GPSR 要求的风险评估和技术文件
消费品在欧盟上市前，制造商要做内部风险分析、编制技术文件。ohdock 把它变成引导式问卷，每个商品出一份可打印的文件。
GPSR 要求什么
- 产品上市前做内部风险分析（第 9(2) 条）。
- 技术文件至少包括产品的一般描述和与安全相关的主要特性；视风险还要包括可能风险的分析和采取的解决办法、检测报告、采用的标准（第 9(2) 条、附件 II）。
- 技术文件保存 10 年，市场监管部门要求时提供（第 9(3) 条）。
- 考虑谁会使用产品——尤其是儿童、老人和残障人士——以及产品的外观和呈现方式（第 6 条）。
Regulation (EU) 2023/988 (GPSR)
在 ohdock 里怎么做
- 为商品建一份档案，填好标签信息和销售国家。
- 回答问题：描述、使用者、按商品类型建议的危害、措施、标准和检测。
- 打印风险评估和技术文件，或存成 PDF。每次保存的版本都留在你的账号里。
危害
- 小零件 — 能放进幼儿嘴里的零件导致窒息、吞咽或吸入。
- 锐边和尖端 — 边缘、尖端、断裂部件或木刺导致的割伤和刺伤。
- 夹住、卡住 — 手指、四肢、头或颈部被缝隙、孔洞或铰链卡住。
- 绳、带和环 — 勒颈，尤其是幼儿。
- 袋子、薄膜和罩子 — 塑料袋或薄膜盖住口鼻导致窒息。
- 磁铁 — 小而强的磁铁吞下后可能造成内伤。
- 纽扣电池 — 吞下会造成严重的内部灼伤；电池仓必须牢固。
- 电池和充电 — 过热、起火或爆炸，例如锂电池。
- 触电 — 带电部件、破损电线或进水。
- 高温和烫伤 — 高温表面、明火或热液体。
- 易燃 — 产品容易着火或燃烧很快。
- 有害物质 — 重金属、邻苯二甲酸酯、致敏物等经皮肤接触、入口或吸入。
- 稳定性和强度 — 正常使用时翻倒、坍塌或断裂。
- 运动部件 — 运动部件造成挤压、夹伤或割伤。
- 噪声 — 音量大到可能损伤听力，尤其是贴近耳朵时。
- 激光和强光 — 激光或很亮的光源伤眼。
- 像食物或吸引儿童 — 形状、颜色或气味让人——尤其是儿童——放进嘴里。
- 联网功能 — 网络安全问题或软件故障可能让产品变得不安全。
风险等级用简单的「严重程度 × 可能性」矩阵来排优先级，不是 Safety Gate 的官方方法。
示例文件
这是一个示例商品的文件。你的文件用的是你自己的回答。 文件是英文的，市场监管部门普遍接受。主管部门要求时再提供译本。
Risk assessment and technical documentation — 木制叠叠乐玩具（示例）
| Product | 木制叠叠乐玩具（示例） |
|---|---|
| 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.
价格
每个商品 €19，一次性——或包含在 EU Pro（每月 €12）里，所有商品都能用。
一个商品的：风险评估和技术文件、GPSR 标签和商品页文字，保存在你的账号里。
商品页检查和标签生成器仍然免费。
这份文件记录的是你自己的评估，不是法律意见、检测报告或证书，也不能证明产品合规。 ohdock 提供的是软件工具和一般信息，不是法律意见。具体情况请以官方原文为准，或咨询专业顾问。