YY 0459-2025 in English
TO BE VALIDSurgical Implants Acrylic Bone Cement
- Issued on:2025-02-26
- Implemented on:2028-03-01
- File Format:PDF
- Delivery:Via email within 2~4 business days
$446.00
| Standard No: | YY 0459-2025 |
| Document status: | TO BE VALID |
| Title in English: | Surgical Implants Acrylic Bone Cement |
| Title in Chinese: | 外科植入物 丙烯酸类树脂骨水泥 |
| Language: | English |
| File Format: | Electronic (PDF) |
| Delivery: | Via email within 2~4 business days |
| Issued on: | 2025-02-26 |
| Implemented on: | 2028-03-01 |
| ICS Classification: | 11.040.40-Implants for surgery, prosthetics and orthotics |
| Chinese Classification: | C35-Orthopedic devices |
| Professional Classification: | YY-Pharmaceutics |
| Related Keywords: | surgical implants acrylic bone cement scopethis document
bone cement polymeric resin bone cements bone cements cement |
Scope
This document specifies the physical, mechanical, marking and packaging requirements for radiopaque and radiolucent cured polymeric resin bone cements, mainly based on polymethacrylates. These two types of bone cements are available for use in syringes or in dough form, and are mainly used for internal fixation of prostheses in total joint replacement surgery. Bone cements are provided in sets of measured sterile powders and sterile liquids, suitable for mixing at the time of implantation. This document does not address the risks to patients or users of bone cement when using bone cement. All requirements and all tests apply only to sterile products.

Loading PDF document...
Error loading PDF. Please make sure the file is valid and try again.
We also recommend
-

YY/T 1934-2025 in English
Human factors design requirements and evaluation methods for orthopedic implants and surgical instruments
2025-02-26 -

YY/T 1926.2-2024 in English
Preclinical mechanical evaluation and special requirements for spinal implants Part 2: Intervertebral fusion cages
2024-09-29 -

YY/T 1982-2025 in English
Test Method for Morphological Characteristics of Porous Structures in Surgical Implants
2025-06-18 -

YY 0117.1-2005 in English
Implants for surgery - Forgings, castings for bone joint prostheses - Ti6Al4V titanium alloy forgings
2005-12-07 -

YY/T 1502-2016 in English
Spinal implants―Intervertebral body fusion devices
2016-07-29 -

YY/T 0641-2008 in English
Standard test method for transformation temperature of nickel—Titanium alloys by thermal analysis
2008-04-25 -

YY/T 1552-2017 in English
Implants for surgery-Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods
2017-09-25 -

YY 0341.2-2020 in English
Non-active surgical implants—Osteosynthesis and spinal implants—Part 2:Particular requirements for spinal implants
2020-09-27