产品风险评估报告一览表.doc

产品风险评估报告一览表

8
2020年4月19日
文档仅供参考

Department Involved: R&D Department (开发工程)/ Production Department (生产工程)、
Material Control Department (物料部)、Purchasing Department (采购部) 、Quality Department (品管部)
Prepared by (组织人员) :
Responsible Engineer (工程师) :
Date (日期) :

Item Name and No. (产品名称/编号) :
Customer (客户) :
Age Grade (适应年龄) ：
Sale Region (销售地区) :

(A) Mechanical (物理和机械性)
No.
Check Point Description评审项目
Result 评估结果
1
Sharp Point and Protruding parts (利角及突出物) (Puncture Hazard)

– Capable of causing punctures of the skin.（可导致刺伤皮肤）
– Check for existence of points with a cross section of 2 mm or less.（存在横截面等于或小于2mm的尖点）
– Check for existence of metallic wires and other metallic components that are designed and intended to be bent and metallic wires likely to be bent.（存在弯曲的金属线或其它金属组件）
– End protection should be given a sufficiently large surface area to avoid puncturing of the body.（末端应该覆盖足够大的表面积，避免刺穿。）

2
Sharp Edge (利边)

Accessible edges that are likely to cause injury (no exposed sharp plastic or metal edges)存在可导致受伤的可接触边（需无批锋、金属边）

3
Small Part（小物件） (Choking, Ingestion and Inhalation Hazards) (3Y-)（窒息/吸入危害）

Possibility of producing small parts when broken that fits completely into the small part test cylinder (dim. > 31.7 mm) – eg. Wheels that come off cars, buttons and eyes that fall off dolls or plush toys.（产品存在可放入小物件筒的可拆卸物件、脱落物件。如：从车子上脱落的轮胎，从玩偶或毛绒玩具上脱落的纽扣和眼镜。）

4
Small Ball (Choking, Ingestion and Inhalation Hazards) (3Y-)

Any ball that should not entirely passes through template E (dia. 44.5 mm).（任何球都不应该完全经过模板E）（直径.44.5mm）
Housing for small ball/bead should have enough strength to withstand abuse test.

5
Suction Cup (吸盘) (3Y-)

Shall not protrude past through template E (dia. 44.5 mm).（吸盘柄不可突出经过模板E）

6
Rattle, Squeeze toy, Teether or Hand-held activity toys (10M-) - EU

No part of the toy (other than soft-filled part) shall protrude past the base of template A except the mass of the toy is greater than 0.5 Kg.（玩具部件不可突出经过模板A，除非玩具重量大于0.5Kg。）
The nearly spherical, hemispherical or circular flared ends having a mass of 0.5 kg or less, no part of the toy shall protrude past the base of template B(质量等于或小于0.5Kg的近球体，半球体或圆头不可突出经过模板B）

7
Rattle, Squeeze toy (18M-) or Teether - US

No part of the toy (other than soft-filled part) shall protrude past the base of template A.
The nearly spherical, hemispherical or circular flared ends shall protrude past the base of template B（玩具部件不可突出经过模板A，近球体，半球体或圆头不可突出经过模板B）

8
Round, Spherical or Hemispherical end (18-48M) （球体或半球体末端）

The rounded end shall not protrude past the base of template B (dia. 42.7mm, depth 30mm) if the product’s weight is less than 0.5Kg.（如果产品重量小于0.5Kg，则圆头不能突出经过模板B（直径42.7mm，深度30mm））

9
Crib Toy (挂床玩具)

Shall not have hazardous protrusions that could contribute to entanglement injury.（不应当有可导致缠绕而造成危害的突出物）

10
Cord (绳索) (Strangulation and Entanglement Hazards) (3Y-)

– Thickness（厚度）: > 1.5 mm
– Free Length（净长度）: < 220 mm when stretched by a force of (25 ± 2) N.（<220mm，当用（25±2）N的力拉伸时）
– When subjected to a force of (25 ± 2) N, separate into parts not exceeding 220 mm when stretched by a force of (25 ± 2) N.（当以（25±2）N的力拉伸时，绳索不得分成长于220mm）
– Perimeter（周长）: < 380 mm when stretched by a force of (25 ± 2) N.

11
Magnet (磁石) (Choking, Ingestion and Inhalation Hazards) (3Y-)（窒息或吸入危害）

Possibility of producing small magnet when broken that fits completely into the small part test cylinder (dim. > 31.7 mm)（产品可拆卸或脱落的小磁铁可完全投入小物件筒）

12
Gap and Spacing (间隙) (Finger Trap Hazard)

– Driving mechanisms (传动机构) - Clear space between the key or the handle and the body of the toy shall be either > 13 mm or < 5 mm. Any holes in keys or handles shall be < 5 mm diameter.（间隙必须>13mm或5mm）
– Hinge (铰链) - Spacing between parts jointed by hinge shall be either > 13 mm or < 5 mm if the parts > 200 g.如果零件重量>200g，则铰链结合处的间隙>13mm或5mm。）
– Wheel (车轮) - Spaces between the wheels and the body or parts of the body shall be either > 13 mm or < 5 mm（车轮、车身或车身部位的间隙需>13mm或<5mm。）
– Folding or Sliding mechanisms (折叠装置) - Space between moving elements of toy with folding or sliding mechanisms intended to bear or capable of bearing the mass of a child shall be either > 13 mm or < 5 mm（能够承受一个小孩重量的折叠装置玩具的间隙需>13mm或5mm）

13
Circular Hole (圆孔) (Finger Trap Hazard)

Accessible circular hole in any rigid material less than 1.58 mm in thickness should be either < 6 mm or > 13 mm in diameter if depth > 10 mm.（厚度小于1.58mm的钢性材料上的可触及的圆孔，直径需<6mm或13mm，深度需>10mm）

14
Jaw Entrapment (颌骨危险) (18M-)

Scope: Activity tables, Large bulky toy, Stationary floor toy, Push toy, Ride-on toy. （范围：活动桌椅，大型笨重玩具，可固定站立玩具，推动玩具，骑乘玩具。Openings in handles and steering wheels that allow passage of a 19 X 19 mm block of any depth greater than 13 mm must also allow passage of a 38 X 63.5 mm block of any depth greater than 13 mm.开口或方向盘不但可经过一个长宽为19mm，高大于13mm的方块，还应可经过一个长为38mm

15
Projectile (弹射玩具)

– Tip radius > 2 mm. Soft impact surface（子弹半径>2mm.子弹表面需为软材质）
– Design should not able to discharge missiles other than those provided with the toy.（射弹玩具需配有专用子弹，不可换用其它子弹）

16
Durability (坚固) (Mechanical Hazards)

No Small Parts, Sharp Edges or Sharp Points after below abuse tests (3Y-).（滥用测试后无尖点、利边、小物件。）
– Drop Test – Tension Test – Torque Test – Impact Test – Compression Test
– Stability Test – Tip Over Test – Seam Strength Test – Flexibility of wires Test

17
Acoustic (声响)

– Close-to-Ear (80 dBA at 2.5 cm)
– Rattle and Hand-held (85 dBA at 50 cm, 110 dBC at 50 cm)
– Table-top and Floor (110 dBC at 50 cm)

18
Plastic Bag（胶带）

Thickness should be >0.038 mm.厚度应>0.038mm.

19
Warning (警告语)

– Small Part – Small Ball – Entanglement or Strangulation – Mechanical Strength – Magnet – Projectile Toy – Aquatic Toy – Adult Assembly – Adult Supervision

(B) Flammability (易燃性)
No.
Check Point Description评审项目
Result 评估结果
1
Plastic and Textile 塑料和纺织品

1. Do not burn if directly exposed to a flame or spark or other potential seat of fire.（直接接触火焰、火光或其它潜在火源需不可燃。）
2. Not readily flammable (the flame goes out as soon as the ignition source is removed).不易燃（一但火源移开，火焰需立即自行熄灭。）
3. If they do ignite, burn slowly and present a low rate of spread of the flame.（烧缓慢或火焰蔓延速度慢）

(C) Chemical (化学性)
No.
Check Point Description评审项目
Result 评估结果
1
Toxic Chemicals (有毒物质)

All components must comply with RoHS requirement.（所有件需符合ROHS要求。）

2
Heavy Metals (重金属)

All components must comply with EN71 part 3 requirement.（所有部件需符合En71第3部分的要求）

3
Total Lead (总铅含量)

All components must comply with CPSIA total lead requirement.（所有部件需符合CPSIA关于含量的要求）

4
Phthalate (邻苯二甲酸盐)

All components must comply with EU phthalate requirement.（所有部件需符合EU关于邻苯二酸盐的要求）

5
Dangerous Substances (危害物质)

All components must comply with REACH requirement.（所有部件需符合REACH要求）

6
Azo Dyes (偶氮染料)

All textile must comply with directive /61/EC requirement.所有纺织品需符合 /61/EC的指导要求）

7
Allergenic Fragrances（芳香剂过敏）

– Presence of fragrance but at concentrations not exceeding 100 mg/kg.（所使用的芳香剂浓度不能超过100mg/kg。）
– Presence of fragrance with concentrations exceeding 100 mg/kg and label together with warning on package is needed.（所使用的芳香剂浓度超过100mg/kg时，需在包装上贴警告语）

(D) Electric Shock (电气性能)
No.
Check Point Description评审项目
Result 评估结果
1
Nominal Voltage (电压)

No part should exceed 24 volts（不得超过24V）

2
Heat Source (热源)

– Single Component Fault Test.（单个部件故障测试）
– Battery Reversal Test（电池反装测试）
– Battery compartment steel pin Short-Circuit Test（电池短路测试）
– Short Circuit of clearances and creepage distances between parts of different polarity.（不同极性的配件之间短路的间隙及爬电距离）

3
Marking & Instruction (标记及指示)

– Battery Shape（电池型号）arity – Nominal Voltage – Transformer – Rate Voltage
– AC/ DC symbol – WEEE symbol – Battery Installation Instructions （电池安装说明） – Replaceable Battery Instructions（可更换电池说明）Assembly Instructions（组装说明）

4
Durability of Marking（标签持久性）

Rub the marking by hand for 15 s with a piece of cloth soaked with water and again for 15 s with a piece of cloth soaked with petroleum spirit.（用一块用水浸泡过的布条摩擦10S再用一块用酒精浸泡过的布条摩擦10S）

5
Rechargeable Battery（可充电电池）

It shall not be possible to charge rechargeable batteries when they are in the toy unless it is not possible to operate the toy during charging.（不能使用可充电电池，除非玩具在充电过程中不能运行/玩耍。）

(E) Radiation (放射性)
No.
Check Point Description评审项目
Result 评估结果
1
Harmful Radiation （有害辐射）

LED in toy should meet the requirement for Class I lasers in accordance with EN60825-1.
(玩具上的LED必须符合EN60825-1的要求。)

(F) hygiene (卫生性)
No.
Check Point Description评审项目

Result 评估结果
1
Material (物料)

All Material must be new and clean.（所有的物料必须是新的、干净的。）

2
Cleaning（清洁）

Toys for children under 36 months must designed and manufactured in such a way that it can be cleaned. þ Surface Wash （表面清洁） o Soak Wash（浸泡清洗）
（所有为36M一下儿童设计和制造的玩具必须是可清洁的）

3
Fluid（流体）

Fluid must be free of biological contaminants （流体必须无生物污染物）

Comment on the Structure
No.
Comment（意见）
1

2

Applicable Standards 适用标准
Directive No.
Directive Name:
/48/EC
· Directive of the European Parliament and of the Council on the safety of toys.
· 欧盟议会和玩具安全委员会的指令
/108/EC
· EMC Directive.（电磁兼容性指令）
/95/EEC
· Restriction of the use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS).（某些有害物质在电气和电子产品上的使用限令。）
/96/EEC
· Waste Electrical & Electronic Equipment (WEEE).（耗电/电子设备。）
/84/EC
· Annex XVII Items 51 & 52 of the REACH Regulation (EC) No 1907/ & amendment no. 552/

Standard:
Issue:
Title:
EN71 Part 1
EN71-1: and A9:
Mechanical and physical properties（机械性能）
EN71 Part 2
EN71-2: + A1:
Flammability （易燃性）
EN71 Part 3
EN71-3: 1994 and amendment A1: and AC:
Migration of toxic elements （有毒元素的转移）
EN62115
EN62115:
Safety of electric toy （电子玩具的安全性）
EN60825
EN60825-1: 1994 + A1 + A2
Safety of laser products – Part 1（激光产品的安全性）
EMC
EMC: EN55014-1: + A1
Electromagnetic Compatibility – Part 1: Emission
（电磁兼容性）
EMC
EMC: EN55014-2: 1997 + A1 + A2
Electromagnetic Compatibility – Part 2: Immunity
RoHS
/95/EC and amendment /61/EC
Determination of levels of regulated substances in electrotechnical products
电子产品上的管制物质测定水平。
Phthalate
邻苯二甲酸盐

Phthalate content in toys and children articles
（玩具或儿童使用物品上的邻苯二甲酸盐含量）
PRODUCT DESIGN EVALUATION
No.
Description
1
Compliance Findings:
The product should comply with the requirements for children 6 months and up based on the play feature, construction and design according to EN 71 and EN 62115.
（供6M+儿童使用的产品需符合EN71和EN62115标准）
Non-conformity was not identified during this review.（不合格产品将不被认同）
2
Risk Assessment Findings:危害评估
Critical Concerns:
（不可用）
No critical concern was identified.
Major Concerns:
（严重）
No major concern was identified.
Minor Concerns:
（轻微）
No minor concern was identified.
Critical Manufacturing Concerns:
All incoming materials will be inspected by IQC（IQC对所有来料进行检查）
First piece / article from manufacturing process will be inspected by IPQC
（IQC进行首件检查）
Semi-finished product will be inspected by operator in line.
（半成品将会安排人在生产线上检查）
Finished product will be inspected by FQA.（QA对成品进行检查）
Out going product will be inspected by OQC.（QC对出货产品进行检查）
3
Recall History 退货记录
Have any of the same type of toys ever been recalled? * Yes þ No
有任何同类产品被客户退过货吗？
4
RESULTS OF DESIGN EVALUATION （设计评估结果）
Probability of
injury to the end consumer by using this product.
（使用该产品顾客受伤的可能性）

Severity of Injury

SERIOUS AND PERMANENT
SERIOUS NOT PERMANENT
SIGNIFICANT BUT NOT PERMANENT
MINOR

LIKELY
NOT ACCEPTABLE
NOT ACCEPTABLE
NOT ACCEPTABLE
NOT ACCEPTABLE
POSSIBLE
NOT ACCEPTABLE
NOT ACCEPTABLE
NOT ACCEPTABLE
NOT ACCEPTABLE
UNLIKELY
NOT ACCEPTABLE
NOT ACCEPTABLE
NOT ACCEPTABLE
X
ALMOST IMPOSSIBLE
NOT ACCEPTABLE
NOT ACCEPTABLE

5
CONCLUSION（结论）
The probability of a child being injured by using this product is “UNLIKELY” and the
severity is “MINOR”. The conclusion of this assessment is that the product can be classified as safe.
（儿童使用该产品受伤的可能性是“不可能”且受伤程度是“轻微”。结论表明该产品安全。）

Approved by (核实人员) :
Position (职位) : Quality Manager
Date (日期) :