YY 0334-2002General specification for surgical implants made of silicone elastomer (English PDF)

1 Scope

This standard specifies general requirements for chemical and biological properties, sterility, packaging and marking of surgical implants made of silicone elastomer. It does not specify specific indicators of the mechanical and physical properties of them.

These implants are mainly intended for use in orthopaedic and restorative surgery. Surgical implants made of silicone rubber together with other materials are not included in the scope of this standard.

2 Normative References

The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments (excluding corrections) to, or revisions of, any of these publications do not apply to this standard. However, parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition applies.

GB 601 Chemical reagent - Preparations of standard volumetric solutions

GB/T 16175 Biological evaluation test methods for medical organic silicon materials

GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

YY/T 0313 Package, label, transport and storage for medical polymer products

Pharmacopoeia of the People’s Republic of China (2000 Edition)

3 Definitions

For the purposes of this standard, the following terms and definitions apply.

4 Extraneous material

When examined visually under x10 magnification, the surface of the implant shall be free from grit and other extraneous particles.