GPSR 要求的風險評估和技術文件
消費品在歐盟上市前，製造商要做內部風險分析、編製技術文件。ohdock 把它變成引導式問卷，每個商品產出一份可列印的文件。
GPSR 要求什麼
- 產品上市前做內部風險分析（第 9(2) 條）。
- 技術文件至少包括產品的一般描述和與安全相關的主要特性；視風險還要包括可能風險的分析和採取的解決辦法、檢測報告、採用的標準（第 9(2) 條、附件 II）。
- 技術文件保存 10 年，市場監管機關要求時提供（第 9(3) 條）。
- 考慮誰會使用產品——尤其是兒童、長者和身心障礙者——以及產品的外觀和呈現方式（第 6 條）。
Regulation (EU) 2023/988 (GPSR)
在 ohdock 裡怎麼做
- 為商品建一份檔案，填好標籤資訊和銷售國家。
- 回答問題：描述、使用者、依商品類型建議的危害、措施、標準和檢測。
- 列印風險評估和技術文件，或存成 PDF。每次保存的版本都留在你的帳號裡。
危害
- 小零件 — 能放進幼兒嘴裡的零件導致窒息、吞嚥或吸入。
- 銳邊和尖端 — 邊緣、尖端、斷裂零件或木刺導致的割傷和刺傷。
- 夾住、卡住 — 手指、四肢、頭或頸部被縫隙、孔洞或鉸鏈卡住。
- 繩、帶和環 — 勒頸，尤其是幼兒。
- 袋子、薄膜和罩子 — 塑膠袋或薄膜蓋住口鼻導致窒息。
- 磁鐵 — 小而強的磁鐵吞下後可能造成內傷。
- 鈕扣電池 — 吞下會造成嚴重的內部灼傷；電池蓋必須牢固。
- 電池和充電 — 過熱、起火或爆炸，例如鋰電池。
- 觸電 — 帶電零件、破損電線或進水。
- 高溫和燙傷 — 高溫表面、明火或熱液體。
- 易燃 — 產品容易著火或燃燒很快。
- 有害物質 — 重金屬、鄰苯二甲酸酯、致敏物等經皮膚接觸、入口或吸入。
- 穩定性和強度 — 正常使用時翻倒、坍塌或斷裂。
- 運動零件 — 運動零件造成擠壓、夾傷或割傷。
- 噪音 — 音量大到可能損傷聽力，尤其是貼近耳朵時。
- 雷射和強光 — 雷射或很亮的光源傷眼。
- 像食物或吸引兒童 — 形狀、顏色或氣味讓人——尤其是兒童——放進嘴裡。
- 連網功能 — 資安問題或軟體故障可能讓產品變得不安全。
風險等級用簡單的「嚴重程度 × 可能性」矩陣來排優先順序，不是 Safety Gate 的官方方法。
範例文件
這是一個範例商品的文件。你的文件用的是你自己的回答。 文件是英文的，市場監管機關普遍接受。主管機關要求時再提供譯本。
Risk assessment and technical documentation — 木製疊疊樂玩具（範例）
| Product | 木製疊疊樂玩具（範例） |
|---|---|
| Type or model | WS-10 |
| Batch or serial number | B2410 |
| SKU or EAN | SAMPLE-001 |
| Manufacturer | Example Toys Co., Ltd., No. 1 Example Road, Ningbo, China, safety@example.com |
| EU responsible person | Example EU Rep GmbH, Musterstraße 1, 10115 Berlin, Germany, gpsr@example.eu |
| Markets | Germany, France, Netherlands |
| Document | Version 1, saved 2026-10-01 |
| Assessed by | Jane Example, Product Manager |
| Date of assessment | 2026-10-01 |
| Next review | 2027-10-01 |
1. General description of the product GPSR Art. 9(2); Annex II
| Description | Stacking toy of seven painted beech-wood rings on a wooden base, for children from 3 years. Base 12 cm, rings 4–9 cm. Sold in a cardboard box. |
|---|---|
| Essential characteristics (materials, components, power source, packaging) | Solid beech wood; water-based paint; no batteries or electrical parts; cardboard packaging with no plastic film. |
| Intended use | Play by children from 3 years, stacking rings on the pole. |
| Reasonably foreseeable misuse | Use by children under 3; mouthing and chewing the rings; throwing rings. |
2. Who uses the product GPSR Art. 6(1)
| Consumers | Children from 3 to 14 years, Children under 36 months |
|---|
3. Risk analysis and measures taken GPSR Art. 9(2); Annex II
| Hazard | How someone could be harmed | Severity | Likelihood | Risk | Measures taken | Residual risk |
|---|---|---|---|---|---|---|
| Small parts — choking, swallowing or inhalation | A ring or a piece of broken pole could be swallowed by a younger sibling. | 4 — very serious or fatal | Possible | High | Smallest ring is larger than the small parts cylinder; drop and torque tests passed; age warning “Not suitable for children under 36 months” on the box and the listing. | Unlikely · Medium |
| Harmful substances — skin contact, mouthing or inhalation | Paint could come off when the toy is mouthed. | 3 — serious | Possible | High | Paint tested for migration of certain elements; supplier declaration for the paint kept on file. | Unlikely · Medium |
| Sharp edges and points — cuts and punctures | Splinters or sharp edges after the toy is dropped. | 2 — moderate | Unlikely | Low | All edges rounded and sanded; visual check of every batch. | Unlikely · Low |
Risk = severity × likelihood on a simple matrix used to set priorities. It is not the official Safety Gate risk assessment method. Residual risk is the likelihood after the measures taken.
4. Standards and other references applied GPSR Art. 7–8; Annex II
EN 71-1 (mechanical and physical properties), EN 71-2 (flammability), EN 71-3 (migration of certain elements).
5. Tests and reports GPSR Annex II
Test report no. EX-2026-0001 from Example Testing Laboratory, dated 2026-09-15.
6. Instructions, warnings and safety information GPSR Art. 9(7)
| Warnings on the label | Warning: Not suitable for children under 36 months. Small parts. Choking hazard. |
|---|---|
| Own warning text | — |
| Label languages | DE, FR, NL |
| Instructions and other safety information | Age warning and instructions in German, French and Dutch on the box; keep the box for the manufacturer’s address. |
7. Identification and contact details GPSR Art. 9(5), 9(6), 16
| Identifier on the product | WS-10 · B2410 |
|---|---|
| Manufacturer | Example Toys Co., Ltd., No. 1 Example Road, Ningbo, China, safety@example.com |
| EU responsible person | Example EU Rep GmbH, Musterstraße 1, 10115 Berlin, Germany, gpsr@example.eu |
| Importer | — |
8. Complaints, accidents and corrective action GPSR Art. 9(8), 20
Customers can report problems at safety@example.com or through the marketplace. Complaints are reviewed weekly; serious incidents are reported through the Safety Business Gateway and the product recalled if needed.
9. Keeping this documentation GPSR Art. 9(2)–(3)
Keep this documentation for 10 years after the product is placed on the market and make it available to market surveillance authorities on request.
Update it when the product, its components, its users or the applicable rules change, and after any accident or complaint about safety.
Prepared with ohdock (ohdock.com) from the information entered by the manufacturer or seller.
This document records your own assessment. It is not legal advice, a test report or a certificate, and it does not show that the product complies with EU law. Check Regulation (EU) 2023/988 and any product-specific legislation, or ask a qualified adviser or testing laboratory.
價格
每個商品 €19，一次性——或包含在 EU Pro（每月 €12）裡，所有商品都能用。
一個商品的：風險評估和技術文件、GPSR 標籤和商品頁文字，保存在你的帳號裡。
商品頁檢查和標籤產生器仍然免費。
這份文件記錄的是你自己的評估，不是法律意見、檢測報告或證書，也不能證明產品合規。 ohdock 提供的是軟體工具和一般資訊，不是法律意見。具體情況請以官方原文為準，或諮詢專業顧問。