser optical sources, включая светодиоды, under defined methods and conditions. МЭК 62471 report is not clinical-efficacy evidence, market authorization or proof that future batches will be identical.
Gate 5: Have You Separated Buyer Screening from Safety Evidence?
A buyer can identify obvious defects and abnormal behavior, but a desk check cannot certify electrical, оптический, thermal or mechanical safety.
During sample review, record observations such as:
- damaged insulation, exposed conductors or loose connectors;
- adapter and device ratings that do not match the approved specification;
- нестабильная мощность, unexpected shutdown, unusual sound, запах, flicker or visible damage;
- surface temperatures at defined skin-contact areas, controls and connectors during and at the end of a complete intended operating session;
- damaged batteries, припухлость, charging abnormalities or transport restrictions where a battery is included;
- острые края, weak strain relief, loose parts or positioning failures;
- cleaning instructions that conflict with the material or ingress limitations;
- missing warnings, contraindications or eye-protection instructions required by the project’s approved labeling.
Any abnormal result requires a documented investigation. Passing these observations does not replace applicable laboratory tests, engineering verification or regulatory assessment.
Record every temperature observation as a reproducible measurement, not an impression: note the ambient temperature, selected mode, session duration, measurement points, instrument and observed values. If the project has defined a worst-case condition—such as a covered position, maximum brightness or back-to-back sessions—test that agreed condition instead of an improvised one. Do not invent a universal surface-temperature limit or endurance duration during sample review. Set the acceptance criteria from the exact device, contact condition, предполагаемое использование, applicable standards and project risk assessment, then use the same method for the approved sample and later comparison units.
For projects within its scope, МЭК 60601-2-57:2023 addresses basic safety and essential performance for equipment incorporating non-laser optical-radiation sources from 200 нм до 3,000 nm and intended to create photobiological effects in humans for therapeutic, диагностический, мониторинг, cosmetic or aesthetic applications. Applicability still depends on the exact intended use, классификация, target market and standard set. Do not add an IEC standard to a checklist merely because the product contains LEDs.
Gate 6: Do the Label, IFU and Claims Describe the Same Product?
Approve market-facing content as part of the configuration, not as artwork added after the device is frozen.
Match the physical sample and controlled files for:
- product and model name;
- legal manufacturer and other required economic-operator information;
- intended use and permitted claims;
- названия режимов, wavelength wording and performance specifications;
- власть, адаптер, battery and charging information;
- operating steps, cleaning and storage;
- предупреждения, contraindications and stop conditions;
- accessories and replacement-part identification;
- symbols, язык, штрих-код, serial/lot fields and market markings where applicable;
- веб-сайт, distributor deck and listing copy planned for launch.
In the EU medical-device framework, а MDR definition of intended purpose connects the manufacturer’s label, ОБЛАКО, promotional or sales materials and clinical evaluation. This does not classify a particular LED product, but it shows why a medical-project sample cannot pass while the box, manual and sales claims tell different stories.
For a nonmedical beauty or wellness project, keep the same internal discipline even when the applicable legal route differs: freeze one approved claim set and remove unsupported disease-treatment, absolute-safety or borrowed clinical statements.
Gate 7: Is the Packaging a Production-Intent Pack-Out?
Approve the final sellable kit and shipping configuration—not a product wrapped for sample courier delivery.
Проверять:
- every accessory, кабель, адаптер, затыкать, ремень, держатель, eyewear item and manual;
- unit quantity and SKU separation;
- inner tray, сумка, protective film and product orientation;
- retail box dimensions, масса, print revision and closure;
- outer carton quantity, размеры, weight and marks;
- barcode and label scanability after final placement;
- protection of connectors, optical surfaces, flexible circuits and cosmetic finishes;
- storage position that does not exceed the approved bend or pressure limits;
- the agreed transport or distribution test plan for the actual route.
One informal drop does not validate a shipping system. Define the required packaging tests from the product, pack-out, канал, route and market requirements, then retain the report and tested-pack identity.
Gate 8: Does Each Document Cover the Exact Sample?
A document folder is useful only when every relevant file maps to the sample and planned commercial configuration.
Build a model-to-document matrix:
| Document layer | Match these fields | Не предполагайте |
|---|---|---|
| Market authorization or public record, когда это необходимо | Владелец/заявитель, exact device/model, предполагаемое использование, претензии, market and current status | A similar model or factory-level record covers this SKU |
| Quality-management system | Юридический держатель, сайт, стандартный, activity/device scope and validity | Iso 13485 is a product approval or batch test |
| Electrical/EMC or product safety | Заявитель, модель, адаптер, аксессуары, hardware/software and standard edition | One adapter or family report covers a changed configuration |
| МЭК 62471 / оптическая безопасность | Tested sample, модель, режимы, геометрия, conditions and result | A risk-group result proves efficacy or batch consistency |
| Spectrum and irradiance | Идентификатор образца, режим, карта точек, расстояние, инструмент, date and acceptance method | One catalog number describes every point, mode or batch |
| Materials and other applicable reports | Exact material, supplier/specification, contact type and product scope | A component declaration proves whole-product compliance |
| Lithium-battery transport, когда это применимо | Exact cell/battery type, производитель, assembly/configuration, test summary and current transport documents | A charger or electrical-safety report covers battery transport requirements |
| Label/IFU/artwork | Редакция, модель, рынок, язык, использование по назначению и претензии | A draft can be corrected after production without impact |
For medical-device projects with direct or indirect body contact, determine whether the exact materials and contact type and duration are covered by a biological evaluation under Iso 10993-1:2025 and any applicable parts of the series. Iso 10993-1 is a risk-based biological-safety evaluation framework, not one universal “biocompatibility test” or automatic approval for every material.
If the sellable kit contains a lithium cell or battery, verify the exact battery type and configuration against the applicable transport evidence under subsection 38.3 of the UN Manual of Tests and Criteria. Используйте current UNECE Rev.8 and Amendment 1 publication rather than treating “UN 38.3” as a generic certificate label; the market, carrier and shipment still determine the complete transport-document and packaging requirements.
Используйте Руководство по сертификации устройств для светодиодной терапии for the full evidence map. Используйте Контрольный список квалификации OEM-производителей для терапии красным светом if the legal entity, manufacturing site or supplier-level controls are still unresolved. Do not duplicate those audits inside the sample record.
How Should You Create the Golden Sample?
A golden sample is a controlled physical reference, not a substitute for specifications, tolerances and test records.
After all blocking issues are closed:
- Assign the approved unit a permanent sample ID and revision.
- Mark the approval date and released production stage.
- Attach the signed configuration sheet, test-result index and accepted-deviation list.
- Freeze the corresponding artwork, ОБЛАКО, packaging and accessory list.
- Create a dated photo record showing identifying and cosmetic details.
- Retain controlled buyer and supplier references where practical.
- Define storage, access and replacement rules so the sample cannot be swapped, damaged or silently superseded.
- State which requirements are controlled by the physical sample and which are controlled only by drawings, data or test limits.
If the sample wears, ages or is damaged, do not quietly replace it. Create a new controlled revision and preserve the approval history.
Which Changes Require Reassessment?
Approval belongs to the frozen configuration. A change does not always require every test to be repeated, but it always requires a documented impact decision.
Change triggers commonly include:
- LED package, chip, bin, supplier, array or wavelength-mode changes;
- водитель, печатная плата, прошивка, контроллер, таймер, pulse or brightness changes;
- адаптер, затыкать, батарея, cable or connector changes;
- силикон, adhesive, диффузор, optical layer, colorant or dispensing-process changes;
- dimension, curvature, ремень, holder or enclosure changes;
- этикетка, ОБЛАКО, warning, intended use or marketing-claim changes;
- аксессуар, упаковка, carton or logistics changes;
- factory site, critical supplier, процесс, fixture or inspection-method changes;
- component end-of-life substitution or rework introduced after a failure.
For each proposed change, record the reason, affected documents, technical and regulatory impact, required verification, new sample need, cost/timing impact, approvers and implementation revision. “Equivalent component” is a conclusion that needs evidence—not a sufficient change description.
What Must Happen Before Mass Production and Shipment?
Sample approval should feed a production plan; it should not end as a signed unit on a shelf.
Before the production order, подтверждать:
- released specification, спецификация, drawings, firmware and artwork revisions;
- approved golden sample and deviation log;
- supplier work instructions and critical process controls;
- incoming, in-process and final inspection items;
- инструменты, светильники, calibration and data-record requirements;
- pilot, first-article or production-intent confirmation appropriate to the project;
- defect definitions and disposition authority;
- lot identity and traceability requirements;
- shipment sampling or unit-level checks;
- nonconformance, rework and concession process;
- change-notification and reapproval rules;
- who authorizes production release and shipment release.
Where attribute sampling is appropriate, Iso 2859-1:2026 provides AQL-indexed lot-by-lot sampling schemes. It does not supply one universal AQL, defect classification or sample size for every LED therapy project. Define those with the responsible quality team from the product risk, lot, contract, market and inspection purpose. Some critical characteristics may need controls beyond routine lot sampling.
Do not use one golden sample to estimate unit-to-unit variation. At the pilot or pre-production stage, evaluate multiple identified units for the critical optical, thermal and functional characteristics, using a predefined sample count, method and acceptance rule. The number of units and the required distribution or tolerance must come from the project’s risk and quality plan—not from a generic checklist.
Для США. medical-device projects, the FDA’s Положение о системе менеджмента качества became effective on February 2, 2026 and incorporates ISO 13485:2016 into the device QMS framework. That is a manufacturer regulatory context, not a reason to label every beauty/wellness sample a medical device. А Iso 13485 официальная страница likewise describes a medical-device QMS; a certificate does not approve the product sample or guarantee a production lot.
Approve, Approve Conditionally or Reject?
End with an explicit release decision and scope.
| Решение | Use it when | Required record |
|---|---|---|
| Approve for the named next stage | All critical requirements pass; evidence and configuration match; deviations are resolved; production/change controls are defined | Signed approval pack naming the exact sample, пересмотр, next stage and conditions |
| Conditional approval | Only noncritical items remain and they do not affect safety, intended use/claims, core function, critical dimensions, power configuration or evidence scope | Named owner, evidence required, due date and a clear statement of what is—and is not—released |
| Reject / revise | A stop condition remains, the sample does not represent the intended product or the failure requires redesign/retest | Failure record, root question, required revision and resubmission plan |
Avoid the phrase “sample approved” on its own. Write, например:
Sample WL-X, revision C, is approved as the cosmetic and functional reference for pilot build P1, subject to closure of packaging barcode action A-07. It is not shipment approval.
What Should You Send With a Wakelife Sample Request?
Define the approval target before the sample is prepared.
Send:
- exact model or product format;
- target market and channel;
- intended use and planned claims;
- standard versus requested custom configuration;
- Длина волн, режимы, controls and optical specifications that must be verified;
- адаптер, затыкать, язык, произведение искусства, accessories and packaging requirements;
- required document and report list;
- expected quantity and launch timing;
- your sample acceptance tests and internal approvers.
If a flexible platform fits the shortlist, обзор Wakelife’s flexible LED light therapy device category and specify whether you are evaluating the featured G240 platform or an NFY size option. Request the current model-level specification and document map for the quoted configuration; do not rely on a family name alone.
Связаться с Вейклайф with the project brief to confirm sample type, конфигурация, расходы, timing and the evidence available for the exact model. Any production or market release remains subject to the agreed approval record and applicable project requirements.
Итог
A strong LED therapy device sample approval process turns a physical unit into a controlled production definition.
Identify the sample. Test it against written criteria. Connect optical and safety evidence to its exact configuration. Freeze the sellable labeling and pack-out. Record every deviation. Create the golden sample with controlled specifications. Then define how pilot units, production lots, changes and shipments will be checked.
The sample is one piece of evidence. The real approval asset is the traceable chain that tells every team what passed, what remains open, what may change and what the factory is authorized to produce.
Ссылки
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1
Международная организация по стандартизации. Iso 2859-1:2026—Sampling Procedures for Inspection by Attributes—Part 1
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2
НАС. Управление по контролю за продуктами и лекарствами. Положение о системе менеджмента качества (КМСР)
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3
Международная организация по стандартизации. Iso 13485:2016—Medical Devices—Quality Management Systems
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4
Международная электротехническая комиссия. МЭК 62471:2006—Фотобиологическая безопасность ламп и ламповых систем.
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5
Международная электротехническая комиссия. МЭК 60601-2-57:2023—Non-Laser Light Source Equipment
- 6
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7
Международная организация по стандартизации. Iso 10993-1:2025—Biological Evaluation of Medical Devices—Part 1
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8
United Nations Economic Commission for Europe. UN Manual of Tests and Criteria, Редакция 8 and Amendment 1—Subsection 38.3
