Dive masks sit at a regulatory intersection. They are simultaneously: personal protective equipment (目の保護), pressure-containing devices (the air space in front of your eyes), and skin-contact products (the silicone skirt against your face). Depending on the market, different regulatory frameworks apply — and getting any one of them wrong can result in customs holds, marketplace takedowns, or product liability exposure.
This guide covers every certification and testing requirement for dive masks by major market. We address the specific material compliance issues that distinguish dive masks from general snorkeling equipment — particularly tempered glass safety standards, CO₂ retention testing, and silicone biocompatibility. 当社の工場はISOを取得しています 9001:2015, BSCI, and produces CE-compliant products with FDA-compliant materials — this is the compliance baseline we operate from daily.
Regulatory Classification: Where Dive Masks Fit
| 市場 | Regulatory Framework | Classification | Risk Category |
|---|---|---|---|
| 欧州連合 | PPE Regulation (欧州連合) 2016/425 | Personal Protective Equipment — eye/face protection | カテゴリーI (最小限のリスク) for recreational; Category II for professional/commercial diving |
| 米国 | FDA 21 CFR (材料); ANSI Z87.1 (目の保護); CPSC (general product safety) | Not a medical device; subject to material safety and general product safety regulations | Consumer product — general safety obligation |
| オーストラリア | ACCC Consumer Protection Notice; AS/NZS 1338.1 | Consumer product with eye protection standards | Regulated consumer goods |
| 日本 | JIS T 8103 (industrial eye protection); Consumer Product Safety Law | Consumer product; industrial standard reference | Regulated consumer goods |
欧州連合: CE Marking Under PPE Regulation
Applicable Standards
- で 168:1995 — Non-personal eye protection (optical requirements for lenses)
- で 166:2002 — Personal eye protection (the primary standard for dive masks)
- EU Regulation 2016/425 — PPE regulation (the legal framework)
Key Test Requirements Under EN 166
| テスト | What It Measures | Pass Criteria |
|---|---|---|
| Optical power (refraction) | Lens does not distort vision | Within ±0.06 diopters for Class 1 lenses |
| Prismatic power | Lens does not create prism effect | ≤ 0.25 prism diopters |
| Light transmittance | Sufficient light passes through the lens | ≥ 89.3% for clear lenses (クラス 1.1) |
| Diffusion | Lens does not scatter light excessively | Haze ≤ 2.5% |
| 耐衝撃性 (basic) | Lens withstands impact without fracture | 45 m/s steel ball impact — no penetration, no fragmentation |
| 耐衝撃性 (high, if claimed) | Lens withstands high-energy impact | 120 m/s steel ball — marked with “B” rating |
| Resistance to ignition | Frame and skirt do not sustain combustion | Self-extinguishing within 5 seconds after flame removal |
| Corrosion resistance | Metal components resist saltwater corrosion | 48-hour salt spray test with no functional degradation |
CO₂ Retention Testing
This is the test that distinguishes dive masks from swimming goggles. The enclosed air space in a dive mask means exhaled CO₂ can accumulate if the mask design does not allow adequate flushing. The test measures CO₂ concentration inside the mask during simulated breathing.
Pass criteria: CO₂ concentration in the inhaled air must not exceed 2% (by volume) under specified breathing conditions. This is a function of mask internal volume (dead space), exhaust valve design (for full-face masks), and breathing rate.
B2Bバイヤー向け: CO₂ retention is primarily a design issue. Masks with lower internal volume naturally perform better. This is one reason why “low-volume” mask designs are preferred — they reduce dead air space and improve CO₂ flushing.
米国: FDA Material Compliance + ANSI Eye Protection
FDA Material Compliance
Dive masks are not medical devices or FDA-regulated products per se. しかし, if you market your product using material safety claims (“食品グレードのシリコーン,” “FDA準拠の材料,” “低刺激性”), the materials must comply with:
- FDA 21 CFR 177.2600 — Rubber articles intended for repeated use (silicone skirt, bite valve)
- FDA 21 CFR 177.1550 — Acrylic and acrylonitrile copolymers (polycarbonate frame — if food contact is claimed)
Practical requirement: your silicone material supplier must provide an FDA compliance letter or registration number. Keep this on file for marketplace compliance reviews.
ANSI Z87.1 — Eye Protection
While not legally required for recreational dive masks, ANSI Z87.1 compliance is a strong safety signal. It covers:
- 耐衝撃性 (lens and frame)
- 光学的透明度
- カバレッジ (the area of eye protection)
Products meeting ANSI Z87.1 can display the “Z87” mark on the frame — a recognizable safety badge that adds credibility.
CPSC General Product Safety
The Consumer Product Safety Commission has jurisdiction over general consumer product safety. While there is no specific CPSC standard for dive masks, the General Product Safety Act requires that consumer products do not present unreasonable risk of injury. Key areas:
- Lens must not shatter under normal use (tempered glass satisfies this)
- Materials must not cause chemical burns or allergic reactions
- Small parts must not create choking hazards (for products marketed to or accessible by children)
Material-Specific Compliance: 強化ガラス
Tempered glass is the industry-standard lens material for quality dive masks. Its compliance profile:
| 市場 | 標準 | Requirement |
|---|---|---|
| 欧州連合 | で 166 | 耐衝撃性 (45 m/s minimum); fragmentation test (must not produce sharp fragments) |
| 私たち | ANSI Z87.1 | High-impact rating (120 m/s for “Z87+” marking); basic impact (drop ball test) |
| オーストラリア | AS/NZS 1338.1 | 耐衝撃性; optical quality |
Critical note: Polycarbonate lenses are lighter and more impact-resistant than tempered glass, but they scratch more easily. For the EU market, polycarbonate lenses must also meet EN 166 optical requirements — which is achievable but requires hard-coat treatment. Tempered glass meets EN 166 optical requirements naturally.
Material-Specific Compliance: シリコーン
| テスト | 標準 | 対象となるもの | 必要な場合 |
|---|---|---|---|
| FDA compliance | 21 CFR 177.2600 | Repeated-use rubber articles for skin contact | US market; material safety claims |
| Biocompatibility — cytotoxicity | ISO 10993-5 | Material does not kill cells in culture | アマゾン, 大手小売店 |
| Biocompatibility — sensitization | ISO 10993-10 | Material does not cause allergic sensitization | アマゾン, 大手小売店 |
| Biocompatibility — irritation | ISO 10993-23 | Material does not cause skin irritation | アマゾン, 大手小売店 |
| REACH compliance | EC 1907/2006 | No SVHCs (Substances of Very High Concern) above 0.1% | EU market |
| Prop 65 compliance | California Health & Safety Code 25249 | No listed chemicals above safe harbor levels | California market |
Quality Control Tests for Export
Beyond regulatory certifications, these QC tests are standard for export-quality dive masks:
| テスト | Method | Frequency | Pass Criteria |
|---|---|---|---|
| 気密性 | Mask sealed against face form; vacuum applied | 100% (every unit) | No pressure drop in 10 seconds |
| Anti-fog duration | Lens exposed to humid air at 40°C | AQLサンプリング | ≥ 30 minutes before fogging (coated lenses) |
| Skirt bond strength | Peel test on frame-to-skirt joint | Per batch | ≥ 8 N/mm (co-injected); ≥ 2 N/mm (glued) |
| Lens impact | Steel ball drop from specified height | AQLサンプリング | No fracture, no fragmentation |
| 色堅牢度 | 紫外線への曝露 + saltwater soak | Per batch | No visible fading or color shift |
| Strap tensile strength | Pull test on strap attachment lugs | Per batch | Lugs withstand 50N without deformation |
Compliance Documentation Package
For a complete export shipment, prepare this documentation package:
- EU 適合宣言 (for CE marking)
- Test reports from accredited laboratory (で 166, or ANSI Z87.1)
- FDA material compliance letters (for silicone components)
- Biocompatibility test reports (ISO 10993 series)
- REACH compliance statement (for EU)
- Prop 65 compliance statement (for California)
- Material Safety Data Sheets (MSDS) for all components
- Certificate of Origin
- Commercial invoice and packing list
- Third-party inspection report (SGS, インターテック, or TÜV — if commissioned)
よくある質問
Do I need a notified body for CE marking dive masks?
For Category I PPE (recreational dive masks), self-declaration is permitted — you do not need a notified body. For Category II or III (professional/commercial diving masks), a notified body must assess conformity and issue an EU-type examination certificate.
Can I use the same test report for multiple SKUs?
If the SKUs share the same lens material, frame material, and skirt material — differing only in color or strap configuration — a single test report typically covers all variants. If the frame geometry changes (different lens size, different internal volume), a new test report is needed.
What is the cost of full compliance testing for a new dive mask?
Budget approximately $3,000–$8,000 for a complete test package: で 166 testing ($1,500–$3,000), biocompatibility ($800–$2,000), FDA の材料コンプライアンス ($200–$500), REACH/Prop 65 screening ($500–$1,500). タイムライン: 4–8 weeks for all tests to complete.
