Legislative: |
Adopted and promulgated by Ministerial Order No. 11020006330, BSMI, MOEA on 14 September 2021. |
Content: |
1. These Directions are hereby stipulated by the Bureau of Standards, Metrology and Inspection
(BSMI) for implementing the inspection of safety barriers.
2. Inspection Scheme: Type Approved Batch Inspection or Registration of Product Certification
(Module II-Type Test + Module III-Declaration of Conformity to Type) at the choice of the
applicant.
3. Inspection Standards: CNS 16005- Child use and care articles – Safety barriers.
4. Scope of Inspection: Safety barriers that are designed to be fitted across openings to limit a
child’s access inside the home and to prevent young children up to 24 months of age passing
through.
5. Inspection Items:
(1) Quality Items: items stated in CNS 16005
a. Chemical hazards: “migration of certain elements” in accordance with Section 7..
b. Mechanical hazards: “general,” “barrier function,” “gaps,” “opening and closing system,”
“entrapment hazards,” “shearing and crushing hazards,” “protrusion hazards,” “choking and
ingestion hazards,” “suffocation hazards,” “hazardous edges and points,” “structural integrity,” and
“security of the safety barrier from impact test” in accordance with Sections 6.1-6.12.
c. User’s manual.
(2) Chinese Labeling: The following items are to be checked in accordance with the Commodity
Labeling Act and CNS 16005.
a. Item to be labelled: The Commodity Labeling Act and Section 10.2 of CNS 16005, regarding
the content to be labeled.
b. Methods of Labelling: Labeling shall be made on the body of the product and the prominent
place of outer packages.
(3) Commodity Inspection Mark: The mark shall be printed by the obligatory inspection applicant
who is responsible for inspection application in accordance with the provisions of the “Regulations
Governing the Use of Commodity Inspection Mark” and applied to the prominent place of the body
of the product.
6. Relevant Requirements for Type Test:
(1) Type Classification: classified as “metal” or “non-metal” based on the materials.
(2) Principles of Type Determination
a. Same Type: safety barriers having the same material.
b. Main Type: Among products of the same type, the one with the most complicated structure
shall be regarded as the main type.
c. Series of Type: Among products of the same type, those other than the main type shall be
regarded as series of type.
(3) Locations for Performing Type Test: Designated testing laboratories of the BSMI.
(4) Type Test Items: For each product of the main type, all items stated in Clauses 5.(1) and 5.(2),
except the item of “chemcal hazards.” For series of type, only test items of “barrier function,”
“entrapment hazards,” “shearing and crushing hazards,” “protrusion hazards.” mentioned in Clause
5.(1) are required.
(5) The obligatory inspection applicant applying for type test shall submit the electronic files of the
following documents as well product samples to the designated type testing laboratories for
performing the test:
a. Type classification table.
b. Color photos of the safety barriers (4x6 inch or larger-sized photos showing the front, rear and
side views of the product).
c. Samples of the Chinese labels.
d. User's manual.
e. Product information, including diagram of product structure and lists of parts (the
specifications, materials and photos of each component).
f. Declaration of Validated Materials of Safety Barriers.
g. Samples: For each safety barrier of the main type and series of the type, one sample shall be
submitted respectively. However, the designated testing laboratories may request additional test
samples if necessary.
(6) Type Test Fees: The fees shall be collected in accordance with the fee schedules specified by the
designated testing laboratories.
7. Relevant Requirements for Type Approved Batch Inspection:
(1) The obligatory inspection applicant shall first obtain the type approval certificate and make
applications to the inspection authority for inspection before their products are transported out of the
production premises or imported. When applying for inspection, the month and year of manufacture
shall be filled in, and the Commodity Inspection Mark shall be printed on the applicant’s own
responsibility. The Commodity Inspection Mark consists of a diagram and an identification number
(including the letter “T” and a designated code). The identification number shall be proximately
below or to the right of the diagram. The products shall not be transported out of the production
premises until they pass inspection.
Example:
or T00000
T00000
T means Type Approved Batch Inspection
00000 shall be the code designated by the inspection authority to the applicant
(2) The obligatory inspection applicant applying for type approval shall submit to the inspection
authority the type test report, the required documents specified in Clause 6.(5), and the required
documents specified in Subparagraph 1, Paragraph 1, Article 5 of the Regulations Governing Type
Approval of Commodities.
(3) The Review Period of Type Approval: 14 working days from the receipt of the application by the
inspection authority (not including the time for delivery of additional information by the applicant).
Where additional samples are drawn, such period shall be extended to another 7 working days after
the receipt of the samples.
(4) Applicantions for the same batch of safety barriers shall be of the same type and of the same
obligatory inspection applicant.
(5) The inspection authority shall confirm that the safety barriers submitted for inspection are listed
in the Type Approval Certificate. 20% of the applications will be randomly
sampled for inspection and the other 80% are processed by document review. For the 20% sampled
applications, one-third of the items listed in the same application shall be randomly selected for
drawing samples (the number of items less than three shall be counted as three; a minimum of one
item and a maximum of five items shall be selected). For each selected item, one piece of the
products under that item shall be randomly sampled for testing and checked for the Chinese labeling
and the Commodity Inspection Mark. The quantity of selected items and sampled pieces may be
increased if necessary.
(6) For those which are sampled, the BSMI or organizations commissioned by the BSMI shall
perform 2 out of the 7 items (“barrier function,” “gaps,” “entrapment hazards,” “shearing and
crushing hazards,” “protrusion hazards,” “structural integrity,” and “security of the safety barrier
from impact test”) specified in Clause 5.(1)
(7) Inspection Period: 6 working days after the samples are delivered to the designated testing
laboratory.
(8) Where the products are approved for prior release by the inspection authority, the obligatory
inspection applicant shall notify the inspection authority to take samples, seal the products or check
the Commodity Inspection Mark and Chinese label after the products are transported to the storage
site.
(9) The inspection authority shall issue a notice of nonconformity for products that do not comply
with the requirements. The obligatory inspection applicant may apply for re-inspection without any
charge for one time within 15 days after receiving such notice. Products that comply with the
requirements may be released separately. Products that do not comply with the requirements shall be
processed in accordance with the Regulations Governing Disposition of Commodities Failing
Inspection as specified below.
a. Where the non-compliant products are to be returned for the whole batch, the obligatory
inspection applicant shall apply directly to the Customs to return the products, and then to the
inspecton authority to close the case.
b. Where the non-compliant products are to be destroyed for the whole batch, the obligatory
inspection applicant shall apply to the inspection authority by presenting the destruction plan in
order to close the case.
c. Where the non-compliant products are subject to correction under surveillance or part of the
batch are to be destroyed/returned, the obligatory inspection applicant shall present the approval
letter from the inspection authority, notice of nonconformity, import declaration (not applicable to
domestically-manufactured products), and documents verifying the correction when submitting a
new application for inspection to the inspection authority.
d. Where a new application was made, the sampling rate of items specified in Clause 7.(5) applies.
The sampling rate of non-compliant items is doubled after corrective actions are taken.
Non-compliant products, as well as items not sampled, of the new application shall be destroyed or
returned and compliant products may be released separately.
(10) Where the products sampled are found not in compliance with the inspection requiremens,
subsequent safety barriers from the same obligatory inspection applicant shall be inspected by batch.
The sampling rate will be resumed to 20% after compliance of 3 consecutive batches.
(11) For applications not sampled, the inspection authority accepting the application shall compare
the types of products submitted for inspection against the relevant information in the application by
way of document review.
(12) If there are changes to the scope of the products listed in the type approval certificate (e.g.
changes to the main type or series of type, inspection standards or inspection items), the applicant
shall obtain a new type test report from the testing laboratory that issued the original report and
apply to the inspection authority for a replaced certificate.
8. Relevant Requirements for Registration of Product Certification (RPC):
(1) The obligatory inspection applicant shall obtain the RPC certificate before their products are
transported out of the production premises or imported.
(2) To apply for an RPC certificate, the applicant shall apply to the inspection authority and provide
the type test report in accordance with Clause 6, the required documents specified in Subparagraph
1, Paragraph 1, Article 4 of the Regulations Governing Registration of Product Certification, the
conformity assessment document (the Declaration of Conformity to Type) and the documents
specified in Clause 6.(5).
(3) The Review Period of RPC: 14 working days from the receipt of the application by the
inspection authority (not including the time for delivery of additional information by the applicant).
Where additional samples are drawn, such period shall be extended to another 7 working days after
the receipt of the samples.
(4) Applicants granted RPC certificates shall print the Commodity Inspection Mark on their own
responsibility. The Commidity Inspection Mark consists of a diagram and an identification number
(a letter “R” and a designated code). The identification number shall be proximately below or to the
right of the diagram.
Example:
or R00000
R00000
R means Registration of Product Certification
00000 shall be the code designated by the inspection authority to the applicant
(5) If there are changes to the scope of the products listed in the RPC certificate (e.g. changes to
main type or series of type, inspection standards or inspection items), the applicant shall obtain a
new type test report from the testing laboratory that issued the original report and apply to the
inspection authority for a replaced certificate. |