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Xiamen Better Silicone Rubber Co., Ltd · Xiamen, China rubber@better-silicone.com +86 17700081836
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Quality and certifications

Certificates matter, but so does what happens on the floor. Both are covered below.

ISO 13485:2016

Medical device quality management, the standard our medical moulding lines are audited against.

ISO 9001:2015

Company-wide quality management system.

BSCI

Audited social compliance for our Xiamen manufacturing site.

FDA

Food and medical contact compliance for silicone compounds and finished parts.

LFGB

European food contact testing for kitchen and baby products.

RoHS and PAHs

Restricted substance testing on silicone and NBR compounds.

CE and FCC

Product level marking for the lighting and consumer items we assemble.

CPC

Children's Product Certificate for baby pacifiers, clips and toothbrushes.

How quality is actually held

A compliant certificate on a compound is not the same thing as a compliant part. If medical grade silicone is moulded on a press that also runs pigmented industrial rubber, and post cured in the same oven, the paperwork no longer describes what you receive.

  • Medical and food grade product runs in the clean room.
  • Post curing ovens are dedicated separately to medical grade and to food grade silicone.
  • Rubber is mixed and colour matched in a dedicated clean mixing room, then blanked to weight so every cavity gets a consistent charge.
  • Printing, coating and spraying happen in clean rooms, with UV activation before coating so adhesion is repeatable rather than operator dependent.

What we test, in house

  • Dimensional inspection on two automatic 3D projectors.
  • Tensile testing on silicone rubber materials.
  • Parting line and flash inspection under a microscope.
  • Abrasion resistance on printed and coated surfaces.
  • Keypad life cycle testing and actuation force testing.
  • Durometer and hardness verification.
  • Low temperature testing and ageing oven (secondary cure).

Documentation you can ask for

Material certificates, compliance reports, dimensional inspection data and first article reports are issued with production. Copies of any certificate on this page are available on request.

Company certifications

  • ISO 13485:2016, medical device quality management
  • ISO 9001:2015, quality management
  • BSCI social compliance audit

Product and material compliance

  • FDA silicone and FDA LSR
  • LFGB, fumed silicone
  • RoHS, silicone and NBR
  • PAHs, silicone
  • CE and FCC on assembled products
  • CPC for children's products
  • US patent certifications on our own designs
Request certificates

Certificates

Company system certificates, material compliance reports and product level approvals.

ISO13485:2016 Certificate-Xiamen Better Silicone Rubber
ISO13485:2016 Certificate-Xiamen Better Silicone Rubber
ISO 9001:2015 Certificate-Xiamen Better Silicone Rubber
ISO 9001:2015 Certificate-Xiamen Better Silicone Rubber
BSCI Certification - Xiamen Better Silicone Rubber
BSCI Certification - Xiamen Better Silicone Rubber
FDA silicone certification
FDA silicone certification
LFGB fumed silicone
LFGB fumed silicone
PAHS-Silicone certification
PAHS-Silicone certification
ROHS-NBR
ROHS-NBR
ROHS-Silicone
ROHS-Silicone
CE-Certification
CE-Certification
LSR FDA certification
LSR FDA certification
FDA LSR certification
FDA LSR certification
FDA certifications
FDA certifications
Full Face LSR Mask Patent Certification
Full Face LSR Mask Patent Certification
Full Face Mask Certification
Full Face Mask Certification
Silicone FDA Certification
Silicone FDA Certification
Children's Product Certificate (CPC) Certification for Baby Pacifier Clip
Children's Product Certificate (CPC) Certification for Baby Pacifier Clip
US patent certification
US patent certification
Silicone Finger Toothbrush USA Patent Certification
Silicone Finger Toothbrush USA Patent Certification
Silicone Finger Toothbrush Patent Certification
Silicone Finger Toothbrush Patent Certification
Silicone Tongue Toothbrush Patent Certification
Silicone Tongue Toothbrush Patent Certification
CPC Baby Product Certification
CPC Baby Product Certification
LSR Silicone Toothbrush CE certifications
LSR Silicone Toothbrush CE certifications
Silicone Bed Lamp Patent Certification
Silicone Bed Lamp Patent Certification
Silicone Night Light Patent Certifications
Silicone Night Light Patent Certifications
Silicone Lamp CE Certification
Silicone Lamp CE Certification
Silicone Light FCC Certification
Silicone Light FCC Certification
Silicone Bedroom Lamp CE Certification
Silicone Bedroom Lamp CE Certification
FCC Certification for Silicone Bedroom Night Light
FCC Certification for Silicone Bedroom Night Light

Send us a drawing, get a real quote

Tell us the part, the material, the hardness and the annual quantity. We will come back with a process recommendation, a tooling proposal and a piece price.